Chemotherapy Induced Anemia
Conditions
Keywords
anemia, metastatic, breast, cancer
Brief summary
The purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (CIA) in participants with metastatic breast cancer. Hematopoietic response was defined as an increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of sotatercept in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA).
Interventions
BIOLOGICALSotatercept
up to 4 subcutaneous doses of sotatercept given once every 28 days
DRUGPlacebo
up to 4 subcutaneous doses of placebo given once every 28 days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a histologically confirmed diagnosis of breast cancer documented by cytology or biopsy. * Has evidence of metastatic breast cancer with a minimum of one lesion per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v 1.1) criteria. * Is receiving a chemotherapy regimen including one of the following: anthracycline, taxane, gemcitabine, vinorelbine or capecitabine. * Has planned treatment with the same chemotherapy regimen for a minimum of 9 weeks after Day 1 of study intervention administration. * ≥ 30 days elapsed (from Day 1) since previous treatment with an erythropoiesis stimulating agent (ESA) (including treatment with intravenous (IV) iron) for chemotherapy induced anemia. * ≥ 7 days elapsed (from Day 1) since the last red blood cell (RBC) transfusion and receipt of ≤ 2 units of blood in the past 30 days. * Life expectancy of ≥ 6 months.
Exclusion criteria
* Has had prior radiation therapy to \> 20% of the whole skeleton. * Has had \> 5 prior chemotherapy treatment regimens for metastatic breast cancer. * Has a history of autoimmune or hereditary hemolysis or gastrointestinal bleeding. * Has clinically significant pulmonary, endocrine, neurologic, gastrointestinal, hepatic or genitourinary disease unrelated to underlying hematologic disorder. * Has heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher. * Has a recent history of thrombosis, deep vein thrombosis (DVT), pulmonary emboli, or embolic stroke, occurring within the last 6 months. * Has untreated central nervous system (CNS) metastases or CNS metastases treated with whole brain radiotherapy \< 6 months prior to Day 1. * Has a diagnosis of a myeloid malignancy or known history of myelodysplasia. * Has a history of second malignancy within 5 years (except excised and cured basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ). * Has had administration of IV antibiotics or febrile (temperature elevation \> 38 ° C) within 14 days of Day 1. * Has uncontrolled hypertension. * Has known history of hepatitis B surface antigen (HBsAg and HB core antibody (Ab)), human immunodeficiency virus (HIV) antibody or active hepatitis C. * Has clinically significant iron (transferrin saturation \< 20%), vitamin B12, or folate deficiency. * Has a history of anemia as a result of inherited hemoglobinopathy such as sickle cell anemia or thalassemia. * Has a history of autoimmune or hereditary hemolysis; active gastrointestinal bleeding (within the last 6 months as compared to Day 1). * Has received treatment with another investigational drug or device within 1 month prior to Day 1. * Is pregnant or lactating. * Has a history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product. * Has had major surgery within 30 days prior to Day 1 (patients must have completely recovered from any previous surgery prior to Day 1).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a Hematopoietic Response | Baseline and Up to ~145 Days | Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | Up to ~85 Days | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study intervention due to AEs is reported. |
| Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Baseline and Up to ~145 Days | Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days is presented. |
| Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Percentage of participants achieving hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 11 g/dL for 28 consecutive days is presented. |
| Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days is presented. |
| Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 1 g/dL from baseline to the last time there is hemoglobin ≥ 1 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for ≥ 1 g/dL from baseline is presented. |
| Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 2 g/dL from baseline to the last time there is hemoglobin ≥ 2 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented. |
| Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 11 g/dL from baseline to the last time there is hemoglobin ≥ 11 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented. |
| Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 1 g/dL and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 1 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented. |
| Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL | Baseline and Up to ~145 Days | Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 2 g/dL, and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 2 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented. |
| Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline | Baseline and Up to ~145 Days | Time to achieve hematopoietic response based on ≥ 1 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 1 g/dL that was maintained for at least 28 consecutive days. The data for time to achieve hematopoietic response for hemoglobin ≥ 1 g/dL from baseline is presented. |
| Number of Participants Who Experienced an Adverse Event (AE) | Up to ~175 Days | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced AEs is reported. |
| Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline | Baseline and Up to ~145 Days | Time to achieve hematopoietic response based on hemoglobin ≥ 11 g/dL, defined as the time from first dose of study treatment to the first hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented. |
| Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Time to achieve hematopoietic response based on multiple criteria categories, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 1 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 1 g/dL and/or ≥ 11 g/dL from baseline is presented. |
| Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL | Baseline and Up to ~145 Days | Time to achieve hematopoietic response, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 2 g/dL and/or ≥ 11 g/dL from baseline is presented. |
| Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Up to Day 141 | The percentage of participants who received RBC transfusion or treatment with an ESA in each study treatment group as well as within each cycle of each study treatment is presented. |
| Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Baseline and Day 64 | ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 64 is presented. |
| Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Day 64 | ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 64 is presented. |
| Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Day 113 | ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 113 is presented. |
| Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Day 113 | ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 113 is presented. |
| Progression-free Survival (PFS) | From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281 | PFS was defined as the time from start of the chemotherapy regimen (which could have occurred prior to study start and collected as prior anticancer therapy) to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 is presented. |
| Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline | Baseline and Up to ~145 Days | Time to achieve hematopoietic response based on ≥ 2 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 2 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented. |
Countries
Russia, United States
Participant flow
Recruitment details
This study was terminated early after 30 participants were enrolled due to slower than expected rate of enrollment as a result of changes in guidance for the treatment of participants with breast cancer and chemotherapy induced anemia (CIA).
Participants by arm
| Arm | Count |
|---|---|
| Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses. | 8 |
| Sotatercept 0.3 mg/kg Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses. | 10 |
| Sotatercept 0.5 mg/kg Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses. | 7 |
| Placebo Participants received placebo subcutaneously every 28 days up to 4 doses. | 5 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 3 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 3 | 0 |
| Overall Study | Sponsor Decision | 1 | 4 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Sotatercept 0.3 mg/kg | Sotatercept 0.1 mg/kg | Sotatercept 0.5 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50.8 Years STANDARD_DEVIATION 8.51 | 51.6 Years STANDARD_DEVIATION 9.38 | 55.6 Years STANDARD_DEVIATION 12.53 | 49.2 Years STANDARD_DEVIATION 10.62 | 51.9 Years STANDARD_DEVIATION 9.83 |
| Chemotherapy Frequency Less Frequently | 8 Participants | 6 Participants | 6 Participants | 4 Participants | 24 Participants |
| Chemotherapy Frequency Weekly | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 8 Participants | 7 Participants | 4 Participants | 29 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 7 Participants | 5 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Weight | 71.80 Kilograms STANDARD_DEVIATION 9.5 | 67.38 Kilograms STANDARD_DEVIATION 18.338 | 69.94 Kilograms STANDARD_DEVIATION 9.953 | 79.62 Kilograms STANDARD_DEVIATION 9.926 | 71.49 Kilograms STANDARD_DEVIATION 12.647 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 8 | 3 / 10 | 3 / 7 | 0 / 5 | 7 / 30 |
| other Total, other adverse events | 6 / 8 | 7 / 10 | 7 / 7 | 5 / 5 | 25 / 30 |
| serious Total, serious adverse events | 0 / 8 | 2 / 10 | 3 / 7 | 1 / 5 | 6 / 30 |
Outcome results
Primary
Percentage of Participants Who Achieved a Hematopoietic Response
Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Achieved a Hematopoietic Response | Overall | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Achieved a Hematopoietic Response | Received less frequent chemotherapy and showed a response | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Achieved a Hematopoietic Response | Received weekly chemotherapy and showed a response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Achieved a Hematopoietic Response | Received weekly chemotherapy and showed a response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Achieved a Hematopoietic Response | Overall | 33.3 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Achieved a Hematopoietic Response | Received less frequent chemotherapy and showed a response | 33.3 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Achieved a Hematopoietic Response | Received weekly chemotherapy and showed a response | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Achieved a Hematopoietic Response | Overall | 50.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Achieved a Hematopoietic Response | Received less frequent chemotherapy and showed a response | 25.0 Percentage of Participants |
| Placebo | Percentage of Participants Who Achieved a Hematopoietic Response | Overall | 20.0 Percentage of Participants |
| Placebo | Percentage of Participants Who Achieved a Hematopoietic Response | Received less frequent chemotherapy and showed a response | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Achieved a Hematopoietic Response | Received weekly chemotherapy and showed a response | 20 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Who Achieved a Hematopoietic Response | Received weekly chemotherapy and showed a response | 5.6 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Who Achieved a Hematopoietic Response | Overall | 27.8 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Who Achieved a Hematopoietic Response | Received less frequent chemotherapy and showed a response | 22.2 Percentage of Participants |
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Overallp-value: 0.524Fisher Exact
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Weekly Chemotherapyp-value: 0.333Fisher Exact
Comparison: Weekly Chemotherapyp-value: 0.333Fisher Exact
Comparison: Weekly Chemotherapyp-value: 0.333Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: 0.236Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: 0.429Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: 0.519Fisher Exact
Secondary
Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 11 g/dL from baseline to the last time there is hemoglobin ≥ 11 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥11 g/dL increase from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 0.3 mg/kg | Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL | 41.0 Days | — |
| Sotatercept 0.5 mg/kg | Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL | 50.0 Days | Standard Deviation 9.9 |
| Placebo | Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL | 29.0 Days | — |
Secondary
Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 1 g/dL from baseline to the last time there is hemoglobin ≥ 1 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for ≥ 1 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥1 g/dL and less than 2 g/dL increase from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 0.3 mg/kg | Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL | 47.0 Days | Standard Deviation 20.3 |
| Sotatercept 0.5 mg/kg | Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL | 46.5 Days | Standard Deviation 14.85 |
| Placebo | Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL | 29.0 Days | — |
Secondary
Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL
Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 2 g/dL from baseline to the last time there is hemoglobin ≥ 2 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥2 g/dL and less than 11 g/dL increase from baseline.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sotatercept 0.3 mg/kg | Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL | 69.0 Days |
Secondary
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 1 g/dL and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 1 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 0.3 mg/kg | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL | 47.0 Days | Standard Deviation 20.3 |
| Sotatercept 0.5 mg/kg | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL | 50.0 Days | Standard Deviation 9.9 |
| Placebo | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL | 29.0 Days | — |
Secondary
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL
Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 2 g/dL, and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 2 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sotatercept 0.3 mg/kg | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL | 69.0 Days | — |
| Sotatercept 0.5 mg/kg | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL | 50.0 Days | Standard Deviation 9.9 |
| Placebo | Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL | 29.0 Days | — |
Secondary
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study intervention due to AEs is reported.
Time frame: Up to ~85 Days
Population: All participants who received at least one dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sotatercept 0.1 mg/kg | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | 1 Participants |
| Sotatercept 0.3 mg/kg | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | 0 Participants |
| Sotatercept 0.5 mg/kg | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | 4 Participants |
| Placebo | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event | 1 Participants |
Secondary
Number of Participants Who Experienced an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced AEs is reported.
Time frame: Up to ~175 Days
Population: All participants who received at least one dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sotatercept 0.1 mg/kg | Number of Participants Who Experienced an Adverse Event (AE) | 6 Participants |
| Sotatercept 0.3 mg/kg | Number of Participants Who Experienced an Adverse Event (AE) | 7 Participants |
| Sotatercept 0.5 mg/kg | Number of Participants Who Experienced an Adverse Event (AE) | 7 Participants |
| Placebo | Number of Participants Who Experienced an Adverse Event (AE) | 5 Participants |
Secondary
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1).
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 64 is presented.
Time frame: Baseline and Day 64
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Complete Response | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Partial Response | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Stable Disease | 100.0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Progressive Disease | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Not Applicable | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Not Applicable | 16.7 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Progressive Disease | 16.7 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Complete Response | 33.3 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Stable Disease | 16.7 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Partial Response | 16.7 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Partial Response | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Stable Disease | 100.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Progressive Disease | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Not Applicable | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Complete Response | 0 Percentage of Participants |
| Placebo | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Not Evaluable | 0 Percentage of Participants |
| Placebo | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Not Applicable | 50.0 Percentage of Participants |
| Placebo | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Partial Response | 0 Percentage of Participants |
| Placebo | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Progressive Disease | 0 Percentage of Participants |
| Placebo | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Complete Response | 0 Percentage of Participants |
| Placebo | Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). | Stable Disease | 50.0 Percentage of Participants |
Secondary
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 64 is presented.
Time frame: Day 64
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Progressive Disease | 50.0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Not Applicable | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Non-complete Response/Non-progressive disease | 50.0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Non-complete Response/Non-progressive disease | 50.0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Not Applicable | 16.7 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Progressive Disease | 33.3 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Non-complete Response/Non-progressive disease | 100.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Progressive Disease | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Not Applicable | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Progressive Disease | 50.0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Non-complete Response/Non-progressive disease | 25.0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. | Not Applicable | 25.0 Percentage of Participants |
Secondary
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR of non-target lesions at Day 113 is presented.
Time frame: Day 113
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Progressive Disease | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Not Applicable | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Non-complete Response/Non-progressive disease | 100.0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Non-complete Response/Non-progressive disease | 50.0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Not Evaluable | 50.0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Not Applicable | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Progressive Disease | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Non-complete Response/Non-progressive disease | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Progressive Disease | 100.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Not Applicable | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Progressive Disease | 33.3 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Non-complete Response/Non-progressive disease | 33.3 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. | Not Applicable | 33.3 Percentage of Participants |
Secondary
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1.
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 113 is presented.
Time frame: Day 113
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Partial Response | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Stable Disease | 100.0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Progressive Disease | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Not Applicable | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Not Applicable | 100.0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Progressive Disease | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Stable Disease | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Partial Response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Partial Response | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Stable Disease | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Progressive Disease | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Not Applicable | 100.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Not Evaluable | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Not Applicable | 66.7 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Partial Response | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Progressive Disease | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Complete Response | 0 Percentage of Participants |
| Placebo | Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. | Stable Disease | 33.3 Percentage of Participants |
Secondary
Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL
Percentage of participants achieving hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 11 g/dL for 28 consecutive days is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Overall | 20.0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 20.0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Overall | 22.2 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 11.1 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Overall | 75.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 50.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Overall | 20.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 20.0 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 11.1 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Overall | 33.3 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 22.2 Percentage of Participants |
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Overallp-value: 0.206Fisher Exact
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Weekly Chemotherapyp-value: 0.333Fisher Exact
Comparison: Weekly Chemotherapyp-value: >0.999Fisher Exact
Comparison: Weekly Chemotherapyp-value: >0.999Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: 0.429Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: >0.999Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: 0.143Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: 0.519Fisher Exact
Secondary
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL
Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study treatment for at least 2 months (57 days).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Overall | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received less frequent chemotherapy and showed a response | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received weekly chemotherapy and showed a response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received weekly chemotherapy and showed a response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Overall | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received less frequent chemotherapy and showed a response | 11.1 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received weekly chemotherapy and showed a response | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Overall | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received less frequent chemotherapy and showed a response | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Overall | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received less frequent chemotherapy and showed a response | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received weekly chemotherapy and showed a response | 0 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received weekly chemotherapy and showed a response | 0 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Overall | 5.6 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL | Received less frequent chemotherapy and showed a response | 5.6 Percentage of Participants |
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: >0.999Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: >0.999Fisher Exact
Secondary
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL
Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Overall | 20.0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 20.0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Overall | 22.2 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 11.1 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Overall | 75.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 50.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Overall | 20.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 20.0 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received weekly chemotherapy and showed a response | 11.1 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Overall | 33.3 Percentage of Participants |
| All Sotatercept-treated Participants | Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL | Received less frequent chemotherapy and showed a response | 22.2 Percentage of Participants |
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Overallp-value: 0.206Fisher Exact
Comparison: Overallp-value: >0.999Fisher Exact
Comparison: Weekly Chemotherapyp-value: 0.333Fisher Exact
Comparison: Weekly Chemotherapyp-value: >0.999Fisher Exact
Comparison: Weekly Chemotherapyp-value: >0.999Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: 0.429Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: >0.999Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: 0.143Fisher Exact
Comparison: Less Frequent Chemotherapyp-value: 0.519Fisher Exact
Secondary
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA
The percentage of participants who received RBC transfusion or treatment with an ESA in each study treatment group as well as within each cycle of each study treatment is presented.
Time frame: Up to Day 141
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall RBC Transfusions | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 RBC Transfusions | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 ESAs | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 RBC Transfusions | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall ESAs | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 ESAs | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 ESAs | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 RBC Transfusions | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 RBC Transfusions | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Sotatercept 0.1 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 ESAs | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 ESAs | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 Received RBC Transfusions or ESAs | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 ESAs | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 Received RBC Transfusions or ESAs | 22.2 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall ESAs | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 ESAs | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 RBC Transfusions | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 RBC Transfusions | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall Received RBC Transfusions or ESAs | 44.4 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 RBC Transfusions | 22.2 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 Received RBC Transfusions or ESAs | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 ESAs | 0 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 Received RBC Transfusions or ESAs | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 RBC Transfusions | 11.1 Percentage of Participants |
| Sotatercept 0.3 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall RBC Transfusions | 33.3 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 ESAs | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall RBC Transfusions | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall ESAs | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall Received RBC Transfusions or ESAs | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 RBC Transfusions | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 ESAs | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 Received RBC Transfusions or ESAs | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 RBC Transfusions | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 RBC Transfusions | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 ESAs | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 Received RBC Transfusions or ESAs | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 RBC Transfusions | 25.0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 ESAs | 0 Percentage of Participants |
| Sotatercept 0.5 mg/kg | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 Received RBC Transfusions or ESAs | 25.0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 RBC Transfusions | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall ESAs | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 ESAs | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall RBC Transfusions | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 RBC Transfusions | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 1 to Prior to Day 29 RBC Transfusions | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Overall Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 RBC Transfusions | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 Received RBC Transfusions or ESAs | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 85 to Prior to Day 141 ESAs | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 57 to Prior to Day 85 ESAs | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA | Day 29 to Prior to Day 57 ESAs | 0 Percentage of Participants |
Secondary
Progression-free Survival (PFS)
PFS was defined as the time from start of the chemotherapy regimen (which could have occurred prior to study start and collected as prior anticancer therapy) to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 is presented.
Time frame: From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281
Population: All randomized participants who received at least one dose of study intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sotatercept 0.1 mg/kg | Progression-free Survival (PFS) | 188.0 Days |
| Sotatercept 0.3 mg/kg | Progression-free Survival (PFS) | 196.0 Days |
| Sotatercept 0.5 mg/kg | Progression-free Survival (PFS) | 187.0 Days |
| Placebo | Progression-free Survival (PFS) | 157.0 Days |
| All Sotatercept-treated Participants | Progression-free Survival (PFS) | 169.0 Days |
Secondary
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL
Time to achieve hematopoietic response based on multiple criteria categories, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 1 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 1 g/dL and/or ≥ 11 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sotatercept 0.1 mg/kg | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL | NA Days |
| Sotatercept 0.3 mg/kg | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL | NA Days |
| Sotatercept 0.5 mg/kg | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL | 56.0 Days |
| Placebo | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL | NA Days |
Secondary
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL
Time to achieve hematopoietic response, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 2 g/dL and/or ≥ 11 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sotatercept 0.1 mg/kg | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL | NA Days |
| Sotatercept 0.3 mg/kg | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL | NA Days |
| Sotatercept 0.5 mg/kg | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL | 56.0 Days |
| Placebo | Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL | NA Days |
Secondary
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline
Time to achieve hematopoietic response based on hemoglobin ≥ 11 g/dL, defined as the time from first dose of study treatment to the first hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had hematopoietic response of ≥ 11 g/dL increase from baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sotatercept 0.1 mg/kg | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline | NA Days |
| Sotatercept 0.3 mg/kg | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline | NA Days |
| Sotatercept 0.5 mg/kg | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline | 56.0 Days |
| Placebo | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline | NA Days |
Secondary
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline
Time to achieve hematopoietic response based on ≥ 1 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 1 g/dL that was maintained for at least 28 consecutive days. The data for time to achieve hematopoietic response for hemoglobin ≥ 1 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 1 g/dL increase from baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sotatercept 0.3 mg/kg | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline | NA Days |
| Sotatercept 0.5 mg/kg | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline | NA Days |
| Placebo | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline | NA Days |
Secondary
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline
Time to achieve hematopoietic response based on ≥ 2 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 2 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.
Time frame: Baseline and Up to ~145 Days
Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL increase from baseline.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sotatercept 0.3 mg/kg | Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline | NA Days |