Neoplasms, Ovarian
Conditions
Keywords
Platinum-resistant ovarian cancer (PROC), Primary peritoneal cancer, Fallopian tube cancer, MORAb-202, Folate-receptor alpha, ADC, Antibody-drug conjugate, Epithelial ovarian cancer, High grade serous, Farletuzumab ecteribulin
Brief summary
The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.
Interventions
DRUGMORAb-202
Specified dose on specified days
DRUGPaclitaxel
Specified dose on specified days
DRUGPegylated Liposomal Doxorubicin (PLD)
Specified dose on specified days
DRUGTopotecan
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female participants with histologically-confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer. * Platinum-resistant disease, defined as: * For participants who had only 1 line of platinum-based therapy: progression between \> 1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4 cycles. * For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6 months after the last dose of platinum-based therapy. * Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance. * Disease progression per RECIST v1.1 (by investigator assessment) of at least 1 measurable lesion on or after the most recent therapy. * Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) or newly-obtained biopsies must be available for FRα assessment prior to randomization. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Exclusion criteria
Medical Conditions * Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer. * Primary platinum-refractory ovarian cancer defined as disease progression within 1 month of the last dose of the first line platinum-containing regimen. * Pulmonary function test (PFT) abnormalities: FEV1 \< 70% or FVC \< 60%, and DLCO \< 80%. * Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer therapy. * Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage. Physical and Laboratory Test Findings * Evidence of organ dysfunction or any clinically-significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population. Allergies and Adverse Drug Reactions * Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid). * History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment | From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks) | Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose | From first dose of study medication up to 6 months | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. |
| Number of Participants With Serious Adverse Events (SAEs) | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. |
| Number of Participants With AEs Leading to Discontinuation | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. |
| Number of Participants With Treatment-Related AEs | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. |
| Number of Participants With Treatment-Related SAEs | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. |
| Number of Participants With AEs of Special Interest (AESIs) | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. AEs of special interest include: Infusion-related reactions, Interstitial lung disease (ILD) and Pneumonitis |
| Number of Participants Who Died | From first dose of study medication until death due to any cause (up to 70 weeks) | Number of participants who died during the study. |
| Number of Participants With Grade 3-4 Laboratory Abnormalities | From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months) | Number of participants experiencing clinical abnormalities in laboratory testing including hematology, chemistry, liver function, and renal function. Laboratory findings are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal. |
| Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment | From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks) | Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on investigator assessments (using RECIST v1.1) divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Clopper and Pearson estimates of duration of response |
| Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment | From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks) | Duration of Response (DoR) is defined as the time between the date of first documented response (CR or PR) confirmed, to the date of the first objectively documented tumor progression by investigator (per RECIST v1.1) or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response |
| Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment | From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks) | Progression-free Survival (PFS) is defined as the time between the date of randomization and the first date of documented progression, per investigator assessments (using RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of progression-free survival |
Countries
Australia, Belgium, Chile, Israel, Italy, Japan, South Korea, Spain, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Participant flow
Pre-assignment details
Enrollment was stopped and no participants were enrolled into Arm A (MORAb-202 at 33 mg/m\^2)
Participants by arm
| Arm | Count |
|---|---|
| MORAb-202 Participants received MORAb-202 25 mg/m\^2 every 3 weeks for up to 2 years | 70 |
| Investigator's Choice (IC) Chemotherapy Participants received Paclitaxel 80 mg/m\^2 every week; OR
Pegylated liposomal doxorubicin (PLD) 40 mg/m\^2 every 4 weeks; OR
Topotecan 4 mg/m\^2 Days 1, 8,15 every 4 weeks or 1.25 mg/m\^2 Days 1 to 5 every 3 weeks for up to 2 years | 36 |
| Total | 106 |
Baseline characteristics
| Characteristic | Investigator's Choice (IC) Chemotherapy | MORAb-202 | Total |
|---|---|---|---|
| Age, Continuous | 61.3 Years STANDARD_DEVIATION 12.16 | 58.3 Years STANDARD_DEVIATION 9.15 | 59.3 Years STANDARD_DEVIATION 10.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 12 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 57 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 17 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 24 Participants | 50 Participants | 74 Participants |
| Sex: Female, Male Female | 36 Participants | 70 Participants | 106 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 34 / 70 | 18 / 36 |
| other Total, other adverse events | 61 / 70 | 31 / 34 |
| serious Total, serious adverse events | 22 / 70 | 11 / 34 |
Outcome results
Primary
Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Time frame: From first dose of study medication up to 6 months
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MORAb-202 | Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose | 2 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose | 0 Participants |
Primary
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MORAb-202 | Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment | 20.0 Percent of participants |
| Investigator's Choice (IC) Chemotherapy | Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment | 13.9 Percent of participants |
Secondary
Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment
Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on investigator assessments (using RECIST v1.1) divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Clopper and Pearson estimates of duration of response
Time frame: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MORAb-202 | Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment | 80.0 Percent of participants |
| Investigator's Choice (IC) Chemotherapy | Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment | 69.4 Percent of participants |
Secondary
Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment
Duration of Response (DoR) is defined as the time between the date of first documented response (CR or PR) confirmed, to the date of the first objectively documented tumor progression by investigator (per RECIST v1.1) or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response
Time frame: From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks)
Population: All confirmed responders
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MORAb-202 | Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment | 4.42 Months |
| Investigator's Choice (IC) Chemotherapy | Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment | 5.55 Months |
Secondary
Number of Participants Who Died
Number of participants who died during the study.
Time frame: From first dose of study medication until death due to any cause (up to 70 weeks)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MORAb-202 | Number of Participants Who Died | 21 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants Who Died | 6 Participants |
Secondary
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Time frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MORAb-202 | Number of Participants With Adverse Events (AEs) | 67 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With Adverse Events (AEs) | 32 Participants |
Secondary
Number of Participants With AEs Leading to Discontinuation
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Time frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MORAb-202 | Number of Participants With AEs Leading to Discontinuation | 3 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With AEs Leading to Discontinuation | 0 Participants |
Secondary
Number of Participants With AEs of Special Interest (AESIs)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention. AEs of special interest include: Infusion-related reactions, Interstitial lung disease (ILD) and Pneumonitis
Time frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MORAb-202 | Number of Participants With AEs of Special Interest (AESIs) | Pneumonitis | 13 Participants |
| MORAb-202 | Number of Participants With AEs of Special Interest (AESIs) | Infusion-related reactions | 1 Participants |
| MORAb-202 | Number of Participants With AEs of Special Interest (AESIs) | Interstitial lung disease (ILD) | 2 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With AEs of Special Interest (AESIs) | Interstitial lung disease (ILD) | 0 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With AEs of Special Interest (AESIs) | Infusion-related reactions | 1 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With AEs of Special Interest (AESIs) | Pneumonitis | 0 Participants |
Secondary
Number of Participants With Grade 3-4 Laboratory Abnormalities
Number of participants experiencing clinical abnormalities in laboratory testing including hematology, chemistry, liver function, and renal function. Laboratory findings are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Time frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MORAb-202 | Number of Participants With Grade 3-4 Laboratory Abnormalities | Grade 3: Lymphocytes (absolute) | 3 Participants |
| MORAb-202 | Number of Participants With Grade 3-4 Laboratory Abnormalities | Grade 3: Absolute neutrophil count | 3 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With Grade 3-4 Laboratory Abnormalities | Grade 3: Lymphocytes (absolute) | 0 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With Grade 3-4 Laboratory Abnormalities | Grade 3: Absolute neutrophil count | 9 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Time frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MORAb-202 | Number of Participants With Serious Adverse Events (SAEs) | 19 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With Serious Adverse Events (SAEs) | 10 Participants |
Secondary
Number of Participants With Treatment-Related AEs
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Time frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MORAb-202 | Number of Participants With Treatment-Related AEs | 53 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With Treatment-Related AEs | 29 Participants |
Secondary
Number of Participants With Treatment-Related SAEs
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Time frame: From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MORAb-202 | Number of Participants With Treatment-Related SAEs | 1 Participants |
| Investigator's Choice (IC) Chemotherapy | Number of Participants With Treatment-Related SAEs | 2 Participants |
Secondary
Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment
Progression-free Survival (PFS) is defined as the time between the date of randomization and the first date of documented progression, per investigator assessments (using RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of progression-free survival
Time frame: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MORAb-202 | Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment | 4.01 Months |
| Investigator's Choice (IC) Chemotherapy | Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment | 4.40 Months |
p-value: 0.406395% CI: [0.76, 2]Log Rank