Upper Tract Urothelial Carcinomas, Urothelial Bladder Cancer
Conditions
Keywords
FGFR3 Genetic Alterations, Upper Tract Urothelial Carcinomas, UTUC, Muscle Invasive Urothelial Carcinoma, Fibroblast Growth Factor Receptor Inhibitor, BGJ398, FGFR3, Urothelial Bladder Cancer, UBC, Infigratinib Phosphate, Infigratinib, Adjuvant, Nephroureterectomy, Distal ureterectomy, Cystectomy
Brief summary
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer.
Interventions
DRUGInfigratinib
Participants randomly assigned to infigratinib will receive hard gelatin capsules for oral administration of infigratinib 125 mg once a day (administered as one 100-mg capsule and one 25-mg capsule) using a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.
DRUGPlacebo
Participants randomly assigned to placebo will receive placebo matching in appearance the investigational product (infigratinib), which will be provided as hard gelatin capsules for oral use and will be administered once daily on a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.
Sponsors
Helsinn Healthcare SA
QED Therapeutics, a BridgeBio company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
As a double-blind study, participants, investigators, study monitor(s) and the clinical study team will be blinded to the treatment administered.
Intervention model description
Participants will be randomly assigned (1:1) to receive oral infigratinib phosphate or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria 1. Are randomized within 120 days following nephroureterectomy, distal ureterectomy or cystectomy. 2. Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations. Variant histology is allowed provided urothelial carcinoma is predominant (\>50%). Neuroendocrine (including small and large cell), sarcomatoid, and plasmacytoid variants are excluded (any component). 1. Regarding samples and documentation of FGFR3 * i. FGFR3 mutation is confirmed if: FGFR3 gene is mutated in Exon 7 (R248C, S249C), Exon 10 (G370C, A391E, Y373C), or Exon 15 (K650M/T, K650E/Q) OR * ii. FGFR3 gene fusion or FGFR3 rearrangement is confirmed based on the following genomic criteria if: * Any fusion/rearrangement with a literature-derived known partner gene regardless of strand or frame. * Fusion/rearrangements in the same strand that are in frame with a novel partner gene. * Fusion/rearrangements with one breakpoint in the intron 17 - exon 18 hotspot region and the other breakpoint in an intergenic region or another gene. This rule excludes 3' duplications comprising only exon 18. * iii. The amino acid numbers for the FGFR3 mutations refer to the functional FGFR3 isoform 1 (NP\_000133.1) that is the NCBI Refseq ID used to report genetic alterations in FGFR3 by the FoundationOne® CDx test (F1CDx, Foundation Medicine, USA). * iv. FGFR3 alteration must be confirmed by Foundation Medicine for F1CDx testing: * The tumor sample to be used should be from the definitive surgical resection (cystectomy, nephroureterectomy, or distal ureterectomy), or from an archival biopsy of confirmed invasive urothelial carcinoma (≥pT2). 2. If status post neoadjuvant chemotherapy, pathologic stage at surgical resection must be Stage ≥ ypT2 and/or yN+. Prior neoadjuvant therapy is defined as at least 3 cycles of neoadjuvant cisplatin-based chemotherapy with a planned cisplatin dose of 70 mg/m2/cycle. Subjects who received less than this or non-cisplatin-based neoadjuvant treatment are not excluded. 3. If not status post neoadjuvant chemotherapy, is ineligible to receive cisplatin-based adjuvant chemotherapy based on Galsky criteria: 4. Subjects who refuse cisplatin-based chemotherapy or who are ineligible to receive cisplatin-based chemotherapy based on Galsky criteria must also meet the following criteria: 5. Must have a centrally reviewed negative postoperative computed tomography (CT) (defined as lymph nodes with short axis \<1.0 cm and without growth and no distant metastases according to \[RECIST v1.1 criteria or negative biopsy within 28 days before randomization to confirm absence of disease at baseline. 3. Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 4. If a woman of childbearing potential, must have a negative pregnancy test within 7 days of the first dose of study drug. Sexually active males must use a condom during intercourse while taking study drug and for 1 month after the last dose of study drug and should not father a child during this period Key
Exclusion criteria
1. Presence of positive invasive surgical margins following nephroureterectomy, distal ureterectomy, or cystectomy. In subjects not eligible for further surgery, radiotherapy, or other efficacious treatment, microscopic positive noninvasive margins (eg, carcinoma in situ) without gross residual disease are allowed. 2. Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for Non-Muscle Invasive Bladder Cancer (NMIBC) within the previous 30 days. 3. Are currently receiving or are planning to receive during participation in this study, treatment with agents that are known moderate or strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration. Prior anticancer or other therapies are restricted as follows: 1. Prior adjuvant treatment for urothelial cancer is not allowed. 2. Prior neoadjuvant therapy (eg, chemotherapy, immunotherapy, or investigational) is allowed if inclusion criterion #4 is met. Prior neoadjuvant chemotherapy must have been completed within a period of time that is greater than the cycle length used for that treatment before first dose of study drug. 3. Prior biologic, immunotherapy, or investigational therapy should have been completed within a period that is ≥5 half-lives or 30 days, whichever is shorter, before the first dose of study drug. 4. Have previously or currently is receiving treatment with a mitogen-activated protein kinase (MEK) or selective FGFR inhibitor. 5. Have a history of primary malignancy within the past 3 years other than (1) invasive UBC or UTUC (ie, disease under study), (2) noninvasive urothelial carcinoma, (3) any adequately treated in situ carcinoma or non-melanoma carcinoma of the skin, (4) any other curatively treated malignancy that is not expected to require treatment for recurrence during participation in the study, or (5) an untreated cancer on active surveillance that may not affect the subject's survival status for ≥3 years based on clinician assessment/statement and with medical monitor approval. 6. Have current evidence of corneal keratopathy or retinal disorder confirmed by ophthalmic examination. Subjects with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study. 7. Have a history and/or current evidence of extensive tissue calcification 8. Have impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib 9. Have current evidence of endocrine alterations of calcium/phosphate homeostasis (eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis), unless well controlled. 10. Have consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, or Seville oranges or products containing juice of these fruits within 7 days before the first dose of study drug; have taken any Chinese herbal medicine or Chinese patent medicine treatments with anticancer activity within 14 days of the first dose of study drug. 11. Have insufficient bone marrow function: 1. Absolute neutrophil count (ANC) \<1,000/mm3 (1.0 × 109/L). 2. Platelets \<75,000/mm3 (\<75 × 109/L). 3. Hemoglobin \<8.5 g/dL; transfusion support is allowed if \>1 week before randomization and hemoglobin remains stable. 12. Have insufficient hepatic and renal function: 1. Total bilirubin \>1.5 × upper limit of normal (ULN) of the testing laboratory (for subjects with documented Gilbert syndrome, direct bilirubin must be ≤1.5 × ULN and enrollment requires approval by the medical monitor). 2. AST/SGOT and ALT/SGPT \>2.5 × ULN of the testing laboratory. 3. Serum creatinine \>1.5 × ULN or a calculated or measured creatinine clearance of \<30 mL/min. 13. Have amylase or lipase \>2.0 × ULN. 14. Have abnormal calcium or phosphorus: 1. Inorganic phosphorus higher than 1.02 × ULN of the testing laboratory. 2. Total serum calcium (can be corrected) higher than 1.02 × ULN of the testing laboratory. 15. Have clinically significant cardiac disease including any of the following: 1. New York Heart Association (NYHA) Class ≥2B; subjects with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the NYHA classification. 2. Uncontrolled hypertension 3. Presence of CTCAE v5.0 Grade ≥2 ventricular arrhythmias, atrial fibrillation, bradycardia, or conduction abnormality. 4. Unstable angina pectoris or acute myocardial infarction ≤3 months before the first dose of study drug. 5. Average QTcF \>470 msec (males and females). Note: If the QTcF is \>470 msec in the first ECG, a total of 3 ECGs separated by ≥5 minutes should be performed. If the average of these 3 consecutive results for QTcF is ≤470 msec, the subject meets eligibility in this regard. 6. History of congenital long QT syndrome. 16. Have had a recent (≤3 months before the first dose of study drug) transient ischemic attack or stroke. 17. If female, are pregnant or nursing (lactating).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Centrally Determined Disease-free Survival (DFS) | The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. | DFS was defined as the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause (referred as DFS event), whichever occurs earlier. Due to early termination of the study by the sponsor, results will focus primarily on the primary and key secondary endpoints of the study. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metastasis-free Survival (MFS) | The time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause. | MFS was defined as the time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause, whichever occurred earlier. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
| Overall Survival (OS) | The number of months from randomization to death. | Overall survival time was defined as the number of months from randomization to death. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
| Investigator-assessed DFS | The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. | DFS was defined as the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause (referred as DFS event), whichever occurs earlier. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
| Number of Participants With Adverse Events (AEs) | From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm). | Number of participants with AEs |
| Number of Participants With Serious Adverse Events (SAEs) | From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm) | Number of Participants with SAEs |
| Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence | The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause. | Investigator assessment of intraluminal low-risk recurrence as assessed by DFS. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023. |
Countries
Belgium, Bulgaria, Canada, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants with a diagnosis of invasive urothelial carcinoma were recruited to this double-blind, randomized, placebo-controlled global study across 30 study centers (11 in North America, and 19 in Western Europe) based on documented evidence of FGFR3 genetic alteration. The first participant was treated on 18 March 2020. The data cutoff for the primary analysis was 28 February 2023.
Pre-assignment details
Subjects meeting inclusion/exclusion criteria were randomly assigned 1:1 to receive oral infigratinib 125 mg (N=20) or placebo (N=19). Randomization was stratified by lymph node involvement (yes/no), prior neoadjuvant cisplatin chemotherapy (yes/no), stage (pT2 vs \> pT2), and disease (upper tract urothelial carcinoma \[UTUC\] vs urinary bladder cancer \[UBC\]).
Participants by arm
| Arm | Count |
|---|---|
| Infigratinib 125 mg oral infigratinib once daily for the first 3 weeks (21 days) of each 28-day cycle | 20 |
| Placebo Placebo once daily for the first 3 weeks (21 days) of a 28-day treatment cycle | 19 |
| Total | 39 |
Baseline characteristics
| Characteristic | Total | Placebo | Infigratinib |
|---|---|---|---|
| Age, Categorical Age Group <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age Group >=65 years | 27 Participants | 15 Participants | 12 Participants |
| Age, Categorical Age Group Between 18 and 65 years | 12 Participants | 4 Participants | 8 Participants |
| Age, Continuous | 67.8 years STANDARD_DEVIATION 12.39 | 69.7 years STANDARD_DEVIATION 12.75 | 66.1 years STANDARD_DEVIATION 12.1 |
| BMI | 26.96 kg/m2 STANDARD_DEVIATION 4.85 | 26.05 kg/m2 STANDARD_DEVIATION 4.793 | 27.78 kg/m2 STANDARD_DEVIATION 4.882 |
| ECOG PS 0 | 26 Participants | 11 Participants | 15 Participants |
| ECOG PS 1 | 13 Participants | 8 Participants | 5 Participants |
| FGFR3 Fusion Result (Central) Not available | 29 Participants | 15 Participants | 14 Participants |
| FGFR3 Fusion Result (Central) Y | 10 Participants | 4 Participants | 6 Participants |
| FGFR3 Fusion Result (Local) Fusion Positive - Fusion partner known | 1 Participants | 1 Participants | 0 Participants |
| FGFR3 Fusion Result (Local) Not available | 38 Participants | 18 Participants | 20 Participants |
| FGFR3 Mutation Result (Central) G370C | 1 Participants | 1 Participants | 0 Participants |
| FGFR3 Mutation Result (Central) K650E | 1 Participants | 0 Participants | 1 Participants |
| FGFR3 Mutation Result (Central) Not available | 13 Participants | 6 Participants | 7 Participants |
| FGFR3 Mutation Result (Central) R248C | 3 Participants | 2 Participants | 1 Participants |
| FGFR3 Mutation Result (Central) S249C | 16 Participants | 7 Participants | 9 Participants |
| FGFR3 Mutation Result (Central) Y373C | 5 Participants | 3 Participants | 2 Participants |
| FGFR3 Mutation Result (Local) G370C | 1 Participants | 0 Participants | 1 Participants |
| FGFR3 Mutation Result (Local) Not available | 38 Participants | 19 Participants | 19 Participants |
| Histological Subtype Mixed | 6 Participants | 4 Participants | 2 Participants |
| Histological Subtype Papillary urothelial | 15 Participants | 8 Participants | 7 Participants |
| Histological Subtype Urothelial | 18 Participants | 7 Participants | 11 Participants |
| Primary Site of Cancer UBC | 16 Participants | 7 Participants | 9 Participants |
| Primary Site of Cancer UTUC | 23 Participants | 12 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 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 | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 33 Participants | 16 Participants | 17 Participants |
| Region of Enrollment Europe | 25 participants | 13 participants | 12 participants |
| Region of Enrollment North America | 14 participants | 6 participants | 8 participants |
| Screening Diagnosis Category (Pathologic Stage at Definitive Surgery) - Node (N) N0 | 17 Participants | 8 Participants | 9 Participants |
| Screening Diagnosis Category (Pathologic Stage at Definitive Surgery) - Node (N) N1 | 4 Participants | 3 Participants | 1 Participants |
| Screening Diagnosis Category (Pathologic Stage at Definitive Surgery) - Node (N) N2 | 4 Participants | 2 Participants | 2 Participants |
| Screening Diagnosis Category (Pathologic Stage at Definitive Surgery) - Node (N) NX | 14 Participants | 6 Participants | 8 Participants |
| Screening Diagnosis Category (Pathologic Stage at Definitive Surgery) - Tumor (T) T1 | 1 Participants | 1 Participants | 0 Participants |
| Screening Diagnosis Category (Pathologic Stage at Definitive Surgery) - Tumor (T) T2 | 12 Participants | 5 Participants | 7 Participants |
| Screening Diagnosis Category (Pathologic Stage at Definitive Surgery) - Tumor (T) T3 | 23 Participants | 11 Participants | 12 Participants |
| Screening Diagnosis Category (Pathologic Stage at Definitive Surgery) - Tumor (T) T4 | 3 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 33 Participants | 15 Participants | 18 Participants |
| Time from Initial Diagnosis to Randomization (Days) | 277.0 days STANDARD_DEVIATION 591.19 | 393.7 days STANDARD_DEVIATION 837.3 | 166.2 days STANDARD_DEVIATION 91.15 |
| Tumor Mutational Burden Cannot be determined | 1 Participants | 1 Participants | 0 Participants |
| Tumor Mutational Burden High | 5 Participants | 3 Participants | 2 Participants |
| Tumor Mutational Burden Low | 30 Participants | 13 Participants | 17 Participants |
| Tumor Mutational Burden Not available | 1 Participants | 0 Participants | 1 Participants |
| Tumor Mutational Burden Unknown | 2 Participants | 2 Participants | 0 Participants |
| Type FGFR3 Alteration (Central) Fusion | 10 Participants | 4 Participants | 6 Participants |
| Type FGFR3 Alteration (Central) Mutation | 26 Participants | 13 Participants | 13 Participants |
| Type FGFR3 Alteration (Central) Not available | 3 Participants | 2 Participants | 1 Participants |
| Type FGFR3 Alteration (Central) Rearrangement | 0 Participants | 0 Participants | 0 Participants |
| Type of FGFR3 Alteration (Local) Fusion | 2 Participants | 2 Participants | 0 Participants |
| Type of FGFR3 Alteration (Local) Mutation | 1 Participants | 0 Participants | 1 Participants |
| Type of FGFR3 Alteration (Local) Not available | 36 Participants | 17 Participants | 19 Participants |
| Type of FGFR3 Alteration (Local) Rearrangement | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 20 | 1 / 19 |
| other Total, other adverse events | 19 / 20 | 16 / 19 |
| serious Total, serious adverse events | 2 / 20 | 2 / 19 |
Outcome results
Primary
Centrally Determined Disease-free Survival (DFS)
DFS was defined as the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause (referred as DFS event), whichever occurs earlier. Due to early termination of the study by the sponsor, results will focus primarily on the primary and key secondary endpoints of the study. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.
Time frame: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.
Population: Intent-to-treat (ITT) population, which included all subjects who were randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infigratinib 125 mg | Centrally Determined Disease-free Survival (DFS) | 5.3 Months |
| Placebo | Centrally Determined Disease-free Survival (DFS) | 5.4 Months |
Secondary
Investigator-assessed DFS
DFS was defined as the number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause (referred as DFS event), whichever occurs earlier. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.
Time frame: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.
Population: ITT population includes all subjects who were randomized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infigratinib 125 mg | Investigator-assessed DFS | 6.39 Months |
| Placebo | Investigator-assessed DFS | 12.22 Months |
Secondary
Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence
Investigator assessment of intraluminal low-risk recurrence as assessed by DFS. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.
Time frame: The number of months from date of randomization to local/regional invasive or metastatic recurrence or death due to any cause.
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infigratinib 125 mg | Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence | 5.29 Months |
| Placebo | Investigator-reviewed DFS Including Intraluminal Low-Risk Recurrence | 5.62 Months |
Secondary
Metastasis-free Survival (MFS)
MFS was defined as the time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause, whichever occurred earlier. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.
Time frame: The time from randomization to any metastatic recurrence as determined by the investigator, or death due to any cause.
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infigratinib 125 mg | Metastasis-free Survival (MFS) | 6.5 Months |
| Placebo | Metastasis-free Survival (MFS) | 12.2 Months |
Secondary
Number of Participants With Adverse Events (AEs)
Number of participants with AEs
Time frame: From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm).
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infigratinib 125 mg | Number of Participants With Adverse Events (AEs) | 19 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) | 16 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants with SAEs
Time frame: From first dose to last dose of study treatment +30 days (an average of 4 months for the infigratinib arm and 8 months for the placebo arm)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infigratinib 125 mg | Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
| Placebo | Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
Secondary
Overall Survival (OS)
Overall survival time was defined as the number of months from randomization to death. Due to early termination of the study by the sponsor, data were censored for 85.0% to 89.5% of all subjects. Data cutoff 28 Feb 2023.
Time frame: The number of months from randomization to death.
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infigratinib 125 mg | Overall Survival (OS) | 13.1 Months |
| Placebo | Overall Survival (OS) | 16.7 Months |