Trial Outcomes & Findings for A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (NCT NCT04296890)

Last Updated: 2024-08-07

Results Overview

ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

106 participants

Primary outcome timeframe

Up to approximately 15 months

Results posted on

2024-08-07

Participant Flow

Participants were enrolled at 39 sites in North America, Europe, and Asia Pacific.

Participant milestones

Participant milestones
Measure	Mirvetuximab Soravtansine Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W).
Overall Study STARTED	106
Overall Study INV Efficacy Evaluable Population	105
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	68

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirvetuximab Soravtansine Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W).
Overall Study Withdrawal by Subject	1
Overall Study Death	62
Overall Study Lost to Follow-up	3
Overall Study Other than specified	2

Baseline Characteristics

A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirvetuximab Soravtansine n=106 Participants Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
Age, Continuous	62 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	102 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 15 months

Population: The investigator (INV) Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=105 Participants Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	32.4 percentage of participants Interval 23.6 to 42.2

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: All participants that showed a CR or PR according to RECIST 1.1 were analyzed.

DOR was defined as the time from the date of the first response (CR or PR), until the date of progressive disease (PD) or death from any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=34 Participants Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1	6.93 months Interval 5.55 to 9.66

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: The CA-125-Evaluable population was defined as all participants who received at least 1 dose of study drug and whose pretreatment sample was ≥2.0 times the upper limit of normal (ULN), within 2 weeks prior to first dose of mirvetuximab soravtansine, and who had at least 1 postbaseline CA-125 evaluation.

The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=86 Participants Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria	46.5 percentage of participants Interval 35.7 to 57.6

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: INV Efficacy Evaluable population was defined as all participants who received at least 1 dose of study drug and who had measurable disease at baseline by investigator assessment per RECIST 1.1.

PFS was defined as the time from initiation of study drug until the date of PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=105 Participants Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1	4.27 months Interval 3.71 to 5.22

SECONDARY outcome

Timeframe: Up to approximately 27 months

Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=105 Participants Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
Overall Survival Assessed by the Investigator Using RECIST v1.1	15.0 months Interval 11.5 to 18.7

SECONDARY outcome

Timeframe: Up to approximately 27 months

Population: The Safety population was defined as participants who received at least 1 dose of study drug.

An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of Study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Outcome measures
Measure	Mirvetuximab Soravtansine n=106 Participants Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	105 Participants

Adverse Events

Mirvetuximab Soravtansine

Serious events: 36 serious events

Other events: 102 other events

Deaths: 62 deaths

Serious adverse events

Serious adverse events
Measure	Mirvetuximab Soravtansine n=106 participants at risk Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Vascular disorders Vasculitis	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
General disorders Administration site extravasation	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
General disorders Disease progression	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
General disorders General physical health deterioration	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
General disorders Malaise	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
General disorders Pyrexia	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.9% 2/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.9% 2/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Psychiatric disorders Substance-induced psychotic disorder	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Injury, poisoning and procedural complications Ankle fracture	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Injury, poisoning and procedural complications Infusion related reaction	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Cardiac disorders Atrial fibrillation	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Nervous system disorders Brain stem syndrome	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Nervous system disorders Peripheral sensory neuropathy	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Blood and lymphatic system disorders Anaemia	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Abdominal pain	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Ascites	4.7% 5/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Colitis microscopic	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Constipation	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Diarrhoea	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Intestinal haemorrhage	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Intestinal obstruction	1.9% 2/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Intestinal perforation	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Large intestinal obstruction	1.9% 2/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Nausea	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Oesophagitis	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Small intestinal obstruction	4.7% 5/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Hepatobiliary disorders Cholecystitis	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Hepatobiliary disorders Cholecystitis acute	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Hepatobiliary disorders Cholestasis	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Hepatobiliary disorders Hepatitis	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Infections and infestations Clostridium difficile infection	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Infections and infestations Device related infection	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Infections and infestations Peritonitis bacterial	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Metabolism and nutrition disorders Severe protein calorie malnutrition	0.94% 1/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.

Other adverse events

Other adverse events
Measure	Mirvetuximab Soravtansine n=106 participants at risk Participants received single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg AIBW administered IV on Day 1 of every 3-week cycle (Q3W).
Investigations Alanine aminotransferase increased	11.3% 12/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Investigations Aspartate aminotransferase increased	15.1% 16/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Investigations Blood alkaline phosphatase increased	11.3% 12/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Investigations Gamma-glutamyltransferase increased	12.3% 13/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Investigations Weight decreased	5.7% 6/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Nervous system disorders Dysgeusia	7.5% 8/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Nervous system disorders Headache	9.4% 10/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Nervous system disorders Neuropathy peripheral	17.9% 19/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Blood and lymphatic system disorders Anaemia	13.2% 14/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Blood and lymphatic system disorders Neutropenia	15.1% 16/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Blood and lymphatic system disorders Thrombocytopenia	9.4% 10/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
General disorders Asthenia	20.8% 22/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
General disorders Fatigue	30.2% 32/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
General disorders Oedema peripheral	5.7% 6/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Eye disorders Cataract	19.8% 21/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Eye disorders Dry eye	28.3% 30/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Eye disorders Eye pain	8.5% 9/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Eye disorders Keratopathy	32.1% 34/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Eye disorders Photophobia	16.0% 17/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Eye disorders Punctate keratitis	8.5% 9/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Eye disorders Vision blurred	46.2% 49/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Abdominal distension	12.3% 13/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Abdominal pain	24.5% 26/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Abdominal pain upper	12.3% 13/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Ascites	5.7% 6/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Constipation	30.2% 32/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Diarrhoea	31.1% 33/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Dyspepsia	5.7% 6/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.5% 8/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Nausea	38.7% 41/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Gastrointestinal disorders Vomiting	18.9% 20/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Respiratory, thoracic and mediastinal disorders Cough	6.6% 7/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.4% 11/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.5% 9/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Skin and subcutaneous tissue disorders Erythema	5.7% 6/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Musculoskeletal and connective tissue disorders Arthralgia	16.0% 17/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Musculoskeletal and connective tissue disorders Back pain	7.5% 8/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Musculoskeletal and connective tissue disorders Myalgia	10.4% 11/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 6/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Infections and infestations Urinary tract infection	9.4% 10/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Metabolism and nutrition disorders Decreased appetite	18.9% 20/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Metabolism and nutrition disorders Hypokalaemia	10.4% 11/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.
Metabolism and nutrition disorders Hypomagnesaemia	10.4% 11/106 • Up to approximately 27 months Deaths (all-cause) were assessed from first dose until death (survival follow-up). Serious and nonserious AEs (Safety population) were assessed from first dose and within 30 days of the last dose or prior to the start of a new anticancer treatment, whichever occurred first.

Additional Information

CMO, ImmunoGen

ImmunoGen, Inc

Phone: 781-895-0600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place