On September 11, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported findings from an analysis of patient-reported outcomes (PROs) with mirvetuximab soravtansine (mirvetuximab) versus chemotherapy in the randomized Phase 3 FORWARD I study in platinum-resistant ovarian cancer (Press release, ImmunoGen, SEP 11, 2022, View Source [SID1234619367]). The Company also announced population pharmacokinetic (PK) and exposure response (ER) analyses across multiple clinical trials evaluating mirvetuximab monotherapy in folate receptor alpha (FRα)-positive ovarian cancer. These findings will be highlighted in three posters at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Paris, France.
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"The data presented at ESMO (Free ESMO Whitepaper) continue to support mirvetuximab’s potential to displace single-agent chemotherapy in FRα-positive ovarian cancer and will serve as a guide as we seek to advance the broader development program," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "With our biologics license application for mirvetuximab under Priority Review with FDA, we look forward to potentially bringing this novel therapy to patients later this year."
ANALYSES OF PATIENT-REPORTED OUTCOMES WITH MIRVETUXIMAB SORAVTANSINE VERSUS STANDARD CHEMOTHERAPY IN THE RANDOMIZED PHASE 3 FORWARD I STUDY IN OVARIAN CANCER (GOG 3011)
Lead Author: Kathleen N. Moore, MD
Date/Time: September 11, 2022, 12:00 – 1:00 PM CEST / 6:00 – 7:00 AM ET
Poster: #532P
The Phase 3 FORWARD I trial enrolled 366 patients who were randomized 2:1 to receive either mirvetuximab or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligible patients were diagnosed with platinum-resistant ovarian cancer that expresses medium or high levels of FRα and were treated with up to three prior regimens. The primary endpoint was progression-free survival (PFS), which was assessed in the entire study population and in the subset of patients with high FRα expression. Patients completed PRO assessments during screening, on day 1 of cycle 1, every 9 weeks thereafter (±1 week) until disease progression, and at the end of treatment visit.
Key findings:
In the intent-to-treat (ITT) population, a statistically significant improvement in the number of patients achieving a 15-point improvement in gastrointestinal (GI) symptoms was observed at week 8/9 in patients treated with mirvetuximab versus chemotherapy (31.7% vs 14.0% P = 0.0162).
The likelihood of GI symptom deterioration was 70% lower with mirvetuximab in the ITT population compared with chemotherapy (95% CI, 0.15–0.60; P=0.0007).
In the FRα-high population, the likelihood of GI symptom deterioration was 80% lower with mirvetuximab compared with chemotherapy (95% CI, 0.10–0.54; P=0.0007).
In both the ITT and FRα-high patient populations, improvements were seen with mirvetuximab compared with chemotherapy across multiple side effects, including sexuality, hair loss, pain severity, body image, and general improvement in ovarian cancer–specific symptoms.
In both the ITT and FRα-high patient populations, there were statistically significant benefits in physical functioning for mirvetuximab over chemotherapy.
"An unmet need remains for safe, effective, and well-tolerated therapeutic options for patients with platinum-resistant ovarian cancer, despite treatment advancements seen in this setting," said Kathleen Moore, Director of the Oklahoma TSET Phase I Program, Professor of the Section of Gynecologic Oncology at The University of Oklahoma College of Medicine and FORWARD I Co-Principal Investigator. "The improved PROs associated with mirvetuximab compared to chemotherapy reinforce the differentiated tolerability profile of mirvetuximab and, coupled with its compelling anti-tumor activity and favorable safety, support its potential to serve as a new standard of care for patients with FRα-positive ovarian cancer."
EXPOSURE RESPONSE ANALYSIS FOR EFFICACY AND SAFETY OF MIRVETUXIMAB SORAVTANSINE IN PATIENTS WITH FOLATE RECEPTOR ΑLPHA-POSITIVE CANCER
Lead Author: Ursula A. Matulonis, MD
Date/Time: September 11, 2022, 12:00 -1:00 PM CEST / 6:00 – 7:00 AM ET
Poster: #592P
An ER analysis was conducted across three studies – the Phase 1 IMGN853-0401 trial, the Phase 3 FORWARD I trial, and the Phase 3 SORAYA trial – to understand the relationship between exposure to single-agent mirvetuximab and the efficacy and safety responses observed in patients with FRα-positive tumors.
Key findings:
Both efficacy, in terms of objective response rate (ORR) and PFS, and ocular adverse events (AEs) were higher with increased exposure to mirvetuximab.
These data highlight the importance of adherence to recommended mirvetuximab dosing guidelines in clinical practice.
POPULATION PHARMACOKINETIC ANALYSIS OF MIRVETUXIMAB SORAVTANSINE IN PATIENTS WITH FOLATE RECEPTOR ALPHA-POSITIVE CANCER
Lead Author: Kathleen N. Moore, MD
Date/Time: September 11, 2022, 12:00 – 1:00 PM CEST / 6:00 – 7:00 AM ET
Poster: #605P
A PK analysis, taking into account patient demographics and clinical characteristics, was conducted across three studies – IMGN853-0401, FORWARD I, and SORAYA – to understand the efficacy and safety of mirvetuximab in patients with FRα-positive tumors.
Key findings:
Dosing adjustments do not appear to be necessary for patients with mild or moderate renal impairment or mild hepatic impairment.
The analyses support the final recommended dose of 6 mg/kg based on adjusted ideal body weight (AIBW) every 3 weeks with balanced efficacy and safety.
Additional information can be found at www.esmo.org.
ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.