ImmunoGen Announces Mature Data from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status
Results to be Presented in an
Combination Demonstrates Strong Anti-Tumor Activity in Patients with High FRα Expression, with a Confirmed Overall Response Rate of 64%, Median Duration of Response of 11.8 Months and Median Progression-Free Survival of 10.6 Months
High Response Rate, Durable Benefit, and Favorable Tolerability Profile Reinforce Potential of Mirvetuximab to Serve as Combination Agent of Choice for Patients with High FRα Recurrent Ovarian Cancer
"Due to the introduction of effective maintenance therapies, patients with recurrent ovarian cancer are living longer and comprise an increasing population in need of effective, well-tolerated non-platinum based regimens," said
MATURE DATA FROM FORWARD II DOUBLET COHORT WITH BEVACIZUMAB
The cohort enrolled 60 patients with a median age of 60 and a median number of 2 prior lines of therapy (range 1-4). 53% had platinum-resistant disease with a platinum-free interval (PFI) of less than or equal to 6 months; 33% had partially platinum-sensitive disease with a PFI greater than 6 months and less than or equal to 12 months; and 13% had a PFI greater than 12 months. 40% of patients in the cohort were previously treated with bevacizumab and 35% of patients in the cohort were previously treated with a PARP inhibitor. The combination of mirvetuximab with bevacizumab in this cohort demonstrates promising anti-tumor activity with a favorable tolerability profile, particularly among patients with high levels of FRα expression, and is encouraging relative to outcomes with available therapies reported in similar populations. In the oral presentation, key updated data include:
- In the overall patient population, objective responses were seen in 30 patients and the confirmed overall response rate (ORR) was 50% (95% CI, 34, 60), with a median duration of response (mDOR) of 9.7 months (95% CI 6.7, 12.9) and median progression-free survival (mPFS) of 8.3 months (95% CI 5.6, 10.1).
In patients with high FRα expression (n=33), the confirmed ORR was 64% (95% CI, 45, 80), mDOR was 11.8 months (95% CI 6.7, 13.7), and mPFS was 10.6 months (95% CI 8.3, 13.3).
- In high FRα platinum-sensitive patients, who represent a growing population, the combination of mirvetuximab plus bevacizumab achieved a 69% ORR, 12.7 month mDOR, and a 13.3 month mPFS.
- In high FRα platinum-resistant patients, the combination of mirvetuximab plus bevacizumab achieved a 59% ORR, 9.4 month mDOR, and a 9.7 month mPFS.
- The adverse events (AEs) observed with the doublet were manageable and consistent with the side effect profiles of each agent. Treatment-related AEs were generally low grade, with diarrhea (62%), blurred vision (60%), fatigue (60%), and nausea (57%) being the most common. The most common grade 3+ events were hypertension (17%) and neutropenia (13%).
"Despite advances in the maintenance setting of ovarian cancer, a high unmet need for novel, well-tolerated, targeted treatments exists in those patients with recurrent high-grade epithelial ovarian cancer," said
ORAL PRESENTATION SESSION
- Title: "Mirvetuximab Soravtansine, a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Combination with Bevacizumab in Patients with Platinum-Agnostic Ovarian Cancer - Final Analysis"
Monday, June 7from 8:00 a.m. to 11:00 a.m. ET
David M. O'Malley, MD, The Ohio State University College of Medicine
- Abstract: 5504
The following posters will be available on
- Title: "A Phase I Study of Mirvetuximab Soravtansine and Gemcitabine in Patients with FRα-Positive Solid Tumors: Results from the Ovarian Cancer Cohort"
Mihaela C. Cristea, MD, City of Hope National Medical Center
- Abstract: 5542
- Title: "A Phase 2, Two-Stage Study of Mirvetuximab Soravtansine in Combination with Pembrolizumab in Patients with Microsatellite Stable Endometrial Cancer"
Rebecca L. Porter, MD, PhD, Dana-Farber Cancer Institute
- Abstract: TPS5611
Additional information can be found at www.asco.org.
ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.
ABOUT FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in combination with Avastin® (bevacizumab), carboplatin, or Keytruda® (pembrolizumab) in patients with FRα-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.
ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™.
Learn more about who we are, what we do, and how we do it at www.immunogen.com.
Avastin® and Keytruda® are registered trademarks of
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