05/15/2019 | Press release | Distributed by Public on 05/15/2019 15:40
ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced mature data from the FORWARD II expansion cohort evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab) in patients with folate receptor alpha (FRa)-positive platinum-resistant ovarian cancer. These findings will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held May 31 - June 4 in Chicago, IL.
'We are pleased that the combination of mirvetuximab plus Avastin has generated significant anti-tumor activity in patients with platinum-resistant disease, with trends toward deeper, more durable responses seen in individuals with higher FRa expression and a favorable tolerability profile. The outcomes observed in patients with medium or high FRa expression are encouraging with respect to those reported in similar patient populations for Avastin plus chemotherapy,' said Anna Berkenblit, M.D., Vice President and Chief Medical Officer of ImmunoGen. 'Our goal remains to establish mirvetuximab as the combination agent of choice in ovarian cancer, supporting its use in earlier lines of therapy. These mature data support further exploration of this doublet, as well as the ongoing expansion study evaluating a triplet combination of mirvetuximab with Avastin and carboplatin in patients with platinum-sensitive disease.'
DATA FROM FORWARD II EXPANSION COHORT WITH AVASTIN
Mirvetuximab soravtansine in combination with Avastin in patients with FRa-positive platinum-resistant ovarian cancer continues to demonstrate anti-tumor activity with durable responses and a favorable tolerability profile, particularly among the subset of patients who have received up to two prior lines of therapy and have medium or high levels of FRa expression.
Key findings in 66 patients with platinum-resistant disease include:
In the subset of 16 Avastin-naïve patients with medium or high FRa expression who have received up to two prior lines of therapy, the confirmed overall response rate (ORR) was 56 percent (95% CI 30,80), with a median progression-free survival (PFS) of 9.9 months (95% CI 4.1,15.9) and a median duration of response (DOR) of 12 months (95% CI 6,14.9).
In the overall patient population, the confirmed ORR was 39 percent (95% CI 28,52), with a median PFS of 6.9 months (95% CI 4.9,8.6) and a median DOR of 8.6 months (95% CI 4.9, 14.9).
The combination continues to display a safety profile in-line with the known profiles of each agent, with no new safety signals identified.
'Current treatment options for patients with platinum-resistant ovarian cancer have, unfortunately, exhibited limited efficacy with challenging side effects,' stated David O'Malley, M.D., Professor, Director of Gynecology Clinical Trials and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center, and FORWARD II Principal Investigator. 'Final results from the combination of mirvetuximab soravtansine and Avastin expansion cohort demonstrate very encouraging activity and good tolerability in platinum-resistant ovarian cancer patients, especially those with medium or high FRa expression levels. I look forward to further evaluating mirvetuximab in combination with Avastin as well as in the triplet with carboplatin.'
ASCO PRESENTATION DETAILS
Title: 'Mirvetuximab soravtansine, a folate receptor alpha (FRa)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients (pts) with platinum-resistant ovarian cancer: Final findings from the FORWARD II study'
Day/Time: Saturday, June 1, 1:15pm - 4:15pm CDT and discussed at the Poster Discussion Session, 4:30pm-6pm CDT in S406
Lead Author: David M. O'Malley, M.D., The Ohio State University College of Medicine
Location: Hall A
Initial data from an investigator-sponsored trial through the National Comprehensive Cancer Network evaluating mirvetuximab in combination with gemcitabine in patients with FRa-positive recurrent epithelial ovarian, endometrial, or triple negative breast cancer will also be presented. Full dose mirvetuximab appears to combine well with gemcitabine, with a safety profile as expected for these agents and with encouraging anti-tumor activity seen in all three tumor types.
Title: 'A phase 1 study of mirvetuximab soravtansine (IMGN853) and gemcitabine (G) in patients with FOLR1-positive recurrent epithelial ovarian (EOC), endometrial cancer (EC), or triple-negative breast cancer (TNBC)'
Day/Time: Saturday, June 1, 8:00am - 11:00am CDT and discussed at the Poster Discussion Session, 3:00pm-4:30pm CDT in E450
Lead Author: Mihaela C. Cristea, MD, City of Hope
Location: Hall A