Pooled analyses of Phase 1 expansion cohorts demonstrate clinically meaningful activity in patient population being studied in FORWARD I registration trial
Top-line data from FORWARD II indicate favorable safety and efficacy profile in multiple combinations
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Anti-Tumor Activity and Safety Analyses in Pooled Phase 1 Expansion Cohorts
Data from the pooled analyses demonstrate the safety and efficacy profile of mirvetuximab soravtansine in the patient population eligible for the ongoing Phase 3 registration trial, FORWARD I. These data include 113 EOC patients treated with mirvetuximab soravtansine in three expansion cohorts in the Phase 1 trial. In the subset of 36 patients meeting the key eligibility criteria for FORWARD I, which includes patients with platinum-resistant disease and medium or high levels of FRα and who have received up to three prior lines of therapy, the confirmed overall response rate (ORR) was 47 percent (95% CI 30, 65) and median progression-free survival (mPFS) was 6.7 months (95% CI 4.1, 8.3).
"The data observed with mirvetuximab compare favorably with outcomes
typically achieved with currently available single-agent therapies for
platinum resistant ovarian cancer. Current single-agent therapies for
platinum-resistant ovarian cancer have low response rates of 15 to 20%
and short median progression-free survival of three to four months,"
For all 113 patients, the median number of prior regimens was 3, 85 percent had platinum-resistant disease, 67 percent had prior bevacizumab, and 22 percent had a prior poly (ADP-ribose) polymerase (PARP) inhibitor. The safety profile of the pooled population was consistent with data previously reported (2016 ASCO Annual Meeting), which consisted primarily of low grade, manageable adverse events. In this heavily pretreated group of patients, the confirmed ORR was 30 percent (95% CI 22, 39) and mPFS was 4.3 months (95% CI 3.9, 5.4).
Initial Safety and Preliminary Efficacy Data from FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in combination with Avastin®, carboplatin, Doxil® or Keytruda® in patients with FRα-positive EOC, primary peritoneal, or fallopian tube tumors. The data from these arms demonstrate mirvetuximab soravtansine may complement currently available therapies for FRα-positive EOC in a range of treatment settings, including earlier lines of therapy.
The safety profiles for these combinations were manageable and as expected, based on known profiles of each agent, with no new safety signals identified. Key findings in over 60 patients from the dose escalation phase of FORWARD II are as follows:
Based on the encouraging profiles of these combinations in dose escalation, ImmunoGen is moving forward with expansion cohorts for Avastin® and Keytruda® and is evaluating future studies with carboplatin combinations.
"The favorable safety profile of mirvetuximab soravtansine lends itself
well to combination, as evidenced by the data from FORWARD II, showing
the full dose of mirvetuximab soravtansine combines with the full doses
of bevacizumab (Avastin®), carboplatin, pembrolizumab
(Keytruda®) and pegylated liposomal doxorubicin (Doxil®)
in ovarian cancer," stated David O'Malley, M.D., Associate Professor,
Director of Gynecology Clinical Trial and Phase 1 Program,
FORWARD I Trial
The Phase 3 FORWARD I trial was designed based on the promising monotherapy mirvetuximab soravtansine data from the Phase 1 trial and reflects the fastest registration strategy to obtain full approval of mirvetuximab soravtansine as single-agent therapy.
FORWARD I is a registration trial in which 333 patients will be
randomized 2:1 and will receive either mirvetuximab soravtansine or the
physicians' choice of therapy (Doxil®, paclitaxel, or
topotecan). The study is currently enrolling in
"The Phase 1 expansion cohort data being presented at ASCO support the
potential of mirvetuximab soravtansine in the patient population
eligible for FORWARD I," said
ASCO Presentation Details:
Title: Mirvetuximab soravtansine (IMGN853), a folate receptor
alpha (FRα)-targeting antibody-drug conjugate (ADC), in
platinum-resistant epithelial ovarian cancer (EOC) patients (pts):
Activity and safety analyses in phase I pooled expansion cohorts.
Location: Poster Board No.: 369, Location: Hall A
Title: Safety findings from FORWARD II: A phase 1b study
evaluating the folate receptor alpha (FRα)-targeting antibody-drug
conjugate (ADC) mirvetuximab soravtansine (IMGN853) in combination with
bevacizumab, carboplatin, pegylated liposomal doxorubicin (PLD), or
pembrolizumab in patients (pts) with ovarian cancer.
Presenter: David O'Malley, M.D., Associate Professor, Director of Gynecology Clinical Trial and Phase 1 Program,
Location: Poster Board No.: 375, Location: Hall A
Title: FORWARD I (GOG 3011): A randomized phase 3 study to
evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853)
versus chemotherapy in adults with folate receptor alpha (FRα)-positive,
platinum-resistant epithelial ovarian cancer (EOC), primary peritoneal
cancer, or primary fallopian tube cancer.
Location: Poster Board No.: 425b, Location: Hall A
Additional information - including presentation schedule and full abstracts - can be found www.asco.org.
Conference Call Information
ImmunoGen will host a conference call on
ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. ImmunoGen's lead candidate, mirvetuximab soravtansine, is in a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen's ADC technology is used in Roche's marketed product, Kadcyla®, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about the Company can be found at www.immunogen.com.
Avastin®, Doxil®, Keytruda® and Kadcyla® are registered trademarks of their respective owners.
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.
This press release includes forward-looking statements. For these
statements, ImmunoGen claims the protection of the safe harbor for
forward-looking statements provided by the Private Securities Litigation
Reform Act of 1995. It should be noted that there are risks and
uncertainties related to the development of novel anticancer products,
including mirvetuximab soravtansine, including risks related to
preclinical and clinical studies, their timings and results. A review of
these risks can be found in ImmunoGen's Annual Report on Form 10-K for
the fiscal year ended
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