ImmunoGen Presents Initial Data from FORWARD II Expansion Cohort Assessing Mirvetuximab Soravtansine in Combination with KEYTRUDA at ESMO 2018 Congress
Preliminary Data Demonstrate Favorable Safety Profile and Encouraging Activity in Heavily Pretreated Patients with Ovarian Cancer
“A high unmet need exists in patients with platinum-resistant ovarian
cancer, particularly for heavily pretreated patients, and the goal of
this study is to assess whether the addition of a checkpoint inhibitor
prolongs the clinical benefit of mirvetuximab soravtansine in later-line
patients through concomitant activation of the immune system,” said
The data presented at
The combination of mirvetuximab soravtansine (6 mg/kg adjusted ideal body weight) and pembrolizumab (200 mg, supplied by Merck) demonstrates favorable tolerability and encouraging activity. Adverse events were predominantly mild to moderate (≤ Grade 2), consistent with the known safety profiles of each agent.
Preliminary findings related to activity include:
83% of patients (45/54 with at least one post-baseline scan)
experienced tumor shrinkage of target lesions in response to treatment
with mirvetuximab soravtansine and pembrolizumab, with more robust
reductions observed in patients with tumors expressing FRα at medium
or high levels.
- Confirmed partial responses (PRs) were observed in 16 patients, with another 9 patients having unconfirmed PRs at the time of data analysis.
In the subset of patients with medium or high FRα expression levels,
the confirmed overall response rate (ORR) was 31 percent (95% CI, 17,
48), with a median progression-free survival (PFS) of 5.5 months (95%
CI 2.8, 6.3) and a median duration (DOR) of 8.1 months (95% CI 4.2,
upper bound not yet reached).
- At the time of analysis, the data were immature with 16 patients still on study (all with medium or high FRα expression) and a median follow-up of 8.3 months.
- For all patients evaluable for activity, the confirmed ORR was 30 percent (95% CI 18, 44), with a median PFS of 4.2 months (95% CI 2.8, 5.9). The median DOR data of 6.9 months (95% CI 4.2, 8.3) suggest a trend towards improvement over mirvetuximab soravtansine monotherapy.
“The combination of mirvetuximab soravtansine with pembrolizumab
continues to demonstrate a favorable tolerability profile in women with
platinum-resistant ovarian cancer, with preliminary activity consistent
with mirvetuximab monotherapy in heavily pretreated patients,” said
POSTER PRESENTATION DETAILS
- Title: “Mirvetuximab soravtansine, a folate receptor alpha (FRα-targeting antibody-drug conjugate (ADC), with pembrolizumab in platinum-resistant ovarian cancer (PROC): Initial results of an expansion cohort from FORWARD II, a Phase Ib study” (abstract #949P)
October 20, 2018
- Lead author:
Ursula Matulonis, M.D., Chief, Division of Gynecologic Oncology, Dana-Farber Cancer Institute, Boston, MA
Additional information can be found at www.esmo.org.
About FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in combination with AVASTIN® (bevacizumab), or KEYTRUDA® (pembrolizumab) in patients with FRα-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a combination with carboplatin and a triplet combination of mirvetuximab plus carboplatin and AVASTIN in patients with platinum-sensitive ovarian cancer.
ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized 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.
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.” Our lead product candidate, mirvetuximab soravtansine, is in a Phase 3 study for folate receptor alpha (FRα)-positive platinum resistant ovarian cancer, and in Phase 1b/2 testing in combination regimens. Our novel IGN candidates for hematologic malignancies, IMGN779 and IMGN632, are in Phase 1 studies.
Learn more about who we are, what we do, and how we do it at www.immunogen.com.
KEYTRUDA® is a registered trademark of
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's ability to expand the addressable patient
population for mirvetuximab soravtansine and the regulatory and
commercial potential of mirvetuximab combinations in earlier lines of
therapy. 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. Various factors could cause
ImmunoGen's actual results to differ materially from those discussed or
implied in the forward-looking statements, and you are cautioned not to
place undue reliance on these forward-looking statements, which are
current only as of the date of this release. It should be noted that
there are risks and uncertainties related to the development of novel
anticancer products, including risks related to preclinical and clinical
studies, their timings and results, and the potential that earlier
clinical studies may not be predictive of future results. A review of
these risks can be found in ImmunoGen's Annual Report on Form 10-K for
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