- Confirmed objective response rate of
44% and median progression-free survival of 6.7 months seen in
cohort subset mirroring patient population selected for planned
Phase 3 study.
- Company preparing to meet with FDA in
early 3Q2016; targeting initiation of Phase 3 study in
4Q2016.
- Data will be presented at ASCO Annual
Meeting on June 6, 2016.
ImmunoGen, Inc. (Nasdaq: IMGN), a
biotechnology company developing novel antibody-drug conjugate
(ADC) cancer therapeutics, today reported the clinical data from a
46-patient Phase 1 cohort evaluating the efficacy and safety
of mirvetuximab soravtansine as single-agent therapy for
platinum-resistant, folate receptor alpha (FRα)-positive ovarian
cancer. These results have informed the Company’s selection of the
patient population and primary endpoint for a Phase 3 study
scheduled to begin before year-end.
This Phase 1 cohort, which was expanded from 20 to 46 patients
to provide additional information for the design of subsequent
trials, enrolled patients with platinum-resistant ovarian cancer
who had received up to five previous treatment regimens. Patients
also needed to have FRα expressed at or above a predefined level on
at least 25% of tumor cells. Patients were classified as having
low, medium, or high FRα expression based on the percent of tumor
cells meeting this criterion (25-49%, 50-74%, and 75-100%,
respectively). Among the 46 patients, 23 had high, 14 had medium,
and 9 had low expression of FRα. All had previously received
platinum and a taxane.
Among all 46 patients, the confirmed objective response rate
(ORR) was 26% and median progression-free survival (PFS) was
4.8 months (95% confidence interval, 3.9-5.7 months). Among
the 16 patients who received up to three prior regimens and had
high or medium FRα expression – the population selected for the
planned Phase 3 trial – the ORR was 44% and median PFS was
6.7 months (95% CI, 3.9-11.0 months). For the 30 patients with
low FRα and/or who had received four or five prior regimens, ORR
was 17% and median PFS was 4.2 months (95% CI, 2.6-5.5
months).
Current single-agent therapies for platinum-resistant ovarian
cancer typically have an ORR of 15-20% and median PFS of 3-4
months, including in patients receiving no more than two prior
regimens.1
Based upon the findings in this Phase 1 cohort, the planned
Phase 3 trial assessing mirvetuximab soravtansine as single-agent
therapy for platinum-resistant ovarian cancer will enroll patients
who previously received up to three treatment regimens and
whose cancer has high or medium FRα expression, with PFS as the
primary endpoint.
“There is a significant need for new therapies for ovarian
cancer,” commented Dr. Kathleen Moore, Christy Everest Endowed
Chair in Cancer Research and Director of the Oklahoma TSET Phase I
Unit, Stephenson Cancer Center, University of Oklahoma HSC. “We’re
excited about the findings with mirvetuximab soravtansine from this
study and to be advancing this first-in-class agent into a Phase 3
trial for platinum-resistant ovarian cancer.”
“We plan to have Phase 3 testing of mirvetuximab soravtansine up
and running by year end,” commented Dr. Charles Morris, ImmunoGen’s
EVP and Chief Development Officer. “Now that we have the full
results from the 46-patient ovarian cancer cohort, we’ve submitted
a meeting request to the FDA to discuss our proposed path to
approval. This meeting should take place early in 3Q2016, and we
are targeting initiation of FORWARD I Phase 3 testing in
4Q2016.”
Mirvetuximab soravtansine was generally well tolerated, with
most side effects Grade 1 or 2 (least severe grades). Of particular
note, incidence of blurred vision was reduced from 55%, mostly
Grade 2, in the first 20 patients enrolled to 39%, mostly Grade 1,
among the 26 patients added with the expansion of the cohort. Other
side effects reported in more than 20% of patients were diarrhea,
fatigue, nausea, vomiting, peripheral neuropathy, increased AST,
keratopathy, and abdominal pain.
Data Presentation at ASCO 2016
“IMGN853 (mirvetuximab soravtansine), a folate receptor alpha
(FRα)-targeting antibody-drug conjugate (ADC): single-agent
activity in platinum-resistant epithelial ovarian cancer patients”
will be presented in the Gynecologic Cancer Poster Session (Poster
Board #390) taking place on Monday, June 6, from 1:00-4:30 pm CT.
(Abstract #5567).
About the Planned FORWARD I Phase 3 Trial
The FORWARD I Phase 3 trial is intended to support full
marketing approval of mirvetuximab soravtansine for the treatment
of patients with platinum-resistant ovarian cancer who previously
received up to three treatment regimens for whom single-agent
therapy is appropriate. The cancer also must have high or medium
FRα expression. ImmunoGen estimates that 5,000-7,000 patients per
year (US) meet these criteria.
Patients will be randomized 2:1 to mirvetuximab soravtansine or
physician’s choice, which will include pegylated liposomal
doxorubicin, topotecan, and weekly paclitaxel.
PFS will be the primary endpoint of the trial. This study also
will be powered for separate assessment of the endpoint in the full
study population and in the subset with high FRα expression and
will include at least 300 patients.
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.
ImmunoGen is advancing mirvetuximab soravtansine into Phase 3
testing as a single agent for the treatment of platinum-resistant
ovarian cancer. The product candidate is also in Phase 1b/2 testing
in combination regimens for ovarian cancer.
About Ovarian Cancer and FRα
This year, approximately 22,300 new cases of ovarian cancer will
be diagnosed in the US and more than 14,200 women will die from the
disease.2 ImmunoGen estimates that 40% of ovarian cancer cases have
high FRα expression, 20% have medium, 20% have low, and 20% have
very low levels of FRα.
Standard first-line therapy for ovarian cancer is a
platinum-based regimen. Once the cancer becomes platinum-resistant,
patients may receive single-agent therapy.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted cancer therapeutics using its proprietary ADC
technology. The Company’s lead product candidate, mirvetuximab
soravtansine, is being advanced to Phase 3 testing for FRα-positive
platinum-resistant ovarian cancer, and is also in Phase 1b/2
testing in combination regimens for earlier-stage disease. The
Company’s ADC technology is used in three other clinical-stage
ImmunoGen product candidates, in Roche's marketed product,
Kadcyla®, 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.
1From prescribing information and published clinical
data2American Cancer Society (2016), Cancer Facts &
Figures
Kadcyla® is a registered trademark of Genentech, a member of the
Roche Group.
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
(IMGN853), including risks related to clinical studies and
regulatory processes, 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 June 30, 2015 and other reports filed with
the Securities and Exchange Commission.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160518006432/en/
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Michael Lampe,
484-575-5040michael@scientpr.com
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