- Objective response rate (ORR) of 53% –
as single agent – in patients with folate-receptor alpha
(FRα)-positive platinum-resistant ovarian cancer. Majority of
responses are ongoing. Clinical development program advancing,
expanding.
ImmunoGen, Inc. (NASDAQ: IMGN), a biotechnology company that
develops novel anticancer therapeutics using its antibody-drug
conjugate (ADC) technology, today announced the presentation at the
2015 American Society of Clinical Oncology (ASCO) Annual Meeting of
the first clinical findings in a disease-specific patient
population with the Company’s unique, FRα-targeting ADC,
mirvetuximab soravtansine (abstract #5518).
The findings reported today are from an ongoing Phase 1 trial.
Once the recommended Phase 2 dose (RP2D) of mirvetuximab
soravtansine was established during dose finding (abstract #5558),
an expansion cohort was opened to assess the safety and activity of
this ADC specifically in the treatment of patients with
FRα-positive platinum-resistant ovarian cancer. Approximately 80%
of the patients screened have met the criteria for having
FRα-positive disease.
Twenty-two patients were included in the analysis reported today
– two from the dose-escalation phase of the trial and the twenty
enrolled in the expansion cohort at the time of data cutoff for
presentation (4/30/15). All had FRα-positive platinum-resistant
ovarian cancer and had received mirvetuximab soravtansine at the
RP2D (6.0 mg/kg, given every three weeks). All had previously
received taxane as well as platinum therapy. Thirteen were still on
study at the time of data cutoff.
The majority of adverse events reported were low grade (grade 1
or 2), with diarrhea, blurred vision, nausea, vomiting, fatigue,
and abdominal pain the most common treatment-emergent events
reported (>20% of patients).
Seventeen of the 22 patients were included in the efficacy
analysis; the other five patients were still on study and had not
yet reached their first assessment.
- Nine of these 17 patients had an
objective response (8 partial responses, 1 complete response) to
treatment, for an ORR of 53%.
- The responses in six of these nine
patients were ongoing at the time of data cutoff, with five of
these six patients on treatment for more than 15 weeks.
“These initial clinical findings with mirvetuximab soravtansine
in the treatment of patients with FRα-positive platinum-resistant
ovarian cancer are highly encouraging,” commented Dr. Kathleen
Moore, Mai Eager Anderson Chair of Cancer Clinical Trials,
Stephenson Cancer Center, University of Oklahoma HSC. “There is a
significant need for new therapies for patients with ovarian
cancer, including platinum-resistant disease.”
“Based on these findings, we are implementing a development plan
designed to advance mirvetuximab soravtansine as quickly as
possible while also recognizing the potential to benefit the
greatest number of patients,” commented Dr. Charles Morris, EVP and
Chief Development Officer of ImmunoGen. “We’re preparing to
initiate a Phase 2 trial in late 2015 that will assess this ADC as
a single-agent treatment for patients with FRα-positive
platinum-resistant ovarian cancer. It is possible that this trial
could be used for registration in this patient population.”
Dr. Morris continued, “At the same time, we’re preparing to
initiate testing of mirvetuximab soravtansine in combination
regimens as a potential therapy for patients with less heavily
pretreated ovarian cancer. We’re also continuing to explore this
promising ADC as a treatment for other types of FRα-positive solid
tumors, including target-positive endometrial cancer. To complement
our own research, ImmunoGen recently entered into a collaboration
with the National Comprehensive Cancer Network® Oncology Research
Program to investigate mirvetuximab soravtansine in additional
preclinical and clinical studies. ”
About Platinum-Resistant Ovarian Cancer
Each year, there are approximately 21,300 new cases of ovarian
cancer diagnosed in the US and more than 14,200 women die from the
disease.1 ImmunoGen estimates that approximately 2,000-3,000 of
these women have FRα-positive, platinum-resistant ovarian cancer
previously treated with at least three prior lines of therapy.
Standard first-line therapy for ovarian cancer is a
platinum-based regimen (e.g., carboplatin plus a taxane and
potentially additional agents). Once the cancer becomes
platinum-resistant, patients may receive single-agent therapy.
Response rates with these agents in the second-/third-line setting
are typically around 15-20%.2
About the Study Reported
The findings reported today are from a Phase 1 trial assessing
mirvetuximab soravtansine for the treatment of FRα-positive solid
tumors. After the RP2D was established in patients likely to have
FRα-positive disease using a once every 3-week dosing schedule, an
expansion cohort was opened to evaluate the ADC specifically in
patients with FRα-positive platinum-resistant ovarian cancer when
administered as a single agent at this RP2D.
To be eligible for enrollment in this expansion cohort, patients
must have ovarian cancer that responded to primary platinum
therapy, but then progressed within six months or progressed on or
within six months of treatment with subsequent platinum therapy.
The cancer also must be FRα-positive, assessed by
immunohistochemistry. Approximately 80% of patients screened met
this criteria based on the CLIA lab assay.
This expansion cohort has been expanded from 20 to 40 patients
to obtain additional experience in this patient population.
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is a FRα-targeting ADC
developed and wholly owned by ImmunoGen. It is the first and only
ADC to this target to enter clinical testing, and comprises a
FRα-binding antibody conjugated to DM4, a potent cancer-cell
killing agent developed by ImmunoGen specifically for use in ADCs.
The antibody serves to target the DM4 specifically to FRα-positive
cancer cells which the DM4 can then kill.
FRα is highly expressed on many cases of epithelial ovarian
cancer, and on other types of solid tumors including endometrial
cancer and some non-small cell lung cancers. Mirvetuximab
soravtansine is currently being assessed for the treatment of
FRα-positive, platinum-resistant ovarian cancer and for
FRα-positive relapsed/refractory endometrial cancer, with
additional assessments anticipated.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The
Company’s ADC technology uses tumor-targeting antibodies to deliver
an ImmunoGen cell-killing agent specifically to cancer cells. The
Company utilizes its ADC technology with its antibodies to create
ImmunoGen product candidates and also out-licenses limited rights
to use its technology to other companies. Roche’s Kadcyla® is the
first marketed product with ImmunoGen’s ADC technology. More
information about the Company can be found at
www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, a member
of the Roche Group.
NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®,
and all other NCCN Content are trademarks owned by the National
Comprehensive Cancer Network, Inc.
1American Cancer Society (2015), Cancer Facts & Figures.
2From prescribing information and published clinical data.
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, 2014 and other reports filed with
the Securities and Exchange Commission.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150530005009/en/
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Pure Communications,
Inc.Dan Budwick, 973-271-6085
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Aug 2024 to Sep 2024
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Sep 2023 to Sep 2024