ImmunoGen and Merck Establish Collaboration for Clinical Evaluation of Mirvetuximab Soravtansine in Combination with Keytruda® (pembrolizumab) for the Treatment of Ovarian Cancer
− ImmunoGen's mirvetuximab soravtansine folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) to be assessed in combination with Merck's anti-PD-1 therapy −
Mirvetuximab soravtansine is an experimental ADC for FRα-positive cancers that has shown notable activity for FRα-positive ovarian cancer in early clinical testing. Mirvetuximab soravtansine contains a monoclonal antibody that enables it to bind to FRα-positive tumor cells with ImmunoGen's DM4, a maytansinoid cancer-killing agent, attached to kill these cells. In preclinical research conducted by ImmunoGen and academics, ADCs with maytansinoids have been found to enhance the maturation and activation of the dendritic cells of the immune system that stimulate antitumor responses.1,2 Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T-lymphocytes, which may affect both tumor cells and healthy cells.
"We look forward to evaluating our mirvetuximab soravtansine ADC in
combination with Merck's anti-PD-1 therapy, Keytruda," said
"Fully realizing the potential for Keytruda to help patients with cancer
requires strategic collaborations, such as this agreement with
ImmunoGen, that explore how complementary approaches might result in
improved outcomes for patients," said Dr.
ImmunoGen is conducting a Phase 1b/2 clinical trial, FORWARD II, that evaluates mirvetuximab soravtansine for FRα-positive ovarian cancer used in doublet combination with other anticancer agents. The assessment of mirvetuximab soravtansine with Keytruda will be added to this trial, with Merck supplying the Keytruda. ImmunoGen expects this cohort to open for patient enrollment in the second half of 2016.
The agreement is between ImmunoGen and Merck, through a subsidiary. The agreement includes a provision for potential expansion of the collaboration to include a subsequent Phase 3 clinical trial. Additional details were not disclosed.
About Mirvetuximab Soravtansine
ImmunoGen developed mirvetuximab soravtansine as a potential treatment for ovarian cancer and other FRα-positive solid tumors. In early clinical testing, mirvetuximab soravtansine demonstrated notable activity when used as a single agent to treat platinum-resistant FRα-positive ovarian cancer.3 ImmunoGen is assessing the ADC used as a single agent for pretreated FRα-positive ovarian cancer in its Phase 2 trial, FORWARD I, which is intended to support an Accelerated Approval pathway. Mirvetuximab soravtansine is also now being assessed in separate combinations with pegylated liposomal doxorubicin (Doxil®), bevacizumab (Avastin®), and carboplatin in the Phase 1b/2 trial, FORWARD II.
About Ovarian Cancer
Each year there are approximately 240,000 new cases of ovarian cancer diagnosed and 140,000 deaths from the disease on a global basis.4 Among all gynecologic cancers, ovarian cancer accounts for the most deaths on an annual basis.
ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics using its proprietary ADC technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancer and other solid tumors. A number of major healthcare companies have licensed limited rights to use ImmunoGen's ADC technology to develop anticancer therapies; it is used in Roche's marketed product, Kadcyla®. More information about the Company can be found at www.immunogen.com.
1ImmunoGen internal research
2Martin, Müller, et. al, Cancer Immunol Immunother (2014) 63:925-938
3ASCO 2015, abstract 5518 and AACR-NCI-EORTC 2015, abstract C47
4WHO GLOBOCAN 2012
Doxil®, Avastin®, Kadcyla®, and Keytruda® are registered trademarks of their respective owners.
ImmunoGen Forward-Looking Statement
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 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
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