The Independent Data Monitoring Committee (IDMC) decided that ImmunoGen (IMGN) Phase 3 registration trial evaluating mirvetuximab soravtansine as a single-agent therapy for platinum-resistant ovarian cancer will continue as planned without modification.
ImmunoGen has completed full enrollment of the trial two months ahead of schedule and expects top-line results from FORWARD I during the first half of 2019. Enrollment was initially planned to be completed by the end of June.
FORWARD I is an ongoing Phase 3 trial designed to randomize 333 patients 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel).
Eligibility criteria include patients with platinum-resistant ovarian cancer that express medium or high levels of folate receptor alpha (FRα) who have been treated with up to three prior regimens. The primary endpoint of this study is PFS, which is being assessed in the entire study population and in the subset of patients with high FRα expression.
ImmunoGen is partnering with the Gynecologic Oncology Group Foundation Inc., a leader in clinical research in gynecologic malignancies. FORWARD I, which is being conducted in North America and Europe is intended to support full marketing approval of mirvetuximab soravtansine for patients with platinum-resistant ovarian cancer.
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting antibody drug conjugate (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 these targeted cancer cells.
Mirvetuximab is also being assessed in combination regimens for both platinum-resistant and platinum-sensitive disease in the Phase 1b/2 FORWARD II trial.
Knowing in fact, that the IDMC decision is based upon successful completion of a pre-specified interim futility analysis after 80 progression-free survival (PFS) events as determined by blinded, independent central review makes today’s news exciting.
The news is indeed encouraging when one recognizes the fact that ovarian cancer is the leading cause of death from gynecological cancers as the patients have limited treatment options when their cancer develops resistance to platinum therapy. In cases ovarian cancer becomes platinum-resistant, other treatment options include pegylated liposomal doxorubicin, paclitaxel, or topotecan, and combination therapies that include Avastin®. This leaves the oncology clinic with is a significant need for more effective and better-tolerated therapies for recurrent ovarian cancer.
It is estimated that around 19,000 women in the US and approximately 24,000 women in the EU have platinum-resistant ovarian cancer requiring second-line or later treatment.
ImmunoGen estimates that 60% of ovarian cancer cases have medium or high FRα expression, which makes them good candidates for treatment with ImmunoGen ADC product Mirvetuximab soravtansine.
This is promising news that ImmunoGen badly needed.
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives. Also, investing in stocks includes certain risks. Please consult with your own financial adviser before making an investment.