What happened
Shares of ImmunoGen (IMGN +0.00%) surged 30% on Tuesday after the biotech announced promising clinical trial results for its experimental ovarian cancer therapy, mirvetuximab.
So what
The trial was designed to assess the safety and efficacy of mirvetuximab in patients with a form of platinum-resistant ovarian cancer who were already treated with Avastin (bevacizumab), a leading therapy developed by Roche-owned Genentech.
"Despite advances in the platinum-sensitive setting, most patients with ovarian cancer eventually develop platinum-resistant disease, for which there are limited treatment options, especially for those patients who have previously received bevacizumab," co-principal investigator Robert Coleman said in a press release.
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Data from the study showed that mirvetuximab achieved its primary and secondary endpoints with a confirmed objective response rate (ORR) of 32.4% and a median duration of response (DOR) of 5.9 months.
Importantly, mirvetuximab was also well tolerated. Adverse events experienced by patients, such as nausea and blurred vision, were consistent with the drug's known safety profile.
"These data have the potential to be transformative for ovarian cancer patients and their physicians," co-principal investigator Ursula Matulonis said. "In the platinum-resistant setting and particularly in later-line treated patients, response rates with available therapy are in the single digits with significant toxicities.
Now what
ImmunoGen CEO Mark Enyedy said the company is working to submit a biologics license application for mirvetuximab to the U.S. Food and Drug Administration for accelerated approval in the first quarter of next year.
If approved, Matulonis believes mirvetuximab could become a "critical therapeutic option" for patients with the far too often deadly disease.
