ImmunoGen Inc stock more than doubled after the company shared positive topline data from the Phase 3 confirmatory MIRASOL trial evaluating the safety and effectiveness of its experimental ovarian cancer drug Elahere.
The study compared Elahere with chemo in patients with platinum-resistant ovarian cancer, who have received one to three prior lines of therapy.
The Waltham, Massachusetts-based biotech’s Elahere not only bested chemo, but helped extend the lives of patients in the late-stage trial.
Immunogen shares rocketed 129% to $11.92 on the Nasdaq in afrenoon trade.
The study found that Elahere also significantly prolonged the time that a patient lives without the cancer worsening, when compared with chemotherapy.
"I believe the data from the confirmatory MIRASOL trial are practice-changing,” principal investigator Kathleen Moore, who is a professor of gynecologic oncology at the University of Oklahoma, said in a statement.
“They demonstrate ELAHERE's superiority to chemotherapy based on all efficacy endpoints, in particular overall survival, and build on the clinical benefit of ELAHERE previously reported in the SORAYA trial."
Based on the data, ImmunoGen plans to submit a marketing authorization application in Europe and a supplemental Biologics License Application in the US for the conversion to a regular approval of ELAHERE.
The Food and Drug Administration had earlier given accelerated approval for Elahere based on data from a single-arm trial in patients who had received at least one prior line of therapy that included Roche Holding’s Avastin.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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