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ImmunoGen shares plummet by 32% after FDA recommends new Phase 3 trial

pharmafile | May 16, 2019 | News story | Business Services, Research and Development Cancer, Immunogen, Shares, ovarian cancer, pharma, stocks 

Shares in ImmunoGen fell 32% in premarket trading after the firm said the FDA had recommended a new Phase 3 trial of its ovarian cancer drug mirvetuximab soravtansine.

The experimental antibody-drug conjugate (ADC) mirvetuximab soravtansine is being trialled in patients with high folate receptor (FR) alpha-positive, platinum-resistant ovarian cancer.

In March, Massachusetts-based biotech ImmunoGen reported that its 366 patient FORWARD I trial had failed to meet its primary endpoint of progression free survival.

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In response the FDA said that data relating to the secondary endpoints “could not be used to support an application for accelerated approval.” The agency’s recommendation that a new trial would be necessary came in a meeting this week.

ImmunoGen’s chief medical officer Anna Berkenblit said “we appreciate the constructive engagement with the FDA and look forward to aligning with the agency on the design of a new registration trial in this population.”

She suggested the firm was “encouraged by the consistent signal of anti-tumour activity and the favourable benefit-risk profile.”

CEO Mark Enyedy added “the mirvetuximab combination cohorts continue to advance and, with approximately $270 million on the balance sheet as of the end of [the first quarter], we remain focused on developing innovative ADC therapeutics.”

Louis Goss

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