
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.
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
Related Content

Pharma&’s ovarian cancer therapy approved for use by NHS Scotland
Pharma& has announced that its treatment for ovarian cancer, Rubraca (rucaparib), has been accepted by …

LGC Group opens $100M Organic Chemistry Synthesis Centre of Excellence
LGC Group, a life sciences company, has opened its new Organic Chemistry Synthesis Centre of …

Central nervous system cancer metastases – the evolution of diagnostics and treatment
The current forms of immunotherapy, how T cell therapy works and what the future holds






