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ImmunoGen Needs Another Phase III For Its ADC In Ovarian Cancer

 
• By Joseph Haas

The biotech’s hopes for an accelerated approval on subgroup data were dashed by the US FDA, but it will work with the agency to design a Phase III focused on highly FRα-positive patients.

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ImmunoGen is back to the drawing board, needing a new Phase III for its ADC in ovarian cancer

After a disappointing data readout from the Phase III FORWARD 1 study of its antibody-drug conjugate (ADC) mirvetuximab soravtansine in ovarian cancer, ImmunoGen Inc. tried to placate investors with plans to seek an accelerated approval based on overall survival data in a patient subgroup. The company’s stock rebounded somewhat on that strategy, but fell again on 15 May when the Boston-area firm said the FDA declined to consider an accelerated approval.

ImmunoGen shares finished the trading day down 32% at $2.14 apiece, slightly below the stock’s $2.38 price on 1 March, the day it reported FORWARD 1 results. Those data, in...

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