ImmunoGen $IMGN just compounded its woes with their lead drug.
Two months after acknowledging that their antibody-drug conjugate mirvetuximab soravtansine failed a Phase III study for ovarian cancer, the FDA has batted back an attempt to hunt an accelerated approval based on a secondary endpoint, sending their stock price tumbling again.
The FDA now wants to see a new Phase III trial for the drug, which won’t be cheap or easy to pull off.
ImmunoGen had held on to hope that subset data would take them over the finish line, with positive responses among patients with high FRα expression. But the study failed on both big endpoints for both progression-free survival as well as overall survival. The hazard ratio on PFS was an extremely poor 0.98 with a value of 0.897, well over the bar for success.
CEO Mark Enyedy said in a statement that he was encouraged that the agency had helped lay out a regulatory pathway. Investors, though, weren’t encouraged. The biotech’s already battered shares plunge anew, dropping 31% in early trading on Wednesday. Enyedy also noted that the biotech has $270 million in reserves on hand to get it through the next stage.
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