The Food and Drug Administration (FDA) has recommended that ImmunoGen, Inc. conduct a new phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer.

The Company conducted the phase 3 FORWARD I trial in which 366 patients were randomized 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). As part of a Type C meeting, the FDA could not support an application for accelerated approval for mirvetuximab soravtansine because the study did not meet its primary endpoint (progression free survival) and the secondary endpoint data could not be used to support the application.

Mirvetuximab soravtansine is an investigative folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC). It works by using a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

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ImmunoGen also announced the availability of mature data from the FORWARD II expansion cohort evaluating mirvetuximab soravtansine in combination with bevacizumab (Avastin; Genentech) in patients with FRα-positive platinum-resistant ovarian cancer. These findings will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting that is being held May 31 – June 4 in Chicago, IL.

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“We are pleased that the combination of mirvetuximab plus Avastin has generated significant anti-tumor activity in patients with platinum-resistant disease, with trends toward deeper, more durable responses seen in individuals with higher FRα expression and a favorable tolerability profile. The outcomes observed in patients with medium or high FRα expression are encouraging with respect to those reported in similar patient populations for Avastin plus chemotherapy,” said Anna Berkenblit, MD, Vice President and Chief Medical Officer of ImmunoGen.

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This article originally appeared on MPR