ImmunoGen said mirvetuximab, its treatment for patients with platinum-resistant ovarian cancer, performed well in a pivotal SORAYA trial. Mirvetuximab had a confirmed objective response rate (ORR) of 32.4%, the drugmaker said, with a duration of response (DOR) of 5.9 months in the 106-person trial.
ImmunoGen said the data would be submitted to the U.S. Food & Drug Administration as party of the agency's' Biologics License Application process in the first quarter of next year.
"This is an exciting moment, both for the field of ovarian cancer and for ImmunoGen, and the outcomes from SORAYA further validate our longstanding history of innovation in ADCs," said ECEO Mark Enyedy. "We are moving forward expeditiously to complete the BLA for mirvetuximab, with the goal of submitting the application to FDA for accelerated approval in the first quarter of 2022. In parallel, commercial preparations are well underway to support the potential launch of mirvetuximab next year."
"Beyond SORAYA, we expect to generate top-line data from our confirmatory MIRASOL trial in the third quarter of 2022 to support the potential full approval of mirvetuximab," he added. "We are also working to expand mirvetuximab monotherapy into later-line platinum-sensitive disease and, as part of our efforts to establish mirvetuximab as the combination agent of choice, evaluating mirvetuximab doublets in earlier lines of treatment, all with the goal of furthering our mission to offer more patients more good days."
ImmunoGen shares were marked 36.6% higher in early trading to change hands at $6.30 each, a move that would value the Waltham, Massachusetts-based drugmaker at around $1.26 billion.
"Though most investors believed a top-line positive ORR was likely, potential nuances included ability to show a clinically meaningful magnitude of benefit, potential variations between investigator vs. centrally reviewed ORR, and magnitude of DOR benefit," said SVB Leerink analyst Jonathan Chang. "We believe investigator and central-reviewed ORR of >30% and DOR in the ~6 month range are a clinically meaningful result and likely to meet or exceed investor expectations."