ImmunoGen presents initial data from FORWARD II expansion cohort.
ImmunoGen (IMGN) announced initial safety and preliminary anti-tumor activity from the FORWARD II expansion cohort assessing mirvetuximab soravtansine in combination with Merck's (MRK) anti-PD-1 therapy, Keytruda. The data presented at ESMO were for 56 patients with platinum-resistant ovarian cancer, of whom 40 have medium or high folate receptor alpha expression. Patients had received a median of 3 prior therapies. The combination of mirvetuximab soravtansine and pembrolizumab demonstrates favorable tolerability and encouraging activity. Adverse events were predominantly mild to moderate, consistent with the known safety profiles of each agent. 83% of patients experienced tumor shrinkage of target lesions in response to treatment with mirvetuximab soravtansine and pembrolizumab, with more robust reductions observed in patients with tumors expressing FRalpha at medium or high levels. Confirmed partial responses were observed in 16 patients, with another 9 patients having unconfirmed PRs at the time of data analysis. In the subset of patients with medium or high FRalpha expression levels, the confirmed overall response rate was 31%, with a median progression-free survival of 5.5 months and a median duration of 8.1 months. At the time of analysis, the data were immature with 16 patients still on study and a median follow-up of 8.3 months. For all patients evaluable for activity, the confirmed ORR was 30%, with a median PFS of 4.2 months. The median DOR data of 6.9 months suggest a trend toward improvement over mirvetuximab soravtansine monotherapy.
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|Date:||Oct 21, 2018|
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