Initial data from Part 1 of a Phase 2/3 clinical trial, RESILIENT, evaluating Ipsen’s (OTCPK:IPSEY -1.4%) Onivyde (irinotecan liposome injection) in small cell lung cancer (SCLC) patients who progressed following initial treatment with platinum-based chemo showed a treatment effect. The results were presented at the World Conference on Lung Cancer in Barcelona.
Part 1, focused on dose-finding and dose escalation, enrolled 30 subjects who were treated every two weeks for more than 12 weeks. Dose-limiting toxicity was observed in the five patients who received the 85 mg/m2 dose. A lower dose of 70 mg/m2 was tolerable in 12 patients. As of the May 8 data cutoff date, 25 patients had received the lower dose.
The objective response rate was 44% (n=11/25), all partials, while 68% (n=17/25) experienced tumor shrinkage. Seven patients showed stable cancer implying a disease control rate of 72% (18/25). Survival and progression-free survival data are still maturing.
On the safety front, the rate of serious or greater treatment-emergent adverse events (TEAEs) was 40% (n=10/25). Diarrhea (20%) was the most common serious TEAE (n=5/25). Other serious/life-threatening TEAEs were neutropenia (n=4), anemia (n=2) and thrombocytopenia (n=2).
Part 2 has just been initiated.
The FDA approved Onivyde in October 2015 for pancreatic cancer.
The company owns exclusive commercialization rights for all indications in the U.S. Servier owns development and commercialization right ex-U.S. and Taiwan.
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