Based on feedback from an End-of-Phase 2 meeting with the FDA, Iovance Biotherapeutics (NASDAQ:IOVA) plans to add a new cohort of 80 - 100 melanoma patients to its ongoing Phase 2 clinical trial evaluating lead candidate LN-144-01. Enrollment in this new group, called Cohort 4, will begin in early 2019 and should be fully enrolled by Q4 2019/Q1 2020. If all goes well, a U.S. marketing application will be filed in H2 2020, a timeline that appears to disappoint investors (shares down 4% after hours).
Preliminary results showed a 37% objective response rate (ORR) in advanced melanoma patients previously treated with a PD-1 inhibitor and, if BRAF mutation-positive, a BRAF inhibitor. Duration of responses ranged from 1.3 months to over 14 months. An ORR of 31% was observed in patients with recurrent metastatic squamous cell carcinoma of the head and neck and a 27% ORR in patients with recurrent, metastatic or persistent cervical cancer.
Previously: Iovance Bio's mid-stage study of LN-144 in melanoma underway (June 7)
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