Iovance (IOVA) Up 5% on Updated Data From Melanoma Study

Core Insights - Iovance Biotherapeutics announced updated clinical results from the phase II IOV-COM-202 study, showcasing the efficacy of the Amtagvi and Keytruda combination in treating frontline advanced melanoma [1][3] Clinical Results - The Amtagvi/Keytruda combination achieved a confirmed objective response rate (ORR) of 65.2%, with a complete response (CR) rate of 30.4% based on data from 23 patients [2] - Nearly all responses remained ongoing at a median follow-up of 21.7 months, and all evaluable patients showed regression of their target lesions [2] Strategic Implications - The deep and durable response rates support the ongoing phase III TILVANCE-301 study, which aims to evaluate the Amtagvi-Keytruda combo as a potential treatment for frontline advanced melanoma [3] - Analysts noted significant improvement in response rates compared to current standard treatments like Keytruda monotherapy or the combination of Bristol Myers drugs Opdivo and Yervoy [3] Market Reaction - Following the announcement, Iovance's shares increased by over 5% in after-market trading on May 23, with a year-to-date stock increase of 26.2% compared to the industry's 6.0% decline [4] Regulatory and Commercial Developments - Iovance received accelerated FDA approval for Amtagvi for adult patients with advanced melanoma, which progressed after prior anti-PD-1/L1 and targeted therapy [5] - Amtagvi is the first one-time T-cell therapy approved by the FDA for solid tumor cancer and is now a preferred second-line therapy in NCCN guidelines for cutaneous melanoma [6] Enrollment and Demand - Over 100 patients have enrolled for Amtagvi across more than 40 authorized treatment centers (ATCs), with demand for the therapy growing monthly since approval [7] - The company aims to onboard nearly 50 ATCs by the end of the month and expects to close the year with at least 70 ATCs [8] Future Plans - Regulatory applications for Amtagvi in melanoma indications in Europe and Canada are expected to be filed later this year, with additional filings planned for Australia and other countries next year [10]