FDA Lifts Partial Hold on Iovance's NSCLC Trial

By Bobby Samwell • Monday, March 04 15:25 • Permanent Link

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has announced that the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on the registrational iov-LUN-202 trial, which is investigating LN-145 TIL cell therapy in non-small cell lung cancer (NSCLC). This comes after the company collaborated with the FDA and an independent data monitoring committee to develop additional safety and monitoring measures.

The iov-LUN-202 trial is focused on patients with advanced (unresectable or metastatic) NSCLC without certain genomic mutations who have previously undergone specific treatments. Iovance expects to complete enrollment of approximately 120 patients in the iov-LUN-202 registrational cohorts by 2025.

Preliminary data from the iov-LUN-202 trial suggest the potential benefit of one-time TIL therapy, with initial results reported in July 2023 and an updated analysis in November 2023. The updated analysis revealed ongoing responses and a duration of response greater than six months for 71% of the confirmed responders in the trial.

The market has reacted to these announcements by moving the company's shares 2.2% to a price of $17.16. Check out the company's full 8-K submission here.

The above analysis is intended for educational purposes only and was performed on the basis of publicly available data. It is not to be construed as a recommendation to buy or sell any security. Any buy, sell, or other recommendations mentioned in the article are direct quotations of consensus recommendations from the analysts covering the stock, and do not represent the opinions of Market Inference or its writers. Past performance, accounting data, and inferences about market position and corporate valuation are not reliable indicators of future price movements. Market Inference does not provide financial advice. Investors should conduct their own review and analysis of any company of interest before making an investment decision.