Iovance stock falls after lung cancer trial data disappoints

Shares of Iovance Biotherapeutics (NASDAQ: IOVA) initially dropped 15% before recovering to a 6% loss on Thursday after the company shared updated trial results for its lung cancer therapy, lifileucel.

The trial focused on patients with advanced lung cancer whose disease had continued to spread despite exhausting standard treatments like chemotherapy and immunotherapy. Out of 69 total patients, about 25% saw their tumors shrink or disappear—a result consistent with the company’s previous reports.

However, the data revealed that the treatment worked exceptionally well for a highly specific subset of patients: those with a history of smoking whose tumors lacked certain genetic mutations (known as KRAS and HER2 mutations). While this specific group made up less than a third of the total patients in the study, they accounted for over 75% of all the positive responses, achieving an impressive 59% success rate. By contrast, the treatment was largely ineffective for patients who did have the KRAS mutation.

Encouraged by this strong targeted response, Iovance is launching a new, specialized arm of the study called POSITILITY in November 2026. This new phase will exclusively enroll patients matching this specific genetic and smoking profile, with the goal of using the data to support a future path to FDA approval.

Iovance expects to wrap up enrollment for the current trial phase soon, capping it at around 80 patients. The company plans to officially file for FDA approval to treat this specific type of advanced lung cancer in 2027.