Iovance Reports 24.6% Response Rate for Lung Cancer Therapy, Identifies Subgroup at 59.1%
Key Facts
Iovance Biotherapeutics said its cell therapy lifileucel posted an objective response rate of 24.6% among previously treated patients with metastatic non-squamous non-small cell lung cancer, based on data cut off on October 14, 2026. Seventeen of 69 patients in cohorts 1 and 2 of the IOV-LUN-202 study responded, and the company said the result was consistent with the 25.6% rate previously recorded among 39 patients. The responses included 15 confirmed responses and two unconfirmed partial responses pending confirmation. Independent committee radiology reviews are ongoing, according to the company’s statement published on October 29. The new reading puts the overall response rate close to the initial result, while the company is focusing on a subgroup analysis that showed a higher response rate in a specific patient group.
The update added 30 patients to the previous data, bringing the total to 69 patients whose disease progressed during or after platinum-based chemotherapy and after treatment with immune checkpoint inhibitors. In a retrospective analysis, the company identified a group of 22 patients whose tumors were both KRAS and HER2 wild-type and who had a current or former smoking history. Thirteen patients in this group responded, for a rate of 59.1%. The group made up less than a third of participants but accounted for more than three-quarters of the responses recorded in the study. The company said the criteria will be evaluated prospectively in the POSITILITY cohort, so the rate for this group remains the result of a retrospective analysis.
Response rates varied by KRAS status: 43.3%, or 13 of 30 patients, among those with wild-type tumors, compared with 11.4%, or 4 of 35, among those with mutations. The two recorded complete responses occurred in patients whose tumors were KRAS wild-type. These results show a difference between the two groups in the updated data, while the higher rate of 59.1% is associated with a narrower subgroup combining KRAS and HER2 wild-type status with a smoking history. Iovance said response durability and the safety profile remained consistent with previous reports. It also said the study uses an updated regimen with a reduced dose of lymphodepleting preparative treatment, which it said improved the overall safety profile.
The company plans to test the subgroup criteria in a prospective POSITILITY study, while cohorts 1 and 2 of IOV-LUN-202 are nearing full enrollment. Iovance expects the final dataset to include about 80 patients. It also plans to file a supplemental biologics license application for lifileucel in metastatic non-squamous lung cancer in 2027. The company said discussions with the U.S. Food and Drug Administration are ongoing. The FDA approved lifileucel, under the brand name Amtagvi, on February 16, 2024, for adults with unresectable or metastatic melanoma previously treated with a PD-1 inhibitor; it described the therapy as the first tumor-derived T-cell cellular immunotherapy to receive its approval.
The announcement came as Iovance shares fell after the results were published. Investing.com reported that the stock initially dropped 15% on Thursday before recovering some losses to trade down 6% during the session. Reuters coverage carried by Investing.com said the stock fell 8.9% in premarket trading on October 29, after rising about 12% in after-hours trading the previous day. These moves relate to different trading periods, while the stock had closed at $14.81 on October 28. The figures show the reaction following an overall reading broadly consistent with the previous result, alongside investor interest in the higher rate in the subgroup identified by the retrospective analysis.
Iovance is expanding its commercial business while developing lifileucel for uses beyond melanoma. Product revenue was about $99 million in the second quarter of 2026, up 66% from about $60 million in the same period of 2025, while gross margin was 56%. On September 29, the company raised its 2026 product revenue guidance to $410–420 million from a previous range of $350–370 million. It said the midpoint of the new range was $55 million, or about 15%, above the midpoint of the previous range. Management attributed the change to U.S. demand for Amtagvi and Proleukin, and said demand and the manufacturing schedule gave it visibility into revenue for the third and fourth quarters.