Iovance’s Lifileucel Shows 25% Lung Cancer Response Rate, Targets 2027 FDA Filing

Key Points

• Lifileucel produced a 25% objective response rate in 69 previously treated metastatic non-small cell lung cancer patients, including two complete responses. Iovance expects final registrational data in early 2027 and is targeting a supplemental FDA filing during 2027.
• A biomarker analysis found substantially higher response rates among KRAS wild-type patients—43.3% overall and 59.1% in the KRAS/HER2-wild-type current or former smoker subgroup. Iovance plans to evaluate this enriched population in the POSITILITY registrational-intent cohort beginning in late 2026.
• In an early frontline study, lifileucel plus pembrolizumab generated an 85.7% response rate in a seven-patient biomarker-enriched subgroup. The company plans to launch the larger OPTILISM trial in 2027.

Iovance Biotherapeutics NASDAQ: IOVA reported updated data from its registrational IOV-LUN-202 trial of lifileucel in previously treated, non-squamous metastatic non-small cell lung cancer, outlining plans for a supplemental Biologics License Application submission in 2027 and a new biomarker-enriched study.

At an Oct. 14, 2026, data cutoff, 17 of 69 patients in Cohorts 1 and 2 had responded to treatment, representing an objective response rate of about 25% under RECIST 1.1 criteria, according to Interim Chief Executive Officer and President Fred Vogt. Fifteen responses were confirmed, including two complete responses, while two more recent responses were awaiting confirmation.

Vogt said the updated results were consistent with the company’s earlier findings in 39 patients across response rate, durability and safety. The study uses a reduced-dose lymphodepletion regimen before tumor-infiltrating lymphocyte, or TIL, infusion, which he said has improved the overall safety profile while remaining consistent with prior lifileucel experience.

The company is targeting approximately 80 patients for the final registrational data package. Iovance said the 69 patients reported, along with patients still in treatment and additional enrolled participants, represent most of that expected population. Enrollment in Cohorts 1 and 2 is expected to conclude shortly.

Regulatory Path and Durability

Iovance continues to prepare for a supplemental BLA submission for lifileucel in non-small cell lung cancer during 2027. The company said independent review committee assessments, discussions with the Food and Drug Administration, manufacturing-related work and confirmatory trial preparations are ongoing.

During the question-and-answer session, Vogt said response-duration data remain immature. Based on a swimmer’s plot published in the company’s presentation, he said the data appeared to indicate duration of response of roughly one year at present, though he emphasized that a final assessment could not yet be made. He added that an eventual median duration of response of 18 months or more could be “reasonable” based on existing information, but said the final data will determine the outcome.

Vogt said the company expects a final data cutoff early in 2027. He also said FDA generally requires six months of follow-up from the last response, which could place a potential regulatory review into late 2027 or 2028 after a 2027 submission.

The company believes a durable 25% response rate from a one-time treatment could support approval in the broader population, though Vogt noted that discussions with the FDA remain ongoing.

Biomarker-Enriched Strategy

Iovance also presented a subgroup analysis identifying KRAS wild-type status as a potential biomarker associated with a higher response rate. Among 30 KRAS wild-type patients, 13 responded, for an objective response rate of 43.3%. That compared with four responses among 35 patients with KRAS-mutant tumors, or an 11.4% response rate.

The company further analyzed tumor genomic testing and smoking-history data. In a subgroup of patients with KRAS wild-type and HER2 wild-type tumors who were current or former smokers, 13 of 22 patients responded, producing an objective response rate of 59.1%. This subgroup represented less than one-third of the broader 69-patient population but accounted for 13 of the 17 reported responses.

Vogt said Iovance estimates that about 45% of newly diagnosed U.S. non-squamous metastatic non-small cell lung cancer cases could meet the biomarker-enriched criteria. He also said these patients lack targeted treatment options for mutant KRAS, HER2 or other drivers.

The company plans to prospectively evaluate the enriched population in a registrational-intent cohort called POSITILITY, which will be part of the ongoing IOV-LUN-202 program. Initial sites are expected to begin enrolling in November 2026, followed by expansion to more than 70 existing IOV-LUN-202 sites over the following months. The trial will enroll both PD-L1-negative and PD-L1-positive patients.

Frontline Study Plans

Iovance also cited results from Cohort 3A of its IOV-COM-202 study in frontline metastatic non-small cell lung cancer. In a biomarker-enriched subgroup of seven patients without actionable EGFR, ALK and ROS1 mutations, lifileucel combined with pembrolizumab produced six confirmed responses, including one complete response and five partial responses, for an objective response rate of 85.7%.

Across all 14 EGFR wild-type patients in that cohort, the company reported an objective response rate of 64.3%, or nine responses.

Based on those findings, Iovance plans to initiate the OPTILISM trial in 2027. The study is intended to evaluate lifileucel added to frontline standard care of pembrolizumab and platinum-based chemotherapy, regardless of PD-L1 status, in non-squamous patients with KRAS- and HER2-wild-type tumors and a current or former smoking history.

Vogt said the company is also evaluating whether its biomarker insights may apply to other solid tumors, including colorectal cancer, where Iovance is advancing its IOV-5001 program.

About Iovance Biotherapeutics (NASDAQ:IOVA)

Iovance Biotherapeutics, Inc NASDAQ: IOVA is a biotechnology company focused on developing and commercializing personalized cell therapies for patients with cancer. Its technology is based on tumor-infiltrating lymphocytes (TILs), immune cells collected from a patient's tumor, expanded outside the body, and reinfused to help attack cancer cells.

The company's lead product, Amtagvi (lifileucel), is an autologous TIL therapy approved in the United States for certain adults with unresectable or metastatic melanoma that has progressed following prior treatment.

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