Iovance Lung Cancer Therapy Shows 24.6% Response Rate In Updated Data, With FDA Filing Planned For 2027
The cell therapy maker also plans a Phase 3 frontline lung trial in 2027 and lists possible UK and Swiss Amtagvi approvals for the first quarter of 2027.
Iovance Biotherapeutics, which develops cell therapies for solid tumors, reported a 24.6% response rate (17 of 69 patients) for lifileucel in non-squamous lung cancer in an interim October 14, 2026 data cut. The company plans to file for FDA approval in that setting in 2027, according to an investor presentation attached to an 8-K filed Thursday.
Response rates in lung cancer
The 17 responders in the 69-patient group are 15 confirmed responses plus 2 unconfirmed partial responses. Standard chemotherapy in the same setting showed a 12.8% response rate in a separate study the deck cites.
In a biomarker-enriched subgroup of ever-smokers whose tumors lack EGFR, ALK, ROS1, KRAS and HER2 alterations, the rate was 59.1% (13 of 22, including one unconfirmed partial response). The deck also shows exploratory frontline results in small groups: 85.7% (6 of 7) in one and 64.3% (9 of 14) in another. The slides label the 6-of-7 group inconsistently, as EGFR wild-type only and as KRAS wild-type ever-smokers.
2027 filing and trial plans
Iovance plans to submit a supplemental biologics license application to the FDA in 2027 for second-line non-squamous lung cancer. A second submission for the biomarker-enriched population appears under 2028/2029 on one slide and 2028 on the trial slide.
It also plans to start OPTILISM, a Phase 3 trial of lifileucel plus pembrolizumab in frontline lung cancer, in 2027. The deck lists potential Amtagvi approvals in the UK and Switzerland in the first quarter of 2027, and planned 2027 submissions in the EU and Brazil. Soft tissue sarcoma submissions are slated for 2028/2029.
Melanoma as the platform
Amtagvi, a one-time therapy made from a patient's own immune cells, is approved for previously treated advanced melanoma. The deck casts that business as shared infrastructure, with more than 100 treatment centers and a Philadelphia manufacturing site, for later tumor types.
The deck repeats the company's raised 2026 revenue outlook of $410 million to $420 million, up from $350 million to $370 million. Third-quarter revenue was about $122 million, and cash was about $382 million at September 30, 2026, which the company says gives it runway well into 2029.
The next marks are the UK and Swiss decisions the deck lists for the first quarter of 2027 and the OPTILISM start later that year.
Sources
- 8-K Filing — IOVANCE BIOTHERAPEUTICS, INC. (IOVA) — SEC EDGAR
- Exhibit iova-ex99_1.htm — IOVANCE BIOTHERAPEUTICS, INC. 8-K exhibit — SEC EDGAR
- 8-K filed 2026-09-29 — IOVANCE BIOTHERAPEUTICS, INC. (earlier disclosure) — SEC EDGAR
