Iovance Biotherapeutics reports clinical data from Phase 2 IOV-LUN-202 trial

Iovance Biotherapeutics (IOVA) announced interim data from its registrational Phase 2 IOV-LUN-202 trial of lifileucel monotherapy in patients with previously treated advanced nonsquamous NSCLC without actionable genetic mutations. The objective response rate was 25.6% by RECIST v1.1 following one-time treatment with lifileucel monotherapy in patients with advanced nonsquamous NSCLC. An objective response was observed in 10 out of 39 patients, including 2 complete responses, 7 partial responses, and 1 unconfirmed PR (pending confirmatory assessment), with a disease control rate of 71.8%.1 The median duration of response was not reached after a median follow up of 25.4 months. Iovance will present additional data from the IOV-LUN-202 trial at an upcoming medical meeting in 2026. The U.S. Food and Drug Administration previously provided positive regulatory feedback on the IOV-LUN-202 trial design and the proposed potency assay matrix to support registration. This trial design aligns with FDA guidance for single-arm trials to support accelerated approvals in conditions with unmet medical need. The IOV-LUN-202 trial is expected to progress in 2026 towards a supplemental Biologics License Application for lifileucel in nonsquamous NSCLC and a potential launch in the second half of 2027. Following initial treatment with immune checkpoint inhibitor and chemotherapy, patients with advanced NSCLC have limited treatment options and often receive chemotherapy, which has limited durability. Standard-of-care docetaxel monotherapy in patients with nonsquamous NSCLC previously treated with immune checkpoint inhibitors and chemotherapy has recently shown an ORR of 12.8% with an mDOR of 5.6 months and overall survival of 12.3 months, without any complete responses. The safety profile for the lifileucel treatment regimen was consistent with the underlying disease, non-myeloablative lymphodepletion, and interleukin-2. Improvements in the overall safety profile have been observed, without affecting efficacy, following the introduction of an updated regimen of reduced NMA-LD for IOV-LUN-202. Patients treated with the updated regimen showed a reduction of median post-IL-2 hospitalization days by more than half and lower incidence and shorter time to resolution of cytopenias compared with the initial regimen.