Abstract CT246: A phase 2 multicenter study of autologous tumor infiltrating lymphocytes (TIL, LN-145) cell therapy in patients with metastatic non-small cell lung cancer (mNSCLC)

Background Patients with mNSCLC without actionable driver mutation(s) who have progressed after cytotoxic chemotherapy plus immune checkpoint inhibitors (ICI) ± bevacizumab have limited treatment options and represent an unmet need. The safety and efficacy of TIL cell therapy for mNSCLC patients who failed to respond or progressed on nivolumab has been evaluated in a Phase 1 clinical trial (Creelan B., AACR 2020), demonstrating an objective response rate (ORR) of 25% including 17% durable CRs. This provides a clear rationale for initiation of IOV-LUN-202 study, evaluating Iovance Gen 2 TIL cell therapy with LN-145 in patients with mNSCLC without actionable driver mutation(s), who have progressed on or following a single line of approved systemic therapy consisting of combined ICI + chemotherapy ± bevacizumab. Trial Design IOV-LUN-202 (NCT04614103) is a prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study. Patient cohorts (n=40 ea) based on tumor proportion score (TPS) at metastatic diagnosis prior to ICI use are Cohort 1 (TPS