Iovance Biotherapeutics (IOVA) Earnings Call Presentation

Efficacy Highlights - The study demonstrated a high Objective Response Rate (ORR) of 65.2% in ICI-naive advanced melanoma patients treated with lifileucel + pembrolizumab [25], with a Complete Response (CR) rate of 30.4% [25] - All response-evaluable patients (N=22) showed regression of target lesions [5, 25] - The median Duration of Response (mDOR) was not reached, indicating durable responses, with a median follow-up of 21.7 months [36, 39] - 73.3% of responders had a Duration of Response (DOR) of at least 6 months, and 53.3% had a DOR of at least 12 months [36] Safety Profile - The safety profile of lifileucel combined with pembrolizumab is considered manageable and differentiated from ICI combination regimens [5, 51] - Common non-hematologic Treatment-Emergent Adverse Events (TEAEs) included chills (82.6%), pyrexia (78.3%), and nausea (78.3%) [18] - Grade 3/4 hematologic lab abnormalities, such as neutropenia, lymphopenia, leukopenia, and thrombocytopenia, resolved to Grade ≤2 by Day 30 in a high percentage of patients (ranging from 78.3% to 100%) [22] Trial Design and Future Directions - IOV-COM-202 is a Phase 2, multicohort, multicenter study evaluating lifileucel + pembrolizumab in patients with solid tumors, including ICI-naive melanoma [9, 10] - These results support the ongoing TILVANCE-301, a registrational, randomized Phase 3 trial assessing lifileucel + pembrolizumab in frontline advanced melanoma [5, 43]