ImmunityBio Stock Soars On Cancer Trial Progress, FDA Timeline

Core Viewpoint - ImmunityBio Inc. has experienced a stock surge of over 100% year-to-date, driven by positive preliminary fourth-quarter results and promising trial data [1] Group 1: Anktiva Trial Update - Enrollment in the QUILT-2.005 trial for BCG-naïve non-muscle-invasive bladder cancer (NMIBC) has exceeded expectations, with over 85% completion anticipated by Q2 2026 [2] - A biologics license application (BLA) is expected to be submitted to the FDA by the end of 2026, following an interim analysis requested by the FDA to evaluate Anktiva's efficacy [3] - The interim analysis showed that Anktiva significantly prolonged the duration of complete response when combined with BCG, with 85% of patients maintaining a complete response at six months compared to 57% for BCG alone [4] Group 2: QUILT-106 Study Update - The ongoing QUILT-106 study of CAR-NK therapy combined with rituximab for Waldenström Non-Hodgkin lymphoma has shown sustained complete responses lasting up to 15 months, with 100% disease control observed [6] - Four patients have been enrolled in the study, all of whom remain in clinical disease control, with two patients demonstrating durable complete remission at seven and 15 months, respectively [7] - Notably, one patient with extensive disease at baseline achieved a complete response after just four doses of CAR-NK + rituximab, maintaining remission for 15 months without further treatment [9]