Gilead’s Kite presents Phase 1 data on KITE-753, KITE-363

Kite, a Gilead Company (GILD), presented Phase 1 data with efficacy and safety results for its two investigational bicistronic CAR T-cell therapies, KITE-753 and KITE-363, respectively, in patients with relapsed/refractory large B-cell lymphoma. The results of the analysis were shared in an oral presentation at the 67th American Society of Hematology, ASH, Annual Meeting and Exposition. Results for KITE-753 showed that at a median follow-up of 4.0 months overall and 2.9 months at dose level three, 11 of 14 CAR-naive patients receiving DL3 had a complete response, where the cancer completely disappeared. Bridging options in this Phase 1 study were limited to corticosteroid +/- radiation therapy, and all patients had measurable, active disease at the time of their infusion with KITE-753. No patients responded to these bridging therapy measures at DL3. Notably, KITE-753 demonstrated robust expansion despite a tenfold lower dose than DL3 of KITE-363, which highlights the proliferative capacity of KITE-753. Across all dose levels, 14 of 20 CAR-naive patients achieved a complete response. Overall, KITE-753 showed an encouraging safety profile with no dose-limiting toxicities.