Progression-Free Survival

Arcellx reported Phase 2 iMMagine‑1 results for its CAR‑T therapy anito‑cel in relapsed/refractory multiple myeloma. Among 117 patients, the overall response rate reached 96% with 74% achieving complete or stringent complete responses; 95% of evaluable patients attained MRD negativity, 83% sustaining it >6 months. Twelve‑month progression‑free and overall survival were 82.1% and 94.0%, respectively, with median PFS/OS not yet reached. Safety was favorable, showing no delayed neurotoxicities. The company reaffirmed a 2026 U.S. launch in partnership with Kite, aiming for broader global rollout.

Phase 3 CARTITUDE‑4 data show that a single infusion of CARVYKTI (ciltacabtagene autoleucel) given as second‑line therapy to standard‑risk multiple myeloma patients yields 80.5 % progression‑free survival at 30 months, with all MRD‑negative responders remaining disease‑free. Translational analyses link higher baseline CD4⁺ naïve T‑cells and an activated bone‑marrow microenvironment to improved outcomes. Safety remains consistent (84 % CRS, 13 % ICANS, low grade ≥3 rates). FDA approval now includes earlier‑line use, positioning CARVYKTI for broader market share and supporting future combination and allogeneic trials.

Ascentage Pharma’s olverembatinib demonstrated promising Phase Ib results in SDH-deficient GIST, with an ORR of 23.1% and CBR of 84.6%. Median PFS reached 25.7 months. Translational analyses revealed CD36 overexpression and dysregulated lipid metabolism. Olverembatinib reduced CD36 and lipid uptake while inhibiting HIF, FGFR, and VEGFR pathways. It holds Breakthrough Therapy Designation in China. A global Phase III trial (POLARIS-3, NCT06640361) is ongoing.