Multiple myeloma

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.

GSK’s *Blenrep* (belantamab mafodotin-blmf) has received FDA approval for relapsed or refractory multiple myeloma patients after at least two prior therapies. Backed by the DREAMM-7 trial, *Blenrep* combined with bortezomib and dexamethasone showed a 51% reduction in death risk and tripled progression-free survival compared to a daratumumab-based triplet. *Blenrep* is the only anti-BCMA agent accessible in community settings, with a streamlined REMS program. GSK is actively developing *Blenrep* for earlier lines of treatment, with ongoing trials and data expected in the coming years.

C4 Therapeutics announced positive Phase 1 results for cemsidomide in relapsed/refractory multiple myeloma. The drug demonstrated a 50% overall response rate at the highest dose, a favorable safety profile with no treatment discontinuations, and promising immunomodulatory effects. The company plans to initiate Phase 2 trials in Q1 2026 for fourth-line therapy and Phase 1b trials in Q2 2026 for second-line therapy in combination with BCMA BiTE, pursuing two potential accelerated approval pathways. The trial included 72 heavily pre-treated patients.

Johnson & Johnson announced promising results from the Phase 2 RedirecTT-1 study, which evaluated TALVEY (talquetamab) and TECVAYLI (teclistamab) in extramedullary multiple myeloma (EMD) patients. The combination therapy showed an impressive 78.9% overall response rate. These findings suggest a potential off-the-shelf treatment approach for a patient population with limited options and significant unmet needs.