Comparative Efficacy of Talquetamab vs. Real-World Physician's Choice of Treatment in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma: Updated Analyses of MonumenTAL-1 vs. LocoMMotion/MoMMent.
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Einsele Hermann, Moreau Philippe, Bahlis Nizar, Bhutani Manisha, Vincent Laure, Karlin Lionel, Perrot Aurore, Goldschmidt Hartmut, van de Donk Niels W C J, Ocio Enrique M, Martínez López Joaquín, Rodríguez-Otero Paula, Dytfeld Dominik, Jakubowiak Andrzej, Schinke Carolina, Besemer Britta, Anguille Sébastien, Manier Salomon, Rasche Leo, Teipel Raphael, Scheid Christof, Pawlyn Charlotte, Cavo Michele, Diels Joris, Ghilotti Francesca, Lau Bonnie W, Renaud Thomas, Orel Oleksiy, Ong Fenny, Ramos Diogo F, Ammann Eric, Parekh Trilok, Albrecht Claire, Weisel Katja, Mateos María-Victoria
Аннотация
METHODS: External control arms were created for three MonumenTAL-1 cohorts, two without prior T cell redirection (TCR) therapies who received subcutaneously administered talquetamab 0.4 mg/kg weekly (QW; n = 143) or 0.8 mg/kg every other week (Q2W; n = 154) and one with prior B cell maturation antigen (BCMA) TCR (n = 75) who received either schedule (median follow-up [mFU] 38.2, 31.2, and 30.3 months, respectively), from two real-world studies, LocoMMotion (mFU 26.4 months) and MoMMent (mFU 27.1 months). Imbalances in baseline covariates were adjusted using inverse probability weighting and multivariable regression. The relative effectiveness of talquetamab vs. RWPC was estimated for overall response rate (ORR), ≥ very good partial response (VGPR) rate, and ≥ complete response (CR) rate; odds ratios and relative response ratios (RRs) were derived from weighted logistic regression. Hazard ratios (HRs) for duration of response (DOR), progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS) were estimated using a weighted Cox proportional-hazards model.
RESULTS: In the TCR-naïve cohort, talquetamab Q2W had significantly improved outcomes vs. RWPC; RRs were ORR, 2.58; ≥ VGPR, 5.01; ≥ CR, 52.22 and HRs were DOR, 0.52 (p = 0.0011); PFS, 0.47; TTNT, 0.46; OS, 0.35 (all p < 0.0001). Results were similar in the QW cohort. The prior TCR cohort had favorable outcomes with talquetamab vs. RWPC; RRs were ORR, 3.03; ≥ VGPR, 4.88 and HRs were DOR, 0.09, (p = 0.0004); PFS, 0.30 (p < 0.0001); TTNT, 0.26 (p < 0.0001) and OS, 0.37 (p = 0.0020).
CONCLUSION: With longer follow-up, these comparative analyses further demonstrate the clinical benefit of talquetamab over RWPC in patients with TCE RRMM, irrespective of prior TCR therapy.
TRIAL REGISTRATION: MonumenTAL‑1, ClinicalTrials.gov identifier NCT03399799/NCT04634552; LocoMMotion, ClinicalTrials.gov identifier NCT04035226; MoMMent, ClinicalTrials.gov identifier NCT05160584.