Linvoseltamab (LINVO) + bortezomib (BTZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): First results from the LINKER-MM2 trial.
As of Sept 30, 2024, 22 pts had received tx (DL1: n=6; DL2: n=16). Median follow-up duration was 6.3 mos (range 1–21), with 55% of pts still receiving tx. Median age was 68.5 yrs (range 45–77), 68% were male, 23% had ISS stage III, and 55% had extramedullary or paraskeletal disease. Median prior LoT was 3 (range 2–9), including 86% of pts with TCE and 41% with triple-class refractory disease; 59% were refractory to ≥1 PI (9% BTZ-refractory).
Among evaluable pts, ORR was 79% (11/14; DL1 80% [4/5]; DL2 78% [7/9]). The 6-month DOR rate was 90% (95% CI 47–99) and 6-month PFS rate was 79% (95% CI 47–93). PK analysis found LINVO concentrations were not affected by addition of BTZ.
The most common TEAEs were neutropenia (any Grade [Gr] 59%; Gr 3–4 45%), thrombocytopenia (50%; 36%), and cytokine release syndrome (55%; 0%). ICANS was reported in 4 pts (all Gr 1–2 with onset during step-up dosing). Infections were reported in 82% of pts (Gr 3–4 36%); 1 pt died of pneumonia ≤30 days after last dose before start of combination tx. One DLT occurred at DL2 (Gr 3 CMV colitis on day 48; resolved with tx delay and ganciclovir).