Regeneron Pharmaceuticals has announced promising initial results from its Phase 1b LINKER-MM2 trial, evaluating linvoseltamab in combination with proteasome inhibitors carfilzomib or bortezomib for patients with relapsed/refractory multiple myeloma (R/R MM). These findings will be presented at the ASCO 2025 Annual Meeting on June 2.
In the linvoseltamab and carfilzomib cohort, 90% of evaluable patients (19 of 21) achieved an objective response, with 76% (16 of 21) reaching complete response. At 12 months, the estimated probability of maintaining a response was 87%, and progression-free survival was 83%. The patient population included individuals with high-risk features, such as prior exposure to proteasome inhibitors, baseline soft tissue plasmacytomas, and advanced age.
The combination of linvoseltamab and bortezomib also demonstrated high response rates, with an 85% objective response rate and 50% achieving complete response. Both combinations exhibited manageable safety profiles, with common treatment-emergent adverse events including neutropenia, cytokine release syndrome, and thrombocytopenia.
Key Highlights
- Linvoseltamab + Carfilzomib:** Among 21 evaluable patients, the objective response rate (ORR) was 90%, with 76% achieving a complete response. After 12 months, 87% maintained their response, and 83% were progression-free.
- Linvoseltamab + Bortezomib:** In 20 evaluable patients, the ORR was 85%, with 50% achieving a complete response.
- Safety: The most common side effects included neutropenia, cytokine release syndrome, diarrhea, and thrombocytopenia. Serious adverse events were reported, including some fatalities due to infections.
Both combinations showed strong clinical activity, even in patients previously treated with proteasome inhibitors. While these results are early, they point to linvoseltamab-based combinations as promising new options for R/R MM patients. Further studies, including a planned Phase 3 trial, will help determine if these benefits are sustained over time.
*Note: Linvoseltamab combinations are investigational and not yet approved for this use in any country.*
Sources
[1] linvoseltamab-in-combination-with-carfilzomib-or-bortezomib-shows-promising-initial-results-in-earli https://www.biospace.com/press-releases/linvoseltamab-in-combination-with-carfilzomib-or-bortezomib-shows-promising-initial-results-in-earlier-lines-of-treatment-for-relapsed-refractory-multiple-myeloma