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LINKER-MM1

Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma (LINKER-MM1)

Phase 1/2NCT03761108

Population
Relapsed or refractory myeloma that progressed on or after three or more lines including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody, or was triple-class refractory; 200 mg cohort median age 70 years, 39% high-risk cytogenetics, 28% penta-refractory.
Design
First-in-human phase I/II trial of the BCMA x CD3 bispecific antibody linvoseltamab at 50 mg and 200 mg doses. Phase II treatment was weekly through week 14 and then every 2 weeks; 200 mg patients with a very good partial response or better by week 24 moved to every 4 weeks. The primary end point in phase II was overall response rate.
Primary endpoint
ORR
Arms
  • Linvoseltamab 50 mg (experimental, n = 104): Linvoseltamab 50 mg
  • Linvoseltamab 200 mg (experimental, n = 117): Linvoseltamab 200 mg
People
Bumma N
Show the numbers
Results reported for LINKER-MM1
EndpointAnalysisLinvoseltamab 50 mg / Linvoseltamab 200 mgControlEffect
ORRPatients treated at each dose level (200 mg: 117, of whom 105 in phase II and 12 in phase I; 50 mg: 104, all phase II)primaryBumma 202471%—Median follow-up was 14.3 months at 200 mg and 7.4 months at 50 mg. At 200 mg, cytokine release syndrome was grade 1 in 35.0%, grade 2 in 10.3% and grade 3 in 0.9%; ICANS occurred in 7.7%; infections in 74.4% (grade 3, 33.3%; grade 4, 2.6%).
≥CR ratePatients treated at each dose level (200 mg: 117, of whom 105 in phase II and 12 in phase I; 50 mg: 104, all phase II)primaryBumma 202450%——
DOR200 mg responders (83 of 117)primaryBumma 2024median 29.4 months—95% CI 19.2 to not evaluable (lower bound only, so no interval is recorded).
Results reported for LINKER-MM1
EndpointAnalysisLinvoseltamab 50 mg / Linvoseltamab 200 mgControlEffect
ORRPatients treated at each dose level (200 mg: 117, of whom 105 in phase II and 12 in phase I; 50 mg: 104, all phase II)primaryBumma 202471%—Median follow-up was 14.3 months at 200 mg and 7.4 months at 50 mg. At 200 mg, cytokine release syndrome was grade 1 in 35.0%, grade 2 in 10.3% and grade 3 in 0.9%; ICANS occurred in 7.7%; infections in 74.4% (grade 3, 33.3%; grade 4, 2.6%).
≥CR ratePatients treated at each dose level (200 mg: 117, of whom 105 in phase II and 12 in phase I; 50 mg: 104, all phase II)primaryBumma 202450%——
DOR200 mg responders (83 of 117)primaryBumma 2024median 29.4 months—95% CI 19.2 to not evaluable (lower bound only, so no interval is recorded).
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0204060Months (modelled)
  • Linvoseltamab 200 mg (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsLinvoseltamab 200 mg
0100.0%
1865.4%
3741.8%
5527.3%
7417.5%
Primary publication: Bumma N, Richter J, Jagannath S, Lee HC, Hoffman JE, Suvannasankha A, et al. Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2024;42(22):2702-2712. PubMedDOI

Appears in

Sources

  1. Bumma N, Richter J, Jagannath S, Lee HC, Hoffman JE, Suvannasankha A, et al. Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2024;42(22):2702-2712.

    PubMedDOI