ELREXFIO (elranatamab) - Multiple myeloma

The Committee deems that the clinical benefit of ELREXFIO (elranatamab) 40 mg/mL solution for injection is substantial as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Considering: 

• efficacy data from a non-comparative phase 1/2 trial, with an overall response rate (primary endpoint) of 61% (CI95% [51.8; 69.6]) in a life-threatening situation;
• the absence of comparative data with an assessment based on a phase 2 study
  (MagnetisMM-3), the results of which do not enable any robust conclusion to be reached with respect to the therapeutic contribution of elranatamab compared to the available alternatives in adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody;
• limited follow-up on the safety data of elranatamab, with a median follow-up of 14.7 months in the MagnetisMM-3 trial, and a profile marked, in particular, by the frequent occurrence of adverse events of particular interest, of low grade in the majority of cases, such as cytokine release syndrome (CRS) and neurotoxicity (ICANS);
• a partially met medical need with a benefit of having an additional alternative in patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody;
• and pending the results of the phase 3 trial (MagnetisMM-5) comparing elranatamab as monotherapy or in combination with daratumumab versus daratumumab + pomalidomide +
  dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least one prior treatment line, and a maximum of three prior treatment lines, including
  lenalidomide and a proteasome inhibitor;

the Committee deems that, on the basis of currently available data, and pending the results of the phase 3 MagnetisMM-5 trial, ELREXFIO (elranatamab) as monotherapy provides no clinical added value (CAV V) in the care pathway for adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

The Committee considers that the ELREXFIO (elranatamab) development plan proposed by the operating company is likely to provide data that will enable its assessment to be updated. It certifies that this development plan is ongoing, incorporating a phase 3 clinical trial (MagnetisMM-5). The results are expected before 31 December 2024 by the Committee, which will reassess this proprietary medicinal product in the light of these data in 2025.