TALVEY (talquetamab) - Multiple myeloma

The Committee deems that the clinical benefit of TALVEY (talquetamab) 2 mg/ml and 40 mg/ml is moderate in the MA indication.

Considering: 

• efficacy data from a non-comparative phase 1/2 trial, with an overall response rate (primary endpoint) of 74.1% (CI95%: [66.1%; 81.1%]) for cohort A and 71.7% (CI95%: [63.7%; 78.9%]) for cohort C with a follow-up of 18.8 and 12.7 months respectively in a life-threatening situation;
• the absence of comparative data with an assessment based on a phase 1/2 study (Monumental-1), the results of which do not enable any robust conclusion to be reached with respect to the therapeutic contribution of talquetamab 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 talquetamab 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); frequent mucocutaneous toxicity should be noted for this bispecific antibody;
• 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;

the Committee deems that, on the basis of currently available data, TALVEY (talquetamab) 2 mg/ml and 40 mg/ml 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.