Talquetamab (Talvey)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Talvey be reimbursed by public drug plans for the treatment of adult patients with relapsed or refractory (r/r) multiple myeloma (MM) who have received at least 3 prior lines of therapy (LOTs), including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), an anti-CD38 monoclonal antibody (mAb), and a prior B-cell maturation antigen (BCMA)-directed therapy, and have demonstrated disease progression on or after the last therapy if certain conditions are met.
• CDA-AMC previously reviewed Talvey for a broader population of adults with r/r MM who had received at least 3 prior LOTs and had demonstrated disease progression on or after the last therapy and issued a recommendation not to reimburse. This resubmission focuses on a narrower population who have also received prior BCMA-directed therapy and includes new evidence to address gaps identified in the previous review.
• Evidence from the single-arm MonumenTAL-1 study showed that 66.7% of patients responded to Talvey, with responses lasting a median of 19.2 months. Results also suggested that Talvey may delay disease progression and help patients live longer. The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) considered the clinical experts’ input indicating that the treatment response, durability of response, and survival outcomes are clinically meaningful given the poor outcomes and limited treatment options in this population. Supportive evidence from the retrospective REALiTAL study showed generally consistent response and survival outcomes, with no new safety concerns identified. Evidence from an indirect treatment comparison (ITC) suggested that Talvey may improve survival and response compared with treatments used in clinical practice. However, confidence in the clinical value of Talvey was limited by limitations such as the phase I/II, single-arm, open-label study design of the MonumenTAL-1 trial and uncertainty about whether the treatments included in the ITC adequately represented treatment options used in Canadian clinical practice.
• pERC recognized that there is a significant unmet clinical need for patients with r/r MM who have received at least 3 prior LOTs and a BCMA-directed therapy because of poor outcomes and limited effective treatment options. pERC also acknowledged the challenges in generating comparative evidence in this heavily pretreated population. Considering these and the totality of the evidence reviewed, pERC recommended that Talvey be reimbursed because it may address the significant unmet clinical need sufficiently to warrant a positive recommendation despite the uncertainty in the clinical value.