Tafasitamab (Minjuvi)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Minjuvi not be reimbursed by public drug plans for adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from low grade lymphoma), excluding primary refractory disease, who are not eligible for autologous stem cell transplant (ASCT), and have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 2 or less.
• CDA-AMC previously reviewed Minjuvi plus lenalidomide in 2022 for the treatment of adult patients with r/r DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for ASCT, and issued a recommendation of not to reimburse. This is a resubmission based on a post hoc defined subpopulation of the L-MIND study which excluded patients with primary refractory disease and those with unconfirmed DLBCL histology. The resubmission included additional longer follow-up and health-related quality of life (HRQoL) data to address the gaps identified in the previous recommendation.
• The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that it is uncertain whether Minjuvi demonstrates acceptable clinical value versus appropriate comparators in adult patients with r/r DLBCL not otherwise specified (including DLBCL arising from low grade lymphoma), excluding primary refractory disease, who are not eligible for ASCT, and have an ECOG PS score of 2 or less. Appropriate comparators refer to polatuzumab vedotin-bendamustine-rituximab (pola-BR), rituximab-gemcitabineoxaliplatin (R-GemOx), glofitamab-gemcitabine-oxaliplatin (glofit-GemOx), epcoritamab, and glofitamab.
• Evidence from a subpopulation of patients enrolled in the phase II, open-label, single-arm L-MIND trial showed that treatment with Minjuvi in combination with lenalidomide resulted in clinically meaningful objective responses (i.e., partial or complete tumour responses) in patients with r/r DLBCL who did not have primary refractory disease and were ineligible for ASCT. However, the magnitude of clinical benefit attributable to tafasitamab plus lenalidomide remains uncertain because the evidence was derived from a small, post hoc subgroup within a nonrandomized and noncomparative study design. HRQoL, which is important for patients, was not assessed in the L-MIND trial, and the available real-world evidence was descriptive and may not be generalizable to patients in Canada. The committee reviewed additional evidence from 2 sponsor-submitted indirect treatment comparisons (ITCs) comparing Minjuvi plus lenalidomide with R-GemOx. However, important methodological limitations of ITCs precluded pERC from drawing firm conclusions regarding the comparative efficacy and safety of Minjuvi plus lenalidomide versus R-GemOx. No comparative evidence versus other relevant treatment options was available.
• The committee considered whether the drug would address significant unmet clinical or nonclinical needs. pERC acknowledged an unmet need for additional treatment options for patients with r/r DLBCL who are ineligible for ASCT, particularly treatments that prolong survival and remission, control symptoms, improve HRQoL, and have manageable side effects. However, the committee was unable to determine that Minjuvi plus lenalidomide addresses this unmet need with an acceptable level of certainty in clinical value because of the absence of comparative evidence versus other relevant treatment options and uncertainty regarding its efficacy, safety, HRQoL benefits, and tolerability in this patient population. The committee also acknowledged health inequities for patients with r/r DLBCL, including geographic and logistical barriers to accessing specialized therapies. However, pERC was unable to determine whether Minjuvi plus lenalidomide adequately addressed these unmet nonclinical needs and health inequities, as the treatment requires frequent infusions and access to infusion services, which may remain challenging for some patients.
• Based on all of the preceding considerations, pERC recommended that Minjuvi plus lenalidomide not be reimbursed.