Efficacy

Efficacy of Tazverik (tazemetostat) for Lymphoma

Tazverik (tazemetostat) is an orally administered EZH2 inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies. The efficacy of Tazverik in this indication was evaluated in a phase II clinical trial, which demonstrated a meaningful response rate in patients with EZH2 mutant FL. The overall response rate (ORR) was observed to be significantly higher in patients with EZH2 mutations compared to those without such mutations, indicating that Tazverik is particularly effective in the genetically defined subset of FL patients.

For patients with relapsed or refractory FL without an EZH2 mutation, Tazverik was also granted accelerated approval based on ORR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. In the clinical trial setting, Tazverik has shown a manageable safety profile, and the responses achieved have been durable, which is a critical aspect for patients with this chronic and often relapsing form of lymphoma.

Efficacy of Monjuvi (tafasitamab-cxix) for Lymphoma

Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody given in combination with lenalidomide, approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). The approval of Monjuvi was based on a multicenter, single-arm, open-label phase II study (L-MIND trial) that demonstrated significant efficacy in terms of ORR and complete response (CR) rate in the treated population. The combination of tafasitamab and lenalidomide was shown to induce a high rate of objective responses, with a considerable proportion of patients achieving a complete response, which is noteworthy for this patient population with limited treatment options.

The durability of responses to Monjuvi, particularly in combination with lenalidomide, has been a highlight of the clinical trial results, with many patients maintaining their responses for extended periods. This is particularly important in the context of relapsed or refractory DLBCL, where treatment goals include extending survival and improving quality of life. The safety profile of Monjuvi in combination with lenalidomide is consistent with the known profiles of each agent, and the combination therapy has been generally well tolerated in clinical trials.