MorphoSys : Long-term Data Show Prolonged, Durable Responses In DLBCL Patients Treated With Monjuvi

(RTTNews) - MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (MOR), and Incyte (INCY) announced final five-year follow-up data from the Phase 2 L-MIND study showing that Monjuvi (tafasitamab-cxix) plus lenalidomide followed by Monjuvi monotherapy provided prolonged, durable responses in adult patients with relapsed or refractory diffuse large B-cell lymphoma or DLBCL.

At the data cut-off (November 14, 2022) for the full analysis set (80 patients), the overall response rate was 57.5%, and a complete response was observed in 41.2% of patients. A partial response was observed in 16.2% of patients.

MorphoSys said that the totality of the long-term L-MIND data presented at the American Association for Cancer Research further reinforced its confidence that the Monjuvi plus lenalidomide combination remains the in-practice, outpatient, targeted immunotherapy option that can provide sustained remissions for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant.

According to the company, no new safety signals were identified. The majority of adverse events were grade 1 or grade 2 during both combination and monotherapy treatment. Patients experienced a lower frequency of all-grade and grade 3 or higher adverse events during monotherapy. The most common adverse events with combination therapy were neutropenia and thrombocytopenia, which declined after patients switched to monotherapy. Neutropenia and diarrhea were the most common adverse events in the first two years of monotherapy.

In July 2020, the U.S. Food and Drug Administration approved Monjuvi in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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