Tafasitamab Combination Provides Prolonged, Durable Response in Patients with Aggressive DLBCL

MorphoSys US Inc and Incyte announced that combination of tafasitamab-cxix (Monjuvi; MorphoSys) and lenalidomide plus tafasitamab-cxix monotherapy provided a durable and prolonged response in patients with diffuse large B-cell lymphoma (DLBCL)—the most common type of non-Hodgkin lymphoma in adults, according to 5-year follow-up data from the L-MIND study presented in a late-breaking oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida.

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The study included 80 participants with relapsed or refractory DLBCL who had received at least 1 to 3 prior therapies (anti-CD20 target therapy included) and were not eligible for high-dose chemotherapy or refused subsequent autologous stem cell transplant (ASCT).

“Five-year data demonstrating durability of response is meaningful for oncologists as they consider the most appropriate treatment option for a patient,” said Johannes Duell, MD, University Hospital Würzburg Medical Clinic and Polyclinic, in a press release.

DLBCL is an aggressive and historically difficult-to-treat disease, according to Steven Stein, MD, chief medical officer, Incyte, in the press release. At least 40% of patients with DBLCL (the accumulation of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs) do not respond to initial treatment or relapse, and many are not eligible for an ASCT. These factors highlight the need for new and effective therapies.

L-MIND (NCT02399085) was a single arm, open-label phase 2 trial to determine the safety and efficacy of tafasitamab, a humanized Fc-modified CD19 targeting immunotherapy, with lenalidomide for patients with DLBCL. The primary endpoint was overall response rate (ORR), with key secondary endpoints that included duration of response (DoR), progression-free survival (PFS) and overall survival (OS).

At least 57.5% experienced ORR, 41.2% had a complete response (CR), and 16.2% had a partial response (PR). Treatment did not reach the secondary endpoint of DoR by 44 months. In addition, median OS was 33.5 months and median PFS was 11.6 months. Of note, patients who received 1 prior line of therapy had an ORR of 67.5%, whereas those with 2 or more had an ORR of 47.5%.

No new safety signals were observed, and the most common adverse events (AEs) included low-grade neutropenia and diarrhea. Other common AEs were fatigue, cough, fever, swelling in the lower legs or hands, respiratory tract infection, and decreased appetite.

In 2020, the FDA granted tafasitamab and lenalidomide accelerated approval, based on ORR from a 1-year primary analysis of L-MIND, for adult patients with relapsed or refractory DLBCL not otherwise specified and who are not ASCT-eligible. The 5-year data have not yet been reviewed or submitted by the FDA.

“The totality of the long-term L-MIND data presented at AACR further reinforce our confidence that the [tafasitamab] 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,” said Tim Demuth, MD, PhD, chief research and development officer, MorphoSys, in the press release.

Reference

Incyte, MorphoSys U.S. Inc. MorphoSys And Incyte Announce Five-Year Results Of L-MIND Study Showed Prolonged, Durable Responses In Relapsed Or Refractory DLBCL Patients Treated With Monjuvi® (Tafasitamab-Cxix). Incyte. News Relesae. April 16, 2023. Accessed April 17, 2023. https://investor.incyte.com/news-releases/news-release-details/morphosys-and-incyte-announce-five-year-results-l-mind-study