Benzinga | Jun 4, 2021 01:46PM EDT

Incyte, MorphoSys Announce 3-Year Results From Phase 2 L-MIND Study Of Tafasitamab In Combination With Lenalidomide For Treatment Of Relapsed Or Refractory DLBCL

-- Presentation will be available on demand as part of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

Incyte (NASDAQ:INCY) and MorphoSys US Inc., a fully owned subsidiary of MorphoSys AG ((FSE: MOR, NASDAQ:MOR), today announced new three-year follow-up data from the ongoing Phase 2 L-MIND study of tafasitamab (Monjuvi(r)) in combination with lenalidomide in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). A total of 80 out of 81 enrolled study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis at approximately three years follow-up (?35 months)1.The long-term analysis, as assessed by an independent review committee (IRC), showed that patients treated with tafasitamab plus lenalidomide had an overall response rate (ORR) of 57.5% (95% CI = 45.9, 68.5; 46 out of 80 patients), including a complete response (CR) rate of 40% (32 out of 80 patients). Additionally, the median duration of response (DoR) was 43.9 months (95% CI = 26.1, Not Reached [NR]), with a median overall survival (OS) of 33.5 months (95% CI = 18.3, NR) and median progression free survival (PFS) of 11.6 months (95% CI = 6.3, 45.7).

These data (abstract #7513) are available on demand as part of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually June 4-8, 2021, and will be presented as a poster and poster discussion in the Hematologic Malignancies--Lymphoma and Chronic Lymphocytic Leukemia session.

"The three-year efficacy data, combined with the safety and tolerability profile of tafasitamab, further support a therapeutic option for patients with relapsed or refractory DLBCL who are ineligible for transplant -- a traditionally difficult-to-treat population," said Gilles Salles, M.D., Ph.D., Lymphoma Service Chief at Memorial Sloan Kettering Cancer Center, and lead investigator of the L-MIND study*. "I am encouraged to see the confirmed favorable outcome of patients in the L-MIND study, which suggest that this combination treatment regimen could potentially offer a paradigm shift and long-term disease control."

The new results -- based on an October 30, 2020 data cut-off -- build on previous findings showing durable responses and a consistent safety profile of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in autologous stem cell transplantation (ASCT)-ineligible patients with relapsed or refractory DLBCL.

"We are pleased that long-term data from the L-MIND study underscore the clinically-significant durable responses that are possible with tafasitamab plus lenalidomide as a treatment for relapsed or refractory DLBCL," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "We look forward to continuing to build the body of clinical evidence supporting tafasitamab as a treatment option for patients with DLBCL, as well as exploring other potential indications for tafasitamab through our ongoing research and development program."

"The three-year follow-up data not only show a durable response and consistent safety profile in patients with relapsed or refractory DLBCL treated with tafasitamab plus lenalidomide, it also suggests the combination could potentially lead to durable remission," said Nuwan Kurukulasuriya, Ph.D., Senior Vice President, Global Head of Medical Affairs, MorphoSys. "We are looking forward to sharing these long-term follow-up findings with the scientific community."

In July 2020, the U.S. Food and Drug Administration (FDA) approved Monjuvi(r) (tafasitamab-cxix) 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 ASCT. This indication is approved under accelerated approval based on ORR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The U.S. approval is based on an efficacy subgroup of 71 patients confirmed by central lab. The FDA decision represented the first approval of a second-line treatment for adult patients with DLBCL who progressed during or after first-line therapy.