Benzinga | Dec 11, 2021 12:21PM EST

MorphoSys and Incyte Announced Additional Real-World Evidence Results from RE-MIND2 Study of Tafasitamab (Monjuvi) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma at ASH; Said Results Indicate Significant Overall Survival Improvement Compared With Pola-BR and R2

MorphoSys US Inc., a fully owned subsidiary of MorphoSys AG (NASDAQ:MOR), and Incyte (NASDAQ:INCY) today announced additional real-world evidence results from the RE-MIND2 study comparing tafasitamab (Monjuvi(r)) in combination with lenalidomide against the most frequently used treatments in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). These treatments include polatuzumab vedotin plus bendamustine and rituximab (Pola-BR), rituximab plus lenalidomide (R2), and CD19 chimeric antigen receptor T-cell (CAR-T) therapies. The data, which builds on the primary analysis presented at the 2021 Annual Meeting of the Society of Hematologic Oncology (SOHO 2021), will be presented as an oral presentation at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held December 11-14, 2021 in Atlanta, Georgia and virtually.

"In this retrospective cohort analysis, a statistically significant OS difference was observed, favoring tafasitamab plus lenalidomide over pola-BR and R2 in patients with relapsed or refractory DLBCL who are ineligible for transplant a traditionally difficult-to-treat population," said Grzegorz Nowakowski, M.D., Professor of Medicine and Oncology at the Mayo Clinic, and lead investigator for the RE-MIND2 study*. "I am encouraged by the OS difference favoring tafasitamab plus lenalidomide and the comparable OS between tafasitamab and lenalidomide and CAR-T, specifically the potential prolonged survival benefit the tafasitamab plus lenalidomide combination may offer my patients."

Findings from the RE-MIND2 study presented at ASH 2021 indicated that tafasitamab plus lenalidomide resulted in statistically significant differences across several endpoints. Specifically, results showed:

The primary endpoint, overall survival (OS), was met with significant improvement observed for tafasitamab plus lenalidomide at 20.1 months compared to Pola-BR at 7.2 months (p=0.038), and 24.6 months for tafasitamab plus lenalidomide compared to 7.4 months for R2 (p=0.014).A comparable median OS benefit was observed with tafasitamab plus lenalidomide at 22.5 months compared to CAR-T at 15 months without statistical significance.Objective response rate (ORR), a key secondary endpoint, was observed with statistical significance for tafasitamab plus lenalidomide at 63.6% versus R2 at 30.3% (p=0.013).Tafasitamab plus lenalidomide also achieved significantly higher complete response rate (CR), a key secondary endpoint, at 39.4% versus 15.2% for R2 (p=0.0514).While safety endpoints were not included in this study, the most common adverse events (AEs) associated with tafasitamab plus lenalidomide are feeling tired or weak, diarrhea, cough, fever, swelling of lower legs or hands, respiratory tract infection and decreased appetite.Of 3,454 patients enrolled from 200 sites, 106, 106 and 149 patients were treated with pol-BR, R2 and CAR-T, respectively. For the comparative analysis, matched patient pairs were created using 1:1 nearest neighbor matching with a caliper. Matched pairs consisted of: tafasitamab + len vs pol-BR, n=24 pairs; vs R2, n=33; and vs CAR-T, n=37 pairs.

"The RE-MIND 2 Study is an example of our continued commitment to generating practice relevant real-world evidence which, in general, more realistically captures the clinical heterogeneity in cancer and allows us expanded opportunities to dynamically assess the patient experience. These data indicate that tafasitamab plus lenalidomide is a meaningful option for patients and has the potential to become a future backbone therapy in DLBCL," said Nuwan Kurukulasuriya, Ph.D., Senior Vice President, Global Head of Medical Affairs, MorphoSys.

"We are pleased to see the survival benefit for patients with relapsed or refractory DLBCL in the data from the RE-MIND2 study," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "As we continue to establish tafasitamab in combination with lenalidomide as the standard of care in second-line treatment for DLBCL, we look forward to exploring the body of clinical evidence and bringing this novel treatment to patients with DLBCL and potentially even to other indications."

Presentations are available on the ASH website at https://www.hematology.org/meetings/annual-meeting; #183 (oral presentation).

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.