The updated guidelines now include tafasitamab-cxix in combination with lenalidomide with a category 2A designation as an option for the treatment of previously-treated adult patients with relapsed or refractory DLBCL not otherwise specified.
The National Comprehensive Cancer Network (NCCN) has added tafasitamab-cxix (Monjuvi) to the Clinical Practice Guidelines in Oncology for B-cell Lymphomas, according to MorphoSys and Incyte, the co-developers of the agent.1
Specifically, the updated guidelines now include tafasitamab-cxix in combination with lenalidomide with a category 2A designation as an option for the treatment of previously-treated adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma who are ineligible for autologous stem cell transplant (ASCT).
“We are very gratified the NCCN acted quickly to include [tafasitamab-cxix] in combination with lenalidomide with a Category 2A designation in its Clinical Practice Guidelines in Oncology as a treatment for patients with relapsed or refractory DLBCL who are not candidates for transplant. This targeted therapeutic option helps address an immediate medical need for patients who previously had limited treatment options,” Malte Peters, chief research and development officer at MorphoSys, said in a press release. “There is no other FDA-approved second line treatment for these patients with a 2A designation within the NCCN guidelines.”
Tafasitamab-cxix was approved by the FDA in combination with lenalidomide under accelerated approval on July 31, 2020 for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DBLCL arising from low grade lymphoma, and those who are not eligible for ASCT. The approval was based on data from the open label, multicenter, single arm, phase 2 L-MIND study. However, continued approval for this indication may be dependent upon verification and description of clinical benefit in a confirmatory trial(s).
Data from the primary analysis of the L-MIND were presented at the 15th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, with a cut-off date of November 30, 2018.2 In total, 80 patients who had received a median of 2 prior treatment lines were enrolled in the trial with a median age of 72 years.
The primary endpoint of best objective response rate (ORR) compared to published data on the respective monotherapies was met. The ORR was 60%, and the complete response (CR) rate was 43%. Moreover, 82% of the CRs were positron emission tomography (PET)-confirmed.
The median progression-free survival (PFS) was 12.1 months with a median follow-up of 17.3 months. Responses were durable with a median duration of response (DoR) of 21.7 months. However, median overall survival (OS) was not reached (95% CI, 18.3 months – not reached) with a median follow-up time of 19.6 months. The 12-month OS rate was 73.3%.
Overall, the combination of tafasitamab-cxix and lenalidomide was generally well tolerated in this study. Infusion-related reactions (IRRs) for tafasitamab were reported for only 6% of the patients and were limited to grade 1. The most frequent treatment-emergent adverse events (TEAEs) with a toxicity of grade 3 or higher were neutropenia (48%), thrombocytopenia (17%), and anemia (7%). Treatment-related serious AEs occurred in 15 (18.5%) patients, the majority of which were infections or neutropenic fever. Further, 37 (43%) patients required dose reduction with lenalidomide and 62 patients (78%) were able to stay on a daily lenalidomide dose of 20 mg or higher.
“The inclusion of [tafasitamab-cxix] in the NCCN Guidelines will help further inform healthcare providers of this advancement for patients,” Peg Squier, MD, group vice president of US Medical Affairs at Incyte, said in the release. “We believe [tafasitamab-cxix] has the potential to address an urgent medical need for patients with relapsed or refractory DLBCL and are pleased that the NCCN has acknowledged the clinical benefit of this targeted therapeutic option.”
1. National Comprehensive Cancer Network® Adds Monjuvi® (tafasitamab-cxix) to its Clinical Practice Guidelines in Oncology for B-cell Lymphomas [news release]. Planegg, Germany and Munich and Wilmington, Delaware. Published August 18, 2020. Accessed August 20, 2020. https://www.businesswire.com/news/home/20200818005684/en/
2. MorphoSys Presents Primary Analysis Data from L-MIND Study of Tafasitamab (MOR208) in combination with Lenalidomide in r/r DLBCL at ICML 2019 [news release]. Planegg/Munich. Published June 22, 2019. Accessed August 20, 2020.