Tafasitamab-Cxix With Rituximab, Lenalidomide Approved by FDA for Relapsed/Refractory Follicular Lymphoma

The FDA has approved tafasitamab-cxix (Monjuvi; Incyte) in combination with rituximab (Rituxan; Genentech) and lenalidomide (Revlimid; Bristol Myers Squibb) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL), according to a news release from Incyte.¹

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Positive Results From inMIND Trial Bolster Tafasitamab-Cxix

Approval is based on positive results from the phase 3 inMIND clinical trial (NCT04680052), presented as a late-breaking abstract at the 2024 American Society of Hematology Annual Meeting and Exposition. The trial enrolled 548 patients who had received at least 1 prior line of therapy. In the trial, tafasitamab-cxix with lenalidomide and rituximab led to clinically meaningful improvements in progression-free survival (PFS) for patients with R/R FL.^2,3

Among the patients, at a median follow-up point of 14.1 months, the addition of tafasitamab-cxix to lenalidomide and rituximab demonstrated a significantly reduced risk of progression, relapse, or death compared with placebo, with a median PFS of 22.4 months compared with 13.9 months. This PFS benefit was observed to be consistent in all prespecified subgroups, according to an analysis by the investigators.²

“In the phase 3 inMIND trial, tafasitamab demonstrated impressive efficacy and safety for treating certain patients with follicular lymphoma, the most common type of B-cell non-Hodgkin lymphoma,” Steven Stein, MD, chief medical officer of Incyte, said in the news release. “These data, the first to evaluate the novel approach of combining CD19 and CD20 immunotherapies, show the potential of tafasitamab in combination with lenalidomide and rituximab to become a new standard of care for these patients.”¹

Safety and Use Compared With Alternative Regimens

Safety was also evaluated in this patient population. Investigators found that serious adverse events (AEs) occurred in 33% of patients treated with tafasitamab-cxix in combination with rituximab and lenalidomide, with serious infections occurring in 24% of patients, including COVID-19 and pneumonia. The most common adverse events in patients receiving tafasitamab-cxix were reported to be respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.^1,2

Lenalidomide and rituximab is an approved standard of care regimen for patients with FL following at least 1 prior line of treatment. However, immunotherapeutic approaches are preferred due to their increased efficacy, though they face durability issues. Tafasitamab, a humanized monoclonal antibody, is designed to target CD19 and induce direct cytotoxicity against cancer cells, enhancing macrophage immune-mediated mechanisms in patients with FL. It was previously approved in combination with lenalidomide for the treatment of diffuse large B-cell lymphoma (DLBCL), but up until inMIND, it was not vigorously studied in a phase 3, FL setting.^2,4

FL represents up to 30% of non-Hodgkin lymphoma (NHL) cases and is known as the second most common type of NHL. Often, NHL is a treatable disease with a slow-growing nature and prolonged survival. But FL is difficult to treat because of the tendency of the disease to relapse, often necessitating multiple lines of treatment that can have reduced efficacy over time and elicit serious AEs. The approval of tafasitamab-cxix will offer patients a new option in combination with standard of care for durable and safe treatment of FL.¹

“Follicular lymphoma is generally an indolent yet chronic cancer that frequently recurs after treatment, making long-term disease control a critical objective,” Christina Poh, MD, assistant professor of medicine at the University of Washington and Fred Hutchinson Cancer Center, said in the news release. “The FDA approval of [tafasitamab-cxix] in combination with rituximab and lenalidomide marks a significant advancement, offering a chemotherapy-free option that has demonstrated a meaningful reduction in the risk of disease progression across a broad patient population, including those with high-risk disease.”¹

REFERENCES

1. Incyte. Incyte announces FDA approval of Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma. News Release. Released June 18, 2025. Accessed June 19, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-fda-approval-monjuvir-tafasitamab-cxix

2. McGovern G. Tafasitamab with lenalidomide plus rituximab improves PFS in patients with R/R FL. Pharmacy Times. Published December 13, 2024. Accessed June 19, 2025. https://www.pharmacytimes.com/view/tafasitamab-with-lenalidomide-plus-rituximab-improves-pfs-in-patients-with-r-r-fl

3. A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/​Refractory (R/​R) Follicular Lymphoma or Marginal Zone Lymphoma. (InMIND). National Library of Medicine. ClinicalTrials.gov Identifier: NCT04680052. Last Updated April 4, 2025. Accessed June 19, 2025. https://clinicaltrials.gov/study/NCT04680052

4. FDA approves tafasitamab-cxix in combination with lenalidomide for the treatment of DLBCL. Pharmacy Times. Published August 1, 2020. Accessed June 19, 2025. https://www.pharmacytimes.com/view/fda-approves-tafasitamab-cxix-in-combination-with-lenalidomide-for-the-treatment-of-dlbcl