Tafasitamab Plus Lenalidomide and Rituximab Nets European Approval in R/R Follicular Lymphoma

The European Commission (EC) has approved tafasitamab-cxix (Minjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) for the treatment of adult patients with relapsed/refractory grade 1 to 3a follicular lymphoma following at least 1 prior line of systemic therapy.1

The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in November 2025 and was supported by data from the phase 3 inMIND trial (NCT04680052). Data from inMIND showed that patients who received the triplet (n = 273) experienced a median progression-free survival (PFS) of 22.4 months (95% CI, 19.2-not evaluable [NE]) vs 13.9 months (95% CI, 11.5-16.4) for those given placebo plus lenalidomide and rituximab (n = 275) per investigator assessment (HR, 0.43; 95% CI, 0.32-0.58; P < .0001). The independent review committee–assessed median PFS values were not reached (95% CI, 19.3-NE) and 16.0 months (95% CI, 13.9-21.1), respectively (HR: 0.41; 95% CI, 0.29-0.56).1,2

"The EC approval of [tafasitamab] addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory follicular lymphoma,” Bill Meury, president and chief executive officer of Incyte, stated in a news release.1 “Historically, patients [with] follicular lymphoma have had limited treatment options in the second-line setting, and we are proud to drive this important advancement for the lymphoma community as we seek to deliver innovative medicines for patients with cancer.”

In June 2025, the FDA approvedtafasitamab plus lenalidomide and rituximab for the treatment of adult patients with relapsed/refractory follicular lymphoma.3 The approval was also supported by data from inMIND.

What was the design of inMIND?

inMIND was a double-blind, randomized, placebo-controlled trial that enrolled patients with relapsed/refractory follicular lymphoma who had received at least 1 previous line of systemic therapy across 210 centers globally.2Other key eligibility criteria included having an ECOG performance status of 2 or less, have grade 1, 2, or 3a follicular lymphoma or nodal marginal zone lymphoma (MZL), splenic MZL, or extra nodal MZL, and have previously received at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy.4

Eligible patients were randomly assigned 1:1 to receive up to twelve 28-day cycles of intravenous (IV) tafasitamab at 12 mg/kg on days 1, 8, 15, and 22 of cycles 1 to 3 and days 1 and 15 of cycles 4 to 12 or placebo.2 Patients in both arms also received oral lenalidomide at 20 mg per day on days 1 to 21 of cycles 1 to 12 and IV rituximab at 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2 to 5.

The primary end point was investigator-assessed PFS.4 Secondary end points included PET–complete response rate, overall survival, minimal residual disease–negativity rate, overall response rate, duration of response, and duration of response.

What was the safety profile of tafasitamab plus lenalidomide and rituximab?

In terms of safety, tafasitamab was well tolerated with a manageable safety profile.1 Safety and toxicity findings were comparable with the addition of tafasitamab to lenalidomide in combination with rituximab. The most common adverse effects that occurred in at least 20% of patients who received tafasitamab in inMIND included respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain and cough.

References

1. Incyte announces European Commission approval of Minjuvi (tafasitamab) for the treatment of relapsed or refractory follicular lymphoma. News release. Incyte. December 17, 2025. Accessed December 18, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-minjuvir
2. Sehn LH, Hübel K, Luminari S, et al. Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. Lancet. Published online December 5, 2025. doi:10.1016/S0140-6736(25)01778-7
3. FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. FDA. June 18, 2025. Accessed December 18, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma
4. 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). ClinicalTrials.gov. Updated July 8, 2025. Accessed December 18, 2025. https://clinicaltrials.gov/study/NCT04680052