European Commission Approves Tafasitamab Combo in R/R Follicular Lymphoma
The tafasitamab-based regimen was previously approved by the FDA in June 2025 for patients with relapsed/refractory follicular lymphoma.
The FDA had approved the tafasitamab-based combination for the same patient group in June 2025.
The European Commission (EC) has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) for the treatment of adult patients with relapsed/refractory follicular lymphoma, according to a news release from the developer, Incyte.1
In November 2025, the developers received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for tafasitamab plus lenalidomide and rituximab in this relapsed/refractory follicular lymphoma population. Additionally, preceding the CHMP decision, the FDA had approved the tafasitamab-based combination for the same patient group in June 2025.2
Data from the phase 3 InMIND trial (NCT04680052) supported the EC decision, which evaluated the safety and efficacy of the investigational regimen among patients with relapsed/refractory follicular lymphoma. Therein, a statistically significant and clinically meaningful benefit in progression-free survival (PFS) was observed with tafasitamab vs placebo when combined with lenalidomide/rituximab.
Efficacy data revealed that after a median follow-up of 14.1 months, the median PFS was 22.4 months with tafasitamab (95% CI, 19.2-not evaluable [NE]) vs 13.9 months (95% CI, 11.5-16.4) in the control arm per investigator evaluation (HR, 0.43; 95% CI, 0.32-0.58; P <.0001). Additionally, the median PFS as assessed by an independent review committee (IRC) was not reached (95% CI,19.3-NE) vs 16.0 months (95% CI, 13.9-21.1) in the respective groups (HR, 0.41; 95% CI, 0.29-0.56; P <.0001).
Additionally, the overall response rate (ORR) between both arms was 83.5% (95% CI, 78.6%-87.7%) vs 72.4% (95% CI, 66.7%-77.6%).3 The complete response (CR) rate was 49.4% (95% CI, 43.1%-55.8%) vs 39.8% (95% CI, 33.7%-46.1%) in the respective arms (OR, 1.5; 95% CI, 1.04-2.13; P = .0286), and the median duration of response (DOR) was 21.2 months (95% CI, 19.5-NE) vs 13.6 months (95% CI, 12.4-18.6).
Furthermore, the median overall survival (OS) was not reached in either arm, and a positive trend was observed favoring the tafasitamab group vs the placebo arm (HR, 0.59; 95% CI, 0.31-1.13).
“Relapsed/refractory [follicular lymphoma] is an incurable, complex and persistent cancer,” Stefano Luminari, MD, professor of Oncology at the University of Modena and Reggio in Emilia, Italy and inMIND study investigator, said in the news release on the EC decision.1 “The EC approval of [tafasitamab] in combination with lenalidomide and rituximab represents an important innovation, as it brings the first CD19- and CD20-dual-targeted immunotherapy to eligible patients with follicular lymphoma in Europe, which has demonstrated a meaningful reduction in the risk of disease progression, including among those with high-risk disease.”
The global, double-blind, placebo-controlled phase 3 trial randomly assigned patients 1:1 to receive tafasitamab intravenously or intravenous placebo for 12 cycles plus intravenous rituximab for cycles 1 to 5 and oral lenalidomide for 12 cycles. The recommended dose of tafasitamab was found to be 12 mg/kg. Patients had received a median of 1 prior line of therapy; 25% received 2 lines.
The primary end point of the trial was PFS per investigator assessment in the follicular lymphoma population. Secondary end points included PFS in the overall population, which included patients with marginal zone lymphoma; PET-CR rate; and OS.4
The investigators found tafasitamab to be well-tolerated with a safety profile deemed consistent with other CD19 and immunotherapy combination regimens. The most common treatment-emergent adverse events (TEAEs) in the tafasitamab combination group included neutropenia (48.5%), diarrhea (37.6%), COVID-19 (31.4%) and constipation (29.2%). Additionally, TEAEs leading to tafasitamab delay or interruption were observed in 74% of patients, and 11% discontinued treatment due to TEAEs.
References
- Incyte announces European Commission approval of Minjuvi® (tafasitamab) for the treatment of relapsed or refractory follicular lymphoma. Press release. Incyte. December 17, 2025. Accessed December 17, 2025. https://tinyurl.com/45x2t743
- FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. FDA. June 18, 2025. Accessed December 17, 2025. https://tinyurl.com/njjw9rpu
- Sehn LH, Luminari S, Scholz CW, et al. Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: results from a phase 3 study (inMIND). Blood. 2024;144(suppl 2):LBA-1. doi:10.1182/blood-2024-212970
- 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). Updated July 8, 2025. Accessed December 17, 2025. https://tinyurl.com/yp9aayst
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