Highlights 

  • Incyte receives positive CHMP opinion for Minjuvi in relapsed or refractory follicular lymphoma 
  • Decision could deliver Europe’s first CD19/CD20 dual-targeted immunotherapy in second line 
  • Phase 3 inMIND trial showed meaningful improvement in progression-free survival 
  • Median PFS increased to 22.4 months vs. 13.9 months in the control arm 
  • European Commission review now underway for final approval 

Incyte (NASDAQ:INCY) has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma after at least one prior systemic therapy. 

If cleared by the European Commission, the combination would become the first dual-targeted CD19- and CD20-directed immunotherapy available in Europe for the second-line FL setting. This represents an important development for patients, especially given the recurring nature of the disease and the declining effectiveness of treatments with each relapse. FL affects an estimated 2–4 individuals per 100,000 people in Western countries, underscoring the ongoing demand for improved therapeutic options. 

Phase 3 inMIND Trial Delivers Meaningful PFS Improvement 

The CHMP’s positive opinion is supported by findings from the global Phase 3 inMIND trial, which evaluated Minjuvi combined with rituximab and lenalidomide in 548 adults with relapsed or refractory FL. 

The therapy met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival. Investigator assessment showed a median PFS of 22.4 months for patients receiving the Minjuvi combination, compared with 13.9 months for those in the control arm (hazard ratio 0.43; P<0.0001). Independent Review Committee analysis confirmed these outcomes, with median PFS not reached in the Minjuvi group versus 16.0 months in the control group. 

Safety findings were consistent with the known profile of tafasitamab. The most frequent adverse reactions included respiratory tract infections, diarrhea, rash, fatigue, constipation, and cough. Overall tolerability was considered manageable, providing confidence in the therapy’s suitability for broader clinical use if approved. 

A Potential New Second-Line Alternative for FL 

In current European practice, patients who relapse after first-line treatment face a limited set of second-line therapies, many of which still rely on chemotherapy. Minjuvi’s pending approval would offer an important chemotherapy-free option. 

Investigators highlighted that the combination demonstrated a substantial reduction in the risk of disease progression across a wide demographic range, positioning it as a meaningful addition to the FL treatment landscape. 

Conclusion 

The positive CHMP opinion marks an important milestone for Incyte’s Minjuvi, opening the door to a new immunotherapy option for patients with relapsed or refractory FL in Europe. With inMIND data reinforcing its clinical benefit, the therapy now moves to European Commission review, where a final decision could establish its place as a key second-line treatment alternative. 

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