Incite Says Phase 3 Trial of Monjuvi in Follicular Lymphoma Patients Meets Endpoints

MT Newswires Live12-11

Incyte (INCY) said Tuesday that late-breaking results from a phase 3 trial of tafasitamab, or Monjuvi, showed that it met a primary endpoint of progression-free survival, or PFS.

The study evaluated tafasitamab in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma, the company said.

Data show that the drug demonstrated "a statistically significant and clinically meaningful improvement" in PFS in 548 patients and that the benefit was consistent across all patient groups irrespective of the number of previous lines of therapy. The study also met key secondary endpoints including improvement in complete response, overall response rate, and duration of response, the company said.

The company added that it plans to file a supplemental biologics license application in the US for tafasitamab in follicular lymphoma by the end of 2024.

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