MorphoSys : Long-term Data From L-MIND Study Confirms Primary Analysis Results

(RTTNews) - MorphoSys AG (MOR) and Incyte (INCY) announced updated results from the ongoing Phase 2 L-MIND study investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma or r/r DLBCL. The results corroborate previously reported primary analysis data.

In this long-term analysis of the L-MIND data, 80 study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis.

After a minimum of two years' follow-up, outcomes from the L-MIND study are consistent with the primary analysis and confirm the durability of the response and overall survival of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in autologous stem cell transplantation (ASCT)-ineligible patients with r/r DLBCL.

The company noted that assessment by an independent review committee at data cut-off showed an objective response rate of 58.8% and a complete response rate of 41.3%. Median duration of response(mDOR) was 34.6 months, with median overall survival (mOS) of 31.6 months and median progression-free survival (mPFS) of 16.2 months.

The safety profile was consistent with that observed in previously reported studies of tafasitamab in combination with lenalidomide, the company said.

A Biologics License Application for tafasitamab in combination with lenalidomide for r/r DLBCL is currently under Priority Review by the U.S. Food and Drug Administration. The PDUFA action date is August 30, 2020.

In January 2020, MorphoSys and Incyte reached a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved, MorphoSys and Incyte will co-commercialize tafasitamab in the United States while Incyte has exclusive commercialization rights outside the United States.