Incyte(US:INCY) ZACKS·2026-01-06 16:20Core Insights - Incyte (INCY) announced positive top-line results from a late-stage lymphoma study of Monjuvi/Minjuvi (tafasitamab), indicating its potential as a first-line treatment option for newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients [1] Group 1: Drug Approval and Indications - Monjuvi, in combination with Bristol Myers' Revlimid (lenalidomide), is approved in the US and EU for adult patients with relapsed or refractory DLBCL [2] - The FDA has recently approved Monjuvi in combination with Revlimid and Roche's Rituxan (rituximab) for adult patients with relapsed or refractory follicular lymphoma (FL), expanding its application in hematologic malignancies [3] Group 2: Study Results and Efficacy - The pivotal phase III frontMIND study demonstrated that Monjuvi/Minjuvi combined with Revlimid and R-CHOP improved progression-free survival compared to R-CHOP alone, meeting its primary endpoint [4][6] - The study also achieved its key secondary endpoint of event-free survival, with no new safety signals reported, indicating a favorable safety profile [6][7] Group 3: Market Potential and Future Plans - Incyte plans to submit a supplemental biologics license application to the FDA for label expansion of Monjuvi for first-line DLBCL treatment in H1 2026, highlighting the company's commitment to addressing unmet medical needs [10] - DLBCL accounts for about 40% of non-Hodgkin lymphoma cases in adults, with approximately 24,000 new diagnoses annually in the US and up to 36,000 in the EU, underscoring the significant market potential for effective treatments [11]