Genmab A/S (NASDAQ:GMAB) released results Thursday of the Phase 3 EPCORE FL-1 trial evaluating subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
The study met its dual primary endpoints of overall response rate (ORR) and progression-free survival (PFS), demonstrating statistically significant and clinically meaningful differences in both endpoints, reducing the risk of disease progression or death by 79%.
The company is developing the drug in partnership with AbbVie Inc.(NYSE:ABBV).
The results, derived from a pre-planned interim analysis, will be submitted for presentation at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will serve as the basis for global regulatory submissions.
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Separately, on July 24, the U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2 following at least one prior systemic therapy.
The sBLA submission was based on data from a first interim analysis demonstrating statistically significant ORR and PFS improvements.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 30, 2025.
If approved, epcoritamab plus R2 would be the first bispecific antibody combination regimen available in the U.S. as a second-line treatment option for patients with R/R FL.
The safety profile of epcoritamab in combination with R2 in adult patients with R/R FL was consistent with the known safety profiles of the individual regimens.
No new safety signals were observed.
The U.S. FDA has granted accelerated approval of single-agent epcoritamab as Epkinly for adults with relapsed or refractory follicular lymphoma (R/R FL) after two or more lines of systemic therapy.
On Thursday, the European drugmaker reported revenue of $1.64 billion for the first half of 2025, compared to $1.38 billion a year ago.
Second-quarter sales were $925 million, exceeding the consensus of $914.76 million.
The 19% increase was primarily driven by higher royalties for Darzalex and Kesimpta, achieved under collaborations with Johnson & Johnson (NYSE:JNJ) and Novartis AG (NYSE:NVS), respectively, as well as higher Epkinly net product sales.
Genmab raised its fiscal year 2025 sales guidance from $3.34 billion to $3.66 billion to $3.5 billion to $3.7 billion, exceeding the consensus of $3.61 billion.
Price Action: GMAB stock is down 5.16% at $21.52 at the last check on Friday.
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