Mosunetuzumab

When added to a regimen of Rituxan and Revlimid (R2), AbbVie and Genmab’s Epkinly reduced the risk of disease progression or death by 79%. Genmab and AbbVie are taking key steps toward moving their blood cancer drug Epkinly into earlier lines of treatment in follicular lymphoma (FL).On Thursday, Genmab reported results from a phase 3 trial showing that the addition of Epkinly to a regimen of Rituxan and Revlimid (R2) provided statistically significant and clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) in patients with relapsed or refractory FL.When compared to R2 alone, the Epkinly combo reduced the risk of disease progression or death by 79%, according to a pre-planned interim analysis.The detailed results will be presented at the American Society of Hematology (ASH) annual meeting in Orlando in December, Genmab said.In addition, Copenhagen-based Genmab said that the FDA last month accepted the partners' application—based on an earlier interim analysis of the trial—to approve Epkinly plus R2 following at least one prior systemic therapy in patients with relapsed or refractory FL. The U.S. regulator has established a decision date of November 30.With a nod, the combo would become the first bispecific antibody combination regimen available as a second-line option for patients with FL.“These important phase 3 results support our goal to move Epkinly into earlier lines of therapy in order to benefit more cancer patients,” Genmab CEO Jan van de Winkel, Ph.D., said in a quarterly conference call on Thursday. Also on the call, Genmab’s chief medical officer, Tahamtan Ahmadi, M.D., Ph.D., said that the data highlight Epkinly’s “potential to completely transform and disrupt the current treatment paradigm.”Epkinly was originally approved in 2023 to treat diffuse large B-cell lymphoma (DLBCL) after at least two lines of systemic therapy. Then a year ago, the FDA blessed Epkinly in FL after at least two lines of therapy.Epkinly isn’t the only CD20xCD3 T-cell engager to be approved for FL. Roche’s Lunsumio got there first in 2022 as a third-line treatment. Then in 2023, Roche’s Columvi, which is in the same drug class, earned a DLBCL nod. Last month, the FDA rejected the company’s bid to move Columvi into an earlier DLBCL treatment setting.Despite the competition in the class, AbbVie and Genmab's Epkinly boasts one edge as it's the only approved CD20xCD3 T-cell engager to be administered subcutaneously. Genmab reported Epkinly’s first half sales at $211 million for a 74% year-over-year increase. The company’s revenue for the first half came in at $1.64 billion, which was a 19% boost from the first half of 2024.