AbbVie and Genmab have glided into Roche’s slipstream in the race to bring a CD3xCD20 bispecific to market, securing FDA priority review and a May decision date—and triggering an $80 million milestone payment in the process.
The partners cleared the path to submission earlier this year with the release of results from a clinical trial that evaluated the bispecific antibody, epcoritamab, in 157 patients with relapsed or refractory large B-cell lymphoma. Epcoritamab chalked up objective and complete response rates of 63% and 39%, respectively, and a median duration of response of 12 months.
Armed with the data, AbbVie and Genmab sought approval and secured priority review. The FDA’s decision to put epcoritamab into the fast lane means the partners will learn their fate by May 21. The PDUFA date for Roche’s mosunetuzumab, which is up for review in follicular lymphoma, is Dec. 29.
The advance of epcoritamab toward approval triggered an $80 million payday for Genmab, two years after it received $750 million from AbbVie for the right to jointly develop the candidate and two other molecules. AbbVie agreed to pay up to $3.15 billion in milestones across three programs. Genmab will share commercial responsibilities in the U.S. and Japan and get royalties of 20% to 26% in other markets.
Other companies are alert to the blockbuster potential that led AbbVie to bet big bucks on its Genmab alliance. CD20xCD3 bispecific antibodies are designed to turn T cells against malignant B cells, driving CAR-T-like efficacy in blood cancers without the complexity associated with cell therapies. Regeneron and Xencor are among the companies chasing Roche and the AbbVie-Genmab alliance to market.
Like some of their rivals, AbbVie and Genmab have embarked on a broad R&D program for epcoritamab in a bid to establish the bispecific across lines of therapy in a range of hematologic malignancies. The suite of studies includes a pair of phase 3 trials that are assessing the molecule in patients with diffuse large B-cell lymphoma and follicular lymphoma.