Roche’s Lunsumio could soon become the first bispecific to join the U.S. treatment armamentarium for non-Hodgkin lymphoma.
Wednesday, Roche said the FDA has put its application for Lunsumio, also known as mosunetuzumab, under priority review. Roche is seeking an FDA blessing for the CD20xCD3 bispecific for follicular lymphoma after at least two prior systemic therapies.
Under the expedited review pathway, the FDA has set Dec. 29 as its target decision date. Before that, Lunsumio last month nabbed its global-first green light from European authorities for the same third-line use.
The FDA review puts Lunsumio on a collision course with CAR-T therapies. Gilead Sciences’ CD19-targeted CAR-T drug Yescarta won approval for third-line follicular lymphoma (FL) last March, and Novartis’ Kymriah just got the same go-ahead in late May.
But Lunsumio boasts a convenience edge over those CAR-T drugs, which require lengthy and cumbersome procedures to manufacture and administer.
“Since Lunsumio does not require the collection or genetic modification of patient cells, it could become an effective, fixed-duration outpatient option without the barriers of travelling to a major academic center,” Roche’s chief medical officer Levi Garraway, M.D., Ph.D., said in a statement.
Lunsumio also boasts decent tumor response results. In the phase 1/2 GO29781 study, Lunsumio shrank tumors in 80% of heavily pretreated FL patients and cleared signs of tumors in 60% of patients after a median follow-up of 18.3 months. The median duration of response in all responders was 22.8 months.
For Yescarta, in its early-stage ZUMA-5 study, the Gilead CAR-T drug registered a response rate of 94% and a complete response rate of 79% in heavily pretreated FL patients after a median follow-up of 24.4 months.
Given that Roche currently only has single-arm tumor response data, a potential approval in December will likely be wired through the accelerated approval pathway, just like Yescarta and Kymriah. That means Roche would need to provide additional confirmatory evidence to maintain the indication.
Roche already has a plan underway for a potential confirmatory trial. The phase 3 Celestimo trial started in October and is pitting a combination of Lunsumio and Bristol Myers Squibb’s Revlimid against a combo of Revlimid and Roche’s own Rituxan in follicular lymphoma after one line of systemic therapy.
If cleared in December, Lunsumio will be the first bispecific for any non-Hodgkin lymphoma in the U.S. Besides FL, an indolent form of lymphoma, Roche has its eyes on the aggressive diffuse large B-cell lymphoma. All told, analysts at Jefferies have estimated Lunsumio and another Roche CD20xCD3 bispecific called glofitamab could both reach $2 billion in peak sales.