Roche gets FDA nod for Lunsumio, offering convenient option to gene therapies in follicular lymphoma

Upon the FDA approval for its bispecific antibody Lunsumio (mosunetuzumab) as a third-line therapy for follicular lymphoma, Roche was quick to point out that its treatment was an “off-the-shelf, accessible” option.

The reference, of course, was to the competition Lunsumio now faces as it takes on Novartis’ Kymriah, Bristol Myers Squibb’s Breyanzi and Gilead’s Yescarta.

As gene therapies, the high-profile trio are anything but “off the shelf,” as they have complex manufacturing processes requiring patients to wait weeks for infusions, which are conducted in designated treatment centers. Convenience and accessibility are the edges Roche hopes to exploit as it tries to muscle into the crowded market.  

“As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed-duration could change the way advanced follicular lymphoma is treated,” Elizabeth Budde, M.D., Ph.D., a professor in the lymphoma division at City of Hope and a clinical trial investigator from the study that helped win Lunsumio’s approval, said in a release.  

In the phase 2 study, Lunsumio shrank tumors in 80% of patients with heavily pretreated follicular lymphoma, with 60% of them achieving complete remission. Those results came after a median follow-up of 18.3 months. Patients also had a median duration of response of 22.8 months, or the length of time a tumor continues to respond to treatment without the cancer growing or spreading. 

By comparison, the CAR-T therapy Kymriah triggered a response in 86% of patients in its phase 2 ELARA trial, including 69% who saw complete remission. Yescarta, in its early-stage ZUMA-5 study, registered a response rate of 94% and a complete response rate of 79%.

Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody given as an infusion. Approved under the FDA's accelerated pathway, the drug will be subject to a confirmatory phase 3 trial. Roche said the drug will become available in the “coming weeks.” It was endorsed in Europe for the same indication in June of this year.

Roche has another bispecific from the same class, glofitamab, which has shown promise in the most common form of lymphoma—diffuse large B-cell lymphoma, or DLBCL—with more than 25,000 cases diagnosed each year in the U.S. Both drugs could reach peak sales of $2 billion, according to analysts at Jefferies.

Follicular lymphoma is a form of non-Hodgkin lymphoma in which tumors grow slowly but can become more aggressive over time. It is the second most common type of lymphoma, accounting for 13,000 new cases annually in the U.S.

“This additional treatment option is good news for people whose blood cancer has not responded to multiple lines of treatment because it can become more difficult to treat each time it returns,” Lee Greenberger, Ph.D., chief scientific officer of the Leukemia & Lymphoma Society, said in the release.

The approval helps Roche overcome its loss of exclusivity for blood cancer treatment Rituxan. Two of the company's other cancer stalwarts, Herceptin and Avastin, are also facing eroding sales from biosimilar competition.