Lunsumio, Blood Cancer Drug By Roche Gets Global Approval

Roche is exploring new products to refill its blood cancer armoury after Rituxan’s patent expiration. Swiss pharma is launching a novel bispecific lymphoma medicine with a first-in-class clearance that will compete with strong CAR-T therapies.

Lunsumio, or mosunetuzumab, has acquired provisional European Commission clearance to cure follicular lymphoma in individuals who have had at least two prior therapies. Lunsumio is now the first CD20xCD3 bispecific antibody to be approved globally. In December, Roche submitted the medicine to the FDA for approval. People will not have to wait to begin the treatment because Lunsumio is an off-the-shelf medicine that is easily available, Roche said recently. That statement appears to be a direct aim at CAR-T cell treatments, a category of effective but inconvenient medications.

Prior to the approval of Lunsumio, European regulators authorised Novartis’ CD19-directed CAR-T treatment Kymriah for the identical third-line follicular lymphoma (FL) indication last month. Yescarta, Gilead Sciences’ competing CAR-T treatment, is awaiting official extension into FL after a minimum of three prior lines of therapy, thanks to a favourable opinion from the European Medicines Agency.

In Europe, Bristol Myers Squibb’s Breyanzi has been approved as a third-line treatment for grade 3B FL, which is often misdiagnosed as diffuse large B-cell lymphoma (DLBCL). However, custom CAR-T therapies require lengthy manufacturing processes that take more than two weeks to complete before the final product arrives at the patient for infusion. Patients must presently seek CAR-T treatment at certified major treatment centres.

Roche is now emphasising Lunsumio’s advantage in terms of convenience. In addition, the drug’s efficacy appears to be competitive. Lunsumio decreased tumours in 80% of patients with extensively sensitised FL in the phase 1/2 GO29781 research, including eliminating tumour symptoms in 60% of patients. The findings occurred after an average follow-up of 18.3 months for the trial’s patients.

In the phase 2 Elara trial, Kymriah elicited a response in 86% of patients, including 69% who had a full response. According to Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of worldwide product development, Lunsumio’s strong responses, off-the-shelf accessibility, and early ambulatory administration could alter how aggressive follicular lymphoma is treated.

Lunsumio binds to CD3 on the membrane of T cells and redirects immune cells to assist in removing malignant B cells, in addition to CD20, which is already addressed by Roche’s off-patent Rituxan. Glofitamab, a CD20xCD3 bispecific from Roche, has demonstrated some encouraging benefits in aggressive DLBCL. Both medications are expected to hit $2 billion in peak sales, according to Jefferies analysts. Lunsumio’s approval comes just days after Roche received crucial EU approval for Polivy in initial therapy for DLBCL. In second-line DLBCL, Roche is conducting the SUNMO study, which combines Lunsumio and Polivy. It was also announced that in the first-line scenario, a phase 3 trial combining Polivy with one of the two CD20xCD3 bispecific antibodies will begin this year.

It also comes at a time when Roche is battling biosims for its older cancer stalwarts. The biosimilars to Rituxan, Herceptin, and Avastin lost 4.5 billion Swiss francs in global sales last year, according to the manufacturer.