New First-in-Class Therapy Should Help Ease Disease Burden for People With Follicular Lymphoma

The FDA recently approved a new first-in-class agent for follicular lymphoma, an important development for people with the condition, according to one oncologist. Payers and oncologists both agreed that the drug’s approval should help ease the disease burden somewhat for people suffering from the condition, according to a Zitter Insights survey.

On Dec. 22, the FDA gave accelerated approval to Roche Group member Genentech USA, Inc.’s Lunsumio (mosunetuzumab-axgb) for the treatment of adults with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy. The drug is a first-in-class CD20xCD3 T-cell engaging bispecific antibody. Dosing for the agent — which can be done in an outpatient setting — is 1 mg via intravenous infusion on day one of cycle one, 2 mg on day eight of cycle one and 60 mg on day 15 of cycle one, each over a minimum of four hours. On day one of cycle two, dosing is 60 mg, and then in cycle three and following cycles, dosing is 30 mg on day one; administration can be reduced to two hours if cycle one infusions were tolerated. Dosing for eight cycles is recommended. If people have a partial response or stable disease after eight cycles, an additional nine cycles may be administered. The drug’s price for eight cycles is about $180,000.

Follicular lymphoma is typically a slow-growing form of non-Hodgkin lymphoma, representing about 20% to 30% of all NHL cases. According to the Lymphoma Research Foundation, the condition is considered a chronic disease. However, it “remains incurable and relapse is common, with outcomes worsening following each consecutive treatment,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development for Genentech and Roche, in a press release announcing Lunsumio’s approval.

The drug’s approval “is an important event,” Matthew Matasar, M.D., an investigator of a Phase II Lunsumio study, chief of the Division of Blood Disorders at Rutgers Cancer Institute and professor at Rutgers Robert Wood Johnson Medical School, told CancerNetwork. “This is a critically important approval for this patient population. Patients with follicular lymphoma have relatively few options prior to the approval of mosunetuzumab. In terms of FDA-approved therapy, we have CAR T-cell [chimeric antigen receptor T-cell] therapy, and we have some PI3K inhibitors available.”

In contrast to the CAR-Ts — which have complex manufacturing that takes weeks, a process that has lengthened to months under supply constraints — Lunsumio is “off-the-shelf and readily available, so that patients do not have to wait to start treatment,” Genentech noted in its press release.

The approval was based on results of a Phase II trial of people with heavily pretreated follicular lymphoma that saw an overall response rate of about 80% and a complete response rate of almost 60%. “It is increasingly clear that these responses can indeed be durable with median follow-up reported of over two years without having achieved median progression-free survival, duration of response, duration of complete response, and we’re seeing both good tolerability, as well as excellent durability of these responses, in an otherwise hard-to-treat patient population,” commented Matasar.

For the Managed Care Oncology Index: Q2 2022, from June 9, 2022, to July 12, 2022, Zitter Insights polled 34 commercial payers covering 110.4 million lives, 28 Medicare payers representing 39.3 million lives and 100 oncologists about Lunsumio. Payers covering more than half of commercial lives said they were at least somewhat aware of the agent, while those representing almost 70% of Medicare lives ranked their awareness level similarly. Almost two-thirds of oncologists reported the same.

Both AIS Health and Zitter Insights are divisions of MMIT.

With the drug’s availability, payers with almost all commercial and Medicare lives said that the level of unmet need will decline a bit, but they still rate it as moderate to high. Similarly, Lunsumio’s availability will lessen the disease burden for patients, according to respondents (see chart).

And while commercial payers with 80% of covered lives and Medicare payers with 68% of beneficiaries said they expect to manage the drug to label, payers representing 12% of commercial lives and those with 28% of beneficiaries said they are likely to not cover the drug.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jkettler@mmitnetwork.com.

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