FDA Approves Genentech’s Columvi to Treat B-Cell Lymphoma

Rare Daily Staff

The U.S. Food and Drug Administration approved Genentech’s Columvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

The FDA granted Columvi accelerated approval based on response rate and durability of response in the phase 1/2 NP30179 study. Continued approval for the indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The company said Columvi will be available in the United States in the coming weeks.

Diffuse large B-cell lymphoma (DLBCL) is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin’s lymphoma in the United States. While many people with DLBCL are responsive to treatment, the majority of those who relapse or are refractory to subsequent treatments have poor outcomes.

Columvi is the first and only CD20xCD3 T-cell engaging bispecific antibody for the treatment of R/R DLBCL that is given for a defined period of time. Unlike treat-to-progression approaches where treatment is given indefinitely until the cancer progresses or the therapy cannot be tolerated, Columvi is administered in 13 intravenous infusions over a maximum of 12 cycles (including step-up dosing) or until disease progression or the treatment cannot be tolerated, whichever occurs first.

Columvi is a chemotherapy-free treatment option that is off-the-shelf and ready for infusion. Patients are pretreated with a single dose of obinutuzumab seven days prior to starting Columvi. Patients are also given a corticosteroid, a fever-reducing medicine and an antihistamine as premedications to reduce the risk of cytokine release syndrome, an over-reaction by the immune system.

“People with diffuse large B-cell lymphoma who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options,” said Levi Garraway, chief medical officer and head of Global Product Development for Genentech. “As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this aggressive lymphoma is treated, reinforcing our dedication to bringing innovative treatment options to people with critical unmet needs.”

In the phase 1/2 NP30179 study, people with 132 with relapsed or refractory DLBCL were given Columvi as a fixed course for 8.5 months including about one-third who had received prior CAR T-cell therapy. Additionally, 83 percent were refractory to their most recent therapy.

Results showed patients treated with fixed-duration Columvi achieved durable remission, with 56 percent of patients achieving an overall response, and 43 percent of patients achieving a complete response. Over two-thirds of those who responded continued to respond for at least nine months. The overall response rate is the combination of complete response rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response was 1.5 years. Data from the NP30179 study were recently published in the New England Journal of Medicine.

Among 145 patients who received Columvi in the study, the most common adverse events were cytokine release syndrome (70 percent), which may be serious or life-threatening, musculoskeletal pain (21 percent), fatigue (20 percent) and rash (20 percent). Cytokine release storm was generally low grade.

Photo: Levi Garraway, chief medical officer and head of Global Product Development for Genentech