US FDA approves Roche’s Columvi? (glofitamab-gxbm) for the treatment of Relapsed/Refractory DLBCL.

Columvi is part of Genentech’s CD20xCD3 T-cell-engaging bispecific antibody clinical development program. It received accelerated approval from the US FDA for treating relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) based on positive phase I/II NP30179 study results. The study included 132 patients with DLBCL who had relapsed or were refractory to prior therapies, including 30% of these having received chimeric antigen receptor T-cell therapy, and 83% were nonresponsive to it.

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Columvi was administered in the form of Intravenous infusion for a fixed course of 8.5 months; the fixed duration of therapy is being argued as the big differentiator. Phase I/II results confirmed few durable responses of 56% overall response rate (ORR), 43% complete response rate (CRR), a median response duration of 18.4 months, and 68.5% continued to show response for 9 months.

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After the accelerated approval, Roche is working to provide confirmatory data with the phase 3 STARGLO trial, that is comparing Columvi in combination with chemotherapy against the Rituxan-chemo combo in second-line DLBCL patients who are ineligible for stem cell transplant. Other than Columvi, Genentech has another big bispecific antibody in the hematology portfolio (Lunsumio) that gained accelerated approval for treating adult patients with R/R follicular lymphoma after systemic therapy.

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Roche’s Columvi is competing with AbbVie and Genmab’s Epkinly, which has better efficacy data and comes with a convenient form of administration of an under-the-skin injection. Roche is catching up with Epkinly and studying the subcutaneous formulation.

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Source: US FDA