Dr Burke Discusses Glofitamab and the STARGLO Trial

In this month's Chief Insights in Oncology, John M. Burke, MD, hematologist-oncologist at Rocky Mountain Cancer Centers and editor-in-chief of Targeted Therapies in Oncology, discusses his column on the FDA's Oncologic Drugs Advisory Committee (ODAC) meeting held in May 2025 discussing the use of glofitamab (Columvi) in combination with gemcitabine and oxaliplatin (GemOx) in diffuse large B-cell lymphoma (DLBCL).

The ODAC voted 8 to 1 that findings from the phase 3, confirmatory STARGLO trial (NCT04408638) evaluating glofitamab in addition to GemOx for the treatment of relapsed/refractory DLBCL are not applicable to the US patient population.¹ While the data showed an improvement in overall survival, only 9% of patients enrolled in the US and 48% in Asian regions, leading the FDA to question whether the results were sufficiently applicable to a US patient population.

"At that face value one might expect, with an overall survival benefit, that the FDA would just approve glofitamab and give it a full approval in combination with Gem/Ox for patients with relapsed DLBCL in the second line.... What the problem that the FDA identified with the STARGLO trial is that of the 274 patients that were in the trial, only 25 of them were from North America, meaning that the study was largely conducted outside of the United States," Burke says.

More recently, the FDA issued a complete response letter on July 21, 2025, indicates that data from the phase 3 STARGLO study did not provide sufficient evidence to support the proposed second-line DLBCL indication within the US patient population.² This decision means that, while the sBLA for the combination therapy was not approved for this specific second-line indication, glofitamab retains its existing accelerated approval in the US for adult patients with R/R DLBCL not otherwise specified or with large B-cell lymphoma arising from follicular lymphoma after 2 or more lines of systemic therapy. The FDA's action underscores the stringent regulatory scrutiny applied to novel oncology therapies, particularly when seeking expanded indications based on specific patient subsets and treatment lines.

Check out the full interview with Dr Burke on YouTube.

REFERENCES:

1. Meeting of the Oncologic Drug Advisory Committee. FDA. May 20, 2025. Accessed July 24, 2025. https://tinyurl.com/5n7mwvjt

2. Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma. News release. Genentech. July 21, 2025. Accessed July 24, 2025. https://tinyurl.com/2bbtwdpa