Panel Wants More U.S. Patient Data on Glofitamab
FDA’s Oncologic Drugs Advisory Committee 5/20 voted (8 to 1) that clinical trial data supporting a supplemental BLA for Genentech’s Columvi (glofitamab) injection are not applicable to the U.S. population. The supplement seeks Columvi’s approval for use in combination with gemcitabine and oxaliplatin for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.
Panel members seemed to support FDA’s briefing document that found the “results from the intended confirmatory study, STARGLO, require careful consideration to assess the robustness of the efficacy and safety data in light of the inconsistent treatment effects across multiple endpoints observed between regions and the applicability of the overall results to a U.S. patient population with R/R DLBCL following at least one line of systemic therapy, who are considered ineligible for autologous stem cell transplantation.”
During the voting period, numerous panel members cited STARGLO’s enrollment of just 25 Americans in the study and the difficulty in determining the data’s applicability to the U.S. population. Avera Medical oncologist Heidi McKean said she voted no due to the inconsistencies in the results. “I think we need to look at subgroup analyses in this case, and, quite frankly, more patients in the U.S. need to be looked at to prove efficacy and safety.” University of Colorado Cancer Center associate director for clinical research Christopher Lieu said he also voted no because a sufficient number of U.S. participants were not enrolled to support a robust assessment of the safety and effectiveness in U.S. patients.
At the conclusion of the panel meeting, Oncology Center of Excellence acting director Rick Pazdur noted the importance of increasing clinical trial enrollment in the U.S. “Unfortunately, if you take a look at all the oncology trials that come to us, only about 20% of the population is derived from the United States,” he said. “We’d like to see robust increased enrollment in the United States. We'd like to understand the reasons why sites are not enrolling in the United States. Potentially, that could be a lack of interest because many times the control arms are not appropriate for a U.S. population. And I'd like to make sure that people understand this is going to be an area that the Oncology Center of Excellence is looking at quite closely to ensure that control arms are basically applicable to the United States and represent current standards here in the United States, not just the weakest control arm that we have.”