A federal advisory panel voted 8-1 Tuesday that results from the global STARGLO trial, which was intended as the confirmatory trial for full approval of glofitamab-gxbm, were not applicable to the US patient population.
The central concern was the regional variation in the trial’s outcomes. While glofitamab showed a significant overall survival benefit in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), nearly half of the 274 participants were enrolled in Asia, where the benefit was most pronounced. In contrast, only 9% were from the US and high hazard ratios in that subgroup raised concerns.
“Are the STARGLO population and trial results applicable to the proposed US patient population?” was the panel’s voting question.
“While I’m a strong proponent of drug development, strong proponent of access to therapies, the question that was asked of me is, are the results from the trial applicable to the US general population? I’m not convinced with the data that is provided by the sponsor that it is applicable to the general population,” said Ajay Nooka, MD, MPH who voted no.
The sole yes came from patient representative Paul Majkowski, Esq, who provided the rationale for his “yes” vote.
“While it is on the sponsor to meet the burden of proof, maybe I was willing to relax that burden of proof for the considerations of the patient perspective,” he said.
