The FDA’s Oncologic Drugs Advisory Committee (ODAC) met for what chairperson Christopher Lieu called, at the end, “an incredibly long day” to decide whether approval of immune checkpoint inhibitors should be restricted in accordance with expression levels of PD-L1.
Researchers from University of Tsukuba published data from a study designed to identify novel biomarkers for predicting treatment responses to nivolumab plus ipilimumab combination therapy.
It’s another setback for Jounce Therapeutics Inc. Top-line data from the phase II Select study of vopratelimab, the company’s lead candidate, combined with pimivalimab vs. pimivalimab alone in 69 patients missed its primary endpoint of mean tumor change when averaged over nine and 18 weeks. The clinical trial participants were immunotherapy naïve, immunotherapy TISvopra biomarker-selected, second-line non-small-cell lung cancer (NSCLC) patients.
Cytomx Therapeutics Inc. CEO Sean McCarthy said earlier this month that the firm was “not ready to guide on specific response rates” that the company hopes for in the phase II study with anti-PD-L1 Probody CX-072 in combination with ipilimumab, or ipi (Yervoy, Bristol-Myers Squibb Co.) in patients with relapsed refractory melanoma.
