The phase III JAVELIN Ovarian 100 study exploring frontline avelumab (Bavencio) in ovarian cancer has been ended after an independent panel determined the study would not meet its primary endpoint of progression-free survival (PFS), according to Merck KGaA and Pfizer, the co-developers of the PD-L1 inhibitor.
This is the second recent report of a phase III trial of avelumab in ovarian cancer that has missed its primary endpoint. Last month, Merck KGaA and Pfizer reported that findings from the phase III JAVELIN Ovarian 200 trial showed that avelumab alone or in combination with pegylated liposomal doxorubicin (PLD) did not induce a statistically significant improvement in overall survival (OS) or PFS versus PLD alone in patients with platinum–resistant/refractory ovarian cancer, missing the primary endpoints of the study
Avelumab plus PLD led to an HR for PFS of 0.78, which did not meet the prespecified criteria for superiority (repeated confidence interval [RCI], 0.587-1.244; one-sided P value = .0301). The OS endpoint with the avelumab combination was also not met (HR, 0.89; RCI, 0.744-1.241; one-sided P value = .2082).
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