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Trial Watch: Avelumab Falls Short of PFS OS Improvement in Phase 3 Ovarian Cancer Trial

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Gina Columbus writing in Targeted Oncology reports that the findings from the phase III JAVELIN Ovarian 200 trial, avelumab (Bavencio) either alone or in combination with pegylated liposomal doxorubicin (PLD) did not induce a statistically significant improvement in overall survival (OS) or progression-free survival (PFS) in patients with platinum–resistant/refractory ovarian cancer compared to PLD monotherapy. Based on these findings, the primary endpoints of the trial were not met, according to a press release from Merck KGaA and Pfizer, the developers of the PD-L1 inhibitor.

Avelumab plus PLD led to an HR for PFS of 0.78, but the combination did not meet the prespecified criteria for superiority (repeated confidence interval [RCI], 0.587-1.244; one-sided P value = .0301). The avelumab combination also failed to meet the OS endpoint (HR, 0.89; RCI, 0.744-1.241; one-sided P value = .2082).

Follow the link for the rest of Ms. Columbus’ article

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