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Merck KGaA, Pfizer: JAVELIN Ovarian 200 Trial Did Not Meet Primary Endpoints

German drugmaker Merck KGaA (MKGAY.PK) and Pfizer Inc. (PFE) said Monday that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab alone or in combination with pegylated liposomal doxorubicin or PLD, a type of chemotherapy, compared with PLD did not meet the prespecified primary endpoints of overall survival (OS) or progression-free survival (PFS) in patients with platinum-resistant or -refractory ovarian cancer.

JAVELIN Ovarian 200 is a Phase III, multicenter, randomized study investigating the efficacy and safety of avelumab alone or in combination with PLD versus PLD alone in 566 women with ovarian cancer that is resistant or refractory to platinum chemotherapy. The primary objectives of the trial were to demonstrate superior OS or PFS for one or both avelumab-based treatment regimens compared with PLD.

According to the two companies, signals were observed in the combination arm relative to PLD, and further analyses of the trial are warranted.

However, no new safety signals were observed for avelumab alone or in combination, and the safety profile for avelumab in this trial was consistent with that observed in the overall JAVELIN clinical development program.

The data are currently being analyzed, and detailed results will be shared with the scientific community, the companies said.

"Although OS and PFS did not reach statistical significance, study results indicate potential clinical activity of the combination of avelumab and chemotherapy which will be analyzed further," said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the Biopharma business of Merck KGaA, which in the US and Canada operates as EMD Serono.

In addition to JAVELIN Ovarian 200, the avelumab ovarian cancer clinical development program includes several ongoing clinical trials investigating avelumab in combination with other therapies.

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