Merck KGaA and Pfizer's Bavencio falls short in ovarian cancer

Merck KGaA and Pfizer’s Bavencio (avelumab) has missed its primary endpoints in the treatment of platinum-resistant or -refractory ovarian cancer, whether as a monotherapy or in combination with chemotherapy.

In a study of 566 ovarian cancer patients, the pair’s drug failed to improve overall survival (OS) or progression-free survival (PFS), when used alone or in combination with pegylated liposomal doxorubicin, compared to pegylated liposomal doxorubicin alone.

Objective response – the study’s secondary endpoint – was recorded as 13.3% for the Bavencio/chemotherapy combo, compared to 3.7% for Bavencio alone and 4.2% for chemotherapy alone.

"JAVELIN Ovarian 200 enrolled a high proportion of patients with aggressive, refractory disease that had no response to prior platinum-based chemotherapy, a population known to have disease that is challenging to treat; as such, this group of patients is typically not included in Phase III ovarian cancer trials," explained Dr Chris Boshoff, Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology at Pfizer. "We initiated the JAVELIN Ovarian 200 trial as the first Phase 3 study of a checkpoint inhibitor in the platinum-resistant or -refractory setting recognising these patients have the most pressing need for new treatment options. The results speak to the significant challenges these women face."

Dr Luciano Rossetti, Executive Vice President, Global Head of Research & Development at Merck KGaA, added: "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 analysed further. We thank the patients, their families and the investigators who participated in the JAVELIN Ovarian 200 trial, and wish to underscore that the alliance remains committed to driving advances in ovarian cancer, a commitment that includes two ongoing Phase 3 trials in previously untreated patients testing avelumab in combination with chemotherapy and, separately, one in combination with chemotherapy followed by maintenance treatment of avelumab in combination with a PARP inhibitor."

Bavencio reportedly generated $21.7 million in the third-quarter of this year, a considerable increase from the $8 million it made a year previously, and is approved for the treatment of metastatic Merkel cell carcinoma in 35 countries around the world.

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