Bavencio Fails to Meet Primary Objectives in Certain Ovarian Cancer Patients in Phase 3 Trial

Bavencio Fails to Meet Primary Objectives in Certain Ovarian Cancer Patients in Phase 3 Trial

The immune checkpoint inhibitor Bavencio (avelumab), with or without chemotherapy, is no better than chemotherapy alone at prolonging the lives of ovarian cancer patients who failed prior platinum-based chemotherapy, results from a Phase 3 trial suggest.

The trial (NCT02580058), called JAVELIN Ovarian 200, which tested Bavencio alone or in combination with pegylated liposomal doxorubicin (PLD), versus PLD alone, also failed to show a delay in disease progression or death among Bavencio-treated patients, failing to meet both its primary goals.

Further analyses of the trial results are now being conducted and will be shared with the scientific community at a later date, according to Merck KGaA (which operates as EMD Serono in the U.S. and Canada) and Pfizer, who jointly developed the therapy.

“Although [overall survival] and [progression-free survival] 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, MD, executive vice president, global head of research and development at the biopharma business of Merck KGaA, said in a press release.

Rossetti thanked the patients, their families, and the investigators involved in the trial. He added that Merck KGaA’s alliance with Pfizer “remains committed to driving advances in ovarian cancer.”

Bavencio is a type of therapy called an immune checkpoint inhibitor, as it binds to the PD-L1 protein in cancer cells, blocking the mechanism used by tumors to evade the immune response.

The Pfizer-sponsored multicenter study aimed to determine if the treatment could improve survival outcomes among ovarian cancer patients with aggressive disease who had failed prior platinum-based chemotherapy — the standard of care for ovarian cancer.

It included 566 women who were randomly assigned either a Bavencio infusion, given once every two weeks; Bavencio plus PLD, administered into the vein once a week; or PLD alone. PLD is a kind of chemotherapy where the agent doxorubicin is enclosed in tiny spheres that last longer in circulation and have higher affinity to cancer cells.

The trial’s primary objectives were to show superior overall survival or progression-free survival — the length of time during or after treatment without cancer progression — for one or both Bavencio-based treatment regimens compared with PLD.

While Bavencio failed to extend both survival outcomes, more patients receiving the Bavencio-chemo combination responded to treatment (13.3%), compared with Bavencio (3.7%), or chemotherapy alone (4.2%).

No new safety signals were found for the two Bavencio regimens. In addition, Bavencio’s safety profile was consistent with that of the overall JAVELIN clinical development program.

According to Chris Boshoff, MD, PhD, Pfizer Global Product Development’s senior vice president and head of immuno-oncology, early development and translational oncology, women not responding to platinum-based chemotherapy are typically not included in Phase 3 trials of ovarian cancer, given the difficulty of treating them.

“The results speak to the significant challenges these women face,” he said in the release.

“Effective management of platinum-resistant or -refractory ovarian cancer remains the biggest unmet medical need facing women with recurrent ovarian cancer today,” said Eric Pujade-Lauraine, MD, PhD, head of the Women Cancers and Clinical Research Department at Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu in France.

“As a researcher and clinician, I know how important it is to continue to improve the outlook for women with advanced ovarian cancer and look forward to the results of more trials exploring the role of avelumab in delaying recurrence in platinum-sensitive patients and earlier lines of therapy,” Pujade-Lauraine added.

Besides JAVELIN Ovarian 200, an open-label, international Phase 3 trial (NCT02718417) called JAVELIN Ovarian 100 is testing Bavencio either in combination with platinum-based chemotherapy, following platinum-based chemotherapy, or both. The trial is for previously untreated women with locally advanced or metastatic epithelial ovarian cancer.

Another Phase 3 trial (NCT03642132) called JAVELIN Ovarian PARP 100 is assessing Bavencio plus chemotherapy in patients with previously untreated advanced ovarian cancer. This study is still recruiting participants; more information is available here.

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