- The latest clinical results for Pfizer and Merck KGaA's cancer drug Bavencio won't help the companies make up ground in immuno-oncology, showing the checkpoint inhibitor failed to beat out chemotherapy in tough-to-treat forms of ovarian cancer.
- In the study, called JAVELIN Ovarian 200, Bavencio as a monotherapy and in combination with chemo was compared to chemo alone in patients with platinum-resistant or refractory disease. Topline results released by the companies, however, showed neither Bavencio regimen met the trial's overall survival or progression-free survival goals.
- The companies noted the patients studied aren't often included in other ovarian cancer studies and reiterated their belief Bavencio can work to treat the cancer type. JAVELIN Ovarian 200 is the first Phase 3 study of a checkpoint inhibitor in this ovarian cancer setting.
The failure of Bavencio (avelumab) in ovarian cancer isn't entirely a surprise, as checkpoint inhibitors have had less success in this tumor type than in others like lung cancer and melanoma. None of the currently approved checkpoint inhibitors are cleared for use in ovarian cancer in the U.S.
Drugmakers are trying to change that, but with mixed results. For example, the TOPACIO study, which combined Tesaro's PARP inhibitor Zejula (niraparib) and Merck & Co.'s anti-PD-1 antibody Keytruda (pembrolizumab), showed similar overall response rates between the combination arm and the PARP inhibitor monotherapy arm.
Bavencio is a latecomer to the immuno-oncology field. The PD-L1-targeting antibody only has two US accelerated approvals to date, for metastatic Merkel cell carcinoma (MCC) in March 2017 and for locally advanced or metastatic urothelial carcinoma in May 2017.
This means that Pfizer and Merck KGaA have some catching up to do. This latest setback, however, is the third clinical miss over the last year or so.
Late last year, Bavencio fell short of its goal in the JAVELIN Gastric 300 study as a third-line treatment in metastatic gastric cancer. And in February of this year, the drug failed to improve overall survival in unresectable, recurrent or metastatic non-small cell lung cancer in the Phase 3 JAVELIN Lung 200 study.
More recently, however, Pfizer and Merck KGaA released some positive news. In September, the two companies announced positive interim clinical results from the JAVELIN Renal 101 study. The combination of Bavencio and Pfizer's Inlyta (axitinib) met the study's primary endpoint, outperforming Pfizer's Sutent (sunitinib).
Like others in the space, the partners also have a broad clinical development plan for the drug, including three other late-stage studies in ovarian cancer.