Merck, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer are dropping the Phase III Javelin Ovarian PARP 100 study in which they tested avelumab combined with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV), as they described in the press release on Wednesday.
According to the announcement, several emerging factors since the trial has begun lead to this, including the previously announced interim results from JAVELIN Ovarian PARP 100. The companies pointed out that it wasn’t for safety reasons.
“The alliance determined that the degree of benefit observed with avelumab in frontline ovarian cancer in that study does not support continuation of the Javelin Ovarian PARP 100 trial in an unselected patient population and emphasizes the need to better understand the role of immunotherapy in ovarian cancer,” they said.
Additional factors include the rapidly changing treatment landscape and the approval of a PARP inhibitor in the frontline maintenance setting.
Futhermore, PARP 100 program dropping won’t affect the currently approved indications for avelumab or the remainder of the ongoing Javelin clinical development program, the companies said. Javelin overall involves at least 30 clinical programs and more than 9,000 patients evaluated across more than 15 different tumor types, including breast, gastric/gastro-esophageal junction, and head and neck cancers, Merkel cell carcinoma, non-small cell lung cancer, and urothelial carcinoma.
Avelumab and talazoparib are under clinical investigation for the treatment of advanced ovarian cancer and have not been demonstrated to be safe and effective for this use, it was noted in the press release.
About Avelumab (Bavencio )
Avelumab (Bavencio) is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.4-6 Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.6 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.