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Pfizer and Merck KGaA Set to Launch Two Additional Late-Stage Trials for Avelumab

The PD-L1 inhibitor study additions will bring the total late-stage program to six studies

Merck KGaA and Pfizer are moving forward with two new clinical trials for the programmed death ligand 1 (PD-L1) inhibitor avelumab. This will make the companies the first to get into a phase III study for platinum resistant/refractory ovarian cancer, and the second study will be in a first-line setting in patients with locally advanced or metastatic urothelial cancer.

According to FierceBiotech, both companies have a lot riding on their success here, with Pfizer looking to prove it can make another big splash in the cancer field as Merck KGaA tries to overcome a series of major setbacks that have prevented it from gaining any major new drug approvals in well over a decade. Roche, meanwhile, is following Merck and Bristol-Myers Squibb with its own phase III program, while AstraZeneca has been falling behind.

A phase III, randomized (1:1:1), open-label, parallel, multicenter, global study (JAVELIN Ovarian 200) is designed to evaluate the superiority of avelumab as a monotherapy or in combination with pegylated liposomal doxorubicin (PLD), compared with PLD alone, in treating patients with platinum-resistant/refractory ovarian cancer. The primary endpoint is overall survival (OS). Study investigators anticipate enrolling approximately 550 patients across more than 190 sites in Asia, Europe, and North America.

Merck KGaA, of Darmstadt, Germany, and Pfizer have also initiated a phase III study (JAVELIN Bladder 100) investigating avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer. This is currently the only phase III trial designed to evaluate an immunotherapy agent as a maintenance treatment, in the first-line setting, in patients with urothelial cancer.

This open-label, multicenter, randomized, global, phase III study is designed to evaluate the safety and efficacy of avelumab plus best supportive care (BSC), compared with BSC alone, in patients with unresectable locally advanced or metastatic urothelial cancer whose disease did not progress on (or following) completion of first-line treatment with a platinum-containing chemotherapy. The primary endpoint of the study is OS, which will be assessed in two urothelial cancer patient populations: patients with PD-L1 positivity and all randomized patients.

JAVELIN Bladder 100 is expected to enroll 668 patients across more than 200 sites in 38 countries. PD-L1 expression status will be determined by retrospective analysis of mandatory tumor samples collected from patients enrolled in the trial. It is estimated that at least half of those patients randomized to treatment will be PD-L1-positive.

The clinical development program for avelumab now includes more than 1,500 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastroesophageal junction cancers, head and neck cancer, melanoma, Merkel cell carcinoma, non–small-cell lung cancer, ovarian cancer, renal cell carcinoma, and urothelial (bladder) cancer. The alliance has initiated six pivotal trials, reaching its goal for 2015, with additional trials expected to start in 2016.

Source: FierceBiotech, December 22, 2015.

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