Merck KGaA and Pfizer yesterday confirmed that the FDA granted accelerated approval for their fully human anti-programmed cell death ligand-1 (anti-PD-L1) monoclonal antibody (mAb) Bavencio® (avelumab) as a treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease progressed during or following platinum-containing chemotherapy therapy, or who exhibit disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The FDA granted the antibody accelerated approval as a treatment for metastatic Merkel cell carcinoma (MCC) just a couple of months ago. 

Approval of Bavencio for the UC indication was confirmed in advance of Roche reporting today that its engineered anti-PD-L1 mAb Tecentriq® (atezolizumab) failed to meet its primary endpoint in the Phase III IMvigor211 trial in UC patients. Tecentriq was granted accelerated approval by the FDA in May last year.

Accelerated FDA approval of Merck KGaA and Pfizer’s Bavencio for the UC indication was based on data from UC patient cohorts in the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study evaluating Bavencio in the treatment of various solid tumors.

Bavencio will be co-commercialized by Pfizer and Merck KGaA’s North Amercian biopharma business EMD Serono. “This approval builds on the ongoing clinical development program for Bavencio in UC and reinforces our commitment to providing new medicines to patients with difficult-to-treat cancers,” said Liz Barrett, global president, Pfizer Oncology.

“Once UC progresses after treatment with chemotherapy, the 5-year survival rate is alarmingly low,” said Andrea Apolo, M.D., from the National Cancer Institute in Bethesda, MD. “Until recently, there had been limited innovation in UC, and this approval gives us another treatment to help battle this aggressive disease.”

Bavencio is separately being evaluated in the Phase III JAVELIN Bladder 100 study, in combination with best supportive care for the maintenance therapy of patients with locally advanced or metastatic UC whose disease did not progress after completion of first-line platinum-containing chemotherapy.

The international JAVELIN clinical development program for avelumab involves more than 30 clinical programs, including nine Phase III trials, and more than 5200 patients across more than 15 tumor types.

Pfizer and Merck KGaA signed their potentially $2.85 billion deal to develop the latter's avelumab (MSB0010718C) in November 2014. 

The two companies separately reported today a clinical trials collaboration with EpiThany, through which the latter will carry out a Phase II study evalauting avelumab in combination with its own EP-101 STEMVAC cancer vaccine candidate in women with breast cancer.