European Commission Approves BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved BAVENCIO^® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.

“Avelumab is the only immunotherapy to demonstrate a significant improvement in overall survival in the first-line setting in a Phase III study in advanced or metastatic bladder cancer. With this approval by the European Commission, we can now offer patients a potential new first-line maintenance standard of care that may help them live longer,” said Professor Thomas Powles, MD, Director of Barts Cancer Centre, London, UK.

In the pivotal JAVELIN Bladder 100 trial, BAVENCIO plus best supportive care (BSC) as first-line maintenance demonstrated a significant improvement in median overall survival (OS) vs BSC alone at the prespecified interim analysis (data cut-off date Oct. 21, 2019): 21.4 months (95% CI: 18.9 to 26.1) vs 14.3 months (95% CI: 12.9 to 17.8) in the coprimary population of all randomized patients (HR 0.69; 95% CI: 0.56 to 0.86).¹ In the coprimary population of patients with PD-L1+ tumors (n=358), OS was also significantly longer with BAVENCIO plus BSC (median not reached; 95% CI: 20.3, not reached) vs BSC alone (17.1 months; 95% CI: 13.5, 23.7; HR 0.56; 95% CI, 0.40 to 0.79).^1,2 Based on these data, the BAVENCIO first-line maintenance regimen was added to the recently updated ESMO Clinical Practice Guidelines for bladder cancer.³

Updated OS results with a data cut-off of Jan. 19, 2020 also showed BAVENCIO significantly extended OS among all randomized patients vs BSC alone (HR 0.70; 95% CI, 0.56 to 0.86; two-sided P=0.0008), with median OS of 22.1 months (95% CI, 19.0 to 26.1) vs 14.6 months (95% CI, 12.8 to 17.8), respectively.¹

“Today’s announcement is the latest example of our decades-long commitment to developing new treatments for people with genitourinary cancers,” said Andy Schmeltz, Global President, Pfizer Oncology. “This approval by the EC addresses an urgent unmet need, and we look forward to providing a new treatment option for people in Europe with locally advanced or metastatic urothelial carcinoma.”

“This approval allows us to extend the reach of BAVENCIO to even more patients with bladder cancer and offer the hope of extended survival,” said Rehan Verjee, President of EMD Serono and Global Head of Innovative Medicine Franchises for the Healthcare business sector of Merck KGaA, Darmstadt, Germany. “This is a clear demonstration of our commitment to transform standards of care in cancer.”

BAVENCIO was first approved in the US as a first-line maintenance treatment for advanced UC by the US Food and Drug Administration (FDA) in June 2020 and is now approved for this indication in 38 countries. Additional regulatory applications are under review in 13 countries, including in Japan, where approval is expected in H1 2021.