BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

Feltham (Merck) & Walton Oaks (Pfizer) – Merck and Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO^® (avelumab) as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with platinum‑based induction chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in early 2021.

The opinion was based on positive findings from the Phase III JAVELIN Bladder 100 trial, results of which were published in The New England Journal of Medicine in September 2020.¹ BAVENCIO is the only immunotherapy to significantly prolong overall survival (OS) in locally advanced or metastatic UC in the first-line maintenance setting in a Phase III trial.

Dr Simon Crabb, Associate Professor in Medical Oncology, University of Southampton explains, “The prognosis and quality of life for patients with urothelial carcinoma is unacceptably poor. Despite high response rates to first-line platinum-based chemotherapy treatment, which is the current standard of care, it has limited durability and most patients will ultimately experience disease progression within nine months of initiation of treatment. Introducing BAVENCIO as a first-line maintenance treatment after chemotherapy can sustain and extend the benefits of treatment and significantly prolong overall survival, compared to best supportive care, without a detrimental impact on a patient’s quality of life. I believe this strategy will now change clinical practice for the treatment of patients with locally advanced or metastatic urothelial carcinoma.”

“BAVENCIO is the only immunotherapy treatment to demonstrate in the first-line maintenance setting the ability to help patients with locally advanced or metastatic urothelial carcinoma live longer,” said Danny Bar-Zohar, MD, Global Head of Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. “Now with this positive opinion, we have come a big step closer to being able to offer a new option that may shift the treatment paradigm for patients in Europe.”

Based on 2018 results, bladder cancer is the tenth most common cancer worldwide.² In 2018 in Europe alone, nearly 200,000 people were diagnosed with bladder cancer and more than 60,000 patients died from the disease, despite available treatments.³ UC, which accounts for about 90% of all bladder cancers, becomes harder to treat as it advances, spreading through the layers of the bladder wall.^4,5 For patients with advanced UC, the five-year survival rate is 5%.⁶ About 4% of bladder cancers are diagnosed at an advanced stage. ⁷ 

“Patients living with locally advanced or metastatic urothelial carcinoma in Europe are in urgent need of more treatment options that have the potential to extend their lives,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “The overall survival results from JAVELIN Bladder 100 show the potential benefits of a first-line maintenance approach with BAVENCIO as a significant advancement for patients with locally advanced or metastatic urothelial carcinoma.”

Avelumab is not licensed in the UK as monotherapy for the first line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with platinum-based induction chemotherapy and a marketing authorisation application for this indication is currently under review by the European Medicines Agency (EMA).