ROCKLAND - EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) 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 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.
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.1 BAVENCIO is the only immunotherapy to significantly prolong overall survival (OS) in locally advanced or metastatic UC in the first-line setting in a Phase III trial.
'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.'
Bladder cancer is the tenth most common cancer worldwide.2 In Europe alone, nearly 200,000 people are diagnosed with bladder cancer each year and more than 60,000 patients die 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
'BAVENCIO is the only immunotherapy treatment to demonstrate in the first-line setting the ability to help patients with locally advanced or metastatic urothelial carcinoma live longer,' said Danny Bar-Zohar, M.D., 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.'
In June 2020, the US Food and Drug Administration (FDA) approved BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy. Additional regulatory applications have been submitted in Japan and other countries.
About JAVELIN Bladder 100
JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus best supportive care (BSC) versus BSC alone in patients with locally advanced or metastatic UC. A total of 700 patients whose disease had not progressed after platinum-based induction chemotherapy as per RECIST v1.1 were randomly assigned to receive either BAVENCIO plus BSC or BSC alone. The primary endpoint was OS in the two primary populations of all patients and patients with PD-L1+ tumors.
About BAVENCIO (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO 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, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.8-10 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.
About EMD Serono, Inc.
EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.
About Merck KGaA, Darmstadt, Germany-Pfizer Alliance
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany and Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germany and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices - the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of EUR 16.2 billion in 66 countries.
The company holds the global rights to the name and trademark 'Merck' internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.
Contact:
Noelle Piscitelli
Tel: +1 781 427 4351
PFIZER, INC. 
