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).

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 and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO. 

BAVENCIO Approved Indications in Europe

The European Commission (EC) has authorized the use of BAVENCIO in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized by the EC for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).¹¹

BAVENCIO is currently approved for patients in 50 countries for at least one use.

BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)¹¹

The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting.

About Merck-Pfizer Alliance

Immuno-oncology is a top priority for Merck and Pfizer. The global strategic alliance between Merck 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. 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.

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