On March 27, 2023 Merck reported that it has strengthened its Oncology franchise by regaining exclusive worldwide rights to develop, manufacture, and commercialize anti-programmed death ligand-1 (PD-L1) antibody BAVENCIO (avelumab) following the termination of their Alliance agreement with Pfizer (Press release, Merck & Co, MAR 27, 2023, View Source [SID1234629392]).
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"On behalf of Merck, I’d like to thank Pfizer for their partnership and collaboration over the last nine years, and for the role they have played in the success of BAVENCIO," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "Our joint efforts have delivered meaningful therapeutic value to patients around the world who are living with cancer. This has been an incredible journey for us, and thanks to Pfizer’s partnership we are now very well positioned to continue to deliver this therapy to patients in need."
"Our alliance with Merck allowed us to combine our complementary strengths to develop and launch BAVENCIO to help meet the needs of people with cancer globally," said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. "We are proud of our achievements together, including introducing BAVENCIO as an important treatment option for patients with metastatic Merkel cell carcinoma, locally advanced or metastatic urothelial carcinoma, and in combination with INLYTA for advanced renal cell carcinoma. We thank our colleagues at Merck for a tremendous partnership and wish them well in their future plans for BAVENCIO."
Reflecting a long-held interest of Merck, effective June 30, 2023, Merck, through its affiliate Ares Trading S.A., will take full control of the global commercialization of BAVENCIO. The current profit share will be replaced by a 15% royalty to Pfizer on net sales of BAVENCIO. Merck and Pfizer will continue to operationalize their respective ongoing clinical trials for BAVENCIO, and Merck will control all future research and development activities. As it is currently, product manufacturing and supply chain will remain solely with Merck, ensuring continuous and reliable access to BAVENCIO for patients.
"This is an excellent example of our focused leadership strategy in action, as we are now fully accountable to reinforce BAVENCIO’s position as a standard of care in advanced urothelial carcinoma for the benefit of patients in need, and as an important therapeutic option for appropriate patients with renal cell carcinoma and Merkel cell carcinoma," says Peter Guenter, Chief Executive Officer Healthcare at Merck. "With our late-stage pipeline, our broader Oncology portfolio, and now with full ownership of BAVENCIO, we look forward to demonstrating the strength of our Oncology Franchise as we amplify our efforts to deliver important innovation to patients."
BAVENCIO was discovered in-house at Merck. The Alliance between Merck and Pfizer was executed in 2014 to co-develop and co-commercialize BAVENCIO with the goal to accelerate development of the human anti PD-L1 antibody. With this announcement, Bavencio will further contribute to Merck’s Big 3 strategy focusing on new Healthcare products, Process Solutions and Life Science Services, as well as Semiconductor Solutions.
BAVENCIO is an anti PD-L1 monoclonal antibody that is widely recognized in international guidelines as the standard-of-care 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. BAVENCIO in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
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.1-3 In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.
BAVENCIO Approved Indications
The European Commission (EC) has authorized the use 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. BAVENCIO in combination with axitinib is indicated 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).
In the US, BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced RCC. Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
BAVENCIO is currently approved for patients in 68 countries for at least one use.
BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)
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. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.