Merck and Pfizer Announce First Patient Treated in Phase III Combination Study with Avelumab and INLYTA® in Renal Cell Carcinoma

Merck and have announced the treatment of the first patient in a Phase III study of avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in an advanced renal cell carcinoma (RCC) setting. The study, JAVELIN Renal 101, is the first pivotal trial investigating avelumab in combination with INLYTA® (axitinib), a tyrosine kinase inhibitor (TKI), in patients with previously untreated advanced RCC, and the only Phase III trial currently evaluating an anti-PD-L1 immunotherapy in combination with a vascular endothelial growth factor (VEGF)-receptor TKI in this setting. The 5-year survival rate for patients with distant metastatic RCC is approximately 12 percent.

“Pfizer has a strong heritage in the treatment of metastatic RCC, and through the strategic alliance with Merck, we aim to further accelerate the development of potential therapies to help improve the lives of patients living with this disease,” said Chris Boshoff, M.D., PhD., Vice President and Head of Early Development, Translational and Immuno-Oncology at Pfizer Oncology. “As renal cell carcinoma is an immunogenic type of tumor that can respond to immunotherapy and to anti-angiogenic treatment, there is a strong scientific rationale for combining avelumab with INLYTA® and we believe that this combination may help improve outcomes for patients with this cancer.”

JAVELIN Renal 101 is a multicenter, international, randomized (1:1), open-label Phase III trial designed to evaluate the potential superiority, assessed by the progression-free survival (PFS), of first-line avelumab combined with INLYTA® compared with SUTENT®(sunitinib malate) monotherapy, an oral, small-molecule, multi-targeted receptor TKI, in patients with unresectable, locally advanced or metastatic RCC with clear cell component. The study will enroll 583 patients across approximately 170 sites in Asia, Europe, Latin America and North America.

“The first patient receiving treatment in this pivotal trial marks an important milestone in the strategic immuno-oncology alliance between Merck and Pfizer,” said Alise Reicin, M.D., Head of Global Clinical Development at the biopharma business of Merck. “As part of the JAVELIN clinical development program, we are exploring the potential of innovative, rational combination therapies, which combine avelumab with other treatment modalities to address significant unmet needs that exist in challenging cancers, such as advanced renal cell carcinoma.”

The clinical development program for avelumab now includes more than 1,600 patients who have been treated across more than 15 tumor types.

INLYTA® is currently approved in the United States for the treatment of advanced RCC after failure of one prior systemic therapy. INLYTA® is also approved by the European Medicines Agency for use in the European Union in adult patients with advanced RCC after failure of prior treatment with SUTENT® or a cytokine. Following its approval in 2012, INLYTA® has become a standard of care for second-line advanced RCC and has been used by an estimated 12,000 metastatic renal cell carcinoma patients in the United States. INLYTA® is under investigation in combination with avelumab for the indication studied in this Phase III trial.

*Avelumab is the proposed International Non-proprietary Name for the anti-PD-L1 monoclonal antibody (MSB0010718C). Avelumab is under clinical investigation and has not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.


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