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A two punch combo for RCC
09-11-2018
by Mel J. Yeates  |  Email the author
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Darmstadt, Germany and New York—Merck KGaA, Darmstadt, Germany, and Pfizer Inc. have today announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating BAVENCIO (avelumab) in combination with INLYTA (axitinib), compared with SUTENT (sunitinib) as an initial therapy for patients with advanced renal cell carcinoma (RCC).
 
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody which 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, avelumab releases the suppression of the T cell-mediated antitumor immune response. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity in vitro. Axitinib is an oral therapy designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3; these receptors can influence tumor growth, vascular angiogenesis and the progression of cancer.
 
JAVELIN Renal 101 is a global Phase III multicenter randomized (1:1) study investigating the efficacy and safety of avelumab in combination with axitinib as a first-line treatment option, compared with sunitinib monotherapy, in 886 patients with advanced RCC across all risk groups. The primary objectives are to demonstrate that avelumab in combination with axitinib is superior to sunitinib monotherapy in prolonging PFS or OS in patients with PD-L1+ tumors. Avelumab was administered at 10 mg/kg IV every two weeks in combination with axitinib at 5 mg orally twice daily; sunitinib was administered at 50 mg orally once daily, four weeks on and two weeks off.
 
As part of a planned interim analysis, an independent Data Monitoring Committee confirmed that the trial showed a statistically significant improvement in progression-free survival (PFS) by central review for patients treated with the combination whose tumors had programmed death ligand-1-positive (PD-L1+) expression greater than 1% (primary objective), as well as in the entire study population regardless of PD-L1 tumor expression (secondary objective). According to the statistical analysis plan, if PFS was statistically significant in the PD-L1+ subgroup, then PFS in the entire study population was to be analyzed for statistical significance.
 
“JAVELIN Renal 101 is the first positive Phase III study combining an immune checkpoint blocker with a TKI, supporting the potential of BAVENCIO and INLYTA as a new cancer treatment approach for patients with advanced RCC,” noted Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. “These positive results reinforce Pfizer’s long-standing heritage in advancing standards of care for people with RCC, and we look forward to discussing these data in greater detail with health authorities.”

JAVELIN Renal 101 will continue as planned to the final analysis for the other primary endpoint of overall survival (OS). No new safety signals were observed, and adverse events for avelumab, axitinib and sunitinib in this trial were consistent with the known safety profiles for all three medicines. The alliance intends to pursue a regulatory submission in the U.S. based on these interim results, and these results will be discussed with global health authorities. A detailed analysis will also be submitted for presentation at an upcoming medical congress.
 
In December 2017, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for avelumab in combination with axitinib for treatment-naïve patients with advanced RCC. Despite available therapies, the outlook for patients with advanced RCC remains poor. Approximately 20% to 30% of patients are first diagnosed at the metastatic stage. The five-year survival rate for patients with metastatic RCC is approximately 12%.
 
“We are encouraged by these data which illustrate the impact of BAVENCIO in combination with INLYTA as a potential first-line treatment for people with advanced RCC, a serious and life-threatening cancer,” said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the Biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. “They also support our firm belief in the promise of combining BAVENCIO with currently approved therapies and novel agents, a strong focus of the overall JAVELIN clinical development program.”
 
Code: E09111801

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