Pfizer and Merck Submit Regulatory Applications in the US, EU, and Japan for Bavencio (Avelumab) Plus Inlyta (Axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma

Source: BioValley 　2019-03-11                                                                                                               A- A+

Pfizer and its partner Merck recently announced that the European Medicines Agency (EMA) has accepted a Type II variation application for the PD-L1 tumor immunotherapy Bavencio (avelumab), in combination with the tyrosine kinase inhibitor Inlyta (axitinib), for the treatment of patients with advanced renal cell carcinoma (RCC).

Currently, the supplemental Biologics License Application (sBLA) for this combination therapy in the treatment of advanced renal cell carcinoma (RCC) is also undergoing priority review by the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of June 2019. Previously, the FDA had granted Breakthrough Therapy designation to this combination as a first-line treatment for advanced RCC. In addition, Pfizer and Merck have also submitted a supplemental application in Japan for the use of the Bavencio and Inlyta combination in patients with unresectable or metastatic RCC.

Despite the availability of current treatment options, the prognosis for patients with advanced renal cell carcinoma (RCC) remains poor. It is estimated that approximately 20%–30% of patients present with metastatic disease at initial diagnosis, and the 5-year survival rate for patients with metastatic RCC is approximately 12%.

This regulatory submission is based on data from the JAVELIN Renal 101 study. This was a global, multicenter, randomized Phase III study conducted in 886 patients with newly diagnosed advanced renal cell carcinoma (RCC) to evaluate the efficacy and safety of Bavencio in combination with Inlyta (axitinib) as first-line therapy compared with Sutent (sunitinib). Sutent, developed by Pfizer, has been the standard-of-care agent for first-line treatment of RCC over the past decade. The primary objective of the study was to demonstrate whether the Bavencio plus Inlyta combination regimen was superior to Sutent in prolonging progression-free survival (PFS) or overall survival (OS) in patients with PD-L1–positive advanced RCC.

The full results of this study were presented at the 2018 European Society for Medical Oncology (ESMO) Congress held in Munich, Germany. The results showed that, compared with Sutent, the Bavencio + Inlyta combination therapy significantly reduced the risk of disease progression or death by 39% in patients with PD-L1-positive tumors (expression level ≥1%) (median PFS: 13.8 months vs. 7.2 months; HR=0.61 [95% CI: 0.475–0.790], p<0.0001), and significantly reduced the risk of disease progression or death by 31% in the overall study population (median PFS: 13.8 months vs. 8.4 months; HR=0.69 [95% CI: 0.563–0.840], p=0.0001). In terms of objective response rate (ORR), the Bavencio + Inlyta combination therapy was more than twice that of Sutent (55.2% vs. 25.5%). Importantly, the efficacy of the Bavencio + Inlyta combination therapy was independent of patient prognosis, demonstrating consistent benefits across favorable, intermediate, and poor prognostic groups.

The JAVELIN Renal 101 study is part of the JAVELIN clinical development program, which encompasses at least 30 clinical trials involving more than 15 different tumor types and over 9,000 patients. In addition to ovarian cancer, these tumor types include breast cancer, gastric/gastroesophageal junction cancer, head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer, renal cell carcinoma, and urothelial carcinoma.

Inlyta, developed by Pfizer, is an oral therapy designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2, and 3, which may promote tumor growth, angiogenesis, and cancer progression (tumor spread). In both the United States and the European Union, Inlyta is approved for the second-line treatment of advanced renal cell carcinoma (RCC).

Bavencio is a PD-(L)1 tumor immunotherapy, a highly regarded class of cancer immunotherapies that harnesses the body’s own immune system to combat cancer. By blocking the PD-1/PD-L1 signaling pathway, it induces cancer cell death and holds potential for treating multiple types of tumors.

In November 2014, Pfizer signed an agreement worth up to $2.85 billion with Merck KGaA to enter the PD-(L)1 field. In March 2017, Bavencio received accelerated approval from the U.S. FDA for the treatment of metastatic Merkel cell carcinoma (mMCC) in pediatric patients aged 12 years and older and in adults. This approval made Bavencio the first oncology immunotherapy globally for the treatment of mMCC, an aggressive skin cancer with a poorer prognosis than melanoma. In May 2017, Bavencio received further accelerated approval from the U.S. FDA for: (1) patients with locally advanced or metastatic urothelial carcinoma (mUC) who experienced disease progression during or after platinum-containing chemotherapy; and (2) patients with locally advanced or metastatic urothelial carcinoma (mUC) who experienced disease progression within 12 months following neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. (Bioon.com)

Original Source: EUROPEAN MEDICINES AGENCY VALIDATES APPLICATION FOR BAVENCIO® (AVELUMAB) PLUS INLYTA® (AXITINIB) FOR THE TREATMENT OF ADVANCED RENAL CELL CARCINOMA

Original Title: First-Line Treatment for Advanced Renal Cell Carcinoma! Pfizer/Merck Immunotherapy & Targeted Therapy Combination Bavencio + Inlyta Seeks Approval in the US, Japan, and Europe

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