Pfizer and Merck's Bavencio plus Inlyta Combination Receives NICE Approval as First-Line 'Immunotherapy plus Targeted Therapy' for Advanced Renal Cell Carcinoma in the UK

August 03, 2020 News /BioonBIOON/ -- The UK's National Institute for Health and Care Excellence (NICE) recently recommended the use of Merck KGaA's products within the National Health Service (NHS).Pfizer(Pfizer) The combination regimen of the anti-PD-L1 therapy Bavencio (avelumab) and the tyrosine kinase inhibitor Inlyta (axitinib) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

This scheme will be funded through the Cancer Drugs Fund (CDF) in the United Kingdom.Previously, the Bavencio + Inlyta combination was approved for provision through the Early Access to Medicines Scheme (EAMS) in August 2019, enabling more than 150 patients in the UK to receive treatment ahead of schedule.

Despite some progress in recent years, the prognosis for patients with advanced renal cell carcinoma (RCC) remains poor, with a 5-year survival rate of only approximately 12%, highlighting an urgent need for additional first-line treatment options.

Bavencio + Inlyta is an “immunotherapy + targeted therapy” combination regimen, wherein: Bavencio is an immune checkpoint inhibitor targeting PD-L1, and Inlyta is an anti-angiogenic VEGF-targeted TKI; the complementary mechanisms of action of these two drugs targetTumorTwo Key Pathways of Growth.

In the United States and the European Union, the Bavencio + Inlyta combination was approved in May and October 2019, respectively, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Notably, in April and September of the same year, Merck & Co.’s anti-PD-1 therapy Keytruda in combination with Inlyta was approved in the United States and the European Union, respectively, for the first-line treatment of patients with advanced RCC.

Data from the Phase III JAVELIN Renal 101 study demonstrated that, across all prognostic risk groups (regardless of PD-L1 status), the Bavencio plus Inlyta combination significantly reduced the risk of disease progression or death by 31% and nearly doubled the objective response rate (ORR) compared with sunitinib (52.5% vs. 27.3%). The study is ongoing to determine overall survival benefit.

Medicine Specializing in Renal Cell CarcinomaTumorProfessor Amit Bahl, an academic advisor, stated: “This positive recommendation from NICE provides an effective and well-tolerated treatment option for patients with advanced renal cell carcinoma. Results from the randomized Phase III trial confirmed the benefits of the Bavencio plus Inlyta combination therapy in terms of progression-free survival and objective response rate.”

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.Tumormetastasis). In the United States and the European Union, Inlyta is approved for second-line treatment of advanced RCC.

Bavencio, developed by Merck KGaA, is a PD-(L)1 tumor immunotherapy. This class of tumor immunotherapies has garnered significant attention for its aim to harness the body’s own immune system to combat cancer by blocking the PD-1/PD-L1 signaling pathway, thereby inducing cancer cell death, and demonstrating efficacy in treating various typesTumorpotential.

In November 2014, Pfizer and Merck KGaA signed an agreement worth up to $2.85 billion to enter the PD-(L)1 field. To date, the approved indications for Bavencio include: (1) treatment of metastatic Merkel cell carcinoma (mMCC) in pediatric patients aged 12 years and older and adults; (2) treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy; (3) treatment of patients with locally advanced or metastatic UC who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy; (4) first-line treatment of patients with advanced renal cell carcinoma (RCC) in combination with Inlyta; and (5) maintenance treatment of patients with locally advanced or metastatic UC who have not progressed with first-line platinum-containing chemotherapy, an indication approved in late June 2020.

It is worth mentioning that Bavencio is the United StatesFDAThe First Approved Phase III Trial for First-Line Maintenance Therapy in UCClinical TrialImmunotherapy proven to deliver significant overall survival (OS) benefits. Data from the Phase III JAVELIN Bladder 100 study showed that first-line maintenance treatment with Bavencio plus standard of care extended median OS by 50% compared with standard of care alone (21.4 months vs. 14.3 months). (Bioon.com)

Original source: NICE backs Bavencio combo for kidney cancer