The European Commission (EC) has approved a combination regimen of Bavencio (avelumab) injections plus Inlyta (axitinib) tablets for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC), the most common type of kidney cancer.

The combination can be used in patients regardless of their predicted prognosis and PD-L1 status.

The EC’s decision followed a positive recommendation issued in September by the Committee for Medicinal Products for Human Use, an arm of the European Medicines Agency.

The U.S. Food and Drug Administration (FDA) also approved the combination in May for adults with advanced RCC. In Japan, a supplemental application for a similar indication was submitted in January 2019.

In Europe, approval was based on preliminary results of the ongoing JAVELIN Renal 101 Phase 3 trial (NCT02684006), which demonstrated that Bavencio plus Inlyta extended median time without disease worsening or death from eight to 13 months, which represents a 31% lower risk of disease progression or death.

It also nearly doubled the proportion of patients whose tumors reduced in size compared to standard-of-care therapy Sutent (sunitinib) — 52.5% versus 27.3%. Since few patients have died, data on survival is immature, but results suggest a 20% lower risk of death in patients taking the combination, researchers say.

Such positive effects were seen in patients with advanced RCC, regardless of their prognostic risk (predicted chances of survival) and their PD-L1 status.

PD-L1 testing is sometimes done to see if patients are likely to benefit from certain immunotherapies called checkpoint inhibitors, such as Bavencio. In this case, the combination is approved for patients regardless of whether their cancer tests were positive or negative for PD-L1.

“There is a high incidence of kidney cancer in Europe, and for the most common type, renal cell carcinoma, we continue to need additional treatment options, particularly for patients with advanced disease, where outcomes are poorest,” James Larkin, PhD, oncologist at the Royal Marsden NHS Foundation Trust and professor at the Institute of Cancer Research, and one of the investigators involved in JAVELIN, said a news release.

“We’ve seen a demonstrated efficacy benefit and safety and tolerability profile for avelumab [Bavencio] in combination with axitinib [Inlyta] across all prognostic risk groups in patients with advanced renal cell carcinoma, so today’s approval in Europe brings an important option that can help healthcare professionals optimize treatment strategies across risk stratification,” Larkin added.

An estimated 136,500 new cases of kidney cancer were diagnosed in Europe last year, with about 54,700 deaths due to the disease.

Often, patients with advanced RCC do not receive additional treatment after first-line therapy, either because patients do not respond to treatment or due to side effects from their initial therapy. The five-year survival rate for patients with this type of advanced cancer is low at approximately 12%.

Bavencio (avelumab) is a lab-made antibody that targets programmed death ligand-1 (PD-L1), a cell-surface protein overproduced by several cancers, which acts as a “brake” to keep the body’s immune cells from recognizing and killing cancer cells. The medicine is jointly developed and commercialized by EMD Serono (known as Merck KGaA in Europe) and Pfizer, and is also approved for skin and urinary tract cancers.

Inlyta (axitinib), also sold by Pfizer, is an inhibitor of tyrosine kinases designed to prevent new blood vessels from forming, and thereby reduce oxygen and nutrient supply to tumors, helping to stop cancer growth and spreading. The medicine is used as a standalone therapy for advanced RCC when a prior treatment regimen has failed.

“This first European approval of an anti-PD-L1 as part of a combination treatment for advanced renal cell carcinoma builds on our commitment to bringing innovative treatment options to patients with hard-to-treat cancers through our extensive JAVELIN clinical trial program,” said Rehan Verjee, president of EMD Serono and global head of innovative medicine franchises for the biopharma business of Merck KGaA.

“RCC is the most common form of kidney cancer, accounting for 90% of diagnoses. We are now working to make Bavencio in combination with axitinib [Inlyta] available for patients with advanced renal cell carcinoma as quickly as possible,” he said.

Recommended doses of the combination therapy is 800 mg of Bavencio administered by infusion into the vein (intravenously) over 60 minutes every two weeks and 5 mg of Inlyta tablets taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.

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