FDA News

FDA approves Bavencio-Inlyta combination for advanced renal cell carcinoma

Robert Motzer, MD
Robert J. Motzer

The FDA approved avelumab in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma.

Avelumab (Bavencio; EMD Serono, Pfizer) is a human anti-PD-L1 antibody. Axitinib (Inlyta, Pfizer) is a small molecule tyrosine kinase inhibitor.

The FDA based the approval — its first of an anti-PD-L1 therapy as part of a combination regimen for advanced renal cell carcinoma — on results of the randomized phase 3 JAVELIN Renal 101 study.

The multicenter, open-label study included 886 patients with advanced renal cell carcinoma enrolled regardless of tumor PD-L1 expression.

Researchers assigned patients to the avelumab-axitinib combination or sunitinib (Sutent, Pfizer).

PFS assessed by blinded independent central review, as well as OS among patients whose tumors had PD-L1 expression of 1% or greater, served as the primary efficacy outcomes.

Patients assigned the combination achieved significantly longer median PFS (13.8 months vs. 8.4 months; HR = 0.69; P = .0001) and were more likely to achieve objective response (51.4% vs. 25.7%).

Researchers observed greater benefit of the combination among patients with PD-L1-positive tumors (median PFS, 13.8 months vs. 7.2 months; HR = 0.61; P < .001; ORR, 55.2% vs. 25.5%).

Investigators are continuing to follow patients for OS.

The most common adverse reactions among patients treated with the combination included diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache.

Thirty-five percent of patients treated with the combination experienced serious adverse reactions.

“As we look to continue to improve outcomes for people with advanced renal cell carcinoma, new treatment approaches have the potential to benefit patients,” Robert J. Motzer, MD, principal investigator of JAVELIN Renal 101 and Jack and Dorothy Byrne chair in clinical oncology at Memorial Sloan Kettering Cancer Center, said in a press release. “With [this] approval of avelumab in combination with axitinib, we can now offer patients with advanced renal cell carcinoma a first-line treatment option that combines a PD-L1 immunotherapy with a well-known VEGF receptor TKI to provide a significant reduction in the risk of disease progression or death and doubling of the response rate compared with sunitinib.”

Robert Motzer, MD
Robert J. Motzer

The FDA approved avelumab in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma.

Avelumab (Bavencio; EMD Serono, Pfizer) is a human anti-PD-L1 antibody. Axitinib (Inlyta, Pfizer) is a small molecule tyrosine kinase inhibitor.

The FDA based the approval — its first of an anti-PD-L1 therapy as part of a combination regimen for advanced renal cell carcinoma — on results of the randomized phase 3 JAVELIN Renal 101 study.

The multicenter, open-label study included 886 patients with advanced renal cell carcinoma enrolled regardless of tumor PD-L1 expression.

Researchers assigned patients to the avelumab-axitinib combination or sunitinib (Sutent, Pfizer).

PFS assessed by blinded independent central review, as well as OS among patients whose tumors had PD-L1 expression of 1% or greater, served as the primary efficacy outcomes.

Patients assigned the combination achieved significantly longer median PFS (13.8 months vs. 8.4 months; HR = 0.69; P = .0001) and were more likely to achieve objective response (51.4% vs. 25.7%).

Researchers observed greater benefit of the combination among patients with PD-L1-positive tumors (median PFS, 13.8 months vs. 7.2 months; HR = 0.61; P < .001; ORR, 55.2% vs. 25.5%).

Investigators are continuing to follow patients for OS.

The most common adverse reactions among patients treated with the combination included diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache.

Thirty-five percent of patients treated with the combination experienced serious adverse reactions.

“As we look to continue to improve outcomes for people with advanced renal cell carcinoma, new treatment approaches have the potential to benefit patients,” Robert J. Motzer, MD, principal investigator of JAVELIN Renal 101 and Jack and Dorothy Byrne chair in clinical oncology at Memorial Sloan Kettering Cancer Center, said in a press release. “With [this] approval of avelumab in combination with axitinib, we can now offer patients with advanced renal cell carcinoma a first-line treatment option that combines a PD-L1 immunotherapy with a well-known VEGF receptor TKI to provide a significant reduction in the risk of disease progression or death and doubling of the response rate compared with sunitinib.”

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