Opdivo and Yervoy Approved for First-Line Treatment of Lung Cancer

May 15, 2020 – The U.S. FDA has approved a new indication for Opdivo® (nivolumab – Bristol Myers Squibb), used in combination with Yervoy® (ipilimumab – Bristol Myers Squibb), to provide first-line treatment for adult patients who have metastatic non-small cell lung cancer (NSCLC) and whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Lung cancer is the leading cause of death from cancer in the United States, with non-small cell lung cancer accounting for up to 85% of all lung cancer diagnoses. Prognosis for patients who have lung cancer is often poor, with a five-year survival rate of 35% if the cancer has spread from the lungs to nearby areas of the body or the lymph nodes, and just 6% once the cancer has spread to more distant regions, such as the brain, bones, or other organs. Many NSCLC tumors express a protein called programmed death ligand 1 (PD-L1), which prevents the immune system from recognizing and attacking cancer cells. Opdivo and Yervoy work by helping the immune system identify and destroy cancer cells.

In a clinical trial, the combination of Opdivo and Yervoy delivered a median overall survival time of 17.1 months compared to 14.9 months with chemotherapy. Sixty-three percent of patients treated with Opdivo and Yervoy survived at least one year compared to 56% of patients who received chemotherapy. At two years, 40% of patients treated with Opdivo and Yervoy were still alive compared to 33% of patients treated with chemotherapy, and at three years, 33% of patients treated with Opdivo and Yervoy were alive compared to 22% of those treated with chemotherapy. Overall response rate with Opdivo and Yervoy was 36% compared to 30% for chemotherapy. In addition, Opdivo and Yervoy demonstrated a higher median duration of response at 23.2 months compared to 6.2 months with chemotherapy.

Recommended dosing under the new indication is Opdivo 3mg/kg of patient’s body weight, administered via a 30-minute intravenous (IV) infusion once every two weeks, and Yervoy 1mg/kg of patient’s body weight administered once every six weeks via 30-minute IV infusion. Treatment should continue until disease progression or for up to two years in patients without disease progression. Dosage modification or treatment discontinuation may be required based on individual patient factors, including infusion reactions. A black box warning cautions that the use of Yervoy is associated with immune-mediated adverse reactions that can be severe or fatal. In rare cases, these reactions may occur weeks to months after discontinuation of treatment with Yervoy.

Opdivo first received FDA approval in 2014 and, in addition to NSCLC, is indicated to treat melanoma, small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, hepatocellular carcinoma, and colorectal cancer. Originally FDA approved in 2011, Yervoy is indicated to treat melanoma, renal cell carcinoma, colorectal cancer, and hepatocellular carcinoma in addition to NSCLC.