FDA Approves Nivolumab + Ipilimumab as First-Line Treatment of Metastatic, Recurrent Non-Small Cell Lung Cancer

The therapy is approved for patients with squamous or non-squamous disease and regardless of programmed death-ligand 1 (PD-L1) expression.

The FDA has approved nivolumab (Opdivo, Bristol Myers Squibb), 360 mg and ipilimumab (Yervoy, Bristol Myers Squibb) 1 mg/kg injections for intravaneous use administered with 2 cycles of platinum-doublet chemotherapy for the first-line treatment of adults with metastatic or recurrent non-small lung cancer (NSCLC) with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic abberations.

The therapy is approved for patients with squamous or non-squamous disease and regardless of programmed death-ligand 1 (PD-L1) expression.

The combination therapy was reviewed under the FDA's Real-Time Oncology Review pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible. Further, nivolumab and ipilimumab was approved by the FDA on May 15 as a first-line treatment for certain patients with metastatic NSCLC whose tumors express PD-L1 ≥ 1% as determined by an FDA-approved test.

The approval is based on a pre-specified interim analysis from the phase 3 CheckMate -9LA trial, in which nivolumab and ipilimumab combined with 2 cycles of platinum-doublet chemotherapy demonstrated superior overall survival (OS) versus chemotherapy regardless of PD-L1 expression or tumor histology.

Median OS (mOS) was 14.1 months among those treated with the combination versus 10.7 months among those administered chemotherapy. In a follow-up analysis at 12.7 months, the hazard ratio improved numerically to 0.66, with mOS of 15.6 months and 10.9 months, respectively. At 1 year, 63% of patients treated nivolumab and ipilimumab with limited chemotherapy were still alive compared with 47% of those treated with chemotherapy.

Nivolumab is associated with immune-mediated warnings and precautions, such as pneumonitis, colitis, hepatitis, and endocrinopathies. Other adverse reactions include embryo-fetal toxicity and increased mortality in patients with multiple myeloma when nivolumab is added to a thalidomide analogue and dexamethasone.

“We have come a long way in understanding the role of dual immunotherapy-based approaches in cancer and the potential impact on patients’ long-term outcomes,” said David P. Carbone, MD, PhD, CheckMate -9LA investigator and director of the James Thoracic Oncology Center at The Ohio State University, in a press release. “The positive findings from CheckMate -9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for NSCLC patients regardless of PD-L1 status. With today’s approval, more patients now have access to an nivolumab + ipilimumab-based option and a chance at a longer life.”

REFERENCE

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer [news release]. BusinessWire. May 26, 2020. Accessed May 27, 2020. https://www.businesswire.com/news/home/20200526005870/en/U.S.-Food-Drug-Administration-Approves-Opdivo%C2%AE-nivolumab.