ASCO 2015: Nivolumab Extends Survival for Patients With Nonsquamous Non–Small Cell Lung Cancer


Key Points

  • Among patients with nonsquamous non–small cell lung cancer who progressed after platinum-based doublet chemotherapy, overall survival was 12.2 months for those treated with nivolumab vs 9.4 months for those treated with docetaxel. 
  • Response rates were 19.2% in the nivolumab group vs 12.4% in the docetaxel group. 
  • Median duration of response was 17.1 months with nivolumab group vs 5.6 months with docetaxel.

Superior overall survival was experienced by patients receiving the anti–PD-1 antibody nivolumab (Opdivo) in a randomized phase III study of patients with nonsquamous non–small cell lung cancer (NSCLC) whose disease progressed after a platinum-based doublet chemotherapy. Study participants treated with nivolumab had overall survival of 12.2 months, compared to 9.4 months for those treated with docetaxel.

“This is the first phase III study to show that immunotherapy is effective against nonsquamous cell NSCLC, and appears to be particularly active in patients with PD-L1–positive tumors,” said lead study author Luis Paz-Ares, MD, PhD, Professor of Medicine at Hospital Universitario 12 de Octubre in Madrid, Spain. “While nivolumab appears to be more potent against this most common lung cancer, it is important to note that it is also far easier on patients compared to the standard second-line treatment, docetaxel.” Dr. Paz-Ares discussed the findings at a press conference at the 2015 ASCO Annual Meeting in Chicago and will present detailed results at the clinical science symposium on immunotherapy, Saturday, May 30 (Abstract LBA109).

NSCLC is the most common form of lung cancer, accounting for 85% of all lung cancers. More than two-thirds of those are nonsquamous cell cancers. Dr. Paz-Ares stated that nivolumab could potentially become a new standard therapy for patients with previously treated NSCLC.

Longer Lasting Responses

The CheckMate 057 study randomly assigned 582 patients with advanced nonsquamous NSCLC to treatment with nivolumab or docetaxel. The 292 patients in the nivolumab group received 3 mg/kg every 2 weeks, and the 290 patients in the docetaxel group received 75 mg/m2 every 3 weeks. Response rates were higher in the nivolumab group compared to the docetaxel group (19.2% vs 12.4%).

Responses lasted significantly longer in the nivolumab group (median duration of response, 17.1 months vs 5.6 months).

For the subgroup of patients with high levels of PD-L1 in their tumor (≥ 1% cells), median overall survival was even higher than the 12.2 months in the entire nivolumab group, exceeding 17 months. Overall, patients who received nivolumab had a 27% lower risk of death compared to those who received docetaxel, but the subgroup of patients with the high levels of PD-L1 had a 41% to 60% reduction in risk of death, which was not observed in cases of low or undetectable PD-L1 levels. “Importantly, PD-LI emerged as a clear predictive factor for the benefit of nivolumab,” Dr. Paz-Ares stated at the press conference.

Fewer Serious Side Effects

Nivolumab was well tolerated overall, with 10.5% of patients receiving nivolumab experiencing serious side effects, compared to 53.7% of patients receiving docetaxel. Toxic side effects led to 4.9% patients discontinuing nivolumab vs 14.9% patients discontinuing docetaxel. Nearly half of the patients who stopped treatment subsequently received systemic therapy. There was one treatment-related death in the docetaxel group and none in the nivolumab group.

“Even 5 years ago, an effective immunotherapy for lung cancer was largely considered impossible. Today, we have such a treatment, and it surpasses the standard therapy both in terms of efficacy and patient quality of life,” noted ASCO Expert Gregory A. Masters, MD, FACP, FASCO. Dr. Masters is an attending physician at the Helen F. Graham Cancer Center, Newark, Delaware, and serves as an Associate Professor at the Thomas Jefferson University Medical School.

Earlier this year, the U.S. Food and Drug Administration approved nivolumab as a second-line treatment for advanced squamous NSCLC, but nivolumab is not yet available for patients with lung cancer in Europe.

This study received funding from Bristol-Myers Squibb. Dr. Paz-Ares reported honoraria from Roche/Genentech, Lilly, Pfizer, Boehringer Ingelheim, Clovis Oncology, Bristol-Myers Squibb, and MSD.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.