Encouraging 5-Year Survival Data With Nivolumab in Advanced NSCLC

The 5-year survival estimate from a study evaluating nivolumab in a subset of patients with advanced non-small cell lung cancer (NSCLC) is significantly longer than the historic survival numbers in these patients, according to data that will be presented at the annual meeting of the American Association of Cancer Research (AACR).

EGFR

ALK

Patients diagnosed with advanced NSCLC, who carry a mutation in the epidermal growth factor receptor gene () or rearrangements in anaplastic lymphoma kinase (), have poor survival—a majority die within 1 year of diagnosis, despite molecularly targeted treatments. However, results of a trial that was initiated in 2010 has found encouraging results in a subset of these patients.

In the study, 129 patients were treated at 11 sites around the United States with standard chemotherapy or the programmed death-ligand 1 inhibitor nivolumab.

Nivolumab was administered intravenously as a 1-hour infusion every 2 weeks in 8-week treatment cycles in an outpatient setting. Treatment was continued for up to 96 weeks or until unacceptable toxicity, confirmed complete response, confirmed disease progression, or withdrawal of consent.

The data presented at AACR shows 16 patients survived 58 months (nearly 5 years)—12 of the 16 did not receive further therapy at the time of data analysis in November 2016 and were without worsening disease symptoms.

said in a statement

“A small subset of nonsmall cell lung cancer patients appear to respond to nivolumab and have beaten the odds that most patients with this cancer face,” Julie Brahmer, MD, program leader of the trial at the Johns Hopkins Bloomberg—Kimmel Institute for Cancer Immunotherapy, .

The 16 patients must have some unique biological characteristics that have led to their improved performance over the remaining cohort. However, the authors have yet to identify the genes or proteins that may be responsible for their long-term survival. Brahmer believes that combination immunotherapy regimens could further boost the number of responsive patients.

Journal of Clinical Oncology

Previous results from the trial, published in the , found the most common adverse events (AEs) following a median of 13.6 weeks of therapy, were fatigue, decreased appetite, and diarrhea. Treatment-related severe AEs included skin, gastrointestinal, and pulmonary events. The trial also documented treatment-related deaths due to pneumonitis.

Defining which patients need continued therapy and which do not is a cost-saving opportunity for these very expensive medications, according to Brahmer. This is a valid argument, because duration of treatment with immuno-oncology agents remains a topic of debate.