NIVOLUMAB FAILED IN NSCLC FIRST LINE TRIAL

The immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb) has failed as a first-line monotherapy for lung cancer.

The drug did not meet its primary endpoint of progression-free survival in the CheckMate-026 trial in patients with previously untreated advanced non-small cell lung cancer (NSCLC), the company announced today.

To be included in the trial, patients had to have had tumors that expressed the biomarker PD-L1 at 5% or greater.

The results are a disappointment because nivolumab had previously been shown to be effective in the second-line setting in patients with NSCLC that had progressed during or after platinum-based chemotherapy. The US Food and Drug Administration approved this second-line indication in both squamous and nonsquamous NSCLC.

The news is a boon to Merck, whose rival immunotherapy pembrolizumab (Keytruda) is also approved for the treatment of advanced NSCLC in the second-line setting. Recent news reports indicate that a similar trial investigating the use of pembrolizumab in the first-line setting vs chemotherapy had met its primary endpoint.

CheckMate-026 is a phase 3, open-label, randomized study of nivolumab monotherapy vs investigator's-choice chemotherapy in patients with untreated, advanced NSCLC.

The trial randomly assigned 541 patients to receive nivolumab 3 mg/kg intravenously every 2 weeks or investigator's-choice chemotherapy in patients with squamous NSCLC (gemcitabine with cisplatin; gemcitabine with carboplatin; paclitaxel with carboplatin) and nonsquamous NSCLC (pemetrexed with cisplatin; pemetrexed with carboplatin) until disease progression, unacceptable toxicity, or completion of 6 cycles.

"While we are disappointed CheckMate-026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase 3 CheckMate-227 study exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients," said Giovanni Caforio, MD, chief executive officer, Bristol-Myers Squibb, in a press statement.