Pooled Analysis Shows Long-Term Benefit with Opdivo in Non-Small Cell Lung Cancer

Patients with previously treated, advanced non-small cell lung cancer (NSCLC) who received Opdivo (nivolumab) therapy experienced a survival benefit over many years, according to a pooled analysis of four studies.

Across the four studies — Checkmate-017, -057, -063, -003 – 14 percent of patients treated with the PD-1 immune checkpoint inhibitor were alive at four years. Of note, those with PD-L1 status of 1% or more and less than 1% demonstrated a four-year overall survival rate of 19% and 11%, respectively.

“These analyses in a large population of patients with previously-treated advanced non-small cell lung cancer show, for the first time, that response to Opdivo correlates to a survival benefit over many years,” Scott Antonia, M.D., Ph.D., director of the Duke Cancer Institute Center for Cancer Immunotherapy, said in a press release. “These long-term survival outcomes are particularly interesting given that, historically, the average five-year survival rate for this patient population is approximately 5%.”

The pooled analyses — for which two studies represent the longest follow-up from phase 3 randomized trials of patients with previously treated advanced NSCLC treated with immuno-oncology therapy – were conducted to evaluate the long-term benefit of Opdivo, as well as the impact of response or disease control on subsequent overall survival.

The analysis included patients with NSCLC across histologies treated with Opdivo from CheckMate-017, -057, -063 and -003 (664 patients), and for patients randomized to Opdivo (427 patients) or docetaxel (427 patients) in pooled analyses from CheckMate-017 and -057.

In the pooled analysis of CheckMate-017 and -057, the four-year overall survival rate for Opdivo-treated patients was 14% compared with 5% for docetaxel-treated patients.

In addition, exploratory landmark analysis of overall survival showed that patients who experienced a complete or partial response at six months, 58% of those treated with the PD-1 inhibitor were alive at four years compared with just 12% treated with docetaxel. Moreover, of the patients who had stable disease at six months, 19% treated with Opdivo were alive four years later versus 2% in the docetaxel arm.

Long-term safety data appeared consistent with the known side effect profile associated with Opdivo, with no new safety signals. The discontinuation rate due to treatment-related side effects was 8.7%. The most common side effects was fatigue (21.7%).

“The positive survival curve observed in these pooled analyses offers a more holistic view of long-term survival outcomes than what we’ve seen in the individual studies and provides new insights into the value Opdivo can provide for lung cancer patients in the second-line setting,” Sabine Maier, M.D., development lead of thoracic cancers at Bristol-Myers Squibb, said in the release. “These data also serve to reinforce our longstanding commitment to delivering cancer therapies that may offer more durable responses for patients in critical need.”