Opdivo Boosts Long-Term Survival of Advanced Lung Cancer Patients, Phase 3 Trials Show

Opdivo (nivolumab) continues to increase the long-term overall survival of patients with advanced non-small cell lung cancer (NSCLC) compared to the chemotherapy Taxotere (docetaxel), according to pooled data from two Phase 3 trials.

The findings were presented in an oral presentation, titled “Five-Year Outcomes From the Randomized, Phase 3 Trials CheckMate 017/057: Nivolumab vs Docetaxel in Previously Treated NSCLC,” at the 20th World Conference on Lung Cancer, hosted by the International Association for the Study of Lung Cancer and held recently in Barcelona, Spain.

“The five-year CheckMate-017 and 057 data underscores the durable efficacy for Opdivo in this patient population compared to traditional chemotherapy,” presenter Scott Gettinger, MD, professor of medical oncology at Yale Cancer Center, said in a news release.

Opdivo is an immune checkpoint inhibitor developed by Bristol-Myers Squibb. It works by binding to a protein found on the surface of immune cells called programmed cell death (PD-1) and preventing it from interacting with its ligands, PD-L1 and PD-L2. This disruption in the PD-1 signaling pathway allows immune cells to find and eliminate cancer cells.

Two pivotal, open-label, randomized, Phase 3 trials — CheckMate-017 (NCT01642004) and CheckMate-057 (NCT01673867) — are currently ongoing to evaluate the safety and efficacy of Opdivo compared with Taxotere in patients with advanced NSCLC whose disease progressed during, or after completing, first-line treatment with platinum-based chemotherapy agents.

Patients in both trials were randomly assigned to received either Opdivo at a dose of 3 mg/kg once every two weeks, or Taxotere at a dose of 75 mg/m² once every three weeks, until disease progression or unacceptable toxicity.

The primary outcome for both studies was to assess patients’ overall survival. Secondary outcomes included the time patients lived until disease progression or death, the percentage of patients who responded to treatment, and duration of response.

At the conference, Gettinger presented new findings from a pooled analysis that included five-year data on 854 patients participating in both trials. Key findings showed that:

• A higher percentage of patients treated with Opdivo were still alive after five years of treatment (13.4%), compared with those on Taxotere (2.6%).
• The long-term survival benefit associated with Opdivo was found in all patient subgroups, including among those whose tumors produced very low levels of PD-L1 and among those whose cancer had already spread to their liver or adrenal glands at baseline.
• A higher percentage of patients on Opdivo were alive and progression-free after five years of treatment (8%), compared with those treated with Taxotere (0%).
• More patients responded to Optivo (20%) than to Taxotere (11%), and approximately a third of the patients (32.2%) who responded to Opdivo continued to show a response after five years, whereas none of the patients treated with Taxotere had a sustained treatment response that lasted five years.
• Opdivo increased the median duration of response from 5.6 to 19.9 months.
• The safety profile of Opdivo was consistent with findings from previous trials; no new safety concerns were reported during these trials.
• Between the third and fourth year of follow-up, two of the 70 patients still participating in the trials reported a new treatment-related adverse event; no new treatment-related adverse events were reported between the fourth and fifth year of follow-up by the 55 patients still remaining in the studies.

“Since the U.S. Food and Drug Administration [FDA] approval in second-line non-small cell lung cancer in 2015, Opdivo has become an important treatment option for this population of patients, who historically faced five-year survival rates of less than 5% when treated with standard chemotherapy,” said Sabine Maier, MD, development lead of thoracic cancers at Bristol-Myers Squibb.

“The long-term survival outcomes from these two studies in a large patient population add to the body of evidence supporting the durability of Opdivo-based regimens, which has now been demonstrated across multiple tumor types and lines of therapy,” Maier added.

Opdivo has been approved by the FDA for the treatment of several cancers, including melanoma, kidney, liver, and lung cancer.