Opdivo (nivolumab) the long-term overall survival of patients with advanced non-small cell lung cancer (NSCLC) compared to chemotherapy taxotere (docetaxel), according to pooled data from two Phase 3 studies.
The findings were presented in an oral presentation entitled “Five Year Results of the Randomized Phase 3 Trials CheckMate 017/057: Nivolumab Versus Docetaxel in Treatment-experienced NSCLC,” at the 20th World Conference on Lung Cancer, organized by the International Association for the Study of Lung Cancer and recently held in Barcelona, Spain.
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“The five-year CheckMate-017 and 057 data underscore the sustainable efficacy of Opdivo in this patient population compared to traditional chemotherapy,” presenter Scott Geter, MD, professor of medical oncology at Yale Cancer Center, said in a press 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 prevent it from interacting with its ligands, PD-L1 and PD-L2. This disturbance in the PD-1 signaling pathway enables immune cells to find and eliminate cancer cells.
Two pivotal, open-label, randomized, phase 3 studies — CheckMate-017 (NCT01642004) and CheckMate-057 (NCT01673867) — are currently evaluating the safety and efficacy of Opdivo compared to Taxotere in patients with advanced NSCLC whose disease progressed during or after completion of first-line treatment with platinum-based chemotherapy agents.
Patients in both studies were randomly assigned to either Opdivo at a dose of 3 mg/kg every other week, or Taxotere at a dose of 75 mg/m22 once every three weeks, until disease progression or unacceptable toxicity.
The primary outcome measure for both studies was assessing patients’ overall survival. Secondary outcomes were the time patients lived to disease progression or death, the percentage of patients who responded to treatment, and the duration of response.
At the conference, Gettinger presented new findings from a pooled analysis of five-year data from 854 patients enrolled in both studies. The main findings showed that:
- A higher percentage of patients treated with Opdivo were alive after five years of treatment (13.4%) compared to those receiving Taxotere (2.6%).
- The long-term survival benefit of Opdivo was found in all subgroups of patients, including those whose tumors produced very low levels of PD-L1 and those whose cancer had already spread to their liver or adrenal glands at the start.
- A higher percentage of patients on Opdivo lived after five years of treatment (8%), compared to those treated with Taxotere (0%).
- More patients responded to Optivo (20%) than to Taxotere (11%) and approximately one third of patients (32.2%) who responded to Opdivo continued to respond after five years, while none of the patients treated with Taxotere a sustained treatment response lasting 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 studies; no new safety issues were reported during these studies.
- Between the third and fourth years of follow-up, two of the 70 patients remaining in the studies reported a new treatment-related adverse reaction; between the fourth and fifth years of follow-up, no new treatment-related adverse events were reported by the 55 patients remaining in the studies.
“Since the US Food and Drug Administration [FDA] approval for second-line non-small cell lung cancer in 2015, Opdivo has become an important treatment option for this patient population, which has historically experienced a five-year survival rate of less than 5% when treated with standard chemotherapy,” says Sabine Maier. , MD, thoracic cancer development leader at Bristol-Myers Squibb.
“The long-term survival results of 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 shown for multiple tumor types and lines of therapy,” Maier added.
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