Denise Myshko

After a four year follow up, a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) continued to prolong survival in patients with advanced non-small cell lung cancer, according to findings presented at the virtual 2021 ASCO Annual Meeting.

Progression-free survival (time during and after treatment when the patient lives without disease progression) and duration of response (length of time a tumor responds to treatment without growing or spreading) benefits were also maintained at four years, said lead author Dr. Luis Paz-Ares, head of the H12O-CNIO Lung Cancer Clinical Research Unit of the Spanish National Cancer Research Centre in Madrid, Spain.

“Taken together, these updated results continue to support the use of (Opdivo/Yervoy) as a first-line treatment of advanced (non-small cell lung cancer),” he said.

Paz-Ares presented updated four-year efficacy and safety results for this study and an efficacy analysis in patients who discontinued the combination because of treatment-related side effects.

The median four-year overall survival (time from diagnosis or treatment start when patients are alive) in patients with PD-L1 greater than or equal to 50% who received Opdivo and Yervoy was 21.2 months.

For patients receiving Opdivo alone, the median overall survival was 18.1 months, for patients receiving chemotherapy, the overall survival was 14 months.

Median four-year overall survival in patients with PD-L1 less than 1% who received Opdivo and Yervoy was 17.2 months. For patients receiving Opdivo plus chemotherapy, the overall survival was 15.2 months. For patients receiving chemotherapy, the overall survival was 12.2 months.

Four-year updated duration of response in patients with PD-L1 greater than or equal to 1% who received Opdivo and Yervoy was 23.2 months. The duration of response for patients with PD-L1 greater than or equal to 1% who received Opdivo alone was 15.5 months. And duration of response was 6.7 months for patients who received chemotherapy.

For patients with PD-L1 greater than or equal to 50%, the four-year updated duration of response in patients who received Opdivo and Yervoy was 31.8 months. For those who received Opdivo alone, the duration of response was 16.8 months and duration of response was 5.8 months for patients receiving chemotherapy.

Four-year updated duration of response in patients with PD-L1 less than 1% who received Opdivo and Yervoy was 18 months compared with 8.3 months for those who received Opdivo plus chemotherapy. For patients receiving chemotherapy only, the duration of response was 4.8 months.

Sixty-six patients (17%) with PD-L1 greater than or equal to 1 discontinued Opdivo and Yervoy because of side effects. The median duration of response after discontinuation was 52.6 months. Ninety-seven patients with PD-L1 greater than or equal to 1% and those less than 1% discontinued Opdivo and Yervoy because of side effects. The median duration of response after discontinuation was 34.2 months in this group.

“In (an) analysis, discontinuation of (Opdivo and Yervoy) due to (side effects) did not have a negative impact on the long-term benefits seen in all randomized patients,” Paz-Ares said. “Approximately half of the responders who had (side effects) leading to discontinuation maintained their responses for at least three years after treatment discontinuation.”

The FDA approved the combination of Opdivo and Yervoy in May 2020 as a first-line treatment for patients with metastatic non-small cell lung cancer with PD-L1 greater than or equal to 1% based on the CheckMate-227 study. The most common (20% or more) side effects in patients receiving the combination were fatigue, rash, decreased appetite, musculoskeletal pain, diarrhea/colitis, shortness of breath, cough, itchy skin, nausea and hepatitis.

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