It is the first phase 3 study demonstrating that an immunotherapy combination improves disease-free survival and complete pathological response in the neoadjuvant setting of non-small cell lung cancer. It is the study that compares the effectiveness of the combination of nivolumab plus chemotherapy to that of chemo alone, administered before surgery. A result that comes from an interim analysis for an association that had previously shown significant improvement in pathological complete response (pCR), another primary endpoint of the study.
“Although the purpose of surgery is curative in resectable non-small cell lung cancer, between 30% and 55% of patients develop recurrence after surgery and ultimately surrender to the disease, confirming a strong need of additional options that can break this cycle, ”said Nicolas Girard, MD, Ph.D., professor of respiratory medicine at Paris Saclay University and head of the Thorax Institute Curie Montsouris in Paris. “The positive disease-free survival data observed with neoadjuvant nivolumab plus chemotherapy are groundbreaking and may have important implications in the treatment of resectable non-small cell lung cancer.”
Lung cancer is the leading cause of cancer death globally. Non-small cell lung cancer (NSCLC) is the most common type, accounting for 84% of diagnoses and presenting as non-metastatic in 60% of cases. Although many patients with non-metastatic NSCLC are cured with surgery, 30% to 55% develop a recurrence and die from the disease despite resection, confirming the need for treatment options to be given before surgery (neoadjuvants) and / or after surgery (adjuvants) to improve long-term results.
“The combination of nivolumab and chemotherapy initially showed a statistically significant improvement in the pathologic complete response rate, with no impact on surgery results, and has now extended the time patients live free of disease progression, relapse or death,” Said Abderrahim Oukessou, MD, vice president, thoracic cancers development lead, Bristol Myers Squibb. “Disease-free survival data from the CheckMate-816 study reinforce the evidence for the potential of nivolumab-based therapies to improve long-term, early-stage clinical outcomes in non-metastatic cancers.”
The scientific rationale for the use of immunotherapy in the neoadjuvant setting is twofold: the presence of a tumor during immunotherapy therapy can allow for a greater immune response, potentially making treatment against a primary tumor more effective, while offering the opportunity to target occult micrometastases. Currently, nivolumab has shown greater efficacy in the neoadjuvant or adjuvant treatment of four types of cancers: lung, bladder, esophagus / gastroesophageal junction, and melanoma.
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