Small progress grows. And so thanks to the combination of two immunotherapies plus two cycles of chemotherapy after four years 21% of patients with metastatic non-small cell lung cancer are still alive compared to 16% of patients treated with chemotherapy alone. These numbers contain the good news that we are giving to patients affected by this, which is the most common form of the lung cancer ‘family’, who await with curiosity – together with the specialists who treat them – the most promising news coming from the Annual Congress of the American Society of Clinical Oncology (American Society of Clinical Oncology) underway in Chicago. These data are those announced by Bristol Myers Squibb of the Phase 3 CheckMate -9LA study.
CheckMate -9LA is a multicenter, randomized Phase 3 study evaluating nivolumab (360 mg every 3 weeks) plus ipilimumab (1 mg/kg every 6 weeks) combined with chemotherapy (two cycles), compared with chemotherapy alone (up to 4 cycles followed by maintenance therapy) as first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and histology. Patients in the investigational arm (n=361) were treated with dual immunotherapy for up to two years or until disease progression or unacceptable toxicity. Patients in the control arm (n=358) received up to 4 cycles of chemotherapy and optional pemetrexed maintenance therapy (if available) until disease progression or unacceptable toxicity.
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Follow-up results presented at Asco demonstrate sustained long-term benefits with nivolumab plus ipilimumab and two cycles of chemotherapy versus four cycles of chemotherapy alone. Notably, after a minimum of 47.9 months, the dual immunotherapy combination continued to prolong overall survival with 21% of patients treated with nivolumab plus ipilimumab and two chemotherapy cycles alive at four years compared with 16 % of patients treated with chemotherapy alone.
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Findings in patients with PD-L1 expression
At extended follow-up, the clinically meaningful efficacy benefit of nivolumab plus ipilimumab and two cycles of chemotherapy was maintained across secondary endpoints and subgroups of patients with tumor PD-L1 expression less than 1% and squamous histology, representing primarily those with high unmet clinical need. Notably, among patients with tumor PD-L1 expression <1%, the overall survival rate was 23% for those treated with the dual immunotherapy-based combination compared with 13% for chemotherapy alone, representing a lower 34% reduction in the risk of death.
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Results on patients with squamous histology
Among patients with squamous histology, twice as many of those treated with nivolumab plus ipilimumab and chemotherapy were alive at four years as those treated with chemotherapy alone (20% versus 10%). In this group, the combination based on dual immunotherapy reduced the risk of death by 36% compared with chemotherapy alone.
The comment of the experimenter
These data were the subject of a late-breaking poster presentation (Abstract #LBA9023) at the American Society of Clinical Oncology Annual Meeting. “The durable results observed over four years with nivolumab plus ipilimumab and chemotherapy, especially in patients with poor prognosis, demonstrate the long-term benefits of combining dual immunotherapy with a reduced course of chemotherapy for patients with non-small cell lung cancer advanced or metastatic, which remains a particularly complex disease to treat,” he says David P. Carbone, MD, Ph.D., CheckMate -9LA study investigator and Director of the Thoracic Oncology Center at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute. “The data in patients with tumor PD-L1 expression less than 1% and squamous histology are particularly encouraging, showing that combination therapy continues to reduce the risk of death by approximately one-third compared with chemotherapy alone at four years of follow-up in patient groups that historically have worse outcomes.
An increasingly tailored oncology
Lung cancer is the leading cause of cancer death worldwide. The two main types of lung cancer are non-small cell and small cell. Non-small cell cancer (NSCLC) is one of the most common, accounting for 84% of diagnoses. Survival rates vary depending on the stage and type of cancer at the time of diagnosis. “Oncological treatment – he declares Abderrahim Oukessou, MD, Vicepresident, thoracic cancers development lead, Bristol Myers Squibb – it’s not a one-size-fits-all approach, because patients with thoracic cancers, such as non-small cell lung cancer, have different needs. We are committed to finding solutions that work for more patients and have the potential to help improve outcomes and fill areas of high unmet clinical need.” Nivolumab plus ipilimumab combinations have shown significant improvements in overall survival in six Phase 3 clinical trials in five cancers to date: metastatic NSCLC, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma, and esophageal squamous cell carcinoma .