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Medscape
2 days ago
- Health
- Medscape
Nivolumab Plus Chemotherapy Improves Survival in Lung Cancer
Adding nivolumab to neoadjuvant chemotherapy significantly improved 5-year overall survival among patients with resectable non-small cell lung cancer (NSCLC), according to findings from a phase 3 trial presented at the recent American Society of Clinical Oncology (ASCO) 2025 annual meeting. The survival benefit was more pronounced in patients who achieved a pathologic complete response or a presurgery clearance of circulating tumor DNA (ctDNA). METHODOLOGY: The phase 3 CheckMate 816 trial has shown that compared with neoadjuvant chemotherapy alone, nivolumab plus chemotherapy improvespathologic complete response rates and event-free survival in patients with stage IB-IIIA resectable NSCLC. Based on these findings, this regimen was approved for this patient population in the US, EU, and other places. compared with neoadjuvant chemotherapy alone, nivolumab plus chemotherapy improvespathologic complete response rates and event-free survival in patients with stage IB-IIIA resectable NSCLC. Based on these findings, this regimen was approved for this patient population in the US, EU, and other places. Researchers are now reporting the final, prespecified analysis of overall survival. In the trial, 358 patients with stage IB-IIIA resectable NSCLC were randomly assigned to receive either nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone every 3 weeks for three cycles. Surgery was performed within 6 weeks of completing neoadjuvant treatment. Postoperative adjuvant chemotherapy, radiotherapy, or both were permitted. Primary endpoints were event-free survival and pathologic complete response. Overall survival was the key secondary endpoint. The median follow-up duration was 68.4 months. TAKEAWAY: The 5-year overall survival rate was 65.4% with nivolumab plus chemotherapy vs 55.0% with chemotherapy alone. Nivolumab plus chemotherapy reduced the risk for death by 28% (hazard ratio [HR], 0.72; P = .048). = .048). Among patients who received the combination therapy, the 5-year overall survival rate was 95.3% for those who achieved a pathological complete response vs 55.7% for those who did not. Overall, 24% of patients in the nivolumab group achieved a pathological complete response vs only 2.2% in the chemotherapy group. ctDNA clearance before surgery was a strong prognostic indicator, regardless of treatment. At 5 years, overall survival was 75.0% among patients with ctDNA clearance vs 52.6% in those without (HR for death, 0.38 in the nivolumab group and 0.39 in the chemotherapy-only group). The combination therapy was associated with consistent survival benefits across disease stage and PDL-1 expression levels. The 5-year lung cancer-specific survival rate was 74.9% with nivolumab plus chemotherapy vs 65.1% with chemotherapy alone (HR, 0.65). No new safety concerns emerged, and there were no new deaths related to a trial treatment. IN PRACTICE: 'In this trial, we found that the use of neoadjuvant nivolumab plus chemotherapy resulted in significantly longer overall survival than chemotherapy alone, along with long-term benefit regarding event-free survival,' the authors wrote. 'These findings support the hypothesis that neoadjuvant chemoimmunotherapy can have a profound impact on the course of a patient's life when paired with the curative potential of surgical resection.' SOURCE: This study, led by Patrick M. Forde, MB, BCh, PhD, Trinity St. James's Cancer Institute, Trinity College Dublin, Dublin, Ireland, was published online in The New England Journal of Medicine and presented at ASCO. LIMITATIONS: Although the overall survival with nivolumab plus chemotherapy achieved statistical significance, the margin was narrow. Additionally, several subgroups in the exploratory analyses were too small for adequate statistical comparison, requiring cautious interpretation of these results. Black patients were underrepresented, which may have affected the generalizability of the findings. DISCLOSURES: This study was funded by Bristol Myers Squibb. Five authors declared being employees of Bristol Myers Squibb, with some holding stock or stock options with the company. Several authors declared working as consultants or having other ties with various sources including Bristol Myers Squibb.
Irish Independent
03-06-2025
- Health
- Irish Independent
Long term survival for lung cancer patients improved with new treatment combination, new Irish research reveals
The patients with lung cancer who received an immunotherapy drug, nivolumab, along with standard chemotherapy before surgery had improved long term survival compared to those who received chemotherapy alone, at five years after completing treatment. Results from the phase 3 clinical trial were published in the New England Journal of Medicine. Prof Patrick Forde of the Trinity St James's Cancer Institute (TSJCI), Trinity College Dublin School of Medicine, presented the findings at the American Society of Clinical Oncology Annual Meeting in Chicago, USA, at the weekend. Prof Forde led the CheckMate 816 trial which enrolled 358 patients globally who were diagnosed with the most common type of lung cancer, non-small cell lung cancer (NSCLC), at a stage where it could be removed by surgery. However, despite undergoing surgery, 50pc of patients with stage 2 or 3 lung cancer will eventually have relapse of their cancer. Immunotherapy drugs known as immune checkpoint inhibitors, in particular those that block a receptor called PD-1, have led to improved survival for patients with advanced cancers by unmasking the tumour to the patient's immune system. However, up until now, no study had shown long-term benefit to this treatment in helping to cure earlier stage lung cancer. Earlier in his career as an oncologist at Johns Hopkins in the United States Prof Forde led the first clinical trial of immunotherapy prior to surgery (neoadjuvant therapy) for lung cancer which was published in the New England Journal of Medicine in 2018. That study showed that among 20 patients who underwent surgery after two doses of immunotherapy, almost half had little or no remaining cancer at the time of their operation. In an earlier report of the CheckMate 816 trial, patients with lung cancer who received immunotherapy along with chemotherapy prior to surgery were more likely to have had their cancer eliminated completely by the time of surgery and also had lower rates of cancer relapse. Side effects were not increased with the addition of immunotherapy, and in general, surgeries went well. These findings led to the approval of the neoadjuvant nivolumab plus chemotherapy in several countries globally, including as a standard treatment for eligible patients in Ireland. In the latest update from the trial, patients who received immunotherapy plus chemotherapy before surgery were approximately 10pc more likely to be alive at five years than those who just received chemotherapy. Among the 24pc of patients treated with immunotherapy plus chemotherapy who had no cancer remaining at the time of surgery - known as a pathologic complete response - no patient had died from lung cancer by five years. Prof Forde is also co-leading an international clinical trial open in Ireland at TSJCI, Beaumont, Galway and Mater Hospitals that is aimed at further improving outcomes for patients undergoing surgery. Results from part of this study were also published this week in the prestigious Nature Medicine journal. In the NeoCOAST-2 trial, patients who received standard chemo-immunotherapy plus a new treatment called an antibody drug conjugate (ADC) before surgery were more likely to have no viable cancer remaining at the time of surgery, suggesting that this additional treatment could improve outcomes further. Prof Forde said: 'Immunotherapy has helped many patients with stage 4 lung cancer live longer with good quality of life. "Until recently we have not had new treatments available that can increase the chances of cure after lung cancer surgery. The use of immunotherapy with chemotherapy before lung cancer surgery has now been shown to reduce the risk of cancer coming back and improve long term survival. "Cancer clinical trials are key to improving outcomes for patients with cancer and offer the potential for early access to the latest cutting edge cancer treatments. I am delighted to be able to help expand clinical trial options for patients in Ireland.' In 2024, Prof Forde joined the Trinity St James's Cancer Institute (TSJCI) as the Patrick Prendergast Professor of Clinical Immuno-Oncology. This position was established by a philanthropic gift from Dr Stanley Quek, Trinity alumnus and former Pro-Chancellor of the University. In collaboration with colleagues across Ireland, Prof Forde's goal is to improve access for patients to cutting edge cancer clinical trials.
