Results from a phase 3 clinical trial published in the New England Journal of Medicine, today (June 2nd) show that 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 5 years after completing treatment. 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 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 >50% 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 2 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 10% more likely to be alive at 5 years than those who just received chemotherapy. Among the 24% 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 5 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.
You can read the NEJM paper, Survival with Neoadjuvant Nivolumab 3 plus Chemotherapy in Lung Cancer at the following link, when the embargo lifts: www.nejm.org/doi/full/10.1056/NEJMoa2502931
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Patrick Forde, bio
Patrick Forde is a consultant medical oncologist and currently holds the Prendergast Chair in Immuno-Oncology at Trinity College Dublin. He is originally from Co. Clare, attended medical school in Dublin before undertaking 7 years of medical and oncology training in Ireland. He then joined Johns Hopkins University in the United States where he rose to become Professor of Oncology and co-director of the Upper Aerodigestive Malignancies division. His research focuses on development of immunotherapy clinical trials to treat cancer and in his current role he sees patients at the Trinity St. James's Cancer Institute in Dublin.
