- The results of the Phase III CheckMate-816 study, in which the Vall d’Hebron Institute of Oncology (VHIO), part of the Vall d’Hebron Campus, has participated, and that are published in The New England Journal of Medicine, demonstrate that neoadjuvant treatment with nivolumab plus chemotherapy given before surgery in patients with resectable non-small cell lung cancer (NSCLC) improves both event-free survival and long-term complete pathological response.
- The results are particularly notable in patients with stage IIIA non-small cell lung cancer, the subgroup that had the worst prognosis so far.
- Based on this study, nivolumab in combination with chemotherapy has been approved in the United States by the U.S. Food and Drug Administration (FDA) as neoadjuvant therapy for adult patients with resectable NSCLC, and is expected to bring about a change in the standard of treatment for these patients in Europe.
Barcelona, 12 April 2022– The New England Journal of Medicine has just published the results of the CheckMate 816 Phase III study. The study enrolled 352 patients with resectable non-small cell lung cancer (NSCLC) who had either received neoadjuvant therapy with immunotherapy (nivolumab) plus chemotherapy or chemotherapy alone, prior to surgery. The median event-free survival was 31.6 months in the first group versus 20.8 months in the second group, which had only received chemotherapy. The complete pathological response rate was 24% in immunotherapy plus chemotherapy, compared with 2.2%% in the second group, with chemotherapy alone. Of the patients who participated in the study, more who had received combined treatment underwent surgery (83.2% versus 75.4% of those who received chemotherapy alone).
At one year, 76.1% of patients treated with nivolumab and chemotherapy survived without progression of the disease compared with 63.4% of those treated with chemotherapy alone. At 2 years, data were for 63.8% patients in the first group versus 45.3% in the second group. These data demonstrate that neoadjuvant treatment with three cycles of nivolumab (an anti-PD-1 antibody that restores the function of existing anti-tumour T cells) plus chemotherapy can improve long-term clinical outcomes in patients with resectable stage IB-IIIA NSCLC without impeding viability of surgery or increasing the incidence of adverse events compared with chemotherapy. Based on this study, nivolumab in combination with chemotherapy has been approved in the United States as neoadjuvant therapy for adult patients with resectable NSCLC.
“The use of immunotherapy in combination with chemotherapy as neoadjuvant therapy can offer a promising treatment option in patients with resectable NSCLC prior to surgery; This will allow us to treat the disease early and improve event-free survival for these patients, reducing the risk of relapse,” says Dr Enriqueta Felip, Head of Section of the Medical Oncology Department of the Vall d’Hebron University Hospital, Head of the Thoracic Tumours and Head and Neck Cancer Group of the Vall d’Hebron Institute of Oncology (VHIO) and President of the Spanish Society of Medical Oncology (SEOM). “Until now, immunotherapy had already demonstrated its benefits in advanced stages of the disease and in postoperative treatment, but the results of this study could lead to a change in clinical practice and incorporate chemotherapy in combination with immunotherapy into preoperative treatment,” adds Dr Felip, who is one of the authors of this study, in which Dr Mariano Provencio, president of the Spanish Lung Cancer Group (GECP), chief of Medical Oncology at Puerta de Hierro Hospital in Madrid and assistant professor at George Washington University, has also participated. Previously, the NADIM study, led by Dr Provencio and GECP, had already demonstrated excellent results with chemotherapy combined with nivolumab in the preoperative treatment of patients with stage IIIA NSCLC.
Approximately 20-25% of patients diagnosed with non-small cell lung cancer (NSCLC) have resectable disease; however, 30-55% of patients who have curative surgery experience recurrence and eventually die from their disease.
Patrick M. Forde, Jonathan Spicer, Shun Lu, Mariano Provencio, Tetsuya Mitsudomi, Mark M. Awad, Enriqueta Felip, Stephen R. Broderick, Julie R. Brahmer, Scott J. Swanson, Keith Kerr, F.R.C.Path., Changli Wang, Tudor-Eliade Ciuleanu, Gene B. Saylors, Fumihiro Tanaka, Hiroyuki Ito, Ke-Neng Chen, Moishe Liberman, Everett E. Vokes, Janis M. Taube, Cecile Dorange, Junliang Cai, Joseph Fiore, Anthony Jarkowski, David Balli, Mark Sausen, Dimple Pandya, Christophe Y. Calvet, Nicolas Girard, for the CheckMate-816 Investigators. “Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer”. The New England Journal of Medicine. April 11, 2022. DOI: 10.1056/NEJMoa2202170