#Checkmate 227 trial

#Checkmate 227 trial

Hellmann serves as the principal investigator for CheckMate -227, a large, open-label, randomized phase III trial of nivolumab, nivolumab plus ipilimumab, or nivolumab plus platinum-doublet chemotherapy (PT-DC) versus PT-DC alone in people with stage IV or recurrent NSCLC who had not received prior treatment. For example, if combination immunotherapy is the best option for someone in the first-line setting, then it provides a potentially effective and durable option upfront, sparing the use of chemotherapy initially while saving an effective option with chemotherapy for the second line if needed.”ĭr. “These results show that combination immunotherapy can be a new treatment option in the first-line setting and contribute to our ongoing effort to match people with the best therapies for them. “In the CheckMate -227 trial, we applied the emerging data about TMB to validate this as a biomarker to predict who will best respond to this combination therapy,” explained Dr. However, responses occur in only a minority of people with NSCLC, and biomarkers are needed to more effectively identify who is most likely to benefit from immunotherapy. Checkpoint inhibitors, such as nivolumab, have recently emerged as a critical new treatment option for people with NSCLC. For people without a targetable oncogene, chemotherapy has long been the standard of care, but this treatment is characterized by its short duration of response and moderate toxicity. Lung cancer is the greatest cause of cancer deaths worldwide. The identification of a new biomarker for predicting who can benefit from this immunotherapy combination is encouraging and continues the progress we have made through precision medicine in treating people with lung cancer.”Īnswering the Critical Question: Who Will Respond to Treatment? “This is the first phase III study to evaluate TMB, a measurement of the mutations carried by tumor cells, as a predictive biomarker for immunotherapy as a co-primary endpoint. “This study demonstrates the efficacy of nivolumab plus ipilimumab immunotherapy as a first-line treatment for people with high-TMB NSCLC,” explained Dr. This research is featured in the meeting’s press program, and findings are being presented in the Clinical Trials Plenary Session, “Immunotherapy Combinations: The New Frontier in Lung Cancer.” This data is being simultaneously published in the New England Journal of Medicine. Data from the CheckMate -227 trial is being reported by Matthew Hellmann, MD, of Memorial Sloan Kettering Cancer Center, at the AACR Annual Meeting 2018. The combination of nivolumab (Opdivo ®) and ipilimumab (Yervoy ®) has shown improved progression-free survival (PFS) compared with chemotherapy as a first-line treatment for people with a high tumor mutational burden (TMB) in advanced non-small cell lung cancer (NSCLC).