First-line treatment of advanced lung cancer, immune combination therapy February 06, 2018 Source: WuXi PharmaTech Today, Bristol-Myers Squibb (BMS) announced that its ongoing Phase 3 clinical trial, CheckMate-227, has reached a common primary endpoint for progression-free survival (PFS). The trial evaluated the efficacy of immunological combination therapy Opdivo (nivolumab) and Yervoy (ipilimumab) in first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). The results of this study cover a population of patients who do not consider PD-L1 expression levels and have high (≥10 mutations/megabase) tumor mutation burden (TMB). According to the American Cancer Society (ACS), more than 222,000 Americans were diagnosed with lung cancer in 2017, and non-small cell lung cancer (NSCLC) accounted for 85% of all lung cancer. It is estimated that about 60% of lung cancer patients in the United States have entered advanced stage at the time of diagnosis. Although new treatments for lung cancer have emerged in recent years, we still have a long way to go to completely conquer this evil. Opdivo is a PD-1 immunological checkpoint inhibitor that uses the body's own immune system to help restore anti-tumor immune responses, providing a new option for patients with advanced lung cancer. As the world's first approved PD-1 immunological checkpoint inhibitor, Opdivo is currently available in more than 60 countries including the United States, the European Union, and Japan, making it an important treatment option for a variety of cancers. In October 2015, the company's Opdivo and Yervoy combination regimen became the first immunocombination therapy approved for the treatment of metastatic melanoma, and has been approved for marketing in more than 50 countries, including the US and the European Union. The trial, CheckMate-227, is an open-label, phase 3 clinical trial involving more than 2,500 patients. The results released today evaluate the efficacy of the Opdivo+Yervoy regimen in the first-line treatment of patients with advanced NSCLC compared with platinum-based chemotherapy. There are two common primary endpoints in this segment: overall survival (OS) in patients with PD-L1 tumor expression, and PFS in patients with TMB (regardless of PD-L1 expression levels). Today's results indicate that the study reached a second common primary endpoint, demonstrating that Opdivo + Yervoy combination therapy showed statistically significant PFS in a specific patient population compared to chemotherapy. In this study, TMB was evaluated using Foundation Medicine's analytical validation assay FoundationOne CDx. TMB is a quantitative biomarker that reflects the total number of mutations carried by tumor cells. Tumor cells with high TMB have higher levels of new antigens and are thought to help the immune system recognize tumors and stimulate an increase in anti-cancer T cells and an anti-tumor response. Approximately 45% of TMB can assess a patient's tumor with high expression of TMB. As a biomarker, TMB is expected to help predict patient response to immunotherapy. In addition, based on an interim analysis of the OS, the Data Monitoring Committee recommends that research continue. Security is also consistent with the results in previous reports. ▲Dr. Matthew D. Hellmann, oncologist at the Sloan-Kettering Cancer Center (Source: Commemorative Sloan-Kettering Cancer Center) "TMB has become an important biomarker for immunotherapeutic activity. This phase 3 study for the first time demonstrated superior PFS for first-line immunocombination therapy in pre-defined NSCLC patients with high TMB," Memorial Sloan-Kettering Cancer Center Dr. Matthew D. Hellmann, an oncologist, said: "CheckMate-227 indicates that TMB is an important and independent predictive biomarker that identifies groups of first-line NSCLC patients who may benefit from nivolumab plus ipilimumab combination therapy." Dr. Giovanni Caforio, Chairman and CEO of BMS commented: “We believe that the data from CheckMate-227 is a breakthrough in cancer research and is determining which first-line lung cancer patients may benefit the most from the combination of Opdivo and Yervoy. A meaningful step. These findings demonstrate our deep understanding of cancer biology, leading the ability of translational medicine to develop new treatments for cancer patients." We expect more patients with advanced lung cancer to benefit from this immunocombination therapy. Reference materials: [1] Bristol-Myers' Lung Cancer Opdivo-Yervoy Combo Wows in Phase III Study [2] Pivotal Phase 3 CheckMate -227 Study Demonstrates Superior Progression-Free Survival (PFS) with the Opdivo Plus Yervoy Combination Versus Chemotherapy in First-Line Non-Small Cell Lung Cancer (NSCLC) Patients with High Tumor Mutation Burden (TMB) [3] Statement: Bristol-Myers Squibb Validates Predictive Role of Tumor Mutation Burden in Phase 3 CheckMate -227 Program in First-Line Non-Small Cell Lung Cancer Tetanus Shot,Tetanus Vaccine,Hepatitis B Injection,Hep B Vaccine FOSHAN PHARMA CO., LTD. , https://www.fspharmamedicine.com
First-line treatment of advanced lung cancer, immune combination therapy