First line immunotherapy for lung cancer! BMS combination therapy opdivo + yevoy applied for new indications in Japan to treat patients with PD-L1 positive NSCLC!

December 27, 2019 / BIOON / -- Ono Pharmaceutical and bmskk recently announced that they have submitted a supplementary application in Japan to change the production and marketing approval of two drugs, i.e intravenous infusion of anti-PD-1 monoclonal antibody (Chinese trade name: odevo, common name: nivolumab, nevumab) and injection of anti-CTLA-4 monoclonal antibody yevoy (ipilimumab, eplimmma) Some projects have been approved, including: expanding the application of opdivo + yevoy combination therapy for the first-line treatment of non resectable, advanced or recurrent non-small cell lung cancer (NSCLC) This application is mainly based on the results of the first part (Part 1) of the opdivo first-line treatment of NSCLC phase III checkmate-227 trial This is a global, multipart, open label, randomized trial conducted by Ono Pharma in collaboration with BMS in patients with stage IV or recurrent NSCLC who have not previously received chemotherapy (initial chemotherapy) The first part is divided into: (1) 1A part, comparing the patients with PD-L1 expression treated by opdivo combined with low-dose yevoy, opdivo single drug therapy and chemotherapy; (2) 1b part, comparing the patients with PD-L1 expression treated by opdivo combined with low-dose yevoy, opdivo combined chemotherapy and chemotherapy According to the results released at the end of September this year, part 1a of the study reached the common end point of total survival (OS): when the first-line treatment of NSCLC patients with PD-L1 ≥ 1%, the combination of opdivo + low-dose yevoy showed superiority in OS compared with chemotherapy (HR = 0.72, 97.72% CI: 0.65-0.96) In addition, in exploratory analysis, the results showed that in NSCLC patients with tumor expression of PD-L1 < 1%, the combination of opdivo + low dose yevoy also improved OS (HR = 0.62, 95% CI: 0.48-0.78) The 2-year survival rate of PD-L1 ≥ 1% patients and PD-L1 < 1% patients treated with opdivo + low dose yevoy combination scheme was 40%, and that of PD-L1 ≥ 1% patients and PD-L1 < 1% patients in the chemotherapy group was 33% and 23%, respectively These results represent the first time that dual immunooncology (I-O) is superior to chemotherapy in overall survival (OS) of NSCLC The safety of the combination of opdivo + low dose yervoy was consistent with the previous NSCLC study, and no new safety signal was observed Opdivo and yevoy are tumor immunotherapy (I-O) They target different regulatory elements in the immune system and use the immune system of human body to fight against tumor Opdivo targets to block PD-1 / PD-L1 pathway, yevoy targets to block CTLA-4 Up to now, opdivo + yervoy immunotherapy has been approved for: (1) treatment of unresectable or metastatic melanoma; (2) first-line treatment of patients with advanced renal cell carcinoma (RCC); and (3) treatment of children aged 12 and over and adults with high microsatellite instability (MSI-H) or mismatch repair defect (dmmr) metastatic colorectal cancer (mCRC) In February this year, BMS also released the results of checkmate-650, a phase II clinical study of opdivo + yervoy combination in the treatment of metastatic castration resistant prostate cancer (mcrpc) The data showed that oy combination showed strong evidence of efficacy in the treatment of mcrpc, which also made oy combination the first immunotumor with strong efficacy in this refractory patient group Learn (I-O / I-O) combination therapy Opdivo was first approved in Japan in July 2014 It is the first PD-1 immunotherapy approved in the world The treatment indication is melanoma By using the human autoimmune system to fight against cancer, opdivo has become an important treatment option for a variety of cancers In Japan, Ono launched opdivo in September 2014 to treat unresectable melanoma Since then, opdivo has been approved for a variety of cancer indications in Japan, including: (1) non resectable, advanced or recurrent non-small cell lung cancer; (2) non resectable or metastatic renal cell cancer; (3) recurrent or refractory classic Hodgkin's lymphoma; (4) recurrent or metastatic head and neck cancer; (5) non resectable advanced or recurrent gastric cancer after chemotherapy Cancer; (6) unresectable advanced or recurrent malignant pleural mesothelioma after chemotherapy; (7) adjuvant treatment of melanoma In addition, Ono has also submitted a supplementary application for the treatment of microsatellite instability high (MSI-H) colorectal cancer and esophageal cancer by opdivo, and is carrying out clinical development projects including esophageal cancer, esophageal gastric junction cancer, small cell lung cancer, liver cell cancer, glioblastoma, urothelial cancer, ovarian cancer, bladder cancer, colorectal cancer, pancreatic cancer, biliary cancer and other cancers Eye Ono pharmaceutical is the original developer of opdivo In 2011, the company entered into a cooperation with Bristol Myers Squibb to authorize the development and commercialization rights of Bristol Myers Squibb except Japan, South Korea and Taiwan In July 2014, the two sides further expanded strategic cooperation to develop and commercialize multiple immunotherapies (including single drug and combination therapy) for cancer patients in Japan, South Korea and Taiwan Up to now, opdivo has been approved in more than 65 countries, including Japan, South Korea, China, the United States and the European Union Original source: ono and bmskk submit supplementary application for app roval of opera and yevoy combination theory to expand the use for first line treatment of unexpected, advanced or recurrent non small cell lung cancer in Japan