First line immunotherapy for lung cancer! The combination of bestimer opdivo with low dose yevoy and chemotherapy in phase III was successful, which significantly prolonged the overall survival period

October 23, 2019 / BIOON / -- BMS recently announced the results of critical phase III checkmate-9la test The trial is an open label, multicenter, randomized trial that is evaluating the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with opdivo (odivo, common name: nivolumab, nevumab) and low-dose yevoy (ipilimumab, eplimmab) without considering PD-L1 expression and histology In the study, the experimental group received opdivo (360mg, once every three weeks, q3w) + yevoy (1mg / kg, once every six weeks, Q6W) + chemotherapy (2 cycles), for up to two years, or until the disease progresses or unacceptable toxicity The control group received chemotherapy (up to 4 cycles) followed by optional pemetrexed maintenance therapy (if eligible) until disease progression or toxicity The primary end point was total survival (OS) in the intention to treat (ITT) population, and the secondary end points included progression free survival (PFS), total response rate (ORR), and efficacy evaluation based on biomarkers The results showed that the study had reached the primary end point of overall survival (OS) in a pre-determined mid-term analysis In the study, the safety of opdivo combined with low dose yevoy and two cycles of chemotherapy reflects the known safety of immunotherapy and chemotherapy components in first-line NSCLC BMS will complete a comprehensive assessment of the checkmate-9la trial data, which will be published at the upcoming medical conference and shared with regulators "We are excited about the results of the checkmate-9la trial, which shows the potential of opdivo in combination with low-dose yevoy and a limited course of chemotherapy for the first-line treatment of non-small cell lung cancer patients," said Fouad namouni, MD, director of cancer development at BMS These results are based on the efficacy of opdivo and yevoy combination in the first-line treatment of melanoma and renal cell carcinoma as well as the recently shown first-line treatment of lung cancer, which may provide a new first-line treatment option for NSCLC patients " At the end of September this year, BMS released the results of the first part (Part 1) of opdivo's phase III checkmate-227 trial for first-line treatment of NSCLC 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 The results showed that part 1a of the study reached the common end point of total survival time (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 and only time that dual immunooncology (I-O) is superior to chemotherapy in terms of 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 (CRC) 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 Original source: checkmate-9la, a phase 3 trial evaluating operation (nivolumab) plus low dose yevoy (ipilimumab) combined with chemotherapy, meets primary endpoint monitoring superior overall survival compared to chemotherapy alone in first line lung cancer