First-line immunotherapy for lung cancer! BMS star immune combination Opdivo-Yervoy has been approved by the FDA for the fifth indication, significantly extending survival!

2020 May 17 News /BioValleyBIOON / - Bristol-Myers Squibb (BMS) announced today that the US Food and Drug Administration (
FDA

) has approved anti-PD-1 therapy Opdivo (Ou Diwo, generic name: nivolumab, Wu Li You satisfied mAb) 3mg / kg anti-CTLA-4 therapy Yervoy (ipilimumab, ipilimumab) 1mg / kg combination therapy, first-line treatment for non-tumor EGFR or ALK gene aberrations, a tumor expressing a PD-L1 (≥1%) of metastatic non-small cell lung cancer (NSCLC) patientsOpdivo + Yervoy (OY combination) is FDA approved the first and only dual immunotherapyThe approval also marks OY combination of regulatory approval in the US 5th indicationsOpdivo + Yervoy combination therapy with two kinds of potential synergy mechanism, for two different immune checkpoint (PD-1, and CTLA-4), and play a role in a complementary mannerUp to now, Opdivo + Yervoy composition has beenFDAapproved for the treatment of cancer five types (a melanoma, a, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma , non-small cell lung cancer)The approval, (Part1a) based on the results of Part III of 1a CheckMate-227 testThis is a global, multi-part, open-label, randomized trial, conducted in not previously received chemotherapy (chemotherapy-naïve) patients with stage IV or recurrent NSCLC inThe study consists of two parts: (1) a first part: 1a section compares Opdivo (3mg / kg) combined Yervoy (1mg / kg), Opdivo monotherapy, chemotherapy for cancer patients PD-L1 expression;IB section compares Opdivo joint Yervoy, Opdivo combination chemotherapy, a treatment of a cancer chemotherapy do not express PD-L1; (2) part II: Comparative Opdivo combination chemotherapy, chemotherapy, regardless of PD-L1 expressionresult from the display portion 1a: line treatment of tumors expressing PD-L1≥1% of NSCLC patients (no matter how tumor histology ), the minimum follow-up of 29.3 months, with chemotherapy ( n = 397) compared, Opdivo + Yervoy group (n = 396) exhibit the advantages (median OS in overall survival (OS): the vs14.9 months 17.1 months; HR = 0.79,95% CI: 0.67-0.94, p = 0.0066) In this test, one-year survival rate Opdivo + Yervoy group and chemotherapy group were 63%, 56%, 2-year survival rate of 40%, 33%, third year (median follow-up of 43.1 months) survival rate 33%, 22% The evaluation blinded independent central review (BICR), the minimum follow-up of 28.3 months, Opdivo + Yervoy group acknowledgments overall response rate (ORR) was 36% (complete remission [CR] = 5.8%, partial remission [ PR] = 30.1%), chemotherapy confirmed ORR was 30% (CR = 1.8%, PR = 28.2%) In patients with the disease in remission, the median Opdivo + Yervoy group duration of response (DOR) of 23.2 months (95% CI: 15.2-32.2), chemotherapy group was 6.2 months (95% CI: 5.6-7.4) Descriptive ORR and DOR are pre-specified analysis These results represent the first time a dual immune tumor school (I-O) therapy for first-line treatment of NSCLC in overall survival (OS) in terms of more effective than chemotherapy Opdivo + NSCLC and safety studies before combining scheme coincides Yervoy, no new safety signals were observed Opdivo and Yervoy are tumor immunotherapy (the IO), by targeting the immune system of different regulatory elements, using the body's own immune system to fight a a tumor, wherein the targeting blocking Opdivo PD-1 / PD-L1 pathway, Yervoy the targeted blocking CTLA-4 Up to now, Opdivo + Yervoy combination therapy has been approved for immunological 5 indications: (1) first-line treatment of tumors expressing PD-L1 (≥1%), no EGFR or ALK genomic tumor < br /> distortion adult patients with metastatic NSCLC; (2) the treatment of melanoma unresectable or metastatic ; (3) high risk first-line treatment of advanced renal cell carcinoma (RCC) patients; (4 ) treatment microsatellite stability is not high (MSI-H) or mismatch repair defects (dMMR) with metastatic colorectal cancer (mCRC) children (≥12 years old) and adult patients; (5) the treatment of previously received sorafenib Nigeria (sorafenib) in hepatocellular carcinoma (HCC) patients Opdivo in July 2014 the first to receive approval in Japan, is the world's first approved PD-1 immunotherapy by using the body's own immune system to fight cancer , Opdivo has become an important treatment option for many types of cancer in China, Opdivo (Oudi Wo) in June 2018 approved the listing, the market has become China's first tumor immune (I-O) therapy Up to now, Opdivo has approved three indications in China, including: non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (SCCHN), gastric / gastroesophageal junction adenocarcinoma a (Biovalley Bioon.com) ORIGINAL: U.S.FoodandDrugAdministration app rovesOpdivo® (nivolumab) + Yervoy® (ipilimumab) asFirst-LineTreatmentofPatientswithMetastaticNon-SmallCellLungCancerWhoseTumorsExpressPD-L1≥1%