First-line immunotherapy for lung cancer! BMS star immune combination Opdivo-Yervoy is approved by the U.S. FDA for the fifth indication to treat metastatic non-small cell lung cancer patients!

The U.SFood and Drug Administration (FDA) has approved the use of Odivo (Navuliu monoantigen, 3 mg / kg) in combination with Epiwood monoantigen (1 mg / kg, intravenous lygative) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) adult patients, The U.SFood and Drug Administration (FDA) has announcedPatients are required to undergo an FDA-approved test to determine that their tumor expression PD-L1 is positive (-1%) and that there is no EGFR or ALK gene mutationthis approval is based on data from The CheckMate -2271a clinical study in Phase IIIThe results showed that at a minimum follow-up time of 29.3 months, the total survival (OS) of patients was significantly improved compared to chemotherapy (n-397) for chemotherapy (hazard s.HR) 0.79; 95% confidence interval s/ci: 0.67 to 0.94, regardless of the patient's tumor histology type; P-0.0066)The median OS in patients in the Odivo combined Ipitaph monoantigen group was 17.1 months (95% CI: 15.0 to 20.1) and the chemotherapy group was 14.9 months (95% CI: 12.7 to 16.7)In this trial, the one-year survival rate of Odivo and chemotherapy group patients was 63% and 56%, respectively, 40% and 33% in 2 years, and 33% and 22% in 3-year survival (median follow-up period: 43.1 months), respectivelyThe objective remission rate (ORR) of patients in the Odivo United Ipitano treatment group was 36% (142/396), at a minimum of 28.3 months, according to the results of the Independent Review Committee (BICR)95% CI: 31 to 41, of which 5.8% are full remission (CR) and 30.1% are partially remission (PR) and 30% of patients in the chemotherapy group have ORR (119/397, 95% CI: 26 to 35, 1.8% CR, 28.2% PR)In patients with remission, the duration of continuous remission (DOR) in the Odivo combined Ipitano group was 23.2 months (95% CI: 15.2 to 32.2) and the chemotherapy group was 6.2 months (95% CI: 5.6 to 7.4)Both ORR and DOR are pre-specified descriptive analyses"Patients with metastatic lung cancer still need new treatment options that promise long-term benefits," said Matthew DHellmann, a clinical trial researcher at CheckMate-227 and a oncologist at Memorial Sloan Kettering Cancer CenterThe Results of the CheckMate-227 trial show that double immunotherapy offers long-term survival opportunities for patients with metastatic non-small cell lung cancer who meet the indicationsuse of Odiva should follow the following warnings and precautions, including immunomediated adverse events: pneumonia, colitis, hepatitis, endocrine diseases, nephritis and renal insufficiency, adverse skin reactions, encephalitis and other adverse reactions; See the "Important Safety Information" section below, which includes black-box warnings for immunomolyants-related immunomediated adverse reactions "Metastatic lung cancer is a complex and challenging disease," said Bonnie J Addario, co-founder and chairman of the GO2 Foundation Patients with metastatic non-small cell lung cancer have been closely following advances in immunotherapy and are eager to obtain new treatment options that significantly extend their survival Today, some first-time patients have been able to receive immunocombination treatments directly from alternative chemotherapy and continue to demonstrate survival benefits over a period of more than three years, representing another important step in our path to treating the disease Odivo is a unique combination of two immunocheckpoint inhibitors with potential synergies for two different checkpoints (PD-1 and CTLA-4) to help eliminate tumor cells: Epiwood monoresist helps activate and multiply T cells, while Odivo helps existing T-cells detect tumors Some T-cells activated by Epima can differentiate into memory T-cells, which is expected to achieve a long-term immune response But immunotherapy can also target normal cells, leading to adverse immune-mediated reactions that can be severe and even fatal Please refer to the "Important Safety Information" section, which includes black-box warnings for immunomolyants-related immunomediated adverse reactions "In 2015, O'DeVos became the first immunotherapy treatment for non-small cell lung cancer, changing the way non-small cell lung cancer is treated, ushering in a whole new era," said Chris Boerner, chief commercial officer of 's Persimmon Meishi Treasure On this basis, Odivo's approval of the combined Ipitaph monoantigen became the first first-line double-immunological therapy, another milestone in our efforts to help patients with metastatic lung cancer to extend their survival , Dr Matthew D Hellmann, provides paid counseling and consulting services for Persimmon Squibb Note: Ipitano is not yet available in mainland China
CheckMate-227 research CheckMate-227 is a randomized, open, multi-center Phase III clinical trial to evaluate the odivol ® combined Ipitaph mono-anti-platinum-containing double-drug chemotherapy for primary or recurrent non-small cell lung cancer (NSCLC) patients (including cancer and non-squacarcity) The 1a part of the trial was in the group of patients with a positive PD-L1 for tumor expression researchers used PD-L1 IHC 28-8 pharmDx analyzers in a central laboratory to conduct a forward-looking assessment of tumor specimens The critical entry criteria were for patients 18 years and older, phase IV or recurrent NSCLC, and ECOG with a 0/1 rating and no systematic anticancer treatment This study excluded patients with eGFR mutations or ALK translocations, untreated brain metastatic tumors, cancerous meningitis, active autoimmune diseases, or systemic immunosuppressive therapy that are sensitive to known targeted inhibitor therapy 396 patients received a combination of Epivo (3 mg / kg, once every two weeks) in combination with Epimarcas (1 mg / kg, every six weeks) and 397 patients received chemotherapy with platinum-containing double medicine (every three weeks) In patients randomly enrolled in the chemotherapy group, non-squamous patients received pemecosande and cisplatin (or caplatin) treatment, followed by the option of permettase maintenance therapy, and patients with squamous cancer received treatment with gisitabinand and cisplatin (or caplatin) Patients are treated continuously until the disease progresses, unacceptable toxicity, or treatment time reaches 24 months The main end indicator sedatives are OS, and other descriptive outcome indicators include no progression, ORR, and DOR in THE BICR assessment Part of the safety data from the CheckMate-227 study 58% of patients had serious adverse reactions Twenty-four percent of patients discontinued the Odivo combination ipitaph alone therapy due to adverse reactions, and 53 percent discontinued at least one of the drugs due to an adverse reaction The most common severe adverse reactions ( s2%) include infectious pneumonia, diarrhea/colitis, pneumonia, hepatitis, pulmonary embolism, adrenal insufficiency and pituitis The incidence of fatal adverse reactions was 1.7%, including pneumonia (4 cases), myocarditis, acute renal injury, shock, hyperglycemia, multi-system organ failure and kidney failure The most common adverse reactions (-20%) included fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%) and itching (21%) Source: MedSci