Another indication approved! Odivo (Navuliyu monoantigen) combined with Ipitaph mono-resistance and limited course of chemotherapy for first-line treatment in patients with metastasis or recurrent non-small cell lung cancer

On May 26, 2020, The U.SFood and Drug Administration (FDA) has approved Odivo (Navuliyu monoantigen, 360 mg) combined with Epiwood monoantigen (1mg/kg, intravenous) and two cycles of platinum-containing chemotherapy for first-line treatment of metastasis or recurrent non-small cell lung cancer (NSCL) patients with no EGFR and ALK gene mutationsPatients receiving the therapy are not limited by PD-L1 expression and are available in all patients with squamous and non-squamous cancerThe application is reviewed as an FDA Real-Time Oncology Review (RTOR) pilot project to ensure that patients receive safe and effective treatment as early as possibleAs recently as May 15, the FDA approved Odivos United Ipimu monoantigen for first-line treatment of patients with metastatic non-small cell lung cancer of PD-L1 to 1%, who are subject to FDA-approved testsapproval of this Odivo combined Ipitano and limited course of chemotherapy is based on the results of the pre-set phase of the CheckMate-9LA PHASE III clinical trialThe results showed that, at a minimum of 8.1 months, regardless of PD-L1 expression or tumor histology, Odiva's combined ipitaph and two-cycle platinum-containing chemotherapy were able to deliver significant total survival (OS) benefits (risk ratio of HR) 0.69; 96.71% , confidence interval of CI: 0.55 to 0.87; P-0.0006)The median total lifetime (mOS) in patients in the combined treatment group was 14.1 months (95% CI: 13.2 to 16.2) and the chemotherapy group was 10.7 months (95% CI: 9.5 to 12.5)At 12.7 months of follow-up, the risk ratio improved further to 0.66 (95% CI: 0.55 to 0.80), the combined treatment group mOS was 15.6 months (95% CI: 13.9 to 20.0) and the chemotherapy group was 10.9 months (95% CI: 9.5 to 12.5)One year after treatment, 63 percent of patients who received Odivo's combined ipitaph and limited course of chemotherapy survived, compared with 47 percent of those who received chemotherapyuse 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"We have come a long way in understanding the role of dual immunotherapy in cancer treatment and its potential impact on patients' long-term prognosis," said DrDavid PCarbone, director of the James Chest Oncology Center at Ohio State University, a CheckMate-9LA researcherCheckMate-9LA's positive results confirmed that double-immune combined with limited course of chemotherapy could benefit non-small cell lung cancer patients regardless of their PD-L1 expression levelThis approval gives more patients the opportunity to choose a combination of Odivo's combined Ipitano-based treatment sands and gives them the opportunity to extend their survival were evaluated by the Independent Centre for Blindness (BICR) and the objective remission rate (ORR) was 38% (95% CI: 33 to 43) for patients who received Odivo combination ipitaph and limited course of chemotherapy in this trial, compared with 25% (95% CI: 21 to 30) "Non-small cell lung cancer is a complex disease that requires a variety of treatment options to meet the needs of different patient groups," said Adam Lenkowsky, u.S general manager of oncology, immunology and cardiovascular at This is the second adaptation certificate approved for advanced first-line non-small cell lung cancer in Odyvo's combined Ipitaph-based combination therapy, giving more patients the opportunity to choose a combination of double immunotherapy, which allows patients to decide whether to combine limited course scaries of chemotherapy based on their own circumstances and PD-L1 expression levels, thus giving them a chance to survive long-term 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 Andrea Ferris, President and CEO of the LUNGevity Foundation, said: "The approval is an exciting and exciting news for patients with advanced lung cancer, who have new treatment options based on dual immunity and are expected to survive longer The application is a step forward to the FDA Orbis program, which has been reviewed simultaneously by health regulators in Australia, Canada and Singapore in conjunction with the FDA Note: Ipitano is not yet available in China
CheckMate -9LACheckMate -9LA (NCT03215706) is an open label, multicenter, randomized Phase III clinical study, which evaluates and studies with out-of-patient PD-L1 expression levels and histology types Compared with platinum-containing double-drug chemotherapy (up to four cycles, applicable patient follow-up optional pemexalic for maintenance therapy), Navuliyu monoantigen and Ipitaph monoantigen combined two cycles of platinum-containing double-drug chemotherapy first-line for metastatic or recurrent non-small cell lung cancer (NSCLC) patients to treat the results 361 patients were treated for up to two years of chemotherapy for the Odivo ipic and platinum-containing two-drug, until the disease progresses or is not tolerated 358 patients received up to four cycles of platinum-containing chemotherapy, of which non-squamous patients were able to opt-out for pemephore maintenance therapy (if applicable) until the disease progressed or toxic discontinuation The main indicator of efficacy in this trial is total lifetime (OS) Other efficacy indicators include progression less than survival (PFS), objective remission (ORR), and mitigation duration (DOR), which are evaluated by the Blind independent center (BICR) Source: