First-line immunotherapy for lung cancer! Ono Pharmaceuticals submits a first-line treatment NSCLC supplement arying opdivo-Yervoy-chemotherapy combination!

March 29, 2020 /
Biovalley BIOON / -- Ono Pharmaceuticals and Bristol-Myer Squibb K.K., Japan, have jointly announced that they have submitted a supplementary application in Japan seeking approval of anti-PD-1 therapy divOp o (Odivo, generic name: nivolumab, Navudan) united Yervoy (ipilimumab, eprimama) and limited course of platinum-doublet chemotherapy, first-line treatment of non-surgically recital, advanced or recurrent non-small cell lung cancer (NSCLC) this application, based on the results of the key Phase III CheckMate-9LA study This is a global multi-center, random, open label research, conducted by Ono Pharmaceuticals in collaboration with Baishi Meishi guibao, evaluated the opdivo-Yervoy-containing two-drug chemotherapy (2 cycles) combination therapy program, the first-line treatment of platinum-based double-drug chemotherapy treatment non-surgical, late-stage or recurrent NSCLC patients, regardless of PD-L1 expression and histology In the study, the team received Opdivo (360mg, every three weeks, Q3W) and Yervoy (1mg/kg, q6W) and chemotherapy (2 cycles) for up to two years, or until the disease progressed or was unacceptable The control group received chemotherapy (up to 4 cycles) followed by an optional pemerace maintenance therapy (if conditions are met) and treated until the disease progresses or is toxic The primary endpoint is total survival (OS) in the intentional therapy (ITT) group, and the secondary endpoint seinevers include no progression survival (PFS), total remission rate (ORR), and evaluation of efficacy based on biomarker results showed that the study had reached the primary endpoint of total survival (OS) in a pre-specified mid-term analysis: there was a significant improvement in OS in the Opdivo-Yervoy-Yervoy-Chemotherapy group compared to the chemotherapy group In this study, the safety of Opdivo combined with low-dose Yervoy and 2-cycle chemotherapy reflected the known safety of immunotherapy and chemotherapy components in first-line NSCLC Opdivo is a programmatic death-1 (PD-1) immunocheckpoint inhibitor that uniquely uses the human body to the autoimmune system to help restore the immune response to anti-
tumors
by blocking the interaction between PD-1 and its ligands Opdivo was approved in Japan in July 2014 as the world's first approved PD-1 immunotherapy for melanoma By using the human autoimmune system to fight cancer, Opdivo is now an important treatment option for a wide range of cancers in Japan, Ono launched Opdivo in September 2014 to treat melanoma that could not be removed Since then, Opdivo has been approved in Japan for a variety of cancer indications, including: (1) non-resectionable, advanced or recurrent non-small cell lung cancer; (2) non-rectoable or metastatic renal cell carcinoma; (3) recurrent or incurable classic Hodgkin's lymphoma; (4) recurrent or metastatic head and neck cancer; and (5) progression after chemotherapy Non-reprecable late-stage or recurrent gastric cancer; (6) non-reprecable advanced or recurrent malignant pleural mesothelioma after chemotherapy; (7) assisted treatment melanoma ;(8) non-reprecable late-stage or recurrent esophageal cancer; (9) non-reprecyllive late or recurrent microsatellite instable high (MSI-H) colorectal cancer Ono Pharmaceuticals, the original developer of Opdivo, in 2011, a partnership with Persepathi's Squibb authorized the development and commercialization rights of Persegrine's Guibao outside Japan, South Korea and Taiwan In July 2014, the two sides further expanded their strategic cooperation to develop and commercialize a variety of immunotherapies (including monotherapy and combination therapies) for cancer patients in Japan, Korea and Taiwan To date, Opdivo has been approved in more than 60 countries, including Japan, South Korea, China, the United States and the European Union (BioValleyBioon.com) original source: ONO and BMSKK Submit SubmitAl Application for Opdivo plu Yervoy in Combination With The Plus with The Fire y in Japan to Expand the Ue for Firt-Line Treatment of UnreecTable Advanced or Recurrent Non-Cell Cancer