5 types of cancer 6 indications! FDA approves BMS star immunocombination Opdivo-Yervoy-Limited Chemotherapy: First-Line Treatment of Lung Cancer (NSCLC)!

May 28, 2020 /
Biovalley
BIOON/ -- The U.SFood and Drug Administration (
FDA) has approved an application for a supplemental biologics license (sBLA): Opdivo (Odivo, generic name: nivolumab, Navuliu anti-single) 360mg combined Yervoy (ipilimumab, iplimma) 1mg/kg (intravenous preparation) and 2 cycles of platinum-double chemotherapy, first-line treatment of adult patients withno EGFR or ALK genometumormetastasis or recurrent non-small cell lung cancer (NSCLC)this combination therapy is approved for use in patients with squamous cells and non-squamous cell disease, regardless of PD-L1 expression statusThe application was reviewed under the real-timeOncologyReview (RTOR) pilot projectby theFDA to ensure that patients have access to safe and effective therapies as early as possibleso far, two combination therapies based on Opdivo-Yervoy have been approved for first-line treatment for lung cancerOn May 15 this year, the FDA approved Opdivo-Yervoy combination therapy for first-line treatment of patients with metastatic NSCLC who do not have EGFR or ALK genomic tumor aberration, tumor expression PD-L1 (-1%) Opdivo and Yervoy (OY combination) are the The FDA approved the first and only double immunotherapy The latest approval also marks the sixth adaptation approved by OY group in U.S regulation for treatment of five types of cancer, including: melanoma , kidney cell carcinoma, colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer Opdivo-Yervoy is a unique combination of immunocheckpoint inhibitors with potential synergies for 2 different immune checkpoints (PD-1 and CTLA-4) and plays a complementary role in helping to destroy tumor cells Yervoy helps activate and multiply T cells, while Opdivo helps existing T cells discover tumor In addition, some T-cells stimulated by Yervoy also become memory T cells, which can lead to a long-term immune response approved by Opdivo-Yervoy's joint limited chemotherapy regimen, based on pre-specified interim analysis results from the key Phase III CheckMate-9LA study This is a global multicenter, random, open label study, conducted by Ono Pharmaceuticals in collaboration with Baishi Meishi bao, to evaluate the opdivo-Yervoy-containing two-drug chemotherapy (2 cycles) combination therapy program, the first-line treatment of platinum-based double-drug chemotherapy program non-surgically rectructable, 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 October 2019, BMS announced that the study reached the primary endpoint of superior total survival (OS) in a pre-specified mid-term analysis: the Opdivo-Yervoy-2 cycle of platinum-based double-acting chemotherapy treatment groups showed better overall survival than the chemotherapy group Period (HR: 0.69; 96.71% CI: 0.55-0.87; p-0.0006), regardless of PD-L1 expression or tumor histology (at least 8.1 months follow-up) Median total lifetime (mOS) was 14.1 months (95% CI: 13.2-16.2) and 10.7 months (95% CI: 9.5-12.5), respectively In an follow-up analysis, the risk ratio of mOS (HR) increased numerically to 0.66 (95% CI: 0.55-0.80), mOS was 15.6 months (95% CI: 13.9-20.0) and 10.9 months (95% CI: 9.5-12.5) at 12.7 months At one year, 63 percent of patients in the Opdivo-Yervoy-2 cycle chemotherapy group survived, compared with 47 percent in the chemotherapy group In the study, the total remission rate (ORR) was 38% (95% CI: 33-43) in the Opdivo-Yervoy-2-cycle chemotherapy group and 25% (95% CI: 21-30) in the chemotherapy group The safety of Opdivo-Yervoy-2 cycle chemotherapy regimens reflects the known safety of immunotherapy and chemotherapy components in the first-line NSCLC "NSCLC 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 and director of immunology BMS Cardiovascular
Oncology For the advanced NSCLC aspect of first-line therapy, the second approval based on the Opdivo-Yervoy combination will give more patients access to this dual immunotherapy, which can provide patients with the possibility of extended life by applying limited-cycle chemotherapy in combination with the patient and its tumor PD-L1 state "
Opdivo is a programomatic death-1 (PD-1) immunocheckpoint inhibitor that uniquely uses the human autoimmune system to help restore the immune response to anti-
tumors
by blocking the interaction between PD-1 and its ligands Opdivo was the first PD-1 immunotherapy approved in Japan in July 2014 At present, Opdivo has become an important treatment option for a wide range of cancers Opdivo and Yervoy are tumor immunotherapy (I-O), through the target immune system of different regulatory elements, the use of the body's own immune system to fight tumors, where Opdivo targeted blocking PD-1/PD-L1 pathway, Yervoy targeted blocking CTLA-4 At present, Persimmon Squibb is developing opdivo-Yervoy immunocombination for the treatment of a variety of types of tumor (biovalleybioon.com) original origin: U.S Food and Drug Administration apps roves Opdivo ® (nivolumab) and Yervoy® (ipilimumab) Combined with Limited Plusy as First-Line Treatment of Metastatic or Re Nonnow-Small Cell Cancer