Opdivo+Cabometyx Program Was Approved By The US FDA

- Feb 08, 2021-

Bristol-Myers Squibb (BMS) and its partner Exelixis recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-PD-1 therapy Opdivo (generic name: nivolumab) in combination with the targeted anticancer drug Cabometyx (cabozantinib). For the first-line treatment of patients with advanced renal cell carcinoma (RCC). In terms of medication, Opdivo is administered by intravenous infusion of 240 mg once every 2 weeks or 480 mg once every 4 weeks, and Cabometyx is administered orally in 40 mg tablets once a day.


Opdivo and Cabometyx "Immunity + Targeting" combination was approved through the priority review process and real-time oncology review (RTOR) pilot project, approved for all International Metastatic Renal Cancer Database Consortium (IMDC) risk classifications, and will be previously unaccepted The treated population of patients with advanced or metastatic RCC provides an important, new first-line treatment option.


This approval expands Bristol-Myers Squibb's position in the late first-line RCC. Previously, Opdivo and Yervoy (ipilimumab) dual immunotherapy has been approved as the standard treatment for first-line treatment of patients with intermediate or high-risk advanced RCC.


Adam Lenkowsky, General Manager of Oncology, Immunology, and Cardiovascular Diseases of Bristol-Myers Squibb, said: "At Bristol-Myers Squibb, we focus on developing transformative drugs that can improve the survival of cancer patients. Opdivo+Yervoy is the first-line treatment of high-risk advanced RCC. The role in patients has been fully confirmed. Today’s achievements extend the potential of Opdivo-based combination therapy to more patients. The combined application of Opdivo and Cabometyx combines the fine traditions of these two drugs to provide doctors with A new advanced RCC combination treatment regimen improves the prognosis of patients who are suitable for this immunotherapy plus tyrosine kinase inhibitor regimen."


This approval is based on the results of the pivotal Phase III CheckMate-9ER trial. Data show that in patients with advanced RCC who have not previously received treatment, compared with the first-line standard care drug Sutent (Sunitinib, common name: sunitinib, sunitinib, a tyrosine kinase inhibitor, developed by Pfizer), The "immunization + targeting" program Opdivo+Cabometyx showed significant improvement in all efficacy endpoints, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR).


The specific data are as follows: (1) In terms of OS, the Opdivo+Cabometyx group had a significantly lower risk of death by 40% compared with the Sutent group (HR=0.60; 98.89%CI: 0.40-0.89; p=0.0010). The median OS of the two groups was both not reached. (2) In terms of PFS, the primary endpoint of the study, the Opdivo+Cabometyx group doubled compared with the Sutent group (median PFS: 16.6 months vs 8.3 months; HR=0.51; 95%CI: 0.41-0.64; p<0.0001) . (3) In terms of ORR, the Opdivo+Cabometyx group is twice that of the Sutent group (56% vs 27%), and the complete response rate (CR) is higher (8% vs 5%). (4) In terms of DOR, the Opdivo+Cabometyx group was longer than the Sutent group (median DOR: 20.2 months vs 11.5 months). It is worth mentioning that all these key efficacy results are consistent in the pre-designated International Metastatic Renal Cancer Database Consortium (IMDC) risk and PD-L1 subgroups.


In the study, the combination of Opdivo and Cabometyx was well tolerated, reflecting the known safety of immunotherapy and tyrosine kinase inhibitors (TKI) in the first-line treatment of advanced RCC. According to the National Cancer Comprehensive Network Cancer Treatment Function Assessment (NCCN-FACT) Renal Symptom Index 19 (FKSI-19) score, at most time points, patients treated with Opdivo+Cabometyx had a health-related quality of life significantly better than those treated with Sutent.


Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, causing more than 140,000 deaths worldwide each year. The incidence of RCC in men is approximately twice that of women, with the highest incidence in North America and Europe. Globally, the 5-year survival rate for patients diagnosed with metastatic or advanced kidney cancer is only 12.1%. In recent years, although some treatment progress has been made, additional treatment options are still needed to prolong survival.


The results of the CheckMate-9ER study clearly prove that the Opdivo and Cabometyx "immune + targeted" combination therapy program is the first-line treatment of patients with advanced or metastatic RCC, and it is in the key efficacy indicators of progression-free survival (PFS) and overall survival (OS) A clinically significant improvement. In addition, the combination of Opdivo and Cabometyx has good safety.


The active pharmaceutical ingredient of Cabometyx is cabozantinib, which is a tyrosine kinase inhibitor (TKI) that exerts an anti-tumor effect by targeting the MET, VEGFR2 and RET signaling pathways, killing tumor cells, reducing metastasis and inhibiting blood vessels generate. In the United States, the European Union, Japan and other countries and regions in the world, Cabometyx has been approved for the treatment of patients with advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) patients who have previously received sorafenib (sorafenib).


Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, designed to uniquely use the body's own immune system to help restore anti-tumor immunity by blocking the interaction between PD-1 and its ligands answer. Opdivo was the first to be approved in Japan in July 2014 and is the first PD-1 immunotherapy approved worldwide. Currently, Opdivo has become an important treatment option for a variety of cancers.


For the treatment of renal cell carcinoma (RCC), Opdivo has approved indications: (1) for patients with advanced RCC who have previously received anti-angiogenesis therapy; (2) combined with Yervoy (ipilimumab, ipilimumab, Anti-CTLA-4 monoclonal antibody) first-line treatment of patients with intermediate or high-risk advanced RCC.