Renal cell carcinoma: Opdivo+Cabometyx will be approved by EU soon

Renal cell carcinoma: Opdivo+Cabometyx will be approved by EU soon.  First-line treatment for renal cell carcinoma: Bristol-Myers/Exelixis “immune + targeting” combination Opdivo+Cabometyx is about to be approved by EU!

Bristol-Myers Squibb (BMS) recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting the approval of the anti-PD-1 therapy Opdivo (common name: nivolumab) , Nivolumab) combined with the targeted anticancer drug Cabometyx (cabozantinib, cabozantinib) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which is expected to make a final review decision within the next two months. Data from the key Phase 3 CheckMate-9ER trial showed that Opdivo and Cabometyx are compared with Sutent (common name: sunitinib, sunitinib, a tyrosine kinase inhibitor, developed by Pfizer), the first-line standard of care drug. The composition of the “immunization + targeting” program showed sustained curative benefits and significantly improved quality.

In terms of US regulation, the FDA approved the Opdivo+Cabometyx program in January 2021 for the first-line treatment of patients with advanced RCC. Opdivo and Cabometyx “Immunity + Targeting” combination was approved through the priority review process and the 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, ipilimumab, anti-CTLA-4 monoclonal antibody) dual immunotherapy has been approved as the standard treatment for first-line treatment of patients with intermediate or high-risk advanced RCC.

Dana Walker, vice president of BMS genitourinary cancer development project, said: “In recent years, we have seen changes in the field of renal cell carcinoma treatment, and many advances have been made to help improve the prognosis of patients. BMS is under the supervision of Opdivo+Yervoy. After approval, this dual immunotherapy program was launched for the first time in the European Union for patients with renal cell carcinoma. The program has shown long-lasting and long-term survival benefits in the pivotal CheckMate-214 trial. Now, with the active recommendation of CHMP, we are far away It’s one step closer to launching another Opdivo-based program, which has been shown to have better efficacy for patients who may benefit from a combination of immunotherapy and tyrosine kinase inhibitor therapy.”

Kidney cancer (Image source: vecteezy.com)

The approval of the US FDA and the positive review opinions of the EU CHMP are based on the results of the key 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 (Sunitin, generic 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:

(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 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 inhibitor (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 treatment program for the first-line treatment of patients with advanced or metastatic RCC 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. It can kill tumor cells, reduce metastasis and inhibit 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 world’s first PD-1 immunotherapy approved. 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.

(source:internet, reference only)

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