First-line treatment for renal cell carcinoma!

Ono Pharma and Takada Pharma have recently jointly announced that Japanese regulators have approved the anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, nivolumab) combined with targeted anticancer drugs Cabometyx (cabozantinib, Cabozantinib), the first-line treatment of unresectable or metastatic renal cell carcinoma (RCC) adult patients
.

The approval is based on data from the pivotal Phase 3 CheckMate-9ER trial
.

The results show that compared with the first-line standard care drug Sutent (common name: sunitinib, sunitinib, a tyrosine kinase inhibitor, developed by Pfizer), Opdivo and Cabometyx consist of the "immune + targeting" program Shows continuous therapeutic benefits and significantly improves the quality of life

In the United States and the European Union, the Opdivo+Cabometyx program was approved in January 2021 and March 2021, respectively, for the first-line treatment of patients with advanced RCC
.

Cabometyx is a tyrosine kinase inhibitor, and Takeda has obtained a license from Exelixis for development and commercialization in Japan

Kidney cancer is a malignant tumor that originates from the kidney parenchyma
.

Among kidney cancers, renal cell carcinoma (RCC) is the most common cancer, accounting for about 90% of all kidney cancers

The approval of the Opdivo+Cabometyx protocol is based on the results of the pivotal Phase 3 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 (Sutent, sunitinib), the "immune + targeted" regimen Opdivo+Cabometyx showed all efficacy endpoints Significant improvement, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), 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 not Reach
.

(2) In terms of PFS, the primary endpoint of the study, the Opdivo+Cabometyx group doubled compared with the Sutent group (median PFS: 16.

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
.

The incidence of RCC in men is approximately twice that of women, with the highest incidence in North America and Europe

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.
Generated
.
In the United States, the European Union 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)
.
In Japan, Cabometyx was approved in March 2020 for the treatment of unresectable or metastatic RCC, and in November 2020 it was approved for the treatment of unresectable HCC that has progressed after chemotherapy
.

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
.

Original source: Ono and Takeda Receive an Approval for Opdivo® (nivolumab) and CABOMETYX® (cabozantinib) Combination Therapy in Japan for Treatment of Unresectable or Metastatic Renal Cell Carcinoma