Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Continued Survival Benefits with Over Two Years of Follow-Up in First-Line Advanced Renal Cell Carcinoma

News on February 15, 2022 /BioValleyBIOON/ -- Bristol-Myers Squibb (BMS) and Exelixis, Inc. recently announced progress in U.S. clinical trialsTumorKey Phase 3 CheckMate-9ER Trial Presented at the 2022 ASCO Genitourinary Cancers Symposium (ASCO GU)2-Year (Minimum 25.4 Months, Median 32.9 Months) Follow-Up ResultsData show: in previously untreated advanced renal cell carcinoma (RCC) patients, compared with the first-line standard care drug Sutent (Sunitinib, generic name: Sunitinib, a tyrosine kinase inhibitor,PfizerCompared to the development, the combination of targeted anticancer drug Cabometyx (cabozantinib) and anti-PD-1 therapy Opdivo (nivolumab)"Targeted + Immunotherapy" Regimen Shows Sustained Survival and Remission Benefits, and Improves Health-Related Quality of Life (HRQoL).

January 2021, United StatesFDAApproval of Cabometyx + Opdivo Regimen for First-Line Treatment of Advanced RCC Patients. The "Targeted + Immunotherapy" Combination of Cabometyx and Opdivo Proceeds Through Priority Review and Real-TimeTumorThe Real-Time Oncology Review (RTOR) pilot program has been approved for all International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk categories, providing an important new first-line treatment option for previously untreated patients with advanced or metastatic RCC.

The approval was based on results from the pivotal Phase 3 CheckMate-9ER trial. The data showed that, in patients with previously untreated advanced RCC, the "targeted + immunotherapy" regimen of Cabometyx + Opdivo demonstrated superiority compared to the first-line standard-of-care drug Sutent.Significant improvements were demonstrated across all efficacy endpoints, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), complete response rate (CR), and duration of response (DOR).

This ASCO GUMeetingThe 2-year follow-up results published onMedian follow-up time was 32.9 months (minimum 25.4 months)., compared with Sutent (n=328), Cabometyx + Opdivo (n=323)Continued to demonstrate superior OS, PFS, ORR, DoR, and CR. No new safety signals emerged with extended follow-up.

In the overall study population: (1) In terms of OS, the Cabometyx + Opdivo group continued to show a meaningful improvement over the Sutent group in median OS (37.7 months vs. 34.3 months), with a significant 30% reduction in the risk of death (HR=0.70; 95% CI: 0.55-0.90). (2) In terms of PFS, the benefit continued to be maintained, with the Cabometyx + Opdivo group doubling the median PFS compared to the Sutent group (16.6 months vs. 8.3 months; HR=0.56; 95% CI: 0.46-0.68). (3) In terms of ORR and CR, the ORR benefit persisted, with the Cabometyx + Opdivo group nearly doubling that of the Sutent group (55.7% vs. 28.4%), and the complete response rate (CR) doubled (12.4% vs. 5.2%). (4) In terms of DOR, the Cabometyx + Opdivo group showed a longer duration compared to the Sutent group (median DOR: 23.1 months vs. 15.1 months). (5) In terms of safety, the incidence of treatment-related adverse events (TRAEs) of any grade was 97.2% in the Cabometyx + Opdivo group and 93.1% in the Sutent group, while the incidence of grade ≥3 TRAEs was 65.0% and 54.1%, respectively.

In addition, in an exploratory analysis of the depth of target lesion relief by organ site, a higher proportion of patients treated with Cabometyx + Opdivo compared to Sutent experienced relief in the lungs (90.5% vs 76.0%), lymph nodes (88.4% vs 72.6%), kidneys (89.0% vs 71.6%), liver (72.7% vs 53.8%), and bones (85.2% vs 65.0%).TumorReduce Benefits.

In another analysis,Patients treated with Cabometyx + Opdivo continue to report improvements in health-related quality of life.

Currently, clinicians have been looking for treatment methods that can help more patients control their diseases without affecting their quality of life. New data from CheckMate-9ER is of great significance to patients with first-line advanced renal cell carcinoma, as it provides further evidence of the therapeutic benefits of this combination and the positive quality-of-life outcomes reported by patients.

Renal Cell Carcinoma (RCC) is the most common type of kidney cancer in adults, resulting in over 140,000 deaths globally each year. The incidence of RCC in men is approximately twice that in women, with the highest rates observed in North America and Europe. Globally, it isDiagnosisFor patients with metastatic or advanced renal cell carcinoma, the 5-year survival rate is only 13%. In recent years, although some treatment advances have been made, additional treatment options are still needed to extend survival.

The results of the CheckMate-9ER study clearly demonstrate that the combination therapy of Cabometyx and Opdivo, a "targeted + immunotherapy" regimen, provides clinically meaningful improvements in key efficacy endpoints such as progression-free survival (PFS) and overall survival (OS) when used as a first-line treatment for patients with advanced or metastatic RCC. Additionally, the combination of Cabometyx and Opdivo demonstrates a favorable safety profile.

The active pharmaceutical ingredient in Cabometyx is cabozantinib, a tyrosine kinase inhibitor (TKI) that exerts its antitumor effects by targeting and inhibiting the MET, VEGFR2, and RET signaling pathways, capable of killingTumorCells, reduce metastasis and inhibit angiogenesis. In the United States, the European Union, Japan, and other countries and regions around the world, Cabometyx has been approved for the treatment of patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have previously received sorafenib treatment.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to uniquely utilize the human body by blocking the interaction between PD-1 and its ligand.AutoimmunitySystem helps restore resistanceTumorImmune response. Opdivo was first approved in Japan in July 2014, becoming the world's first approved PD-1 immune therapy. Currently, Opdivo has become an important treatment option for various cancers. (Bioon.com)

Source of Original Text:Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Continued Survival Benefits with Over Two Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma