CheckMate-9ER: Nivolumab plus Cabozantinib Extends Progression-Free Survival and Overall Survival Compared with Sunitinib

2021 Year in Review - Renal-Cell Carcinoma - Renal-Cell Carcinoma

Cabozantinib, a tyrosine kinase inhibitor, and nivolumab, an anti–PD-1 immunotherapy, are approved as single-agent therapies for advanced renal-cell carcinoma (RCC). The phase 3 CheckMate-9ER trial evaluated the efficacy of combination nivolumab plus cabozantinib in patients with previously untreated advanced RCC. A total of 651 patients were randomly assigned to receive once-daily cabozantinib 40 mg plus nivolumab 240 mg every 2 weeks or sunitinib 50 mg for 4 weeks followed by 2 weeks off treatment. Progression-free survival was the primary end point. Overall survival, objective response rate, and safety were key secondary end points.1

After a median follow-up of 18.1 months, cabozantinib plus nivolumab significantly improved median progression-free survival versus sunitinib (16.6 vs 8.3 months, respectively; hazard ratio, 0.51; 95% confidence interval, 0.41-0.64; P <.001). Combination therapy with cabozantinib plus nivolumab also improved the rate of overall survival at 12 months (85.7% vs 75.6%), resulting in a 40% improvement versus sunitinib (98.89% confidence interval, 11%-60%; P = .001).1

Confirmed objective response rate was 55.7% with nivolumab plus cabozantinib (8.0% complete response; 47.7% partial response) and 27.1% with sunitinib (4.6% complete response; 22.6% partial response). Among those patients with a response, the median duration was 20.2 months for nivolumab plus cabozantinib and 11.5 months for sunitinib.1

Grade 3 or 4 treatment-related adverse events were reported in 60.6% of patients treated with nivolumab plus cabozantinib and 50.9% of patients treated with sunitinib. In both groups, the most frequently reported grade 3 or 4 adverse events were hypertension (12.5% for nivolumab and cabozantinib vs 13.1% for sunitinib), palmar–plantar erythrodysesthesia (7.5% vs 7.5%, respectively), diarrhea (6.9% vs 4.4%, respectively), and elevated lipase levels (6.2% vs 4.7%, respectively). Discontinuation of ≥1 agents due to adverse events was reported for 19.7% of patients treated with nivolumab plus cabozantinib and 16.9% of patients treated with sunitinib.1

Whereas quality of life deteriorated with sunitinib, validated quality-of-life measures stayed relatively stable with nivolumab and cabozantinib.1

The study investigators concluded that nivolumab and cabozantinib improved survival in previously untreated metastatic RCC and, despite substantial adverse events, maintained quality of life.1 On the basis of the CheckMate-9ER trial results, cabozantinib and nivolumab were approved for use in patients with untreated advanced RCC in January 2021.2

References

  1. Choueiri TK, Powles T, Burotto M, et al; for the CheckMate 9ER Investigators. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2021;384:829-841.
  2. US Food and Drug Administration. FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma. Updated January 22, 2021. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-plus-cabozantinib-advanced-renal-cell-carcinoma. Accessed November 18, 2021.
Related Items
Reduced Starting Dose of Tyrosine Kinase Inhibitors in Patients with Metastatic Renal-Cell Carcinoma
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in Original Article, Renal-Cell Carcinoma, Dose Escalation/Reduction
Minimal Activity with Sapanisertib in Refractory Renal-Cell Carcinoma
2021 Year in Review - Renal-Cell Carcinoma published on January 20, 2022 in Renal-Cell Carcinoma
Active Therapy Improves Survival versus BSC After Disease Progression on Nivolumab and Cabozantinib
2021 Year in Review - Renal-Cell Carcinoma published on January 20, 2022 in Renal-Cell Carcinoma
Real-World Treatment Patterns Have Drastically Changed Over the Past 5 Years
2021 Year in Review - Renal-Cell Carcinoma published on January 20, 2022 in Renal-Cell Carcinoma
Functional Imaging Predicts Outcomes in Patients Treated with Antiangiogenic Therapy
2021 Year in Review - Renal-Cell Carcinoma published on January 20, 2022 in Renal-Cell Carcinoma
Development of a Prognostic Biomarker Score for Nivolumab in Relapsed/Refractory Disease
2021 Year in Review - Renal-Cell Carcinoma published on January 20, 2022 in Renal-Cell Carcinoma
Clinical Activity of Lenvatinib with or without Everolimus in Heavily Pretreated Disease
2021 Year in Review - Renal-Cell Carcinoma published on January 20, 2022 in Renal-Cell Carcinoma
Nivolumab Rechallenge Associated with Moderate Efficacy
2021 Year in Review - Renal-Cell Carcinoma published on January 20, 2022 in Renal-Cell Carcinoma
Stereotactic Radiotherapy Delays Treatment Switch in Those with Oligoprogression
2021 Year in Review - Renal-Cell Carcinoma published on January 20, 2022 in Renal-Cell Carcinoma
Study 218: Higher Lenvatinib Starting Dose Trended Toward Better Outcomes
2021 Year in Review - Renal-Cell Carcinoma published on January 20, 2022 in Renal-Cell Carcinoma
© Amplity Health. All rights reserved.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: