- Cabometyx and nivolumab demonstrated a median overall survival gain of 11.0 months versus sunitinib, the longest for a tyrosine kinase inhibitor and immunotherapy combination in advanced renal cell carcinoma1
- Results continue to support Cabometyx and nivolumab as a standard of care first line treatment
Reno, Nevada (UroToday.com) -- Ipsen announced final results from the Phase III CheckMate -9ER trial of Cabometyx® (cabozantinib) in combination with nivolumab versus sunitinib in people living with previously untreated advanced renal cell carcinoma (aRCC). These final data demonstrated sustained superior efficacy benefits for the combination versus sunitinib over more than five years, extending survival and prolonging time to tumor progression regardless of risk classification based on International Metastatic Renal Cell Carcinoma Database Consortium scores.1 An oral presentation of these data by Dr Robert J. Motzer will take place at the American Society of Clinical Oncology Genitourinary Symposium on 13-15 February 2025 in San Francisco, CA. (Abstract #439).
With a median follow-up of 67.6 months for overall survival (OS), the trial demonstrated that early survival benefits for the combination of Cabometyx and nivolumab were sustained versus sunitinib, with an absolute median OS gain of 11.0 months (46.5 months for the combination vs 35.5 months for sunitinib, hazard ratio [HR] 0.79, 95% confidence interval [CI]: 0.65-0.96).1 Additionally, the combination demonstrated a 42% reduction in the risk of disease progression or death, with median progression-free survival nearly double that for the combination versus sunitinib, at 16.4 vs 8.3 months respectively (HR 0.58, 95% CI: 0.49-0.70).1 The safety profile was consistent with the known safety profiles of the individual medicines, with treatment-related adverse events occurring in 98% vs 93% of patients for the combination versus sunitinib respectively. No new safety signals were identified.1
“Results from the CheckMate -9ER trial have contributed significantly to the transformation of the advanced renal cell carcinoma treatment landscape since the first readout in 2020,” said Sandra Silvestri, EVP and Chief Medical Officer, Ipsen. “Underpinned by the significant long-term benefits demonstrated over more than five years, Cabometyx and nivolumab has become a standard of care treatment option, enabling people to live longer and better with advanced renal cell carcinoma.”There were over 400,000 new cases of kidney cancer diagnosed worldwide in 2022.2 Of these, RCC is the most common type of kidney cancer, accounting for approximately 90% of cases.3,4 It is almost twice as common in men, and male patients account for over two thirds of deaths.2 Early stage RCC often does not show distinct symptoms, leading to 30% of people being diagnosed with an advanced form of the disease.5,6 For people living with aRCC, 60% do not go on to receive a 2L treatment.7-9 If detected in the early stages, the five-year survival rate is high, but for people living with late-stage metastatic RCC, the survival rate is much lower at around 17%.10
“60% of people living with advanced renal cell carcinoma do not reach the point of receiving a second-line therapy, emphasizing the importance of securing efficacious care for patients at the earliest opportunity,” said Prof Camillo Porta, Medical Oncologist, University of Bari ‘A. Moro,’ Italy. “Having only one shot of therapy available for so many patients make the final results of CheckMate-9ER so relevant for everyday clinical practice. Indeed, these data further validate the potential to achieve long-term survival with Cabometyx and nivolumab at this advanced stage of disease.”
References:
- Motzer et al. Nivolumab plus cabozantinib versus sunitinib for previously untreated advanced renal cell carcinoma: results from 67.6-month follow-up of the CheckMate 9ER trial. As presented at ASCO GU Congress 2025 San Francisco, USA
- Kidney Cancer Factsheet. GLOBOCAN 2020. Available: https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf Accessed: February 2025
- Kidney Cancer. Mayo Clinic. Available: https://www.mayoclinic.org/diseases-conditions/kidney-cancer/symptoms-causes/syc-20352664. Accessed: February 2025
- Infographic: Kidney Cancer. Mayo Clinic. Available: https://www.mayoclinic.org/diseases-conditions/kidney-cancer/multimedia/kidney-cancer-infographic/ifg-20441505. Accessed: February 2025
- Kidney Cancer Signs and Symptoms. American Cancer Society: Available https://www.cancer.org/cancer/types/kidney-cancer/detection-diagnosis-staging/signs-and-symptoms.html
- Orlin I. et al. Renal cell carcinomas epidemiology in the era of widespread imaging. Journal of Clinical Oncology. 2019; 37:15. DOI:https://ascopubs.org/doi/10.1200/JCO.2019.37.15_suppl.e13083.
- Shah et al. Real-world Treatment Patterns and Clinical Outcomes for Metastatic Renal Cell Carcinoma in the Current Treatment Era. Eur Urol Open Sci. 2023. 6:49:110-118
- Malik et al. Real World Experience (RWE) of Ipilimumab and Nivolumab compared to Pembrolizumab and Axitinib in Advanced Renal Cell Carcinoma (RCC). As presented at IKCS:Europe International Kidney Cancer Symposum 2023
- Lai et al. Real world treatment sequences and outcomes for metastatic renal cell carcinoma. Plos One. 2023. DOI:https://doi.org/10.1371/journal.pone.0294039
- Survival rates for kidney cancer. American Cancer Society. Available: https://www.cancer.org/cancer/kidney-cancer/detection-diagnosis-staging/survival-rates.html Accessed: February 2025.