Product Highlight - Cabometyx
29 Sep 2021
Renal Cell Carcinoma (RCC)
• Superior efficacy after prior VEGF-targeted therapy1-2 (superiority over everolimus) and in treatment-naive patients (superiority over sunitinib)
• Manageable tolerability with a similar profile to sunitinib3
• Validated by major international bodies and guidelines (NCCN, ESMO and EMA)4-6
Hepatocellular Carcinoma (HCC)
• Efficacy in a broad ITT patient population that is enhanced in a pure second-line setting (TKI with OS in 2L of almost 1 year)7
• Manageable tolerability profile7
• Validated by major international bodies and guidelines (NCCN, ESMO and EMA)8-10
EASL: European Association for the Study of the Liver, ESMO: European Society of Medical Oncology, ITT: Intention-To-Treat, NCCN: National Comprehensive Cancer Network, OS: Overall Survival.
References:
1. Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal-cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016; 17(7): 917–927.
2. Motzer RJ, Escudier B, Powles T, et al. Long-term follow-up of overall survival for cabozantinib versus everolimus in advanced renal cell carcinoma. Br J Cancer. 2018;118(9):1176–1178.
3. Choueiri TK, Hessel C, Halabi S, et al. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update. Eur J Cancer. 2018;94:115–125.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Kidney Cancer. Version 2.2020 – August 2019.
5. Escudier B, Porta C, Schmidinger M, et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(5):706–720.
6. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment report: cabozantinib, 2018. Available from: www.ema.europa.
7. Abou-Alfa GK, Meyer T, Cheng AL, et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med.2018;379(1):54–63.
8. Vogel A, Cervantes A, Chau I, et al. Hepatocellular carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018; 29(Supplement_4): iv238–255.
9. Galle PR, Forner A, Llovet JM, et al. EASL clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2018;69(1):182–236. 10. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Hepatobiliary cancers. Version 1.2020, March 2020.
CMX-MY-000051 June 2021
• Superior efficacy after prior VEGF-targeted therapy1-2 (superiority over everolimus) and in treatment-naive patients (superiority over sunitinib)
• Manageable tolerability with a similar profile to sunitinib3
• Validated by major international bodies and guidelines (NCCN, ESMO and EMA)4-6
Hepatocellular Carcinoma (HCC)
• Efficacy in a broad ITT patient population that is enhanced in a pure second-line setting (TKI with OS in 2L of almost 1 year)7
• Manageable tolerability profile7
• Validated by major international bodies and guidelines (NCCN, ESMO and EMA)8-10
EASL: European Association for the Study of the Liver, ESMO: European Society of Medical Oncology, ITT: Intention-To-Treat, NCCN: National Comprehensive Cancer Network, OS: Overall Survival.
References:
1. Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal-cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016; 17(7): 917–927.
2. Motzer RJ, Escudier B, Powles T, et al. Long-term follow-up of overall survival for cabozantinib versus everolimus in advanced renal cell carcinoma. Br J Cancer. 2018;118(9):1176–1178.
3. Choueiri TK, Hessel C, Halabi S, et al. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update. Eur J Cancer. 2018;94:115–125.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Kidney Cancer. Version 2.2020 – August 2019.
5. Escudier B, Porta C, Schmidinger M, et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(5):706–720.
6. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment report: cabozantinib, 2018. Available from: www.ema.europa.
7. Abou-Alfa GK, Meyer T, Cheng AL, et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med.2018;379(1):54–63.
8. Vogel A, Cervantes A, Chau I, et al. Hepatocellular carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018; 29(Supplement_4): iv238–255.
9. Galle PR, Forner A, Llovet JM, et al. EASL clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2018;69(1):182–236. 10. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Hepatobiliary cancers. Version 1.2020, March 2020.
CMX-MY-000051 June 2021