ESMO 2016: Cabometyx demonstrates clinical benefits over Sunitinib in treatment-naïve RCC patients.
By Dominique Fontanilla, Senior Analyst
14 October 2016
I joined Datamonitor Healthcare’s disease team in 2014 having previously worked as a biochemistry postdoctoral fellow ...
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The first numerical data from Cabometyx’s (cabozantinib; Exelixis/Ipsen/Swedish Orphan Biovitrum) randomized Phase II CABOSUN trial were presented on Monday October 10th, and the results give a positive outlook for the drug’s future commercial potential in renal cell cancer (RCC). Cabometyx demonstrated encouraging clinical efficacy and tolerability in previously untreated advanced or metastatic RCC in comparison to the current first-line standard of care, Sutent (sunitinib; Pfizer). These positive results reinforce Cabometyx’s solid position in this indication and suggest that the drug will eventually be able to compete with Sutent as well as other drugs in development for first-line RCC. At a median follow up of 20.8 months, the median progression-free survival (PFS) favored the Cabometyx arm (8.2 months) as compared to the Sutent arm (5.6 months), demonstrating a 2.6 month improvement in PFS. In addition, the overall response rate was significantly higher in the Cabometyx arm (46%) as compared to the Sutent arm (18%). The median overall survival (OS) was 30.3 months for patients treated with Cabometyx versus 21.8 months for those treated with Sutent (Hazard Ratio = 0.8).Based on the positive results presented from CABOSUN, Exelixis plans to submit a supplemental New Drug Application to expand Cabometyx’s label to include treatment-naïve advanced RCC patients (Exelixis press release, 2016a). Exelixis is currently working to obtain the CABOSUN clinical database as the trial was conducted by the Alliance for Clinical Trials in Oncology as part of a collaboration between Exelixis and the National Cancer Institute’s Cancer Therapy Evaluation Program. Datamonitor Healthcare anticipates that a successful application will result in Cabometyx’s approval for the lucrative first-line RCC setting in the second-half of 2017. Cabometyx previously received US approval for the second-line treatment of advanced RCC in April 2016 and a subsequent approval was granted in Europe for the same treatment setting in September 2016 (Exelixis press release, 2016b; Exelixis press release, 2016c). It is likely that a successful expansion to the first-line setting will encourage further uptake of Cabometyx, enabling it to contend with the current standard RCC therapies and become an important treatment option at all lines of therapy.
Exelixis press release (2016a) Exelixis Announces Positive Results from Phase 2 CABOSUN Trial of Cabozantinib Versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma Presented at ESMO 2016. Available from: http://www.exelixis.com/investors-media/press-releases?cpurl=http%3A%2F%2Fir.exelixis.com/phoenix.zhtml?c=120923%26p=irol-newsArticle%26ID=2210335%26highlight= [Accessed 10 October 2016].
Exelixis press release (2016b) Exelixis Announces FDA Approval of CABOMETYX™ (Cabozantinib) Tablets for Patients with Advanced Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy. Available from: http://ir.exelixis.com/phoenix.zhtml?c=120923&p=irol-newsArticle&ID=2161051 [Accessed 8 August 2016].
Exelixis press release (2016c) European Commission Approves CABOMETYX™ (cabozantinib) Tablets for the Treatment of Advanced Renal Cell Carcinoma Following VEGF-Targeted Therapy. Available from: http://ir.exelixis.com/phoenix.zhtml?c=120923&p=irol-newsArticle&ID=2201671 [Accessed 17 September 2016].
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