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Presidential Symposium 3

1518 - CABOzantinib versus SUNitinib (CABOSUN) as initial targeted therapy for patients with metastatic renal cell carcinoma (mRCC) of poor and intermediate risk groups: Results from ALLIANCE A031203 trial

Date

10 Oct 2016

Session

Presidential Symposium 3

Presenters

Toni Choueiri

Citation

Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435

Authors

T.K. Choueiri1, S. Halabi2, B. Sanford2, O. Hahn3, M..D. Michaelson4, M. Walsh1, T. Olencki5, J. Picus6, E.J. Small7, S. Dakhil8, D. George9, M.J. Morris10

Author affiliations

  • 1 Kidney Cancer Center, Dana-Farber Cancer Institute, MA 02215 - Boston/US
  • 2 Biostatistics & Bioinformatics, Duke University, 27710 - Durham/US
  • 3 Medical Oncology, The University of Chicago Medical Centre, 60637 - Chicago/US
  • 4 Medical Oncology, Massachusetts General Hospital, Boston/US
  • 5 Medical Oncology, Ohio State Univ Medical Center, 43210 - Columbus/US
  • 6 Medical Oncology, Washington University School of Medicine, 63110 - St Louis/US
  • 7 Medical Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco/US
  • 8 Hematology, Cancer Center of Kansas, Wichita/US
  • 9 Medical Oncology, Duke University, 27710 - Durham/US
  • 10 Medical Oncology, Memorial Sloan-Kettering Cancer Center, 10065 - New York, NY/US
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Abstract 1518

Background

Cabozantinib (Cabo) is an oral, potent inhibitor of MET, AXL and VEGFR2 that increases progression free-survival (PFS) and overall survival (OS) in mRCC patients (pts) after VEGF-targeted therapy. This randomized phase II multicenter trial compared the PFS of Cabo to Sunitinib (Sun) as front-line targeted therapy in pts with mRCC.

Methods

Eligible pts had untreated clear-cell mRCC, ECOG performance status 0-2, and were intermediate or poor risk, per the International mRCC Database Consortium Criteria (IMDC, Heng JCO 2009). Pts were randomized 1:1 to Cabo (60 mg QD) or Sun (50 mg QD, 4 weeks on/2 weeks off). Pts were stratified by IMDC risk groups (intermediate vs. poor risk) and bone metastasis (yes, no). With 123 events (progression or deaths), the log-rank statistic has 85% power to detect a hazard ratio of 0.67 for PFS assuming a one-sided type I error of 0.12.

Results

From July 2013 to April 2015, 157 pts were randomized (79 to Cabo and 78 to Sun). Median follow up was 20.8 months (mo). 13 (16.46%) pts remained on therapy in the Cabo arm vs. 2 (2.56%) pts in the Sun arm. 80.9% of pts were IMDC intermediate risk and 36.3% had bone metastases and were equally distributed across arms. Median PFS was significantly increased at 8.2 mo (95% CI = 6.2-8.8) for Cabo vs. 5.6 mo (95% CI = 3.4-8.2) for Sun, with 31% reduction in rate of progression or death (adjusted HR 0.69, 95% CI 0.48 to 0.98, one-sided P = 0.012). ORR was 46% (95% CI 34-57%) for Cabo vs. 18% (95% CI 10-28%) for Sun. Median OS was 26.4 mo. for Cabo vs. 23.5 mo for Sun (adjusted HR 0.87, 95% CI 0.55-1.4). All-causality grade 3 or higher adverse events were 70.5% for Cabo and for 72.2% for Sun, and included diarrhea (Cabo 10%, Sun 11%), fatigue (Cabo 6%, Sun 15%), hypertension (Cabo 28%, Sun 22%), palmar-plantar erythrodysesthesia (Cabo 8%, Sun 4%) and hematological (Cabo 2.6%, Sun 22.2%). In each arm, 16 pts ended treatment due to toxicity.

Conclusions

Cabozantinib demonstrated a significant benefit in PFS and ORR over standard sunitinib in untreated intermediate and poor risk mRCC pts.

Clinical trial identification

NCT01835158

Legal entity responsible for the study

Alliance/CTEP

Funding

Exelixis

Disclosure

T.K. Choueiri: Institutional funds from Exelixis and Pfizer. Advisory board compensation from Pfizer. All other authors have declared no conflicts of interest.

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