RECORD-4 phase 2 trial of second-line everolimus (EVE) in patients (pts) with metastatic renal cell carcinoma (mRCC): Final OS analysis.

Authors

null

Thomas Cosgriff

Hem/Onc Speclst

Thomas Cosgriff , Lin Yang , Anna Alyasova , Dingwei Ye , Andrey Karpenko , Hanzhong Li , Boris Alekseev , Li-ping Xie , Ruben Dario Kowalyszyn , Oleg Karyakin , Yeni Verónica Neron , LaTonya Collins , Thomas Brechenmacher , Chinjune Lin , Liza Morgan , Robert J. Motzer

Organizations

Hem/Onc Speclst, Cancer Hospital, Chinese Academy Medical Sciences, Beijing, China, Federal State Institution, Privolzhsky District Medical Center, under the Federal Medical-Biological Agency of Russia, Nizhny Novgorod, Russia, Fudan University Cancer Hospital, Shanghai, China, Leningrad Regional Oncologic Dispensary, Saint Petersburg, Russia, Peking Union Medical College Hospital, Beijing, China, Hertzen Cancer Research Institute, Moscow, Russia, The First Affiliated Hospital of Zhejiang University, Hangzhou, China, Centro De Investigaciones Clínicas Clínica Viedma S A, Viedma, Argentina, Medical Radiological Research Center, Obninsk, Russia, Centro de Pesquisas Oncológicas-CEPON, Florianopolis-SC, Brazil, Novartis Pharmaceuticals Corporation, East Hanover, NJ, Novartis Pharma S.A.S., Rueil-Malmaison, France, Novartis Oncology, East Hanover, NJ, Memorial Sloan Kettering Cancer Center, New York, NY

Research Funding

Pharmaceutical/Biotech Company

Background: The phase 2 RECORD-4 study assessed EVE in pts with mRCC who progressed after 1 prior anti-VEGF or cytokine (J Clin Oncol 2015;abstr 4518). At primary analysis, median progression-free survival (PFS, primary end point) in the overall population was 7.8 months (95% CI, 5.7-11.0). Here we present results of the final updated primary PFS and final overall survival (OS) analysis. Methods: RECORD-4 enrolled 134 pts with clear cell mRCC into 1 of 3 cohorts based on prior first-line therapy: sunitinib (cohort 1, n=58), other anti-VEGF (cohort 2, n=62: 23 sorafenib, 16 bevacizumab, 13 pazopanib, 10 other), or cytokines (cohort 3, n=14). Pts received EVE 10 mg/d until progression of disease (PD; RECIST, v1.0) or intolerance. Database lock for final analysis was June 26, 2015. Results: Demographics were balanced among cohorts; overall most pts were men (68%) and most had good/intermediate MSKCC prognosis (90%); median age was 59 yrs. Median duration of exposure was 5.8 mo. At the time of final analysis, study discontinuation was primarily due to disease progression (61%). In the overall population, median PFS (95% CI) was 7.4 (5.6-10.5) mo and median OS (95% CI) was 23.8 (17.0-not evaluable [NE]) mo (Table). Overall rate of grade 3 or 4 adverse events (AEs) was 56%. There were 13 on-treatment deaths; primary causes were disease progression, multi-organ failure, and respiratory failure (2.3% each). Conclusions: RECORD-4 final OS analysis supports EVE as a second-line option after sunitinib and other first-line therapies. EVE safety profile was consistent with previous experience. Clinical trial information: NCT01491672

Key efficacy and safety results.

Overall
population
N=134
Prior therapy
Sunitinib
N=58
Other
anti-VEGF
N=62
Cytokines
N=14
Median PFS (95% CI), mo7.4 (5.6-10.5)5.6 (3.7-11.3)7.8 (5.7-11.0)12.9 (2.6-NE)
Median OS (95% CI), mo23.8 (17.0-NE)23.8 (13.7-NE)17.2 (11.9-NE)NE (15.9-NE)
Safety setN=133N=58N=61N=14
Grade 3/4 AEsa, n (%)
Overall74 (56)32 (55)32 (52)10 (71)
Anemia17 (13)6 (10)7 (11)4 (29)
Stomatitis/mouth ulceration9 (7)4 (7)3 (5)2 (14)
Hyperglycemia6 (5)2 (3)4 (7)0 (0)
Hypertriglyceridemia6 (5)3 (5)3 (5)0 (0)

aCommonly reported (>4% in the overall population).

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Abstract Details

Meeting

2016 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Renal Cell Cancer

Clinical Trial Registration Number

NCT01491672

Citation

J Clin Oncol 34, 2016 (suppl 2S; abstr 560)

DOI

10.1200/jco.2016.34.2_suppl.560

Abstract #

560

Poster Bd #

F21

Abstract Disclosures

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