alexa Randomized phase II, three-arm trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in patients (pts) with metastatic renal cell carcinoma (mRCC).
Surgery

Surgery

Medical & Surgical Urology

Author(s): Robert Motzer, Thomas Hutson, Hilary Glen, Dror Michaelson, Ana M Molina

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Background: Lenvatinib (LEN), an oral tyrosine kinase inhibitor of VEGFR1–3, FGFR1–4, PDGFRα, RET, and KIT, in combination with EVE had manageable toxicity and antitumor activity in a phase 1 mRCC trial (CCP 2013;73:181). This phase II, open-label, multicenter study compared LEN, EVE, and LEN+EVE in pts with mRCC.

Methods: Pts with progressive clear cell mRCC following 1 VEGF-targeted therapy were randomized 1:1:1 to LEN (24 mg/d), EVE (10 mg/d), or LEN+EVE (18+5 mg/d) in 28d cycles. The primary objective was progression-free survival (PFS) of LEN+EVE or LEN vs EVE. Secondary objectives included overall survival (OS), objective response rate (ORR), and safety. Primary analysis data cutoff was June 13, 2014.

Results: One hundred and fifty-three pts were enrolled: 99% had one prior VEGF-targeted therapy, 1% had two; 18% had prior immunotherapy. LEN+EVE prolonged PFS vs EVE (Table; hazard ratio [HR] 0.40; 95% confidence interval [CI] 0.24–0.68; P < 0.001). LEN alone also prolonged PFS vs EVE (HR 0.61; 95% CI 0.38–0.98; P = 0.048). LEN+EVE and LEN improved ORR vs EVE (P < 0.001 and P = 0.007, respectively). Median duration of response (months) was longest in LEN+EVE, 13.1; LEN, 7.5; EVE, 8.5. OS analysis showed a trend favoring LEN+EVE vs EVE (HR 0.55; 95% CI 0.30–1.01; P = 0.062); this reached significance (HR 0.51; 95% CI 0.30–0.88; P = 0.024) in an updated analysis on Dec 10, 2014. For LEN+EVE, most common any-grade treatment-emergent adverse events (TEAEs) were diarrhea (84%), decreased appetite (51%), and fatigue (47%). Most common grade ≥ 3 TEAEs were diarrhea (20%), hypertension (14%), and fatigue (10%).

Conclusions: LEN+EVE improved PFS and ORR versus EVE alone in this phase II trial of pts with mRCC following prior VEGF-targeted therapy. Updated OS also showed improvement with LEN+EVE. A phase III randomized trial of the combination in mRCC is planned.

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This article was published in Journal of Clinical Oncology and referenced in Medical & Surgical Urology

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