Meeting
2022 ASCO Genitourinary Cancers Symposium
Efficacy and safety of lenvatinib (LEN) plus pembrolizumab (PEMBRO) versus sunitinib (SUN) in the East Asian subset of patients with advanced renal cell carcinoma (aRCC) from the phase 3 CLEAR trial.
Authors
Sun Young Rha
Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea
Sun Young Rha , Toni K. Choueiri , Vsevolod B. Matveev , Anna Alyasova , Sung-Hoo Hong , Teresa Alonso Gordoa , Howard Gurney , Georg A. Bjarnason , Tomas Buchler , Paolo Pedrazzoli , Toshio Takagi , Se Hoon Park , Jae-Lyun Lee , Rodolfo F. Perini , Cixin He , Jodi A. McKenzie , Masatoshi Eto
Organizations
Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea, Dana-Farber Cancer Institute, Boston, MA, Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation, Moscow, Russian Federation, Prevoljskiy Region Medical Centre, Novgorod, Russian Federation, Seoul National University Bundang Hospital, Seongnam, South Korea, Hospital Universitario Ramón y Cajal, Madrid, Spain, Macquarie University, Sydney, Australia, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada, Charles University and Thomayer University Hospital, Prague, Czech Republic, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, Tokyo Women's Medical University Hospital, Tokyo, Japan, Sungkyunkwan University Samsung Medical Center, Seoul, South Korea, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea, Merck & Co., Inc., Kenilworth, NJ, Eisai Inc., Woodcliff Lake, NJ, Kyushu University, Fukuoka, Japan
Research Funding
Pharmaceutical/Biotech Company
Background: In the phase 3 CLEAR trial that included patients with aRCC, LEN + PEMBRO demonstrated significant improvements in progression-free survival (PFS; hazard ratio [HR] 0.39; 95% CI 0.32, 0.49; P < 0.001), overall survival (OS; HR 0.66; 95% CI 0.49, 0.88; P = 0.005) and objective response rate (ORR; odds ratio 4.35; 95% CI 3.16, 5.97) vs SUN. Here we report the efficacy and safety results of the East Asian population subset of the CLEAR trial. Methods: Patients with aRCC and no prior systemic therapy were randomized (1:1:1) to receive 1 of 3 treatments including LEN 20 mg PO QD + PEMBRO 200 mg IV Q3W and SUN 50 mg PO QD (4 weeks on/2 weeks off). Randomization was stratified by geographic region and MSKCC prognostic groups. This analysis compares the efficacy and safety of LEN + PEMBRO vs SUN in the East Asian subset of the CLEAR trial including patients from Japan and the Republic of Korea. The primary endpoint was PFS; secondary endpoints included OS, ORR and safety. An independent review committee assessed tumors per RECIST v1.1. Median PFS and OS were calculated using the Kaplan-Meier method; HR and 95% CI were estimated by a stratified Cox model. Odds ratios were estimated by a stratified Cochran-Mantel-Haenszel test. Results: Of the 1069 patients randomized, 75 patients in the LEN + PEMBRO group and 65 patients in the SUN group were from East Asia. PFS was improved with LEN + PEMBRO vs SUN (median 22.1 vs 11.1 mo; HR 0.38, 95% CI 0.23, 0.62). Median OS was not reached for both arms; the HR for OS comparing LEN + PEMBRO vs SUN was 0.71, 95% CI 0.30, 1.71. ORR was improved with LEN + PEMBRO vs SUN (65.3% vs 49.2%; odds ratio 2.14, 95% CI 1.07, 4.28). Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 88.0% of patients in the LEN + PEMBRO group and in 79.7% of patients in the SUN group. The incidences and types of TEAEs were generally similar to the overall CLEAR population and were manageable with dose adjustments and appropriate concomitant therapies. Conclusions: Efficacy results for patients in the East Asian subset of the CLEAR trial were consistent with the results of the overall population. The safety profile of LEN + PEMBRO in the East Asian subset was also generally consistent with that of the overall population. Clinical trial information: NCT02811861.
| East Asian Subset | Overall Population | |||
|---|---|---|---|---|
| Parameter | LEN + PEMBRO (n = 75) | SUN (n = 65) | LEN + PEMBRO (n = 355) | SUN (n = 357) |
| Median PFS,mo (95% CI) | 22.1 (13.8, NE) | 11.1 (7.4, 16.6) | 23.9 (20.8, 27.7) | 9.2 (6.0, 11.0) |
| PFS HR vs SUN (95% CI) | 0.38 (0.23, 0.62) | - | 0.39 (0.32, 0.49) | - |
| Median OS, mo (95% CI) | NR (NE, NE) | NR (30.6, NE) | NR (33.6, NE) | NR (NE, NE) |
| OS HR vs SUN (95% CI) | 0.71 (0.30, 1.71) | - | 0.66 (0.49, 0.88) | - |
| ORR, % (95% CI) | 65.3 (54.6, 76.1) | 49.2 (37.1, 61.4) | 71.0 (66.3, 75.7) | 36.1 (31.2, 41.1) |
| ORR odds ratio vs SUN (95% CI) | 2.14 (1.07, 4.28) | - | 4.35 (3.16, 5.97) | - |
| Complete response, % | 17.3 | 7.7 | 16.1 | 4.2 |
Data cutoff date: 28 August 2020. NE, not estimable; NR, not reached.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers
Track
Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer
Sub Track
Therapeutics
Clinical Trial Registration Number
NCT02811861
Citation
J Clin Oncol 40, 2022 (suppl 6; abstr 338)
DOI
10.1200/JCO.2022.40.6_suppl.338
Abstract #
338
Poster Bd #
Online Only
Abstract Disclosures
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