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Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma
Open accessAbstract
BACKGROUND: Lenvatinib in combination with pembrolizumab or everolimus has activity against advanced renal cell carcinoma. The efficacy of these regimens as compared with that of sunitinib is unclear. METHODS: In this phase 3 trial, we randomly assigned (in a 1:1:1 ratio) patients with advanced renal cell carcinoma and no previous systemic therapy to receive lenvatinib (20 mg orally once daily) plus pembrolizumab (200 mg intravenously once every 3 weeks), lenvatinib (18 mg orally once daily) plus everolimus (5 mg orally once daily), or sunitinib (50 mg orally once daily, alternating 4 weeks receiving treatment and 2 weeks without treatment). The primary end point was progression-free survival, as assessed by an independent review committee in accordance with Response Evaluation Criteria in Solid Tumors, version 1.1. Overall survival and safety were also evaluated. RESULTS: A total of 1069 patients were randomly assigned to receive lenvatinib plus pembrolizumab (355 patients), lenvatinib plus everolimus (357), or sunitinib (357). Progression-free survival was longer with lenvatinib plus pembrolizumab than with sunitinib (median, 23.9 vs. 9.2 months; hazard ratio for disease progression or death, 0.39; 95% confidence interval [CI], 0.32 to 0.49; P<0.001) and was longer with lenvatinib plus everolimus than with sunitinib (median, 14.7 vs. 9.2 months; hazard ratio, 0.65; 95% CI, 0.53 to 0.80; P<0.001). Overall survival was longer with lenvatinib plus pembrolizumab than with sunitinib (hazard ratio for death, 0.66; 95% CI, 0.49 to 0.88; P = 0.005) but was not longer with lenvatinib plus everolimus than with sunitinib (hazard ratio, 1.15; 95% CI, 0.88 to 1.50; P = 0.30). Grade 3 or higher adverse events emerged or worsened during treatment in 82.4% of the patients who received lenvatinib plus pembrolizumab, 83.1% of those who received lenvatinib plus everolimus, and 71.8% of those who received sunitinib. Grade 3 or higher adverse events occurring in at least 10% of the patients in any group included hypertension, diarrhea, and elevated lipase levels. CONCLUSIONS: Lenvatinib plus pembrolizumab was associated with significantly longer progression-free survival and overall survival than sunitinib. (Funded by Eisai and Merck Sharp and Dohme; CLEAR ClinicalTrials.gov number, NCT02811861.).
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Citations
Cites
Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma
Motzer, R. J., Tannir, N. M., McDermott, D. F., Arén Frontera, O., Melichar, B., Choueiri, T. K., Plimack, E. R., Barthélémy, P., Porta, C., George, S., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1712126 · Cited by 4,656
Self-citationPembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma
Rini, B. I., Plimack, E. R., Stus, V., Gafanov, R., Hawkins, R., Nosov, D., Pouliot, F., Alekseev, B., Soulières, D., Melichar, B., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1816714 · Cited by 3,403
Self-citationAvelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma
Motzer, R. J., Penkov, K., Haanen, J., Rini, B., Albiges, L., Campbell, M. T., Venugopal, B., Kollmannsberger, C., Negrier, S., Uemura, M., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1816047 · Cited by 2,503
Self-citationMotzer, R. J., Bacik, J., Murphy, B. A., Russo, P., & Mazumdar, M. (2002) · Journal of Clinical Oncology · doi:10.1200/jco.20.1.289 · Cited by 1,576
Self-citationKarnofsky performance status revisited: reliability, validity, and guidelines.
Schag, C. C., Heinrich, R. L., & Ganz, P. A. (1984) · Journal of Clinical Oncology · doi:10.1200/jco.1984.2.3.187 · Cited by 1,517
Systemic Therapy for Metastatic Renal-Cell Carcinoma
Choueiri, T. K., & Motzer, R. J. (2017) · New England Journal of Medicine · doi:10.1056/nejmra1601333 · Cited by 1,284
Self-citationMotzer, R. J., Hutson, T. E., Glen, H., Michaelson, M. D., Molina, A., Eisen, T., Jassem, J., Zolnierek, J., Maroto, J. P., Mellado, B., et al. (2015) · The Lancet Oncology · doi:10.1016/s1470-2045(15)00290-9 · Cited by 945
Self-citationPowles, T., Plimack, E. R., Soulières, D., Waddell, T., Stus, V., Gafanov, R., Nosov, D., Pouliot, F., Melichar, B., Vynnychenko, I., et al. (2020) · The Lancet Oncology · doi:10.1016/s1470-2045(20)30436-8 · Cited by 751
Self-citationLenvatinib plus pembrolizumab in patients with advanced endometrial cancer
Makker, V., Taylor, M. H., Aghajanian, C., Oaknin, A., Mier, J., Cohn, A. L., Romeo, M., Bratos, R., Brose, M. S., DiSimone, C., et al. (2020) · Journal of Clinical Oncology · doi:10.1200/jco.19.02627 · Cited by 522
Self-citationTargeting the HIF2–VEGF axis in renal cell carcinoma
Choueiri, T. K., & Kaelin, W. G. (2020) · Nature Medicine · doi:10.1038/s41591-020-1093-z · Cited by 477
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Cited by
Qin, S., Chan, S. L., Gu, S., Bai, Y., Ren, Z., Lin, X., Chen, Z., Jia, W., Jin, Y., Guo, Y., et al. (2023) · The Lancet · doi:10.1016/s0140-6736(23)00961-3 · Cited by 746
Immune checkpoint therapy for solid tumours: clinical dilemmas and future trends
Sun, Q., Hong, Z., Zhang, C., Wang, L., Han, Z., & Ma, D. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-023-01522-4 · Cited by 598
Llovet, J. M., Kudo, M., Merle, P., Meyer, T., Qin, S., Ikeda, M., Xu, R., Edeline, J., Ryoo, B.-Y., Ren, Z., et al. (2023) · The Lancet Oncology · doi:10.1016/s1470-2045(23)00469-2 · Cited by 469
Self-citationTannir, N. M., Albigès, L., McDermott, D. F., Burotto, M., Choueiri, T. K., Hammers, H. J., Barthélémy, P., Plimack, E. R., Porta, C., George, S., et al. (2024) · Annals of Oncology · doi:10.1016/j.annonc.2024.07.727 · Cited by 231
Self-citationEbrahimi, H., Dizman, N., Meza, L., Malhotra, J., Li, X., Dorff, T., Frankel, P., Llamas-Quitiquit, M., Hsu, J., Zengin, Z. B., et al. (2024) · Nature Medicine · doi:10.1038/s41591-024-03086-4 · Cited by 109
Metadata
- Authors
- Motzer, R., Alekseev, B., Rha, S.-Y., Porta, C., Eto, M., Powles, T., Grünwald, V., Hutson, T. E., Kopyltsov, E., Méndez-Vidal, M. J., Kozlov, V., Alyasova, A., Hong, S.-H., Kapoor, A., Alonso Gordoa, T., Merchan, J. R., Winquist, E., Maroto, P., Goh, J. C., Kim, M., Gurney, H., Patel, V., Peer, A., Procopio, G., Takagi, T., Melichar, B., Rolland, F., De Giorgi, U., Wong, S., Bedke, J., Schmidinger, M., Dutcus, C. E., Smith, A. D., Dutta, L., Mody, K., Perini, R. F., Xing, D., & Choueiri, T. K.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-04-08
- Volume
- 384
- Issue
- 14
- Pages
- 1289-1300
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3131063362
- Cited by
- 1,766
- References
- 18
- FWCI
- 183.83
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Motzer, R., Alekseev, B., Rha, S.-Y., Porta, C., Eto, M., Powles, T., Grünwald, V., Hutson, T. E., Kopyltsov, E., Méndez-Vidal, M. J., Kozlov, V., Alyasova, A., Hong, S.-H., Kapoor, A., Alonso Gordoa, T., Merchan, J. R., Winquist, E., Maroto, P., Goh, J. C., . . . Choueiri, T. K. (2021). Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2035716
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