Lenvatinib/Pembrolizumab is a ‘Powerful Regimen’ in Advanced RCC


According to Thomas E. Hutson, DO, PharmD, FACP, 4-year follow-up data from the phase 3 CLEAR study confirm the maintained benefits of lenvatinib plus pembrolizumab in patients with advanced renal cell carcinoma.

In an interview with CancerNetwork®, Thomas E. Hutson, DO, PharmD, FACP, described lenvatinib (Lenvima) plus pembrolizumab (Keytruda) as a “powerful” treatment option for patients with advanced clear cell renal cell carcinoma (RCC) based on 4-year follow-up data from the phase 3 CLEAR study (NCT0281186) that were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.1

Hutson, director of the Urologic Oncology Program and co-chair of the Urologic Cancer Research and Treatment Center at Baylor University Medical Center in Dallas, as well as a professor of Medicine at Texas A&M College of Medicine, stated that the benefits of the study regimen were maintained across 4 years of follow up, and that there were no new safety signals. Moreover, the benefits appeared to be durable. The FDA approved lenvatinib plus pembrolizumab for advanced RCC in August 2021 based on earlier data from the CLEAR study.2

According to results from the final prespecified OS analysis presented at ASCO, the median overall survival was 53.7 months (95% CI, 48.7-not evaluable [NE]) with lenvatinib plus pembrolizumab compared with 54.3 months (95% CI, 40.9-NE) with sunitinib (Sutent; HR, 0.79; 95% CI, 0.63-0.99; P = .0424). Additionally, the median progression-free survival was 23.9 months (95% CI, 20.8-27.7) vs 9.2 months (95% CI, 6.0-11.0) in each respective arm (HR, 0.47 95% CI, 0.38-0.57; P <.0001).


The greatest takeaway from the updates [of the CLEAR trial assessing] lenvatinib [plus] pembrolizumab in clear cell [RCC] is that the robustness of the benefits is maintained throughout the duration of the study with no new safety signals. This should allow [patients] to feel very comfortable in choosing this regimen [because it] stood the test of time.

These data have matured, and the benefits are there. [In terms of] making sure patients feel comfortable, we do see with long-term follow-up that the same benefits that were touted at the beginning, resulting in the approval of the therapy, are maintained. They should feel very comfortable that their doctor has chosen one of the most powerful regimens for the treatment of their cancer.


  1. Motzer RJ, Porta C, Eto M, et al. Final prespecified overall survival (OS) analysis of CLEAR: 4-year follow-up of lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). J Clin Oncol. 2023;41(suppl 16):4502. doi:10.1200/JCO.2023.41.16_suppl.4502
  2. FDA approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination for first-line treatment of adult patients with advanced renal cell carcinoma (RCC). News release. Merck. August 11, 2021. Accessed July 19, 2023. https://bwnews.pr/3m0p3Vh
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