Compared with sunitinib, the combination of lenvatinib plus pembrolizumab improves long-term outcomes in patients with advanced renal cell carcinoma (RCC), according to follow-up data presented at the International Kidney Cancer Symposium (IKCS) 2021.1

The phase 3 CLEAR trial (ClinicalTrials.gov Identifier: NCT02811861) enrolled treatment-naive patients with advanced clear-cell RCC, and they were randomly assigned to receive lenvatinib plus pembrolizumab, lenvatinib plus everolimus, or sunitinib monotherapy.

Prior results from the trial established that lenvatinib plus pembrolizumab improved progression-free survival (PFS) and overall survival (OS) when compared with sunitinib alone.2 However, it wasn’t clear if these benefits persisted in the long term.


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In a poster at IKCS 2021, researchers presented long-term follow-up data for the lenvatinib-pembrolizumab and sunitinib arms only.

Data from 355 patients in the lenvatinib-pembrolizumab arm and 357 patients in the sunitinib arm were included. The median follow-up was 33.7 months and 33.4 months, respectively.

At the data cutoff, 63.4% of patients in the lenvatinib-pembrolizumab arm and 55.2% in the sunitinib arm were still alive and active on the study.

The objective response rate was significantly higher in the lenvatinib-pembrolizumab arm than in the sunitinib arm — 68.7% and 34.5%, respectively (relative risk, 2.0; 95% CI, 1.7-2.34). The complete response rates were 10.4% and 2%, respectively. The median duration of response was 27.9 months and 14.8 months, respectively.

The median PFS was significantly longer in the lenvatinib-pembrolizumab arm than in the sunitinib arm — 22.1 months and 9.5 months, respectively (hazard ratio, 0.47; 95% CI, 0.38-0.57).

The median OS was not reached in either arm. However, the data favored lenvatinib-pembrolizumab (hazard ratio, 0.72; 95% CI, 0.55-0.93).

The researchers concluded that these data further support lenvatinib-pembrolizumab as a first-line treatment for patients with advanced RCC.

Disclosures: This research was supported by Eisai Inc., and Merck Sharp & Dohme Corp. Some study authors declared affiliations with Eisai and Merck.

References

  1. Choueiri TK, Powles T, Porta C, et al. A phase 3 trial of lenvatinib plus pembrolizumab versus sunitinib as a first-line treatment for patients with advanced renal cell carcinoma (aRCC): Overall survival follow-up analysis (CLEAR study). Presented at IKCS 2021; November 5-6, 2021. Abstract E41.
  2. Motzer R, Alekseev B, Rha S-Y, et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med. 2021;384(14):1289-1300. doi:10.1056/NEJMoa2035716

This article originally appeared on Cancer Therapy Advisor