The following article features coverage from the International Kidney Cancer Symposium 2021. Click here to read more of Cancer Therapy Advisor’s conference coverage.

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.

Read more of Cancer Therapy Advisor’s coverage of IKCS 2021 by visiting the conference page.

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