Treatment with lenvatinib and pembrolizumab was associated with similar or better symptoms and health-related quality of life (HRQOL) compared with sunitinib monotherapy in patients with advanced renal cell carcinoma (aRCC), investigators reported at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.1

The findings were from a new analysis of data from the phase 3 CLEAR trial (ClinicalTrials.gov Identifier: NCT02811861) in which investigators randomly assigned 1069 patients with aRCC to receive lenvatinib plus pembrolizumab (n = 355), lenvatinib plus everolimus (n = 357), or sunitinib alone (n = 357).

Previous results from the trial demonstrated that lenvatinib-pembrolizumab improved progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) compared with sunitinib.2 Results also demonstrated that lenvatinib plus everolimus improved PFS and ORR compared with sunitinib.3


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The new analysis was presented at ASCO 2021 by Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, and colleagues.

The researchers assessed HRQOL via 3 questionnaires — FKSI-DRS, EORTC QLQ-C30, and EQ-5D-3L. Patients completed questionnaires at baseline, at the beginning of every treatment cycle, and once off treatment.

At a mean follow-up of 46 weeks, lenvatinib plus everolimus resulted in similar or worse HRQOL and disease-related symptom scores when compared with sunitinib.

However, lenvatinib plus pembrolizumab produced similar or better HRQOL and symptom scores compared with sunitinib.

Recipients of lenvatinib and pembrolizumab showed significant improvement in physical functioning (least squares mean difference [LS MD], 3.0), fatigue (LS MD, −2.8), dyspnea (LS MD, −2.8), and constipation (LS MD, −2.2), compared with sunitinib.

Recipients of lenvatinib and pembrolizumab also had improved median time to first deterioration (TTD) for various HRQOL measures. For example, the TTD for physical functioning was significantly longer for lenvatinib-pembrolizumab than for sunitinib (15.3 weeks vs 12.7 weeks).

The TTD was significantly longer for lenvatinib-pembrolizumab than sunitinib for dyspnea (39.3 weeks vs 21.1 weeks), appetite loss (18.3 weeks vs 9.1 weeks), and scores on the EQ-5D VAS questionnaire (9.4 weeks vs 9.1 weeks) as well.

Disclosures: This research was supported by Eisai Inc., and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

  1. Motzer RJ, Porta C, Alekseev B, et al. Health-related quality of life (HRQoL) analysis from the phase 3 CLEAR trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) or everolimus (EVE) versus sunitinib (SUN) for patients (pts) with advanced renal cell carcinoma (aRCC). J Clin Oncol. 2021;39:(suppl 15; abstr 4502). doi:10.1200/JCO.2021.39.15_suppl.4502
  2. Motzer RJ, Alekseev, B, Rha SY, et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021;384:1289-1300. doi:10.1056/NEJMoa2035716
  3. Motzer RJ, Porta C, Eto M, et al. Phase 3 trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) or everolimus (EVE) versus sunitinib (SUN) monotherapy as a first-line treatment for patients (pts) with advanced renal cell carcinoma (RCC) (CLEAR study). J Clin Oncol. 2021;39:(suppl 6; abstr 269). doi:10.1200/JCO.2021.39.6_suppl.269

This article originally appeared on Cancer Therapy Advisor