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New Indication: Lenvatinib + Pembrolizumab for advanced renal cell carcinoma

New Indication: Lenvatinib + Pembrolizumab for advanced renal cell carcinoma
Study:
  • Randomized phase III trial (CLEAR)
  • Advanced renal cell carcinoma with no previous therapy
  • Lenvatinib (LEN) + pembrolizumab (PEM) (n=355) vs. lenvatinib + everolimus (EVE) (n=357) vs. sunitinib (SUN) (n=357)
Efficacy:
  • ORR: 71.0% vs. 53.5% vs. 36.1% (RR btw LEN+PEM vs. SUN: 1.97 [1.69-2.29])
  • CR: 16.1% vs. 9.8% vs. 4.2%
  • Median PFS: 23.9 mos vs. 14.7 mos vs. 9.2 mos (HR btw LEN+PEM vs. SUN: 0.39 [0.32-0.49])
  • Median OS: NR for all groups. Significantly longer in LEN+PEM vs. SUN (HR: 0.66 [0.49-0.88])
Safety:
  • Grade 3-4 AEs: Diarrhea (10% vs. 12% vs. 5%), hypertension (28% vs. 23% vs. 19%), hypothyroidism (1.4% vs. 0.6% vs. 0), proteinuria (8% vs. 8% vs. 3%), PPE (4% vs. 3% vs. 4%)

N Engl J Med. Published online on Feb 13, 2021

Motzer R, et al. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma

https://doi.org/10.1056/NEJMoa2035716

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