European Commission Approves LENVIMA Plus KEYTRUDA Combination for Advanced Renal Cell Carcinoma Treatment

Strategic Insights -

The European Commission has granted approval to the combination of LENVIMA (KISPLYX in the European Union) and KEYTRUDA for the first-line treatment of adult patients with advanced renal cell carcinoma. This decision is based on the results of the CLEAR (Study 307)/KEYNOTE-581 trial, which demonstrated statistically significant improvements in progression-free survival (PFS) when compared to sunitinib. The LENVIMA plus KEYTRUDA combination reduced the risk of disease progression or death by 61% (HR=0.39, 95% CI, 0.32-0.49; p30%) for LENVIMA plus KEYTRUDA were diarrhea (61.8%), hypertension (51.5%), fatigue (47.1%), hypothyroidism (45.1%), decreased appetite (42.1%), nausea (39.6%), stomatitis (36.6%), proteinuria (33.0%), dysphonia (32.8%), and arthralgia (32.4%).

  • The combination is now available for marketing in 27 EU member states, plus Iceland, Liechtenstein, Norway, and Northern Ireland.

Statistics:

  • 61% reduction in risk of disease progression or death with LENVIMA plus KEYTRUDA compared to sunitinib (HR=0.39, 95% CI, 0.32-0.49; p<0.001).
  • 61.8% of patients experienced diarrhea as an adverse reaction with LENVIMA plus KEYTRUDA.
  • 51.5% of patients experienced hypertension as an adverse reaction with LENVIMA plus KEYTRUDA.
  • 47.1% of patients experienced fatigue as an adverse reaction with LENVIMA plus KEYTRUDA.

Sources:

  • European Commission
  • Eisai
  • Merck & Co., Inc., Kenilworth, N.J., U.S.A.
  • CLEAR (Study 307)/KEYNOTE-581 trial
  • SmPC (Summary of Product Characteristics)