Merck/Eisai's Keytruda-Lenvima Combo Tops Standard Of Care In Late-Stage Kidney Cancer Study

  • Merck & Co Inc (NYSE: MRK) and Eisai Co Ltd ESALY unveiled new data from the Phase 3 CLEAR study (KEYNOTE-581/Study 307) evaluating a combo of Merck’s Keytruda and Eisai’s Lenvima (lenvatinib) or Lenvima plus chemotherapy everolimus against Pfizer Inc’s PFE Sutent (sunitinib) for the first-line treatment of advanced renal cell carcinoma.
  • The companies presented the data at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium.
  • The combination of Keytruda and Lenvima significantly extended the time patients lived without their disease getting worse in a head-to-head matchup with sunitinib, the standard of care.
  • Keytruda and Lenvima’s combo posted a 61% reduction in the risk of disease progression or death and cut the risk of dying alone by 34%. Patients in the Keytruda plus Lenvima arm saw significant improvement in progression-free survival (PFS) at a median of 23.9 months versus 9.2 months for patients treated with sunitinib alone. 
  • The combo posted a complete response rate of 16.1% and a partial response rate of 54.9% versus 4.2% and 31.9%, respectively, for sunitinib.
  • Median overall survival was not reached in either treatment arm after a median follow-up of 27 months. 
  • By contrast, Lenvima plus everolimus cut the risk of disease progression or death by 35% with a median PFS of 14.7 months versus 9.2 months in the sunitinib arm.
  • Lenvima-everolimus arm did not demonstrate an improvement in overall survival compared with sunitinib. The combination arm posted a complete response rate of 9.8% and a partial response rate of 43.7%, significantly better than sunitinib.
  • Price Action: MRK shares are down 1.2% at $74.1, and ESALY stock decreased 0.68% at $74.1 during market trading on the last check Tuesday.
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