Newsflash
Prodotti competitors / Area Oncology

Merck and Eisai announced that phase III studies in lung cancer (NSCLC) evaluating the combination of pembrolizumab (Keytruda) and lenvatinib (VEGF TKI) failed to meet their primary endpoints

  • 22 settembre 2023
Immagine News
Attenzione! Il presente contenuto è disponibile solo in lingua originale.

Merck and Eisai announced that two NSCLC P3 studies evaluating the combination of pembrolizumab (Keytruda) and lenvatinib (VEGF TKI) failed to meet their primary endpoints:

  • LEAP-006, evaluating pembro + lenvatinib + chemo vs. pembro + chemo in 1L non-squamous NSCLC, failed to meet its coprimary OS & PFS endpoints, as well as its secondary ORR endpoint

  • LEAP-008, evaluating pembro + lenvatinib vs. docetaxel in 2L+ (prior platinum-chemo and IO-experienced) NSCLC failed to meet its coprimary OS & PFS endpoints, as well as its secondary ORR endpoint

The failure of these studies removes this combination as a competitor in 1L NSCLC and in 2L+ NSCLC, also considering the recent failures of pembro + lenvatinib in other indications and the toxicity of this regimen.

Key Takeaways/Potential Implications

  • LEAP-008 was the final P3 study of the IO + TKI class of regimens, and follows previous failures from BMS/Mirati (nivolumab + sitravatinib) and Roche/Exelixis (atezolizumab + cabozantinib)
  • Datopotamab deruxtecan (dato-dxd; TROP2 ADC) in 2L+ NSCLC: the P3 TROPION-Lung01 study was previously announced as positive for PFS in July 2023, with a not-yet-significant trend in OS. Like 2L+ NSCLC, dato-dxd remains the largest competitive threat in 1L NSCLC

    • For domvanalimab, TIGIT regimens from Merck and Roche remain the largest threat, with PFS data from Merck’s P3 KEYVIBE-007 study of pembro/vibostolimab + chemo potentially expected in H1’24

Tags:
Grazie per il tuo feedback!