J&J’s Rybrevant, lazertinib combo tops Tagrisso in pivotal lung cancer study

2023-09-28

临床结果临床3期ASCO会议

Johnson & Johnson’s Janssen Pharmaceutical unit said Thursday that in the Phase III MARIPOSA study, the combination of Rybrevant (amivantamab-vmjw) and Leclaza (lazertinib) significantly improved progression-free survival (PFS) versus AstraZeneca’s Tagrisso (osimertinib) as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer (NSCLC).

Top-line results from a planned interim overall survival (OS) analysis of the trial also showed a trend favouring the Rybrevant and lazertinib combination compared to Tagrisso. Peter Lebowitz, global therapeutic area head for oncology at Janssen Research & Development, said the findings reinforce the regimen’s “potential…in front-line EGFR-mutated non-small-cell lung cancer as a future standard of care.”

MARIPOSA randomised 1074 patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or substitution mutations to receive first-line treatment with the bispecific antibody Rybrevant plus the third-generation EGFR-TKI Leclaza or Tagrisso alone. The study’s primary endpoint is PFS, while secondary goals include OS, objective response rate and duration of response.

Janssen Pharmaceutical said that the combination of Rybrevant and Leclaza demonstrated a statistically significant and clinically meaningful improvement in PFS versus Tagrisso. The company added that patients will be followed for subsequent OS analyses, while the dual regimen’s safety profile was consistent with previously reported data on the combination.

More to come.

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