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J&J touts a Mariposa survival benefit

Johnson & Johnson’s Rybrevant plus Lazcluze have already been approved in first-line EGFR-mutant NSCLC, based on progression-free survival data from the Mariposa trial – now the company has toplined a win from the same study on its overall survival secondary endpoint, versus AstraZeneca’s Tagrisso. J&J would only say that the median OS benefit is expected to exceed one year; full data will be needed to gauge the strength of the combo’s win, which the company deemed clinically meaningful as well as statistically significant. A benchmark comes from Astra’s Flaura study in a similar population, in which Tagrisso produced a median OS of 38.6 months; Mariposa's Tagrisso arm underperformed versus Flaura on PFS. However, Astra has already moved on to a Tagrisso-chemo combo, which gained US approval last year despite its Flaura2 trial not producing an OS benefit – yet. This has raised the question of what might be the relevant comparator for Rybrevant plus Lazcluze. On the plus side for J&J, toxicity with the Tagrisso-chemo combo could stop this regimen from becoming standard of care. However, J&J’s combo has its own issues, including severe rash and venous thromboembolic events. Full data from Mariposa are due at an unnamed upcoming medical meeting.

 

J&J’s Tagrisso target in first-line EGFRm NSCLC

TrialMariposaFlauraFlaura2
RegimenRybrevant + LazcluzeTagrissoTagrissoIressa/TarcevaTagrisso + chemoTagrisso
mPFS (months)23.716.618.910.225.516.7
StatsHR 0.70, p=0.0002HR 0.46, p<0.0001HR 0.62, p<0.0001
mOS (months)N/AN/A38.631.8N/AN/A
StatsN/AHR 0.80, p=0.0462HR 0.75 at 41% maturity

Source: OncologyPipeline & product labels.

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