Astra knocks another hole in J&J's Mariposa plan

Johnson & Johnson investors face a nervous wait for results of the Mariposa study, and today they have something else to worry about. Astrazeneca’s Flaura2 trial has been toplined positive, suggesting – depending on the extent of the hit, of course – that even a convincing win in Mariposa might not count for much. That scenario already looked uncertain since Mariposa passed an interim analysis without being halted for efficacy, suggesting that any benefit might be smaller than hoped for. Flaura2 and Mariposa comprise front-line lung cancer patients with a specific EGFR mutation, a space effectively owned by Astra’s Tagrisso. In Mariposa J&J wants to beat Tagrisso with its Rybrevant plus lazertinib combo, but Flaura2 puts a fly in the ointment: the Astra trial adds chemo on top of Tagrisso and, since this has now been said to be statistically and clinically significant for PFS, Mariposa’s Tagrisso monotherapy comparator might not stay relevant for long. Much will depend on the size of the PFS benefit, which will no doubt prompt cross-trial comparisons to tease out any effect seen in Mariposa, and nothing is yet known about overall survival. Things will become clearer by the end of 2023.

Astra vs J&J in 1st-line NSCLC
Trial Flaura2 Mariposa
Company Astrazeneca Johnson & Johnson
Design Tagrisso + chemo combo, vs Tagrisso Lazertinib +/- Rybrevant, vs Tagrisso
EGFR status Exon 19del or exon 21 L858R Exon 19del or exon 21 L858R
Tumour stages allowed  Locally advanced stage IIIB or IIIC, or metastatic stage IVA or IVB  Locally advanced stage III or metastatic stage IV
Primary endpoint PFS (OS secondary) PFS (OS secondary)
Asset status Toplined statistically significant & clinically meaningful for PFS Passed H1 2023 interim analysis without being halted for efficacy; continues to final readout at the end of 2023

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