Janssen Submits a Marketing Authorisation Application to the EMA for Lazertinib Plus Rybrevant to Treat Lung Cancer
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- The submission was based on the P-III (MARIPOSA) clinical trial evaluating lazertinib + Rybrevant vs osimertinib & vs lazertinib alone as a 1L treatment of patients (n=1,074) with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations. The 1EP of the study includes PFS & the 2EPs include OS, ORR, DoR, PFS2 & intracranial PFS
- As per the results of the trial, the study depicted a statistically significant & clinically meaningful improvement in PFS for lazertinib + Rybrevant vs osimertinib (23.7 vs 16.6mos.). Janssen presented these results at ESMO 2023
- Lazertinib is an oral brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR
Ref: Janssen | Image: Janssen
Related News:- Janssen Reports P-III Study (MARIPOSA) Results of Rybrevant (amivantamab-vmjw) + Lazertinib for EGFR-Mutated Non-Small Cell Lung Cancer
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
