▎WuXiEdited by Kant Content Team

Johnson & Johnson today announced the topline results of its Phase 3 MARIPOSA study. The analysis showed that, compared with the current standard of care, the combination of its bispecific antibody Rybrevant (amivantamab) and the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) oral medication Lazcluze (lazertinib), as a first-line treatment for patients withEGFRExon 19 deletion (ex19del) or exon 21 L858R substitution mutation in locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients can significantly improve overall survival (OS) both clinically and statistically.According to the press release, this is the first one inEGFRIn first-line treatment for mutant lung cancer, therapies showing survival benefits compared to current standard treatments.

MARIPOSA is a randomized Phase 3 study, recruiting a total of 1,074 patients. It evaluates the combination of Rybrevant and Lazcluze versus active control.Efficacy and Safety of Osimertinib Compared.The primary endpoint of the study was progression-free survival (PFS) assessed according to RECIST v1.1 criteria and evaluated by independent blinded central review (BICR). Secondary endpoints included OS, objective response rate (ORR), duration of response (DOR), second progression-free survival (PFS2), and intracranial PFS. Previous trial results showed,Compared with the active control drug, the combination therapy of Rybrevant and Lazcluze reduced the risk of disease progression or death by 30%.The U.S. FDA, based on the PFS results of the trial in August last year,ApprovalThis combination therapy is used to treat the corresponding patient population.

The safety profile of the combination therapy of Rybrevant and Lazcluze is generally consistent with the safety profile of monotherapy. In this combination therapy group, the incidence of adverse events is consistent with other Rybrevant treatment regimens, but venous thromboembolic events were observed.

RybrevantIt is a humanized EGFR/MET bispecific antibody.It has multiple mechanisms of anticancer action, not only blocking EGFR and MET-mediated signal transduction but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications.RybrevantObtained FDA approval in the United States in May 2021Accelerated Approval, used to treat conditions detected by FDA-approved testsEGFRAdult patients with locally advanced or metastatic NSCLC who have exon 20 insertion mutations and whose disease has progressed during or after platinum-based chemotherapy.Lazcluze is a highly selective, third-generation oral EGFR TKI capable of penetrating the blood-brain barrier.。

References:

[1] RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) show statistically significant and clinically meaningful improvement in overall survival versus osimertinib. Retrieved January 7, 2025 from https://www.prnewswire.com/news-releases/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-show-statistically-significant-and-clinically-meaningful-improvement-in-overall-survival-versus-osimertinib-302344323.html

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