On January 7, Johnson & Johnson stated that its recently approved Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) Positive Baseline Results for Overall Survival (OS), the Gold Standard Endpoint in Phase 3 Trial of Combination Therapy. As a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R substitution mutations. The chemotherapy-free combination regimen achieved the final pre-specified secondary endpoint of OS, demonstrating a clinically meaningful and statistically significant improvement in OS compared to the current standard of care, osimertinib. The improvement in median OS is expected to exceed one year.Patients in the trial had the two most common EGFR mutations, which are often associated with females and non-smokers. Unlike progression-free survival (PFS), which tracks the time treatment delays cancer progression, overall survival provides patients with an understanding of how the treatment extends life expectancy from the start of therapy. Prolonging life expectancy is the most meaningful indicator for evaluating treatment efficacy.
Mark Wildgust, Vice President of Global Oncology Medical Affairs at Johnson & Johnson, stated: "We are now seeing that Rybrevant and Lazcluze significantly improve survival rates and, in a way we've never seen before in these types of patients, increase their chances of survival."Rybrevant and Lazcluze were approved in August last year. Although osimertinib has firmly established itself as the standard therapy for the indication, analysts pointed out that overall survival rate is a potential differentiating factor. Tagrisso generated $5.8 billion in sales in 2023 and recently received a label expansion for a chemotherapy combination regimen in the same indication.Survival is the gold standard. In terms of the outcomes for these patients, Johnson & Johnson has truly changed the standard.The final overall survival analysis results are based on the previously reported interim analysis data and the positive outcomes of the progression-free survival analysis. MARIPOSA enrolled 1,074 patients in a randomized Phase 3 study evaluating RYBREVANT® in combination with LAZCLUZE™ versus osimertinib as a first-line treatment for patients with EGFR-mutated NSCLC. The primary endpoint of the study is progression-free survival assessed by blinded independent central review (BICR). Secondary endpoints include overall survival, objective response rate (ORR), duration of response (DOR), second progression-free survival (PFS2), and intracranial PFS.Johnson & Johnson has not yet released its full dataset but said the results will be presented at future medical conferences and shared with "global health authorities."Rybrevant is a bispecific antibody that has been approved for certain non-small cell lung cancer indications since 2021, while Lazcluze is a kinase inhibitor that has only recently been approved asRybrevantPart of the combination has been approved. This approval is based on Phase 3 data from the same study, which showed that the Rybrevant-Lazcluze combination reduced the risk of disease progression or death by 30% compared to Tagrisso.Johnson & Johnson declined to disclose the sales data of Rybrevant and Lazcluze, but Biljana Naumovic, President of Johnson & Johnson’s solid tumor division, stated that the therapy’s adoption in the U.S. "has exceeded our wildest expectations."Follow the official account below to see the world!
