Johnson & Johnson Announces Positive Overall Survival Results from Phase 3 MARIPOSA Study in Asian Patients with EGFR-Mutated NSCLC

(Source: Shanghai Observation News)

Johnson & Johnson today announced the topline positive results of overall survival (OS) in the Asian subgroup of the Phase III MARIPOSA study.

This study aims to evaluate the efficacy and safety of amivantamab plus lazertinib as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. In this subgroup, the EGFR mutation rate is more common than in other regions. This chemotherapy-free combination regimen met the pre-specified final secondary endpoint of OS and demonstrated statistically significant and clinically meaningful improvements compared to osimertinib monotherapy. The median OS in this subgroup is projected to exceed four years, extending survival by more than one year compared to osimertinib monotherapy.

Asia is the region with the highest number of EGFR-mutated NSCLC patients globally, with an estimated prevalence of 30% to 40%, compared to 10% to 15% in Europe and the United States. Despite advancements in treatment, approximately 30% of patients are unable to receive second-line therapy, making the choice of first-line treatment critical. The five-year survival rate for diagnosed patients is less than 20%.

The results of the Asian subgroup in the MARIPOSA study indicate that Amivantamab combined with Lazertinib significantly extends the survival of Asian patients, helping them live longer.

Anthony Elgamal, Vice President of Johnson & Johnson Asia-Pacific and Head of Oncology, stated: "Overall survival is the most meaningful measure of treatment progress. The results of the Asian subgroup in the MARIPOSA study further confirm the significant value of innovative therapies such as Amivantamab combined with Lazertinib in first-line treatment. The MARIPOSA study demonstrated that this innovative therapy can improve the disease progression of EGFR-mutated advanced non-small cell lung cancer and effectively reduce the complexity and heterogeneity of acquired resistance mechanisms. The results of this Phase III study also showed that the median overall survival of patients is expected to exceed four years."

The MARIPOSA study enrolled 1,074 patients in a Phase III randomized controlled trial designed to evaluate the efficacy of amivantamab in combination with lazertinib compared to osimertinib as a first-line treatment for patients with EGFR-mutated non-small cell lung cancer.

The safety profile of Amivantamab combined with Lenvatinib is consistent with the primary analysis results, and no new safety signals were identified during long-term follow-up. Phase II studies of Amivantamab indicate that the use of preventive measures can help reduce the risk of adverse events such as skin reactions, infusion-related reactions, and venous thromboembolic events.

Overall survival results for the Asian subgroup will be presented at an upcoming scientific meeting. Based on data from the global Phase III MARIPOSA trial, amivantamab in combination with lazertinib has been approved in the United States, Europe, and across the Asia-Pacific region in Japan, China, Australia, South Korea, and Taiwan, China, for the first-line treatment of patients with EGFR-mutated non-small cell lung cancer.

Original Title: "New Breakthrough in Lung Cancer Treatment Expected! Johnson & Johnson Discloses Latest Research Data on This Innovative Therapy"

Column Editor: Rong Bing

Source: Author: Tang Weijie, Wen Hui Bao