Johnson & Johnson Announces Positive Topline Overall Survival Results from Asian Cohort of Phase III MARIPOSA Study for Amivantamab Plus Lazertinib in EGFR-Mutated NSCLC

Source: Global Times

On September 11, Johnson & Johnson announced the topline positive results of overall survival (OS) in the Asian subgroup of the Phase III MARIPOSA study. The study aims to evaluate the efficacy and safety of amivantamab in combination with lazertinib as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R substitution mutations. In this subgroup, the EGFR mutation rate is more common than in other regions. This chemotherapy-free combination regimen achieved the pre-specified final secondary endpoint of OS, demonstrating a statistically significant and clinically meaningful improvement compared to osimertinib monotherapy. The median OS in this subgroup is projected to exceed four years, extending beyond 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 still unable to receive second-line therapy, making the choice of first-line treatment crucial. The five-year survival rate for diagnosed patients is less than 20%.

The incidence of EGFR-mutated non-small cell lung cancer is higher in the Asia-Pacific region than in other regions. Due to the rapid progression of the disease and challenges within healthcare systems, many patients may not have access to second-line treatment options. This makes the efficacy outcomes of first-line treatment particularly crucial, as it determines the long-term progression of the disease. Results from the Asian subgroup of the MARIPOSA study indicate that the combination of Amivantamab and Lazertinib significantly extends survival for 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 indicate that the median overall survival of patients is expected to exceed four years."