Median overall survival in Asia cohort is projected to exceed four years, demonstrating a durable benefit and surpassing osimertinib monotherapy by more than one year

First and only chemotherapy-free combination in the first line setting to show survival improvement of this magnitude in a population with the highest-prevalence of EGFR-mutated lung cancer

Johnson & Johnson announced positive topline results for overall survival (OS) from the Asia cohort of the Phase 3 MARIPOSA study, evaluating amivantamab plus lazertinib as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations. In this cohort, where EGFR mutations are more common than in other regions, the chemotherapy-free combination met the final pre-specified secondary endpoint of OS and showed a clinically meaningful and statistically significant survival benefit over osimertinib monotherapy. Median OS improvement is projected to exceed four years, surpassing osimertinib monotherapy by more than one year.

Asia has the largest population of patients with EGFR-mutated NSCLC worldwide, with an estimated prevalence of 30 to 40 percent compared to 10 to 15 percent in Europe and the United States.¹ Despite treatment advances, approximately 30 percent of patients do not reach second-line therapy, making the choice of first treatment critical.² Fewer than 20 percent of patients are alive five years after diagnosis.³

 “EGFR-mutated NSCLC is more common in Asia Pacific than in other regions, which makes outcomes from the first treatment especially important,” said Byoung Chul Cho, M.D., Ph.D., Professor of Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine.* “Because of rapid disease progression and health system challenges, many patients will not have the chance to receive a second-line therapy. Therefore, the first treatment determines how the disease progresses over time. The MARIPOSA Asia cohort results show that survival can be significantly extended with amivantamab plus lazertinib in patients of Asian descent, helping them live longer.”

“For patients and families, every additional year means more time together and the chance to reach milestones that once felt out of reach,” said Kazuo Hasegawa, Founder of Lung Cancer Patients Network ONE STEP.** “The MARIPOSA Asia cohort results matter because they show that extending survival is possible in a disease where progress has often been measured in months.”

“Overall survival is the most meaningful measure of progress, and the MARIPOSA Asia cohort results reinforce the role of therapeutic innovations like amivantamab plus lazertinib in the first-line setting,” said Anthony Elgamal, Vice President of Oncology, Johnson & Johnson Innovative Medicine Asia Pacific. “With its triple mode of action targeting EGFR and MET while also activating immune cells, amivantamab plus lazertinib addresses resistance that often limits tyrosine kinase inhibitor based therapy and delivers durable survival. These findings, with a median overall survival projected beyond four years, mark an important milestone for patients across Asia.”

MARIPOSA, which enrolled 1,074 patients, is a randomized, Phase 3 study evaluating amivantamab in combination with lazertinib versus osimertinib as a first-line treatment of patients with EGFR-mutated NSCLC. The primary endpoint was progression-free survival (PFS) (using RECIST v1.1 guidelines^§) as assessed by blinded independent central review (BICR). Secondary endpoints included OS, objective response rate (ORR), duration of response (DOR), second progression-free survival (PFS2) and intracranial PFS.⁴

The safety profile of amivantamab plus lazertinib was consistent with the primary analysis and no new safety signals emerged with longer-term follow-up. Phase 2 amivantamab studies suggest that using prophylactic measures can help lower the risk of adverse events such as skin reactions, infusion-related reactions and venous thromboembolic events.^5,6,7

Overall survival results from the Asia cohort will be presented at an upcoming congress. The combination of amivantamab and lazertinib is approved in the United States, Europe and the Asia-Pacific region in the Japan, China, Australia, Korea and Taiwan markets for first-line treatment for patients with EGFR-mutated NSCLC based on the global MARIPOSA Phase 3 study.