Efficacy of Amivantamab and Lazertinib Combination Therapy Demonstrated in EGFR-Mutant Lung Cancer

Professor Byungchul Cho Achieves Milestone with Three Publications in NEJM
First in Korea's Oncology Field

A combination therapy used as a first-line treatment for EGFR (Epidermal Growth Factor Receptor) mutation-positive lung cancer has been shown in a Phase 3 trial to improve overall survival compared to existing targeted therapies.

The research team led by Professor Byungchul Cho at the Lung Cancer Center of Yonsei Cancer Hospital announced on September 16 that, in a multinational, randomized Phase 3 study involving patients with untreated EGFR-mutant lung cancer, the combination of amivantamab and lazertinib reduced the risk of death by 25% compared to the current standard therapy, osimertinib.

Professor Byungchul Cho, Lung Cancer Center, Yonsei Cancer Hospital. Yonsei Medical Center

The results of this study were published in the international journal "The New England Journal of Medicine." In the field of oncology, this marks the first time in Korea that Professor Byungchul Cho has published three papers in NEJM. It is also the first time that clinical results for a domestically developed anticancer drug have been published twice in NEJM.

EGFR-mutant lung cancer accounts for 25-40% of all lung cancers and is the most common type worldwide, with approximately 450,000 new cases annually. Until now, osimertinib, used as a first-line treatment, has shown a response rate of 80% and a progression-free survival of 16 to 18 months. However, most patients eventually develop resistance.

Having confirmed the efficacy of the combination therapy in previous Phase 1 and 2 trials, Professor Byungchul Cho proceeded with this multinational, randomized Phase 3 trial. Amivantamab, used in the combination, is a drug for advanced EGFR-mutant lung cancer, while lazertinib is approved for lung cancer with mutations in exon 20 of the EGFR gene. The combination therapy, which Professor Cho previously demonstrated to increase progression-free survival compared to osimertinib, received FDA approval in the United States in August last year.

The three-year survival rate for 429 patients treated with the combination therapy was 60%, an improvement of 9% compared to the osimertinib group. During the 37.8-month observation period, the median overall survival for the amivantamab and lazertinib combination group exceeded the observation period, whereas the median overall survival for the osimertinib group was 36.7 months.

The combination therapy also showed excellent efficacy in patients with brain metastases. The main side effects of the combination therapy were mild and manageable, such as skin rash and inflammation around the nails.

Professor Byungchul Cho stated, "By demonstrating an improvement in overall survival following last year's results on progression-free survival, we have confirmed the clear therapeutic benefit of the amivantamab and lazertinib combination for patients with advanced EGFR-mutant non-small cell lung cancer. This NEJM publication suggests that a first-line chemotherapy-free treatment strategy using next-generation targeted therapies, surpassing traditional chemotherapy, could become the new standard of care."