Leclaza Combination Therapy Proves Effective for 'Brain Metastatic Lung Cancer'... Accelerating the Chase for No. 1 Lung Cancer Treatment

Tumor Reduction Observed in Half of Patients with Brain Metastases
Demonstrating Competitiveness in Brain Metastasis Following Survival Benefit

The primary battleground in the competition for lung cancer treatments is shifting toward "brain metastasis." This shift comes as new research has shown that a combination therapy of the locally developed blockbuster anti-cancer drug Leclaza (ingredient: lazertinib) and Janssen's Rybrevant (ingredient: amivantamab) is effective even in lung cancer patients whose cancer has spread to the brain. In the ongoing rivalry with AstraZeneca's Tagrisso (ingredient: osimertinib), which dominates the global EGFR lung cancer treatment market, the Leclaza and Rybrevant combination therapy is now seen as gaining new momentum.

According to a study published on March 10 in the international journal Journal of Thoracic Oncology, a team of US researchers administered a combination therapy of Yuhan Corporation's Leclaza and Janssen's Rybrevant to 41 patients with EGFR-mutant non-small cell lung cancer who had either brain metastases or leptomeningeal metastases.

As a result, among patients with brain metastases, approximately half (50%) experienced a reduction in tumor size. Notably, 33% of leptomeningeal metastasis patients—who are known to be particularly difficult to treat—also saw tumor shrinkage. EGFR-mutant lung cancer occurs when mutations arise in the EGFR gene, which is involved in cancer cell growth, and is a representative subtype of non-small cell lung cancer that is treatable with targeted therapies.

Brain metastasis is emerging as a critical factor in the treatment of lung cancer. Since the advent of targeted therapies, the survival period of patients with EGFR-mutant lung cancer has increased significantly, leading to a growing number of cases where the cancer spreads to the brain during disease progression. According to academic sources, brain metastases occur in about 30% to 50% of patients with EGFR-mutant lung cancer.

Leptomeningeal metastasis is regarded as the most challenging area in lung cancer treatment. This condition occurs when lung cancer cells spread to the membranes surrounding the brain and spinal cord, with a median survival of only about 3 to 6 months. Because tumor masses are not clearly defined, it is difficult to evaluate treatment effectiveness, and for this reason, most clinical trials for anti-cancer drugs have excluded these patients from their studies. The research team noted, "These results suggest that future clinical studies in lung cancer may include patients with leptomeningeal metastases."

Currently, Tagrisso by AstraZeneca is established as the standard treatment in the EGFR-mutant lung cancer market. Tagrisso records annual sales of over 7.2 billion dollars (approximately 11 trillion won), effectively dominating the EGFR lung cancer treatment market. In particular, it maintains its market position by highlighting its central nervous system efficacy in patients with brain metastases.

In this context, newer therapies have considered securing competitive data in brain metastasis patients, in addition to improving survival, as a core challenge. The combination therapy of Leclaza and Rybrevant has already demonstrated competitiveness in terms of survival benefits. In the global Phase 3 clinical trial "MARIPOSA" announced in 2023, the progression-free survival (PFS) for the Leclaza and Rybrevant combination therapy was 23.7 months, about 7 months longer than the 16.6 months observed in the osimertinib monotherapy group.

Experts predict that the competition between Tagrisso monotherapy and the Leclaza and Rybrevant combination therapy will intensify in the EGFR-mutant lung cancer treatment market going forward. It is now being analyzed that the key variable shaping the future market landscape will be which treatment strategy shows better results in various patient groups, including those with brain metastases. According to a 2024 report by global market research firm EvaluatePharma, the EGFR-mutant lung cancer treatment market is expected to grow to approximately 20 billion dollars (about 30 trillion won) by 2030.

This content was produced with the assistance of AI translation services.