‘Leclaza combo will become the sole standard of care’

Leclaza combination therapy shows superior efficacy

Professor Byoung-chul Cho holds a MARIPOSA trial briefing session to explain the efficacy of Leclaza in combination with other drugs

”OS improved by more than 12 months compared to Tagrisso... Combination therapy will become mainstream”

Professor Byoung-chul Cho of the Department of Oncology at Yonsei Cancer Center

 “The Leclaza + Rybrevant combination therapy has shown a clear improvement in survival compared to Tagrisso monotherapy in the MARIPOSA trial.

 

I am confident that this combination therapy will become the sole standard treatment for EGFR-positive non-small cell lung cancer in the future.” On the 31st, Professor Byoung-chul Cho of the Department of Oncology at Yonsei Cancer Center (Director of the Lung Cancer Center) held a briefing session on the MARIPOSA trial at Kiwoom Securities in Yeouido to evaluate the clinical trial results.

 

The MARIPOSA trial compares the efficacy and safety of the combination of Leclaza and Rybrevant with the single-agent treatment using Targrisso, which is currently used as the first-line treatment for EGFR-positive non-small cell lung cancer.

 

The final overall survival (OS) results of this study were unveiled at the European Lung Cancer Conference (ELCC 2025), which was held in Paris, France for 4 days starting on the 26th of this month.

 

Leclaza is a new EGFR-positive non-small cell lung cancer drug developed by Yuhan Corp and is a third-generation tyrosine kinase inhibitor (TKI) that targets exon 19 and exon 21 (L858R).

 

Janssen's parent company Johnson & Johnson has secured global rights to Leclaza and has been conducting a clinical trial of a combination therapy using Rybrevant, a targeted treatment option targeting the exon 20 and MET mutations.

 

The results presented at this year's ELCC 2025 are the final OS analysis.

 

OS is one of the important indicators for determining the clinical value of anticancer drugs.

 

OS refers to the overall survival period from the start of treatment to the time of death.

 

OS includes not only the side effects and complications of the treatment but also patients who died from causes other than cancer.

 

Phase III MARIPOSA Study Design

The clinical trial was conducted to compare the efficacy and safety of the Leclaza+Rybrevant combination with Tagrisso monotherapy in 1,074 patients with non-small cell lung cancer with the Exon19 and L858R mutations who had no previous treatment experience.

 

Leclaza monotherapy was included to evaluate the contribution component of Rybrevant.

 

Patients were randomly assigned to the Leclaza + Rybrevant group (429 patients), the Tagrisso group (429 patients), and the Leclaza group (216 patients) in a 2:2:1 ratio.

 

After tracking patients for a median of 37.8 months, the Leclaza+Rybrevant group showed a statistically significant improvement in survival compared to the Tagrisso group (p-value