"Leclaza combo improves survival than Tagrisso monotherapy"

ELCC 2025 abstracts made available…the final OS data on the Leclaza plus Rybrevant combination therapy to be presented

Patients treated with Tagrisso had an OS of 36.7 months…Leclaza combination therapy is expected to improve the survival rate by over 1 year

It has been reported that the Leclaza plus Rybrevant combination therapy demonstrated improved overall survival (OS), in addition to progression-free survival (PFS), than Tagrisso.

 

According to industry sources on March 20, the European Society for Medical Oncology made abstracts available for the 'European Lung Cancer Congress 2025(ELCC 2025),' which is scheduled to be held in Paris, France, for four days from March 26.

 

One of the most anticipated study results at the ELCC 2025 is the Phase 3 'MARIPOSA' trial, evaluating the efficacy of Leclaza plus Rybrevant combination therapy.

 

Leclaza, developed by Yuhan, is a new drug for EGFR-positive non-small cell lung cancer (NSCLC).

 

It is a third-generation tyrosine kinase inhibitor (TKI) targeting exon 19 and exon 21 (L858R).

 

Johnson & Jonhson acquired global sales rights of Leclaza and is conducting the MARIPOSA clinical trial, evaluating the efficacy of the drug in combination with Rybrevant, targted treatment option for mutations in exon 20 and MET.

 

Previously, Leclaza plus Rybrevant combination therapy demonstrated efficacy regarding the primary endpoint of PFS.

 

However, only a favorable trend of the combination therapy was shown in terms of the secondary endpoint of OS.

 

The final OS data of Leclaza plus Rybrevant combination therapy were presented at this conference.

 

PFS indicates how long a new treatment can delay the cancer progression, while OS shows data on how long it can extend overall survival.

 

Yuhan

The clinical trial compared the efficacy and safety of Leclaza plus Rybrevant combination therapy to Tagrisso monotherapy in 1074 patients with NSCLC harboring exon 19 and L858R mutations who do not have prior treatment experience.

 

Leclaza monotherapy was included to evaluate the contribution component.

 

Patients were randomly assigned at a 2:2:1 ratio to Leclaza plus Rybrevant combination therapy group (429 individuals), Tagrisso group (429 individuals), and Leclaza group (216 individuals).

 

During the median value of 37.9 months, Leclaza plus Rybrevant combination therapy group had a statistically significant improvement in survival rate compared to Tagrisso group.

 

In detail, the median OS of Leclaza plus Rybrevant combination therapy group could not be estimated (42.9-NE), whereas Tagrisso group had an OS of 36.7 months.

 

Considering the survival rate index distribution of the two groups, Leclaza plus Rybrevant combination therapy group is expected to extend an OS over at least 12 months.

 

Furthermore, at 36 months follow-up, Leclaza plus Rybrevant combination therapy group had a 60% survival rate, whereas Tagrisso group had a 51%.

 

"The Leclaza plus Rybrevant combination therapy is the first therapy in patients with progressive NSCLC harboring EGFR mutation that significantly lowered the death risk compared to Tagrisso.

 

The latest clinical trial showed the potential of the drug as the new standard therapy.

 

The study results indicate that the combination therapy can improve survival rate by at least 12 months compared to Tagrisso," the research team remarked.

 

The study results of the MARIPOSA clinical trial will be orally presented by Professor James Chih-Hsin Yang, Department of Oncology at the National Taiwan University, on March 26.