Leclaza-Rybrevant combo rises as first-line treatment option

Janssen launches patient program in mid-March for Rybrevant...Expectations riseon the Rybrevant-Leclaza combo based on OS data

Will focus on supporting initial drug costs for Rybrevant... will refund the cost based on the Risk-Sharing agreement procedure

The Leclaza-Rybrevant combination therapy, which has emerged as a standard treatment for lung cancer, is expected to be used in earnest in the domestic clinical market.

 

This is because the larger hospitals have launched patient programs for the combination, based on results showing that the combination thearpy’s progression-free survival (PFS) period exceeds that that of Tagrisso (osimertinib, AstraZeneca) with longer overall survival (OS).

 

# According to the medical community on the 24th, Janssen has launched a Patient Assistance Program (PAP) for the Leclaza (lasertinib, Yuhan Cor) and Rybrevant (amivantamab) combination therapy, which was approved by MFDS for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation.

 

To improve patient access to this newly approved thearpy, the pharmaceutical company will provide partial support for drug costs with the approval of the Korea Blood Disease and Cancer Foundation.

 

The Leclaza-Rybrevant combination therapy is attracting more attention because of the preannouncement of the Phase III MARIPOSA study, in which the combination therapy extended OS by more than a year compared to the existing standard treatment, Tagrisso monotherapy.

 

According to the Phase III MARIPOSA trial abstract released by the European Lung Cancer Society prior to its annual congress (ELCC 2025) scheduled to be held from the 26th, the Leclaza-Rybrevant combination therapy was found to be superior to Tagrisso monotherapy in terms of OS by more than 12 months.

 

Since Tagrisso recorded an OS of 38.6 months in the FLAURA study, which because the basis of its approval, this can be interpreted as that the OS of Leclaza + Rybrevant combo exceeds 50 months.

 

The OS of the Leclaza + Rybrevant group had not reached the median value at 37.8 months of follow-up, but the OS of the Tagrisso monotherapy arm was 36.7 months, showing that the risk of death in the Leclaza + Rybrevant combination group was 25% lower.

 

(HR=0.75, 95% CI 0.61-0.92, P<0.005) This is a statistically significant difference, with the overall survival rate at 36 months being 60% for the Leclaza + Rybrevant group and 51% for the Tagrisso monotherapy group.

 

Based on this, the researchers expected that Leclaza + Rybrevant would extend OS by at least 12 months.

 

In other words, the OS extension results and the news of its domestic approval has raised interest in clinical sites and patients.

 

In fact, Professor Sun-min Lim (Oncology) of Yonsei Cancer Center said, “Although we can legally use it because it is currently approved in Korea, the amount of money required is so high that people can't afford it.

 

Based on the clinical results, it is not just a one-year treatment.

 

It must be administered for up to 50 months or more, which would be a huge financial burden for the patient.” To address this, Janssen has launched a patient program since the 14th, focusing on large hospitals that can use the Leclaza-Rybrevant combination therapy.

 

Specifically, it has been confirmed that Janssen will support 72% of the drug price for the first 12 vials of the Leclaza-Rybrevant combination therapy, and 20% of the drug price from the 13th vial and thereafter.

 

In the case of Leclaza, the drug’s cost is refunded to the patient in accordance with the risk-sharing agreement that Yuhan Corporation has signed with the health authorities in the reimbursement process.

 

As a result, only part of Rybrevant’s drug cost will be supported to patients through the patient program.

 

There are opinions that although the introduction of the patient program is welcome at the clinical site, but regrettable in terms of scale.

 

An oncology professor at a tertiary hospital who requested anonymity said, “As OS data from the Leclaza-Rybrevant combination therapy has recently attracted attention, patients receiving actual treatment are also showing great interest.

 

The patient program has been in full swing since mid-March, as previously announced by Janssen.

 

However, looking at the form of support, the scale of support after the initial support leaves something room for desire.”