Leclaza’s cumulative sales reach KRW 30 bil in 2 yrs

Korean new anticancer drugs show rapid growth

Leclaza’s 1H sales KRW 10.3 billion... 50% rise YoY

Cumulative sales have reached KRW 30.2 billion since its release in 2021...sales are expected to continue to increase if the drug’s reimbursement is extended to the first-line

Yuhan Corp’s new anticancer drug, ‘Leclaza’ is gradually expanding its influence in the domestic market.

 

The drug exceeded KRW 30 billion in cumulative sales in only 2 years since its domestic release.

 

Prescriptions are also expected to increase further if the company receives reimbursement for its newly added indication as a first-line treatment.

 

According to the market research institution IQVIA on the 25th, Leclaza posted sales of KRW 10.3 billion in 1H, up 49.5% YoY.

 

In Q1, sales increased by 57.4% YoY to KRW 5.1 billion and then increased by 42.5% YoY to reach KRW 5.2 billion in Q2.

 

Leclaza is a non-small cell lung cancer treatment that was approved as Korea’s 31st homegrown novel drug in January 2021.

 

Leclaza entered Korea’s prescription market in earnest with its reimbursement listing in July 2021.

 

In Q3 and Q4 2021, it recorded sales of KRW 1.5 billion and KRW 2.5 billion, respectively.

 

Last year, the drug had raised KRW 16.1 billion, exceeding the annual sales of KRW 10 billion mark in its second year of release.

 

Since its release, cumulative sales have been estimated to be around KRW 30.2 billion.

 

The drug exceeded KRW 30 billion in cumulative sales within 2 years of its release in Korea.

 

Quarterly Leclaza sales (Unit: KRW 100 million, Data: IQVIA)

Leclaza is considered to have made a smooth start in the market.

 

Anticancer drugs that are usually used in large medical institutions, can only be prescribed after the drug passes each institution’s drug committee, therefore, it takes a considerable amount of time before sales are generated after the initial stage of release.

 

With the added pressure of having to directly compete with outstanding new drug products from multinational pharmaceutical companies, it is not easy for new anticancer drugs developed in Korea to achieve commercial results.

 

Leclaza passed the drug committee of major large medical institutions in Korea and is accelerating its market penetration efforts.

 

The drug is expected to expand further into the market if it receives reimbursement approval as a first-line treatment.

 

It was first approved as a second-line treatment for patients with locally advanced or metastatic NSCLC who developed resistance to a specific gene (T790M) after being treated with 1st generation or 2nd generation EGFR-TKIs.

 

Also, the drug was recently approved as a first-line treatment.

 

The Ministry of Food and Drug Safety approved the change in permission to expand the indication of Leclaza to ‘first-line treatment of non-small cell lung cancer.’ The first-line approval comes 2 years and 5 months after its initial approval in Korea.

 

Leclaza showed statistically significant improvement in progression-free survival (PFS) over existing treatments in a global Phase III trial (LASER 301) that was conducted on 393 locally advanced or metastatic NSCLC patients with EGFR mutations.

 

The trial results were presented at the European Society for Medical Oncology Asia Congress that was held last year in Singapore.

 

The drug has also confirmed its efficacy and effect in the real world.

 

Real-world data (RWD) from a retrospective study that was published on Lung Cancer analyzed the efficacy and safety of Leclaza on 103 patients who received Leclaza at Yonsei Cancer Center and the National Cancer Center from January 2021 to August 2021.

 

Subject patients were EGFR T790M mutation-positive NSCLC patients who developed resistance after being previously treated with EGFR-TKI that received Leclaza.

 

90 of the 103 patients received Leclaza as a second or third-line treatment.

 

The patients’ primary efficacy endpoint in the study, median progression-free survival (mPFS), was 13.9 months.

 

This was consistent with the mPFS of 11.1 months confirmed in LASER201, the study that became the basis of Leclaza’s approval.

 

The objective response rate (ORR) was 62.1%, slightly higher than the 55.3% observed in the LASER201 study.

 

In terms of safety, the drug was also well-tolerated, similar to previous studies.

 

The company had recently applied for the reimbursement of Leclaza as a first-line treatment to the health authorities in Korea.

 

Also, the company plans to provide Leclaza free of charge until the drug is granted reimbursement through an Expanded Access Program (EAP).

 

The drug costs KRW 6 million per month.