Yuhan’s new drug Leclaza on track to become global blockbuster

Leclaza [Courtesy of Yuhan]

South Korea is about to witness the birth of its first global blockbuster treatment with annual sales of more than 1 trillion won ($743.49 million) as Yuhan Corp.’s new drug for non-small cell lung cancer (NSCLC), Leclaza, is well on track to advance further in both the domestic and global markets.

In Korea, the treatment has passed the initial gateway to enter the market for health insurance-covered prescription drugs, raising the possibility of insurance registration early next year. It is expected to catch up with its rival, AstraZeneca PLC’s Tagrisso, which began its attempt to acquire prescription coverage several years ago.

Expectations are also high that Leclaza will make headway into the global market with the success of its clinical trials of its combination therapy with partner company Johnson & Johnson (J&J)’s cancer drug.

According to the Health Insurance Review and Assessment Service (HIRA) on Thursday, the drug benefit assessment committee approved the proposal to expand Leclaza’s primary treatment coverage. Following the approval, Leclaza will be able to compete with Tagrisso for reimbursement on the same starting line. In late June, Leclaza was approved as a first-line treatment and gained approval from the major cancer disease deliberation committee in just over two months. Tagrisso, on the other hand, had been trying to register itself for insurance coverage since 2019, but was only approved by the cancer deliberation committee in March 2023 and then by the drug benefit assessment committee last month. Currently, two steps remain for both Leclaza and Tagrisso to be covered by health insurance-negotiating drug prices with the National Health Insurance Service and the review by the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee.

Originally a second-line treatment for epidermal growth factor receptor (EGFR)-mutated NSCLC, Leclaza has been growing its presence in the market since its approval as a first-line treatment. Yuhan has adopted an expanded access program (EAP) to provide the drug free of charge until it becomes available for prescription coverage since July, with the number of patients participating in the EAP also topping 400 and continuing to grow after large hospitals such as Samsung Medical Center, Severance Hospital, and Seoul Asan Medical Center also joined the program last month. The industry expects the growing number of EAP beneficiaries to help Leclaza take its place in the first-line treatment market and expand prescriptions.

Leclaza’s sales are expected to accelerate even further once the drug becomes eligible for prescription coverage as a first-line treatment. According to pharmaceutical market research firm IQVIA Inc., sales of Leclaza in the first half of this year jumped 49.5 percent from a year earlier to 10.3 billion won, and industry insiders estimate that sales of Leclaza as a first-line treatment could reach 100 billion won.

Clinical trial results for its combination therapy, a key requirement for the drug to become a global blockbuster, are also imminent. As J&J’s pharma subsidiary Janssen Inc. has already announced successful results from the Mariposa trial, which studies the combination of Rybrevant and Leclaza in the first-line treatment of patients with EGFR mutations, the company is now awaiting the specific data to be released.

The top-line results from Mariposa, released on September 28, showed that the combination of Rybrevant and Leclaza provided a clinically and statistically significant improvement in progression-free survival (PFS) compared to the exclusive use of existing drug Tagrisso. The study also confirmed the potential to extend overall survival (OS), the length of time a patient survives from treatment to death. Detailed data from the Mariposa trial will be presented at the European Society for Medical Oncology (ESMO) Congress in Spain on October 23.

With the results in hand, Yuhan can expect revenue from Leclaza’s combination therapy starting in 2025. Analysts note that Janssen and Leclaza, although a latecomer, may have a chance as Tagrisso, the leading global lung cancer treatment, has shown somewhat disappointing clinical results for its combination therapy as it had greater side effects than when the drug was used alone.

Yuhan is also considering the possibility of expanding Leclaza’s monotherapy’s market share overseas, and particularly in underdeveloped countries. After the announcement of Mariposa clinical results, the company, in consultation with its global partner Janssen, plans to target major countries with its combination therapy and less developed countries with its monotherapy.