Yuhan's 'Reclaza', Will It Become the First Domestic Blockbuster Riding on Big Pharma J&J's Wings?

Clinical Data of 'Mariposa' Unveiled at ESMO on 23rd
Combination Therapy of Reklaza and 'Livrivant'
"PFS Improved Compared to Tagrisso Monotherapy"
Blockbuster Expected if Results Surpass Tagrisso

Yuhan Corporation's 'Reclaza' (active ingredient: Lazertinib) is raising expectations as the first blockbuster drug in South Korea. Since its technology transfer to global big pharma Johnson & Johnson (J&J) Innovative Medicine (formerly Janssen) in 2018, the successful results anticipated from the combination clinical trial 'MARIPOSA' with the targeted antibody drug LibriVant (Amivantamab) are challenging AstraZeneca (AZ)'s 'Tagrisso' (Osimertinib), which has dominated the epidermal growth factor receptor (EGFR) mutation non-small cell lung cancer treatment market.

Recently, J&J announced that in the ongoing MARIPOSA trial, the progression-free survival (PFS) of the Reclaza-LibriVant experimental group showed "statistically significant and clinically meaningful improvement" compared to the control group receiving Tagrisso monotherapy, thereby "meeting the primary endpoint." They also added that the overall survival (OS), still under analysis, showed a "favorable trend" for the experimental group compared to the control group. PFS refers to the period during which the cancer does not progress after treatment, and OS is the duration from the start of treatment to the patient's death, both being key indicators for evaluating anticancer drug efficacy.

Detailed related data will be disclosed at the 2023 European Society for Medical Oncology (ESMO 2023), held from the 20th to 24th (local time) in Madrid, Spain. On the 23rd, Jo Byung-chul, director of the Lung Cancer Center at Yonsei Cancer Hospital, who has led clinical trials related to Reclaza, will personally present the related results during the 'Presidential' session, a key presentation within the conference.

Currently, the EGFR mutation treatment market has been led by Tagrisso, with the U.S. National Comprehensive Cancer Network (NCCN) recommending it as the preferred first-line therapy. However, with the emergence of Reclaza challenging the status quo, it is rapidly catching up both domestically and internationally. In South Korea, the two drugs are competing for first-line treatment reimbursement priority, while globally, they are engaged in a battle for dominance in first-line combination therapies.

AZ's trump card to outpace Reclaza globally is the combination of Tagrisso with chemotherapy. At the 2023 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) held last month, the 'FLAURA2' trial results showed that the median PFS (mPFS) was extended by about 9 months compared to the control group (Tagrisso monotherapy), reducing the risk of cancer progression and death by 38%. However, market evaluation remains somewhat ambiguous. This regimen is more likely to be used for a subset of patients rather than as a standard therapy for all EGFR mutation patients, and due to the high side effects of chemotherapy, patient preference is low. Researcher Heo Hye-min from Kiwoom Securities commented, "Due to high side effects, OS may not be prolonged," and "Tagrisso chemotherapy combination therapy may be limited to patients with high tumor burden."

Yuhan Corporation's non-small cell lung cancer treatment 'Leclaza (Lazertinib)'
[Photo by Yuhan Corporation]

Earlier, at the American Society of Clinical Oncology (ASCO) in June, although a small-scale trial, results from the 'CHRYSALIS' trial combining Reclaza and LibriVant showed that more than half of the patients continued treatment even after three years. If such results are replicated in the large-scale MARIPOSA trial, there is hope that Reclaza could rapidly catch up with Tagrisso's market share. Reclaza also demonstrated a median PFS of 20.6 months, surpassing Tagrisso's mPFS, in the 'LASER 301' monotherapy first-line trial announced last December.

If these hopes materialize, Reclaza is expected to become the first blockbuster new drug in South Korea, generating annual sales exceeding $1 billion (approximately 1.361 trillion KRW). In fact, J&J CEO Joaquin Duato has identified the Reclaza-LibriVant combination therapy as one of the key pipelines expected to generate annual sales exceeding $5 billion (approximately 6.8 trillion KRW), lending strong support to these projections.

This content was produced with the assistance of AI translation services.