Yuhan Lung Cancer Drug 'Reclaza' Expands Indication to First-Line Treatment

High Domestic Prevalence of EGFR-Mutated Non-Small Cell Lung Cancer
Following 2021 'Second-Line Treatment' Approval, Change Approval Granted

Ongoing Amivantamab Combination Trial with Janssen
Year-End Results Expected... Potential for Global First-Line Treatment Growth

On the 30th, the Ministry of Food and Drug Safety announced that it has approved the expansion of the indication for Yuhan Corporation's epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treatment, 'Reclaza Tablets (active ingredient: Lazertinib Mesylate Monohydrate),' to include 'first-line treatment of non-small cell lung cancer.'

Yuhan Corporation's non-small cell lung cancer treatment 'Reclaza'
[Photo by Yuhan Corporation]

Reclaza was previously approved in January 2021 as Korea's 31st new drug, a targeted anticancer agent for second-line treatment of locally advanced or metastatic non-small cell lung cancer with the EGFR T790M mutation. In 2020, lung cancer accounted for 11.7% of cancer diagnoses in Korea, the highest proportion among cancers, and non-small cell lung cancer made up 85% of lung cancer cases. Moreover, among NSCLC patients, the proportion of cases caused by EGFR mutations reaches 40% in Asians, making the development of Reclaza highly significant for domestic patients.

However, if anticancer treatments are only approved as second- or third-line therapies, patients may be cured or die during the initial first-line treatment phase, leaving no opportunity to use the drug. To provide more opportunities, Yuhan Corporation has continuously sought to enter the market as a first-line treatment.

Exterior view of Yuhan Corporation headquarters in Dongjak-gu, Seoul [Photo by Yuhan Corporation]

To this end, Yuhan Corporation conducted the 'LASER (LASER 301) 301' clinical trial. According to clinical results announced last year, the median progression-free survival (mPFS), a key endpoint, was 20.6 months, significantly improved compared to 9.7 months for gefitinib (control group), which has been used as a first-line treatment, confirming statistical significance. The median overall survival (mOS) has not yet been determined due to only 29% data maturity. Unlike PFS, which measures the time until patient death or cancer progression after treatment, OS measures only the time until patient death, so all participants must have died to fully assess the data. However, at 18 months post-enrollment, 80% of the treatment group and 72% of the control group were still alive.

Based on these clinical results, Yuhan Corporation applied for an indication expansion in March, and after review and evaluation, the Ministry of Food and Drug Safety approved expanding the patient population for Reclaza to include ‘first-line treatment of patients with EGFR mutation (exon 19 deletion or exon 21 (L858R) substitution)-positive locally advanced or metastatic non-small cell lung cancer.’

A Yuhan Corporation official stated, "We are preparing to apply for reimbursement coverage expansion for Reclaza as a first-line treatment," and added, "We are preparing a humanitarian program (EAP) to provide the drug free of charge to patients until the point when health insurance reimbursement becomes available." This program will run from the Institutional Review Board (IRB) approval date at each institution until the reimbursement coverage expansion for Reclaza.

Kim Yeolhong, Head of R&D at Yuhan Corporation, said, “Reclaza is an innovative new drug born from Yuhan Corporation’s scientific capabilities and relentless efforts, receiving high interest and positive medical evaluations from the development stage.” He continued, “We are very pleased to provide a new treatment option for patients with EGFR mutation-positive non-small cell lung cancer, which has a high prevalence in Korea,” and added, “Having confirmed excellent efficacy and safety, we expect to provide high-quality pharmaceutical treatment opportunities to more patients as a first-line therapy more quickly.”

Meanwhile, Yuhan Corporation licensed Reclaza from Oscotec in 2015 and subsequently sublicensed it to Janssen (a Johnson & Johnson subsidiary) in 2018. Janssen is developing combination therapy with the bispecific antibody 'Rybrevant (Amivantamab).' Recently, combination therapies that use drugs or treatments with synergistic effects rather than single agents have become the mainstream approach in cancer treatment. Accordingly, Joaquin Duato, CEO of Janssen, has identified the Reclaza-Rybrevant combination therapy as one of the key pipelines expected to generate annual sales exceeding $5 billion (approximately 6.6 trillion KRW), reflecting high expectations from both companies.

The first-line combination clinical trial 'MARIPOSA' of Reclaza and Rybrevant is currently underway, with AstraZeneca’s competing drug 'Tagrisso (active ingredient Osimertinib)' monotherapy set as the control group, engaging in fierce competition. Final results are expected within this year. Given that the LASER 301 trial of Reclaza monotherapy showed an mPFS of 20.6 months, the goal is reportedly to surpass this mPFS value.

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