Yuhan Corp. said Thursday that Leclaza (lazertinib mesylate monohydrate), a treatment for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), will receive insurance benefits for the first-line treatment starting Jan. 1, 2024.
The coverage expansion will allow for the first-line treatment of patients with locally advanced or metastatic NSCLC positive for the T790M mutation whose disease progression was previously confirmed after receiving an EGFR-TKI, as well as for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations.
The LASER301 phase 3 trial, which was the basis for this decision, demonstrated the clinical efficacy of Leclaza in first-line treatment.
The trial compared the efficacy and safety of gefitinib and Leclaza in 393 patients (258 Asians and 135 non-Asians) with previously untreated active EGFR mutation-positive locally advanced or metastatic NSCLC.
Results showed a statistically significant improvement in a median progression-free survival (PFS) of 20.6 months in the Leclaza arm compared to 9.7 months in the gefitinib arm. These improvements were consistent in the Asian and Korean subgroups, and patients with Ex19del and L858R mutations also showed significant PFS improvements.
Subgroup analyses also showed that in patients with central nervous system (CNS) metastases, a group with a poor prognosis, Leclaza (mPFS of 16.4 months) demonstrated superior antitumor activity compared to gefitinib (mPFS of 9.5 months).
“As a new treatment option for EGFR-mutated NSCLC, which is common in Korea and is the number one cancer killer, Yuhan is very pleased that the first-line reimbursement expansion will improve access to treatment for patients,” Yuhan Corp. CEO Cho Wook-je said.
Cho also expressed gratitude for all parties involved in Leclaza’s promotion.
"I would like to express my sincere gratitude to all the stakeholders who helped us bring this exciting news to patients, caregivers, and the public in the New Year,” he said. “I would also like to express my respect to the healthcare providers who worked hard to run the Early Access Program (EAP) for Leclaza before the coverage expansion. We will continue to strive to develop innovative new medicines and improve access to care for patients and the public for a healthy life."