Yuhan Corp, a South Korean pharmaceutical company, reported a significant increase in profits following FDA approval and subsequent U.S. sales of its lung cancer drug, Leclaza (lazertinib). The company's operational profit spiked by 690% in the third quarter, reaching US$40.3 million, attributed to the commercial success of Leclaza in the United States.
Leclaza's Clinical Impact
Leclaza, developed in partnership with Johnson & Johnson's Janssen Biotech, is administered orally in combination with J&J’s intravenous drug Rybrevant (amivantamab). Clinical trial data demonstrated that this combination therapy significantly improves outcomes for patients with non-small cell lung cancer (NSCLC). Specifically, the Leclaza and Rybrevant combination reduced disease progression and death by 30% more effectively than AstraZeneca's Tagrisso (osimertinib).
The FDA's approval of this combination provides a new first-line treatment option for patients with epidermal growth factor receptor (EGFR)-mutated NSCLC. This mutation is prevalent in a notable portion of NSCLC cases, particularly among non-smokers. The combination therapy targets this mutation to impede cancer development.
Financial Performance and Market Expectations
Yuhan Corp's overall financial performance also saw substantial gains, with net profit rising by 85.1% to US$17.1 million and sales increasing by 24.8% to approximately US$432 million. Johnson & Johnson will provide Yuhan with a US$60 million milestone payment related to Leclaza's commercialization.
Industry analysts predict that Leclaza will generate approximately US$738 million in annual revenue. This projection supports Yuhan's ambitious goal, set by CEO Cho Wook-je, to double yearly drug sales by 2026 and elevate the company into the world's top 50 pharmaceutical firms.
Clinical Trial Data
Data from a Phase III clinical trial (NCT04487080) revealed a median progression-free survival (PFS) of 23.7 months in the lazertinib with amivantamab arm compared to 16.6 months in the osimertinib arm, as highlighted in an FDA statement. This statistically significant improvement in PFS underscores the clinical benefit of the Leclaza and Rybrevant combination.
Implications for NSCLC Treatment
The approval of Leclaza in combination with Rybrevant marks a significant advancement in the treatment landscape for EGFR-mutated NSCLC. As Johnson & Johnson noted, this regimen is the first and only multitargeted, chemotherapy-free combination with demonstrated superiority versus Osimertinib approved for first-line treatment. This offers a valuable new option for patients, especially considering the prevalence of EGFR mutations in NSCLC, particularly among non-smokers.
