A novel lung cancer therapy developed by South Korea’s Yuhan Corp. is on track to become a global blockbuster drug, with annual sales projected to exceed 1 trillion won ($722 million) by 2027, just three years after its debut in the US market.
According to sources in the pharmaceutical industry on Monday, the first-line treatment that combines Johnson & Johnson’s Rybrevant (amivantamab) and Yuhan’s Lazcluze (lazertinib) has quickly gained traction, as it has been prescribed to one out of four adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) in the US this year.
“About 25% of patients with EGFR-mutated NSCLC are treated with the Rybrevant plus Lazcluze combination in the US,” said Cho Byoung-chul, a professor of the Lung Cancer Center at Yonsei Cancer Center. “It has emerged as one of the most widely prescribed treatments among US doctors.”
Rybrevant by Janssen Biotech Inc. of J&J is a bispecific antibody that targets EGFR and MET with immune cell-directing activity, whereas Lazcluze, which is sold by Yuhan under the brand name Leclaza in Korea, is a kinase inhibitor.
Yuhan R&D center (Courtesy of Yuhan) Clinical trials show that the combination extends the median survival of lung cancer patients by over one year compared to the current standard of care, Tagrisso, or osimertinib, marketed by AstraZeneca.
The AstraZeneca drug, known to extend the median survival to three years, dominates the EGFR-mutated NSCLC drug market.
NSCLC makes up 80 to 85% of lung cancers, according to the American Cancer Society.
Yuhan, which licensed lazertinib to J&J’s Janssen unit in 2018 in a deal worth up to $950 million, collects royalties of more than 10% of sales.
(Graphics by Dongbeom Yun) The Korean company has so far earned 5.4 billion won in royalties and is expected to receive as much as 20 billion won in annual royalty income this year as global sales of lazertinib are forecast to reach up to $200 million this year.
At the current pace, Yuhan’s royalty revenue could climb sharply as global lazertinib sales are poised to cross the 1 trillion won mark by 2027.
The combination has also won approval in Europe, Japan and China, and is awaiting regulatory clearance in Australia and Brazil.
As the Rybrevant subcutaneous (SC) formulation is expected to get a nod from the FDA later this year, demand for Yuhan’s lung cancer treatment is expected to increase further.
In Japan, the combination treatment is forecast to capture more than 40% of the lung cancer treatment market this year.
J&J has already paid Yuhan 310 billion won in milestone fees, and the Korean company is expected to collect the remaining 1 trillion won without any issue.
Yuhan has used most of the milestone payments in research and development of new drugs.
It purchased the lazertinib substance license from Genosco, a Boston-based R&D arm of Oscotec Inc., in the substance development phase in 2015.
