Study results to be presented at the WCLC in August will influence the direction of Yuhan Corp's Leclaza (Ingredient: lazertinib), the nation's 31st novel drug for NSCLC, and the corporate's value, a local analyst said.
"Yuhan will present three abstracts concerning its non-small cell lung cancer (NSCLC) treatment at this year's World Conference of Lung Cancer in Vienna from Aug. 6-9 through poster sessions and oral presentation," NH Securities analyst Park Byung-gook said.
According to Park, the three abstracts comprise two cases of first-line treatment for NSCLC – a phase 1 clinical trial using a combination therapy of Leclaza and Amivantamab and one phase 1 and 2 clinical trials using Leclaza as a monotherapy -- and one phase 1 and 2 clinical trial using a triple combination regiment -- Amivantamab, Leclaza, and platinum-based chemotherapy – for Tagrisso resistant patients.
Park noted that his brokerage released a report immediately after the American Society of Clinical Oncology (ASCO 2022), emphasizing the importance of primary treatment data for Leclaza in the year's second half.
"As the combination data of AstraZeneca's Tagrisso (ingredient: osimertinib) and platinum-based chemotherapy patients at ASCO showed a rather disappointing response rate, the data presented at this WCLCL has become more important," he said. "For patients who have experienced only Tagrisso, a triple combination regiment -- Amivantamab, Leclaza, and platinum-based chemotherapy – is important. In addition, the company plans to hold an oral presentation at WCLC 2022 to demonstrate Leclaza's competitiveness against Tagrisso resistant patients."
The data will have a significant impact on the company's goal to win a breakthrough therapy designation from the U.S. Food and Drug Administration (FDA), Park added.
Regarding the other two clinical trials for using Leclaza as a first-line treatment, Park said that while he will have to see full poster data, the data revealed so far has shown Leclaza's high efficacy as a first-line treatment.
He stressed that the data would help predict future data of the global phase 3 clinical trial of MARIPOSA-2, which started in November last year.
The analyst concluded that his brokerage maintained its "buy" opinion for Boryung's shares at a target price of 80,000 won ($61).
Yuhan had exported the world rights of Lazertinib to Janssen, except for Korea. Janssen is conducting various clinical trials, including combination therapy with the company's dual antibody amivantamab
The treatment received approval as a second-line treatment for NSCLC in Korea in January last year and health insurance benefits from July of the same year.