analyzed that Janssen’s marketing strategy would be important, stating that “Rexraza” (ingredient: Lazertinib) performed well on 5. We are maintaining our purchase valuation and target price of W80,000.
Yuhan announced global Phase 3 monotherapy (LASER301) results of lazertinib, a treatment for EGFR-targeted non-small cell lung cancer, at the European Society of Oncology Asian Conference (ESMO Asia). Overall survival data for LASER301 were not disclosed, but the primary endpoint, progression-free survival (PFS), was 20.6 months in the lazertinib group. It was higher than that of the control group, the “gefitinib” group, at 9.7 months. PFS in patients with brain metastases was 16.4 months with lazertinib and 9.5 months in the control group.
Researcher Park Byung-guk said, “These data make us eagerly await the results of MARIPOSA, a combined clinical study of lazertinib and amivantamab for primary treatment and global release monotherapy.” request approval”.
Data is a good situation, and Janssen’s marketing strategy, which takes into account the market situation in addition to data, is important now. Janssen has international rights to Lazertinib outside of Korea. It is explained that the global release via LASER301 will also be decided by Janssen.
Researcher Park said, “Considering the market situation, such as Tagrisso’s phase 3 trial and chemotherapy (FLAURA2) and drug pricing strategy, it will be very important to launch in developed and non-developed countries.”
It is believed that Janssen’s strategy in developed countries will focus on combination therapy.
is leading FLAURA2, which compares ‘Tagrisso’ in combination with chemotherapy and Tagrisso alone for primary treatment purposes. The results will be published in the first half of next year.
In undeveloped markets, the marketability of lazertinib as monotherapy was expected to be broad. Tagrisso achieved sales of US$600 million in emerging countries (emerging countries) and other countries in the third quarter of this year. This is 44% of total sales. Researcher Park said, “The aim of LASER301 is also to release it as a first-line monotherapy in undeveloped countries such as Asia with a more favorable drug price compared to Tagrisso.
He said the variable for the release of Lazertinib monotherapy in undeveloped countries would be the reference price system (IRP). IRP is a system for negotiating drug prices by referencing drug prices in other countries. It is explained that most of the blockbuster new drugs are approved by the US, so the IRP also affects that. The monthly price of Tagrisso’s drug in Australia and China is half and one-sixth of the United States, respectively.
Researcher Park said, “It would be possible for Janssen to first apply for approval in the United States for monotherapy to launch in undeveloped countries.
Reporter Kim Ye-na [email protected]