Yuhan Corporation announced that it will receive a milestone payment of $15 million (approximately 20.7 billion KRW) from Janssen Biotech, a subsidiary of the multinational pharmaceutical company Johnson & Johnson. The milestone amount is expected to be received within 60 days.
This milestone was triggered by the commercialization of Yuhan’s “Lazertinib” (brand name Leclaza in Korea, Ruziluclast in the U.S.) in combination with Janssen Biotech’s “Amivantamab” (brand name Rybrevant) in Japan. The combination therapy of “Lazertinib + Amivantamab” was approved in March by the Japanese Ministry of Health, Labour and Welfare as a first-line treatment for EGFR-mutated non-small cell lung cancer (NSCLC).
The approval in Japan was based on the results of a Phase 3 clinical trial (MARIPOSA) conducted by Janssen Biotech, which involved 1,074 patients. This trial compared the efficacy and safety of the combination therapy “Lazertinib + Amivantamab” with the current first-line treatment “Osimertinib” (brand name Tagrisso) and Lazertinib monotherapy.
According to the study results, the combination therapy “Lazertinib + Amivantamab” reduced the risk of disease progression or death by 30% compared to Osimertinib monotherapy. The median progression-free survival (PFS) for the combination therapy group was 23.7 months, which was significantly longer than the 16.6 months observed in the Osimertinib monotherapy group.
The duration of response (DoR) for the combination therapy was 25.8 months, which was 9 months longer than the 16.7 months in the Osimertinib monotherapy group. The median overall survival (mOS) of the “Lazertinib + Amivantamab” combination is expected to be extended by more than one year compared to Osimertinib monotherapy.
Previously, in November 2018, Yuhan Corporation signed a license-out agreement with Janssen Biotech for Lazertinib worth a total of $1.255 billion. Since then, the combination therapy “Lazertinib + Amivantamab” has received approvals from the U.S. FDA in August last year and the European Commission (EC) in January this year. As a result, Yuhan Corporation has already received milestone payments of $60 million and $30 million from Janssen Biotech for U.S. and EU approvals, respectively.
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