On 14 October, Yuhan announced top-line Phase 3 study data of Lazertinib as 1st line treatment that has significantly improved progression-free survival (PFS) as the primary endpoint. LASER301, comparing Lazertinib for the primary treatment of EGFR mutated non-small cell lung cancer (NSCLC) with the standard therapeutic agent gefitinib (Brand: Iressa), shows the risk of stage progression or death is reduced by 55%, which confirms statistically significantly improved the efficacy (HR: 0.45, 95% CI 0.34-0.58, p<0.001). PFS is a key evaluation indicator to confirm efficacy of anti-cancer drugs, which refers to the period where the disease does not progress or lead to death.<\/p>\n\n\n\n
Dr. Byun-Chul Cho at Severance hospital, who is leading the LASER301 phase 3 clinical study, said \u201cWe are very excited about the multi-national, 13 countries including South Korea, phase 3 clinical trial results that show great potential of Lazertinib as a new primary therapeutic option for patients with EGFR mutant-positive NSCLC worldwide.\u201d The detailed clinical trial results will be release at a professional conference in December. With the encouraging results, Yuhan will apply for a permit change to expand domestic (South Korea) indications in the first quarter of next year.<\/p>\n\n\n\n
Yuhan signed a technology export and co-development agreement for Lazertinib with Janssen Pharmaceuticals in November 2018. Clinical development is actively underway in combination with Janssen\u2019s EGFRxMET bispecific monoclonal antibody \u2018Amivantamab\u2019 for NSCLC as 1st<\/sup> and 2nd<\/sup> line treatments.<\/p>\n\n\n\n