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.
Dr. Byun-Chul Cho at Severance hospital, who is leading the LASER301 phase 3 clinical study, said “We 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.” 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.
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’s EGFRxMET bispecific monoclonal antibody ‘Amivantamab’ for NSCLC as 1st and 2nd line treatments.
Link to original article (Korean): http://m.biospectator.com/view/news_view.php?varAtcId=17422