Yuhan Corporation’s 3rd generation EGFR TKI, ‘Lazertinib’, has taken another step towards its global blockbuster aspirations.
This achievement comes as a result of successful outcomes in the clinical trial named ‘MARIPOSA,’ in which Janssen evaluated the anti-cancer drug ‘Amivantamab’ in combination with ‘Lazertinib’ compared to AstraZeneca’s ‘Osimertinib’.
According to industry reports on October 2nd, Janssen, a subsidiary of Johnson & Johnson’s pharmaceutical division, recently announced that they have achieved their primary endpoints in the MARIPOSA phase 3 trial.
The trial enrolled 1,074 patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer (NSCLC)in a first-line setting.
Janssen has demonstrated that when ‘Amivantamab’ and ‘Lazertinib’ are administered together, it slows down the progression of cancer, as evidenced by an extended progression-free survival (PFS) compared to the administration of ‘Osimertinib’ alone.
A planned interim overall survival (OS) analysis showed a trend favoring the combination of ‘Amivantamab’ and ‘Lazertinib’ compared to ‘Osimertinib’.
Patients in the study will be followed for subsequent OS analyses, which will determine the statistical and clinical significance of OS.
The detailed results are expected to be announced on October 23rd at the European Society for Medical Oncology (ESMO) conference in Spain.
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.
Landmark Phase 3 MARIPOSA Study Meets Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT® (amivantamab-vmjw) plus Lazertinib Versus Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer | Johnson & Johnson