Approvals

This month, Janssen-Cilag International, part of Johnson & Johnson (J&J) has announced that the European Comission (EC) has approved a combined treatment of rybrevant (amivantamab) and chemotherapy (carboplatin and pemerexed) for the treatment of non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR).

John Reed, MD PhD, executive vice president, Innovative Medicine, R&D, Johnson & Johnson commented “Today’s FDA approval of chemotherapy-free rybrevant plus lazcluze in the first line is an incredible step towards our goal of altering the trajectory of lung cancer and reducing the impact of the world’s leading cause of cancer mortality.”

The decision comes after the results of the phase 3 MARIPOSA study were announced. The study evaluated the safety profile and to the efficacy of amivantamab and chemotherapy in patients with locally-advanced or metastatic EGFR ex19del or L858R substitution NSCLC who had disease progression on or after treatment with osimertinib.

Antonio Passaro, MD PhD, medical oncologist, Division of Thoracic Oncology at the European Institute of Oncology in Milan, Italy stated: “The addition of the bispecific antibody amivantamab to chemotherapy offers an important new treatment option for patients with EGFR ex19del or L858R mutations, progressing on or after osimertinib. In this setting, this combination set the new landmark for overall response rate and reduced the risk of disease progression or death by more than half compared to standard chemotherapy alone. It also demonstrated significant improvements in intracranial progression-free survival.”

The trial met its primary endpoint, reducing the risk of disease progression or death by a significant 52% in comparison to chemotherapy alone. Additionally, amivantamab plus chemotherapy showed an objective response rate (ORR) of 64%, compared to 36 % with chemotherapy alone.