Johnson & Johnson on Expansion Course: EU Agency Recommends New Combination Therapy Against Lung Cancer

Johnson & Johnson has made a significant advancement in the field of oncology: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of the combination of the intravenous EGFR/MET inhibitor Rybrevant and the oral EGFR-TKI inhibitor Lazcluze for certain patients with non-small cell lung cancer (NSCLC). This therapy is intended to be used as a first-line treatment for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitutions. The CHMP's recommendation is based on the results of the Phase III MARIPOSA study, which compared Johnson & Johnson's combination therapy with AstraZeneca's most successful cancer drug, Tagrisso. The study found that the combination of Rybrevant and Lazcluze reduced the risk of disease progression or death by 30% compared to Tagrisso. Additionally, patients on the Johnson & Johnson therapy achieved a median response duration that was nine months longer. These positive developments are set to challenge AstraZeneca's Tagrisso, which currently is the standard treatment for EGFR-mutated NSCLC. The combination therapy already received approval in August from the European Commission, in combination with standard chemotherapy for patients with advanced NSCLC who have not responded to prior therapies. Furthermore, Johnson & Johnson is also seeking approval for a subcutaneous formulation of Rybrevant from the FDA, with this application receiving priority review in August. In addition to NSCLC, the company is investigating Rybrevant for other cancer indications. Recent data from the OrigAMI-1 study for metastatic colorectal cancer show impressive response rates, highlighting the drug's potential.