Thursday marked a significant advancement for Johnson & Johnson (NYSE:) as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of RYBREVANT® (amivantamab) in combination with chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations. This recommendation is a critical step towards addressing the urgent need for innovative treatments for this type of lung cancer, which carries a notably poor prognosis and low five-year overall survival rates.
The recommendation is based on results from the PAPILLON study, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with amivantamab in combination with chemotherapy versus chemotherapy alone. The study, which enrolled 308 patients, met its primary endpoint, with interim overall survival (OS) analysis showing a favorable trend for the combination treatment. The safety profile of the combination was consistent with those of the individual agents, with low rates of treatment-related discontinuations.
According to trial investigator Professor Nicolas Girard, the study results represent an important advancement in the treatment landscape for EGFR exon 20 insertion NSCLC, showing not only improved PFS but also enhancements in functional status and a reduction in lung cancer-related symptoms. This underscores the potential of amivantamab plus chemotherapy to redefine standards of care and offer hope for improved quality of life and treatment outcomes.
The CHMP’s positive opinion underscores the culmination of extensive research and development efforts by Johnson & Johnson to pioneer novel approaches targeting key pathways implicated in lung cancer progression. Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumours, at Johnson & Johnson Research & Development, LLC, emphasized the company’s commitment to redefining treatment paradigms and improving survival rates and overall patient outcomes.
Amivantamab, a fully-human EGFR-MET bispecific antibody, targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications. It received conditional marketing authorization from the European Commission in December 2021 for treating adult patients with advanced NSCLC with EGFR exon 20 insertion mutations after failure of platinum-based therapy. Pending EC approval based on the PAPILLON study, this conditional marketing authorization will be converted into a standard marketing authorization.
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