Combination extends PFS in lung cancer subset
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The addition of amivantamab-vmjw to chemotherapy extended PFS among a subset of patients with non-small cell lung cancer, according to the agent’s manufacturer.
Amivantamab-vmjw (Rybrevant, Janssen) is an EGFR and mesenchymal epithelial transition (MET) factor bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.
In 2021, the FDA granted accelerated approval to the agent for treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.
The randomized phase 3 PAPILLON trial served as a confirmatory study to support the accelerated approval.
Researchers compared the efficacy and safety of amivantamab-vmjw plus chemotherapy vs. chemotherapy alone for patients newly diagnosed with advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
Patients assigned chemotherapy alone could receive amivantamab-vmjw monotherapy in the second-line setting after confirmed disease progression.
PFS by blinded independent central review served as the primary endpoint. Secondary endpoints included overall response rate, PFS after first subsequent therapy, time to symptomatic progression and OS.
The study met its primary endpoint, demonstrating improved PFS among patients assigned the combination, according to a Janssen-issued press release.
The combination exhibited a safety profile consistent with the known profiles of the individual therapies, according to the release.
Complete results from PAPILLON will be submitted for presentation at a scientific congress.
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