Phase 3 trial of Rybrevant plus chemotherapy in lung cancer meets primary endpoint: Janssen

“The results from the PAPILLON study support the efficacy of RYBREVANT plus chemotherapy in the treatment of patients with non-small cell lung cancer with exon 20 insertion mutations,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “RYBREVANT was the first therapy approved in the relapsed/refractory setting for patients with EGFR exon 20 insertion mutations, a population that continues to experience persistent unmet medical needs. This Phase 3 study is the first of several ongoing pivotal programs to read out evaluating RYBREVANT-based regimens in patients with EGFRmutated non-small cell lung cancer.”

PAPILLON (NCT04538664) is a randomized, open-label Phase 3 study evaluating the efficacy and safety of RYBREVANT in combination with chemotherapy, compared with chemotherapy alone, in newly diagnosed patients with advanced or metastatic NSCLC characterized by EGFR exon 20 insertion mutations. The primary endpoint of the study is PFS (using RECIST v1.1 guidelines*) as assessed by blinded independent central review (BICR). Secondary endpoints include overall response rate (ORR), PFS after first subsequent therapy, time to symptomatic progression and overall survival (OS). Patients who received chemotherapy alone were allowed to receive RYBREVANT monotherapy in the second-line setting after confirmation of disease progression.

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