Phase 3 trial of Rybrevant plus chemotherapy in lung cancer meets primary endpoint: Janssen
New Jersey: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced positive topline results from the Phase 3 PAPILLON study evaluating RYBREVANT (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) in patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The Phase 3 PAPILLON study, the first late-stage clinical program for RYBREVANT, is a confirmatory study supporting the approved use for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, and is the first randomized study evaluating patients with newly diagnosed NSCLC with EGFR exon 20 insertion mutations to demonstrate clinically meaningful results. Results showed the PAPILLON Phase 3 study met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients receiving RYBREVANT plus chemotherapy versus chemotherapy alone. The combination of RYBREVANT and chemotherapy demonstrated a safety profile consistent with the safety profiles of the individual regimens. Janssen plans to submit these results for presentation at an upcoming scientific congress.
“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.
