Amivantamab Added to Chemotherapy Improves PFS Among Patients With Non-Small Cell Lung Cancer With EGFR Mutation
Results From the Phase 3 PAPILLON Trial
Results From the Phase 3 PAPILLON Trial
In a press release, Janssen Pharmaceutical Companies of Johnson & Johnson announced the PAPILLON trial evaluating amivantamab among patients with non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) exon 20 insertion mutation met its primary end point of improved progression-free survival (PFS). This confirmatory study is the first randomized study of patients with NSCLC with EGFR exon 20 insertion mutations in the first-line setting to exhibit clinically meaningful results.
This open-label phase 3 study enrolled patients with newly diagnosed advanced or metastatic non-small cell lung cancer with a primary EGFR exon 20 insertion mutation. Patients were randomized to receive pemetrexed plus carboplatin chemotherapy either alone or in combination with amivantamab. The primary end point was PFS as assessed by a blinded independent central review, with secondary end points including overall response rate, PFS following the first subsequent therapy, time to symptomatic progression, and overall survival.
As reported by Janssen Pharmaceutical Companies of Johnson & Johnson, results from this study demonstrated a statistically significant and clinically meaningful improvement of PFS among patients in the combination arm, compared to the chemotherapy alone arm. The safety profile demonstrated with the combination therapy was consistent with the profiles of the individual regimens.
The full results are expected to be presented at an upcoming scientific congress.
Source:
Treatment with RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer. News release. The Janssen Pharmaceutical Companies of Johnson & Johnson; July 17, 2023. https://www.jnj.com/rybrevanttm-amivantamab-vmjw-receives-fda-approval-as-the-first-targeted-treatment-for-patients-with-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations