Product Highlight - VIZIMPRO

In the Phase III ARCHER 1050 study of patients with newly diagnosed advanced NSCLC with EGFR mutations (exon 19 deletion or exon 21 L858R substitution mutations):

• Vizimpro significantly improved median PFS vs gefitinib in the ITT population (per [IRC] review) of 14.7 months vs 9.2 months; HR: 0.59 (95% CI: 0.47-0.74); two-sided P<0.0001.¹
• Vizimpro demonstrated improvement in median OS vs gefitinib in the ITT population of 34.1 months vs 27 months; HR: 0.75 (95% CI: 0.59-0.95); two-sided P=0.0155.²
•  Vizimpro demonstrated clinically meaningful improvement in OS in key subgroups, including Asian and patients with the difficult-to-treat EGFR exon 21 L858R substitution mutations.²
  - Vizimpro showed improvement in median PFS vs gefitinib of 16.5 months vs 9.3 months (HR: 0.509 [95% CI: 0.391-0.662];
  two-sided P<0.0001) as well as in median OS vs gefitinib of 37.7 months vs 29.1 months (HR: 0.759 [95% CI: 0.578-0.996];
  P=0.0457) in Asian population.²
  - Vizimpro also demonstrated improvement in median OS vs gefitinib in patients with exon 21 L858R substitution of 32.5 months vs 23.2 months (HR: 0.665 [95% CI: 0.470-0.941]; P=0.0203).²
• Vizimpro has a manageable safety profile where AEs can be addressed via dose reduction, dose interruption and/or concomitant therapy. Dose reduction does not compromise its efficacy in ITT and Asian populations.^2,3,4,5

NSCLC: Non-small cell lung cancer; EGFR: epidermal growth factor receptor; PFS: progression free survival; OS: overall survival; ITT: intent-to-treat; IRC: independent radiological central; AE: adverse event

References:
1. Wu YL, Cheng Y, Zhou X, et al. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(11):1454-66.
2. Mok TS, Cheng Y, Zhou X, et al. Updated overall survival (OS) from extended follow up in ARCHER 1050: A randomized phase III study comparing dacomitinib with gefitinib as first line therapy for patients (pts) with EGFR mutations. Orally presented at ESMO Asia 2019, Singapore, 22-24 November 2019.
3. Vizimpro Approved Malaysia Prescribing Information CLD dated 7 February 2020.
4. Zhou Q, Wu YL, Corral J, et al. Management of common adverse events related to first-line dacomitinib use in EGFR mutation positive non-small-cell lung cancer: a pooled safety analysis. Future Oncol 2019;15(13):1481-91. 5. Corral J, et al. Effects of dose modifications on the safety and efficacy of dacomitinib for EGFR mutation-positive non-small-cell lung cancer. Future Oncol 2019;15:2795-805.