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Product Highlight - VIZIMPRO

01 Dec 2020

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.



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Most Read Articles
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Pearl Toh, 26 Nov 2020
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
3 days ago
Among patients with moderate-to-severe psoriasis, the use of biologics appears to lower the risk of being hospitalized for the novel coronavirus disease (COVID-19), a new study has found.