EGFR mutation lung cancer first-line treatment of new options! Pfizer Vizimpro EU approved in i.e., therapeutic suspension of AstraZeneta:

Pfizer, the US pharmaceutical giant, has announced that the European Medicines Agency's (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued an active review recommending approval of the second generation of EGFR targeted drug Vizimpro inib, dactinib, 45 mg), as a single-drug therapy, first-line therapy present in adult patients with partial late stage or metastasis non-small cell lung cancer (NSCLC) with a mutated skin growth factor (EGFR) activation mutation.
, CHMP's advice will now go to the European Commission, which usually takes CHMP's advice when making final review decisions. This also means that Vizimpro is likely to be approved within the next 2-3 months for the benefit of NSCLC patients in Europe.
Vizimpro is an oral, daily, irreversible, pan-human skin growth factor subject (pan-EGFR) tyrosine kinase inhibitor (TKI). In the United States, Vizimpro was approved by the FDA at the end of September 2018 for the first-line treatment of patients with a metastasis NSCLC with a FDA-approved test kit that confirmed the presence of exosome 19 or exon L858R displacement mutations in the skin growth factor (EGFR). Recently, Vizimpro was also approved by Japanese regulators for use in patients with EGFR mutation-positive, non-excisive or relapsed NSCLC.
positive opinion of CHMP is based on data from Phase III clinical study ARCHER 1050. The study, a randomized, open-label, head-to-head Phase III study conducted in patients with local late stage or metastasis NSCLC who carried EGFR activation mutations, assessed the efficacy and safety of Vizimpro over AstraZenecon's first-generation EGFR-targeted drug Iressa (Irressa, generic name: gefitinib, gyfytinib) for first-line therapy. The primary endpoint is progress-free lifetime (PFS), and the secondary endpoint is OS.
study data show that vizimpro treatment group PFS achieved statistically significant and clinically significant extensions (medium PFS: 14.7 months vs 9.2 months), risk of death or disease progression compared to the Iressa treatment group A significant decrease of 41% (HR-0.59 (95% CI-0.47-0.74) and p<0.0001) reached the main end of the study. OS data released at the Annual Meeting of the American Society of Clinical Oncology (ASCO2018) in June showed that the mid-OS in the Vizimpro treatment group was 34.1 months (95% CI:29.5-37.7), seven months longer than the Iressa treatment group (middle OS: 26.8 months (95%CI:23.7-32.1). At the 30th month of treatment, the survival rate in the Vizimpro treatment group was 56.2% and in the Iressa treatment group it was 46.3%. Subgroup analysis across most baseline characteristics is consistent with major OS analysis results, including patients with common exon sub-mutations nos. 19 and 20.
safety, the most common adverse reactions in the Vizimpro treatment group (≥20%)include: diarrhea (87%), rash (69%), meth (64%), stomatitis (45%), loss of appetite (31%), dry skin (30%), weight loss (26%), hair loss (23%), cough (21%), itching (21%). In the Vizimpro treatment group, 27 per cent of patients had severe adverse reactions, with the most common (≥1 per cent) severe adverse reactions being diarrhoea (2.2 per cent) and interstitiotic lung disease (1.3 per cent).
Chris Boshoff, Pfizer's chief development officer for global product development oncology, said, "Patients with EGFR mutation NSCLC urgently need more treatment options, and the disease is associated with low survival rates. CHMP's active review is an important step forward in providing a new first-line treatment for NSCLC patients in Europe. Vizimpro was developed as a direct result of Pfizer's focus on precision medicine, creating tailor-made solutions that improve patient prognostics. Although
significant progress has been made in clinical treatment of NSCLC patients with EGFR activation mutations in recent years, the disease remains a challenging disease and there is an urgent need for new treatment options. OS data from the Critical Head-to-Head III study were very encouraging, with the mid-OS in patients treated with Vizimpro's EGFR-activated mutant NSCLC approaching 3 years, a significant improvement over the current clinical first-line treatment, Iressa.
Vizimpro also marks the latest achievement in Pfizer's efforts to advance precision medicine and improve the prognostics of mutation-driven lung cancer patients. Currently, Pfizer has developed two targeted drugs for the treatment of three different types of mutation-driven lung cancer: Xalkori (crizotinib, kertinib) for the treatment of ALK-positive or ROS1-positive NSCLC, and Vizimpro for the treatment of EGFR mutant NSCLC. (Bio Valley)