“AstraZeneca today announced that the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).
“Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: ‘The strong results from the FLAURA trial are very exciting news for patients with EGFR mutation-positive non-small cell lung cancer, providing physicians with a potential new first-line treatment option to improve outcomes in this disease. We will now initiate discussions with global health authorities on the data and regulatory submissions.’ ”
“Adjuvant therapy with gefitinib (Iressa), an epidermal growth factor receptor (EGFR)-targeted agent, was more successful at preventing recurrence than standard-of-care chemotherapy, in a phase III study of patients with EGFR-positive non–small cell lung cancer (NSCLC). Gefitinib extended recurrence-free survival by about 10 months in patients with stage II–IIIA NSCLC. These findings were presented at the 2017 ASCO Annual Meeting.”
“AstraZeneca has presented new data showing that Tagrisso also extends progression-free survival for non-small cell lung cancer (NSCLC) patients who have central nervous system (CNS) metastases.
“According to findings from the AURA3 trial, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC given the drug lived without disease worsening or death for 11.7 months compared to 5.6 months for those receiving chemotherapy.”
“The targeted therapy gefitinib appears more effective in preventing recurrence after lung cancer surgery than the standard of care, chemotherapy. In a phase III clinical trial, patients with epidermal growth factor receptor (EGFR)-positive, stage II-IIIA non-small cell lung cancer (NSCLC) who received gefitinib went about 10 months longer without recurrence than patients who received chemotherapy. The study will be presented at the upcoming 2017 ASCO Annual Meeting in Chicago.
” ‘Adjuvant gefitinib may ultimately be considered as an important option for stage II-IIIA lung cancer patients with an active EGFR mutation, and we may consider routine EGFR testing in this earlier stage of lung cancer,’ said lead study author Yi-Long Wu, MD, a director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. ‘We intend to follow these patients until we can fully measure overall survival as opposed to disease-free survival, which just measures disease recurrence.’ ”
“Osimertinib improves cancer-related symptoms in patients with advanced lung cancer, according to an analysis of patient-reported outcomes from the AURA3 phase III clinical trial presented at the European Lung Cancer Conference (ELCC).
” ‘With my past experience conducting clinical trials, I often see new treatments that might be more effective, but are also usually more toxic,’ said lead author Dr Chee Lee, Medical Oncologist, St George Hospital Cancer Care Centre, New South Wales, Australia. ‘Osimertinib not only increases progression-free survival but it is well-tolerated, which makes a big difference for our patients.’ ”
“The China Food and Drug Administration (CFDA) has approved osimertinib for the treatment of patients with locally-advanced or metastatic EGFR T790M-positive non–small cell lung cancer (NSCLC) with progression following treatment with an EGFR tyrosine kinase inhibitor (TKI).
“Osimertinib was approved under the CFDA’s accelerated Priority Review Pathway. To receive the treatment, patients must have their EGFR T790M mutation status confirmed through a validated test.”
“About 10 percent of lung cancers in the United States and as many as 40 percent in Asia are driven by mutations in the EGFR gene. EGFR targeted treatment advances over the previous decade now result in multiple options for controlling the disease in the body, but due to the reduced ability of many of these drugs to penetrate into the brain, treating of disease in the brain remains challenging. When brain metastases are seen at diagnosis before a patient has tried EGFR-targeted drugs, it has been an open question whether doctors should try drugs alone just in case they work in the brain or move directly to whole-brain radiotherapy or stereotactic radiosurgery (a tightly focused form of radiation) first, followed by targeted medicines. A study published in the Journal of Clinical Oncology looks back at 351 patients with EGFR mutant lung cancer and brain metastases treated at six institutions to offer compelling preliminary evidence as to the best sequence of these techniques: Radiation followed by targeted medicines resulted in the longest overall survival.”
“Genprex, Inc. today announced positive interim data from an ongoing Phase II clinical trial (NCT01455389) evaluating its investigational immunogene therapy candidate Oncoprex™ in combination with the tyrosine kinase inhibitor (TKI) erlotinib (Tarceva®) for the treatment of late stage non-small cell lung cancer (NSCLC) patients.”
“Treatment with icotinib more than doubled intracranial progression-free survival (iPFS) compared with whole brain irradiation (WBI) combined with standard chemotherapy, according to phase III trial results presented at the 17th World Lung Cancer Conference, the Annual Meeting of the International Association for the Study of Lung Cancer (IASLC), in Vienna.
“Icotinib significantly improved median iPFS, the trial’s primary endpoint, to 10.0 months compared with 4.8 months in patients treated with WBI and chemotherapy, HR = 0.56; 95% CI, 0.36-0.90 (P = .014). Secondary endpoints of the trial, including progression-free survival (PFS) and the objective response rate (ORR), were also significantly improved with icotinib over WBI/chemotherapy. Median PFS was 6.8 versus 3.4 months, respectively (HR, 0.44; 95% CI, 0.31-0.63 [P < .001]).”