Tagrisso Shows Benefit in NSCLC Patients With CNS Metastases

Excerpt:

“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.”

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Tagrisso Demonstrates Superiority over Chemotherapy in EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer

Excerpt:

“AstraZeneca today presented data from the AURA3 trial that data is supportive of Tagrisso (osimertinib) potentially becoming the new standard of care for 2nd-line treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive locally-advanced or metastatic non-small cell lung cancer (NSCLC). The first randomised Phase III data showed that Tagrisso 2nd-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy (Hazard Ratio [HR]=0.3). The results were presented at the 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria, hosted by the International Association for the Study of Lung Cancer, and published simultaneously online in The New England Journal of Medicine.”

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AZ' Tagrisso Hits Goals in Second-Line Lung Cancer Trial

Excerpt:

“A Phase III trial assessing AstraZeneca’s lung cancer drug Tagrisso has met its primary endpoint in showing superior progression-free survival compared to standard chemotherapy.

“The AURA3 trial assessed the efficacy and safety of Tagrisso (osimertinib) as a second-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic non-small cell lung cancer (NSCLC), whose disease had progressed following first-line EGFR tyrosine kinase inhibitor (TKI) therapy.

“Full data are to be unveiled at an upcoming medical conference, AZ said, but did also reveal that, in addition to PFS, the objective response rate, disease control rate and duration of response also achieved clinically meaningful improvement versus chemotherapy, while the drug’s safety profile was also consistent with earlier findings.”

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Plasma vs Tissue Genotyping and Outcomes With Osimertinib in Advanced Non–Small Cell Lung Cancer

Excerpt:

“Patients with advanced non–small cell lung cancer (NSCLC) positive for the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor T790M resistance mutation on a plasma assay had similar outcomes with the EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) as did those who were positive on tissue genotyping, according to a study reported by Oxnard et al in the Journal of Clinical Oncology. The findings suggest that a validated plasma assay may allow some patients to avoid tumor biopsy for detection of the mutation.”

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Lung Cancer Highlights from ASCO 2016


This year, the Annual Meeting of the American Society of Clinical Oncology (ASCO) did not produce any truly groundbreaking revelations about new treatments for lung cancer. However, researchers did report quite a few positive findings, and some disappointing ones. I have summarized some of the more prominent presentations below. Continue reading…


Osimertinib Demonstrates Early Efficacy for Leptomeningeal Disease in NSCLC

Excerpt:

“Phase I findings of a study examining the efficacy of osimertinib (Tagrisso) in heavily pretreated patients with EGFR-mutated advanced non–small cell lung cancer (NSCLC) and leptomeningeal disease showed promising activity in the patient population.

“In the BLOOM study, which was presented during the 2016 ASCO Annual Meeting, treatment with the third-generation EGFR TKI osimertinib was associated with radiologic improvement of leptomeningeal disease in 33% and neurologic improvement in patients who presented with neurologic impairment at baseline. In addition, 2 of the 21 patients (9.5%) enrolled experienced clearing of cerebrospinal fluid (CSF) cytology, said James Chih-Hsin Yang, MD, PhD, who announced the results.”

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Tagrisso (Osimertinib) Shows Clinical Activity in Patients with Leptomeningeal Disease from Lung Cancer

Excerpt:

“AstraZeneca today announced clinical and safety data for osimertinib in patients with leptomeningeal (LM) disease, a complication of epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC),1 where cancer cells spread to the cerebrospinal fluid (CSF). LM is a devastating disease often associated with advanced lung cancer.

“The updated BLOOM Phase I trial results, presented at the American Society of Clinical Oncology (ASCO) annual meeting, showed that irrespective of T790M mutation status of patients, osimertinib demonstrated activity through assessments with MRI imaging intracranial response.”

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AstraZeneca's Potential $3 Billion Cancer Pill Wins Early Approval

“A new lung cancer pill from AstraZeneca, designed for patients whose disease has worsened after treatment with other therapies, won early U.S. approval on Friday, in a boost for the British drugmaker.

“Tagrisso, also known as AZD9291, is one of several cancer medicines AstraZeneca hopes will rebuild its sales following patent losses on older drugs. During its defense against a takeover attempt by Pfizer last year, the firm forecast the drug could eventually sell as much as $3 billion a year.

“Industry analysts are more cautious about sales in the next few years, with consensus expectations pointing to revenue of $1.1 billion in 2020, according to Thomson Reuters Cortellis.”