CNS Activity of EGFR Tyrosine Kinase Inhibitor in T790M-Positive Advanced NSCLC

Excerpt:

“In a planned subgroup analysis of the phase III AURA3 trial reported in the Journal of Clinical Oncology, Wu et al found that the third-generation EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) produced higher central nervous system (CNS) response rates vs platinum plus pemetrexed (Alimta) in patients with advanced EGFR T790M-positive non–small cell lung cancer (NSCLC).

“In AURA3, 419 patients with disease progression on prior EGFR tyrosine kinase inhibitor treatment were randomized 2:1 to receive osimertinib at 80 mg once daily or platinum plus pemetrexed. The current subgroup analysis was conducted in patients with measurable or nonmeasurable CNS lesions on baseline brain scan by blinded independent central neuroradiologic review.”

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EGFR-mutant NSCLC: Choice of First-Line Treatment May Get More Complicated


Medical guidelines for treatment of newly diagnosed non-small cell lung cancer (NSCLC) mandate upfront testing of tumor tissue for mutations in the EGFR gene (as well as ALK and ROS gene translocation). EGFR mutations are found in 10 to 15% of white patients, but in patients of East Asian origin such mutations are in encountered in approximately 48%. However, with new data and drugs entering the playing field, newly diagnosed patients’ treatment decisions could become more complex.

There is a good reason to test for EGFR mutations: the accumulated data show that, compared to first-line chemotherapy, treatment with drugs that inhibit the activity of EGFR in patients with activating EGFR mutations improves patients’ median progression-free survival (PFS) time from 4.6 to 6.9 months to 9.6 to 13.1 months, and has a higher objective response rate (ORR). Moreover, EGFR inhibitors are associated with a significantly lower incidence of adverse effects and better control of disease symptoms. Continue reading…


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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Osimertinib Approved in China for EGFR T790M+ NSCLC

Excerpt:

“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.”

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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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Biodesix®’ VeriStrat® Test Identifies T790M-Mutated Advanced Non-Small Cell Lung Cancer Patients Who Are More Likely to Have Improved Progression-Free Survival on Third Generation EGFR-TKI Therapy

Excerpt:

“Combined results from subset analyses of the TIGER-X and TIGER-2 clinical trials show that the VeriStrat test stratifies T790M-mutated patients with previously-treated, advanced non-small cell lung cancer (NSCLC) who are more or less likely to experience longer progression-free survival (PFS) when treated with a third-generation EGFR-TKI therapy. Clinical trial data suggesting the test’s potential for identifying better candidates for third-generation EGFR-TKI therapy were presented in Chicago last Friday at the at the IASLC Multidisciplinary Symposium in Thoracic Oncology hosted by the International Association for the Study of Lung Cancer.”

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ELCC 2016 Press Release: Osimertinib Given as First-line Treatment May Alter Biology of EGFR-Mutated Non-Small-Cell Lung Cancer

Excerpt:

“The third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib is effective in the first-line treatment of EGFR mutated non-small-cell lung cancer (NSCLC), according to a late-breaking abstract presented at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland. A second late-breaking abstract confirms the drug’s effectiveness in patients with the T790M mutation.

“EGFR inhibition is the standard of care for NSCLC patients with EGFR activating mutations but nearly 50 to 60% develop resistance by developing a T790M mutation. Osimertinib is a potent inhibitor of the original EGFR mutations (exon 19 and exon 21) and the T790M. The study presented today investigated whether the use of osimertinib as first-line therapy for EGFR mutation positive NSCLC would result in favourable efficacy due to delayed T790M mediated resistance.

“The study included 60 patients from two phase I expansion cohorts of the AURA trial that had locally advanced or metastatic EGFR mutated NSCLC. Thirty patients received 80 mg a day and 30 received 160 mg a day in the first-line setting. The median follow-up was 16.6 months.”

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Clovis Oncology Announces Rociletinib New Drug Application Scheduled for Presentation at Upcoming FDA Oncologic Drugs Advisory Committee Meeting

“Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

“The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

“ ‘We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib,’ said Patrick J. Mahaffy, President and CEO of Clovis Oncology. ‘New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.’ “


High Response Rate Produced by Osimertinib in EGFR T790M-Mutant NSCLC

“Osimertinib (AZD9291), the third-generation TKI, demonstrated a 71% objective response rate (ORR) in those with EGFR T790M-mutant non-small cell lung cancer (NSCLC), following resistance to frontline anti-EGFR therapy, according the findings of the phase II AURA2 trial that was presented at this year’s World Conference on Lung Cancer (WCLC).

“The ORR consisted of 2 complete responses and 139 partial responses. The stable disease rate at ≥6 weeks was 21%, for a disease control rate of 92%. After a median follow-up of 6.7 months, the median progression-free survival (PFS) was 8.6 months. The median duration of response was 7.8 months (27% maturity).”