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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Cuba's Lung Cancer Vaccine: Hype or Hope?

Excerpt:

“Now that relations between the United States and Cuba are thawing, there has been a growing interest in forming medical partnerships.

“Of particular interest is a lung cancer vaccine called CimaVax, which was developed for non-small cell lung carcinoma. Available in Cuba since 2011, the vaccine has caught the attention of researchers and physicians not only in the United States but in other countries as well.

“But while intriguing, the question remains: Is it really a breakthrough in lung cancer treatment?”

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Leptomeningeal Metastases Are More Common in NSCLC Patients With EGFR Mutations

Excerpt:

“Leptomeningeal metastases (LM), a devastating complication and predictor of poor survival in lung cancer patients, was found to be more prevalent in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. Patients receiving tyrosine kinase inhibitors (TKIs) targeting EGFR mutations had a longer overall survival (OS) than those who did not receive TKIs, demonstrating the effectiveness of TKIs for LM therapy.

“The leptomeninges are the membranes that surround the brain, including the arachnoid mater and pia mater, and ensue when cancer cells metastasize to intracranial structures and the cerebrospinal fluid (CSF). LM occurs in 10-26% of  and the presence of LM is a devastating complication for patients and often associated with poor survival. Treatment strategies for LM include epidermal growth factor receptor  (EGFR-TKIs), chemotherapy, whole brain radiotherapy (WBRT), intrathecal chemotherapy (ITC), surgery, and ventriculoperitoneal (VP) shunt operations. However, therapeutic options for treating LM are challenging with no standard treatment. The use of EGFR-TKIs markedly prolong survival in patients with EGFR mutations and frequent EGFR mutations.”

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Adding Pemetrexed to Gefitinib Improves PFS in EGFR-Mutated NSCLC

Excerpt:

“The combination of pemetrexed and gefitinib offered improved progression-free survival (PFS) over gefitinib alone in East Asian patients with advanced nonsquamous non–small-cell lung cancer (NSCLC) and activating EGFR mutations, according to a new randomized, open-label study.

“EGFR tyrosine kinase inhibitors (TKIs) including gefitinib have been shown to improve outcomes in patients with EGFR-mutated NSCLC. ‘Given their different mechanisms of action, combination treatment with EGFR-TKIs and chemotherapy may further improve outcomes,’ wrote study authors led by James Chih-Hsin Yang, MD, PhD, of National Taiwan University Hospital in Taipei. Previous trials of such combinations have not shown clinical benefit, however, though this could have been because of antagonism between the agents used or because wild-type EGFR patients were included.”

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Liquid Biopsies for Identification of EGFR Mutations and Prediction of Recurrence

Excerpt:

“Three manuscripts published in the recent issue of the Journal of Thoracic Oncology, the official journal of the International Association for the Study of Lung Cancer (IASLC), explored the versatility of liquid biopsies by identifying EGFR mutations using circulating tumor DNA (ctDNA) in urine and plasma and examining circulating tumor cells (CTCs) in plasma to predict the risk of lung cancer recurrence after surgical resection. Collectively, these findings illustrate the potential and reach of liquid biopsies in both identifying patients suitable for targeted treatment as well as predicting cancer recurrence.

“Lung cancer is the most common type of cancer with the highest cancer-related mortality worldwide. Non-small cell lung cancer (NSCLC) accounts for roughly 85% of lung cancer and most patients present with advanced disease at diagnosis. Surgical resection is the preferred treatment option for patients with medically operable tumors. However, disease recurrence occurs in approximately 50% of cases. Patients with advanced disease are often not candidates for surgical resection and commonly harbor driver mutations that can be targeted by drugs. A major challenge for assessing driver mutations, such as epidermal growth factor receptor (EGFR) mutations, in advanced disease is the scarcity of suitable biopsy tissue for molecular testing. A minimally invasive alternative to invasive tissue biopsy is the use of liquid biopsy, which analyzes ctDNA or CTCs in a liquid biological sample (i.e. urine, blood, or serum).”

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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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