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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Bevacizumab/Erlotinib Combo Approved in Europe for NSCLC

Excerpt:

“The European Commission approved bevacizumab (Avastin) in combination with erlotinib (Tarceva) as a frontline treatment for patients with unresectable advanced, metastatic, or recurrent EGFR-mutant non–small cell lung cancer (NSCLC).

“The approval was based on findings from the phase II JO25567 study, which showed a 46% reduction in the risk of progression or death with the combination versus single-agent erlotinib. The median progression-free survival (PFS) with the addition of bevacizumab was 16 versus 9.7 months with erlotinib alone (HR, 0.54; 95% CI, 0.36-0.79; P = .0015).

“ ‘The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer,’ Sandra Horning, MD, chief medical officer and Global Head of Product Development at Roche, the company developing the combination, said in a statement. ‘This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond 1 year, representing important progress for a group of patients who typically face a poor prognosis.’ ”

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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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Clinical Development of Rociletinib in Lung Cancer Ends

Excerpt:

“Clovis has stopped clinical development of rociletinib, its once promising EGFR inhibitor for the treatment of patients with EGFR T790M–mutated non–small cell lung cancer (NSCLC).

“In a statement, the company reported that it had been notified by the FDA that it would receive a complete response letter on or before the scheduled PDUFA date of June 28, 2016. Receiving such correspondence means that the FDA is not approving a new drug application based on the available data.

“Clovis has terminated enrollment in all ongoing rociletinib studies, including the phase III TIGER-3 trial, and has withdrawn its application for regulatory approval in the European Union. Rociletinib will continue to be provided to patients whose clinicians recommend continuing therapy, according to Clovis.”

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CHMP Recommends EU Approval for Roche's Avastin in Combination With Tarceva for Patients With a Specific Type of Advanced Lung Cancer

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world. Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year or 90 every day.”

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First-Line Osimertinib Yields Nearly 80% Response in Advanced Lung Cancer

Excerpt:

“First-line osimertinib, a targeted therapy against EGFR mutations, was found to be effective in patients with advanced non–small-cell lung cancer (NSCLC), resulting in a 77% overall response rate, according to the results of recent study. In addition, the treatment-naive patients in the study achieved a median progression-free survival of 19.3 months.

“The data from two phase I expansion cohorts were presented by Suresh Ramalingam, MD, professor of hematology and medical oncology at Emory School of Medicine and deputy director of the Winship Cancer Institute in Atlanta, at the European Lung Cancer Conference 2016 in Geneva (LBA 1_PR).”

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US Widens Use of Boehringer's Lung Cancer Drug Gilotrif

Excerpt:

“US health officials have expanded the approved indications for Boehringer Ingelheim’s Gilotrif, clearing its use in patients with squamous cell carcinoma of the lung.

“Gilotrif (afatinib), an oral, once-daily EGFR-directed therapy, is currently cleared in the US for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.

“Approval for squamous cell carcinoma of the lung, a disease linked with a particularly bleak poor prognosis of one-year survival post diagnosis, was based on data from the head-to-head LUX-Lung 8 trial in patients whose tumours progressed after first-line chemotherapy.”

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