ASCO 2014 Lung Cancer Roundup

Every year, thousands of people gather in Chicago, Illinois, for the American Society of Clinical Oncology (ASCO) Annual Meeting. The largest meeting of its kind, ASCO brings together doctors, researchers, nurses, patient advocates, pharmaceutical company representatives, and more to discuss the latest in cancer research. Here are some of the most exciting new developments in lung cancer research presented last week at ASCO 2014: Continue reading…

ASCO: Zykadia Works Before or After Targeted Lung Ca Tx

Ceritinib (Zykadia) produced good response in non-small cell lung cancer (NSCLC) overexpressing ALK, regardless of prior treatment for that target, an early phase trial showed.

Ceritinib was associated with an overall response rate of 55% in patients previously treated with crizotinib (Xalkori) and 66% in those naive to that ALK inhibitor, Dong-Wan Kim, MD, of the Seoul National University Hospital, and colleagues found.

Editor’s note: This article is about a drug called ceritinib (brand name Zykadia), which was recently approved by the U.S. Food and Dug Administration (FDA), allowing doctors in the U.S. to prescribe it to patients who 1) have advanced non-small cell lung cancer (NSCLC), 2) have tumor cells with mutations in the ALK gene, as detected by molecular testing, and 3) have tried treatment with crizotinib (Xalkori) but experienced worsening of their cancer. According to the new research described in this article, ceritinib may actually be beneficial whether or not the patient was previously treated with crizotinib.

ARIAD Presents Updated Phase 1/2 Data on AP26113 in Patients with ALK+ Non-Small Cell Lung Cancer

“ARIAD Pharmaceuticals, Inc. today announced updated clinical results on its investigational tyrosine kinase inhibitor (TKI), AP26113, in patients with advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. These study results show anti-tumor activity of AP26113 in patients with crizotinib-resistant anaplastic lymphoma kinase (ALK) positive NSCLC, including patients with brain metastases. Crizotinib is approved for ALK-positive NSCLC patients.”

Editor’s note: This story is about a targeted drug called AP26113, which may benefit some patients with advanced non-small cell lung cancer (NSCLC). Specifically, it has shown promise for patients whose tumors have mutations in the ALK gene, as detected by molecular testing, and who have already been treated with the drug crizotinib (Xalkori) but have grown resistant to it.

Responses with Crizotinib in MET-Amplified Lung Cancer Show New Targetable Form of Disease

In 2011, the drug crizotinib earned accelerated approval by the US FDA to target the subset of advanced non-small cell lung cancers caused by rearrangements of the anaplastic lymphoma kinase (ALK) gene, and subsequently was granted regular approval in 2013. The drug also has shown dramatic responses in patients whose lung cancers harbored a different molecular abnormality, namely ROS1 gene rearrangements. Previously unreported phase 1 clinical trial results now show that crizotinib may have a third important molecular target. In advanced non-small cell lung cancer patients with intermediate and high amplifications of the MET gene, crizotinib produced either disease stabilization or tumor response. Sixty-seven percent of patients with high MET amplification showed prolonged response to the drug, which lasted from approximately 6 months to nearly 2.5 years.”

Editor’s note: Crizotinib (aka Xalkori) is a targeted therapy drug that kills cancer cells by targeting certain molecules found in the cells. It was already known that crizotinib works well for some patients with advanced non-small cell lung cancer (NSCLC) whose cancer cells have mutations in the ALK gene and in the ROS1 gene; such mutations, or “molecular biomarkers,” are detected by a medical procedure known as “molecular testing,” or “genetic testing.” Now, scientists say that crizotinib may also be effective for patients with advanced NSCLC whose tumors have abnormally high activity of a protein called MET, which can also be detected via molecular testing.

Thwarting Drug Resistance in Lung Cancer

If you’ve read up on lung cancer research in the last few years, you probably know that large strides have been made in targeted therapies for non-small cell lung cancer (NSCLC). Targeted therapies are drugs that identify and attack specific mutated proteins that are detected in tumors. Because noncancerous cells do not have these specific mutations, targeted therapies can make a beeline for cancer, while leaving healthy tissue unharmed. Continue reading…

FDA Approves Ceritinib (Zykadia) for Metastatic Lung Cancer

“Earlier today the US Food and Drug Administration granted accelerated approval to ceritinib (Zykadia) for the treatment of patients with metastatic ALK-positive non–small-cell lung cancer (NSCLC). About 2% to 7% percent of NSCLC patients have ALK-positive disease.

“The new drug, a tyrosine kinase inhibitor, was approved 4 months early under the FDA’s accelerated approval program and is intended for the treatment of patients who previously received the ALK-inhibitor crizotinib.”

Editor’s note: FDA approval means that doctors can now begin prescribing ceritinib to treat patients with advanced non-small cell lung cancer (NSCLC) whose tumors have mutations in the ALK gene, as detected by molecular testing. We previously posted about ceritinib here.

New Drug Successfully Treats Crizotinib-Resistant, ALK-Positive Lung Cancer

“Although the targeted cancer treatment drug crizotinib is very effective in causing rapid regression of a particular form of lung cancer, patients’ tumors inevitably become resistant to the drug. Now a new drug called ceritinib appears to be effective against advanced ALK-positive non-small cell lung cancer (NSCLC), both in tumors that have become resistant to crizotinib and in those never treated with the older drug. The results of a phase 1 clinical trial conducted at centers in 11 countries are reported in the March 27 New England Journal of Medicine.”

Editor’s note: Crizotinib and ceritinib are meant to treat patients whose tumors have mutations in the ALK gene, as detected by molecular testing.

Phase III Study: Crizotinib Prolongs Progression-Free Survival in Previously Untreated ALK-Positive Advanced NSCLC

“In the phase III PROFILE 1014 study, the anaplastic lymphoma kinase (ALK) inhibitor crizotinib (Xalkori) was found to significantly prolong progression-free survival in previously untreated patients with ALK-positive advanced nonsquamous non–small cell lung cancer (NSCLC) compared with standard platinum-based chemotherapy.

“No unexpected safety issues were identified in the current study, and adverse events were consistent with the known safety profile for crizotinib. Efficacy and safety data from this study will be submitted for presentation at a future medical meeting.”

Editor’s note: Xalkori is a targeted therapy that is meant to treat patients whose tumors have mutations in the ALK gene, as detected by molecular testing.

EML4-ALK Fusion Testing, Targeted Crizotinib Treatment Not Cost-Effective in NSCLC

“EML4-ALK fusion testing to identify patients with advanced non–small cell lung cancer eligible for first-line, targeted treatment with crizotinib may not be cost-effective, according to study results.

“Researchers in Ontario used a Markov model to compare the cost-effectiveness of two treatment approaches for patients with stage IV nonsquamous NSCLC. One approach consisted of molecular screening and targeted treatment with crizotinib (Xalkori, Pfizer). The other approach consisted of standard care, which included platinum doublet (cisplatin and gemcitabine) as first-line therapy, second-line pemetrexed (Alimta, Eli Lilly) and third-line erlotinib (Tarceva; Genentech, Astellas Pharma).”

Editor’s Note: Molecular testing can be used to identify genetic mutations in a patient’s tumor that may point to the use of a certain treatment, personalized for him or her. This study explores the costs associated with these treatments. Of course, every patient’s treatment decisions will be made for his or her own personal reasons. You can talk to your doctor to find out if molecular testing and targeted therapies are good choices for you.