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MDx/CDx Focus: Enzo Launches Lung Cancer Dx; Zelboraf Survival Data; Caris' Tumor Profiling Service

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Enzo Begins Marketing Dx Test for Early Lung Cancer Detection

Enzo Clinical Labs this week launched a diagnostic test to help oncologists detect lung cancer early and gauge which patients are at heightened risk for disease progression.

The company is launching the blood-based test, called EarlyCDT-Lung, through its clinical laboratory in the New York metropolitan market, in New Jersey, and in Eastern Pennsylvania. The New York State Department of Health has approved the lab-developed test to be marketed to residents.

"The test is directed at patients with a high risk of developing lung cancer, including heavy smokers, those exposed to suspect environmental conditions, and patients with a [computed tomography] nodule under surveillance," Enzo said in a statement announcing the availability of the test, which is meant to be used in conjunction with diagnostic imaging.

EarlyCDT-Lung was developed by Oncimmune. Enzo and Oncimmune have an agreement that allows only Enzo to market the test in the aforementioned geographic areas.

Studies have shown that CT screening could potentially reduce lung cancer mortality but that the method also has a high false positive rate, is costly, and exposes patients to radiation.

EarlyCDT-Lung measures a panel of autoantibodies to detect lung cancer early. "Autoantibodies are detectable up to five years before a tumor is visible," Oncimmune explains on its website. "Autoantibodies form early as an immune response to the presence of tumor antigens."

According to Enzo, if the test gauges that any immuno-biomarker in the panel is elevated above a predetermined cutoff point, then the patient might have a lung tumor. The company said the test can also be used to gauge disease progression in high-risk patients who have indeterminate lung nodules by CT scanning.

Enzo also markets ColonSentry, a blood-based diagnostic that gauges expression of seven mRNA biomarkers associated with increased risk of colon cancer or disease severity in patients at the time the test is performed. ColonSentry is developed by GeneNews (PGx Reporter 2/22/2012).


Phase I Trial Data Show Some Patients Live for Three Years on BRAF Inhibitor Zelboraf

Mature data from a Phase 1 trial involving Roche/Plexxikon's BRAF inhibitor Zelboraf (vemurafenib) showed that 26 percent of melanoma patients were alive at three years follow-up.

The data suggest "that long-term survival with Zelboraf can be achieved in a subset of metastatic melanoma patients with the BRAF V600E mutation," Plexxikon announced in a statement earlier this month.

The Phase I study included 32 patients with BRAF V600E mutation-positive melanoma. As of July 17, 55 percent of patients were alive after one year, 36 percent were alive at two years, and 26 percent were alive at three years. Median progression-free survival in the study was 7.7 months.

To date, five patients are still on Zelboraf, of which three still are experiencing a complete response and one is having a partial response.

In the trial, 14 of the 32 patients received Zelboraf post-progression. "Data also suggest a potential benefit of vemurafenib's use in conjunction with post-progression surgery, as well as continued drug administration in some patients with isolated melanoma metastases," Plexxikon said in a statement.

The most common adverse events in the trial were joint pain, rash, nausea, sun sensitivity, fatigue, cutaneous squamous cell carcinoma, itching, and hand-foot syndrome.

The US Food and Drug Administration approved Zelboraf in 2011 alongside a companion test, developed by Roche, for gauging BRAF mutations. The agency approved the drug based on interim data from the BRIM3 trial, a Phase III study comparing Zelboraf against dacarbazine in 675 patients with previously untreated metastatic melanoma who harbored BRAF-positive tumors.

In June 2012, Roche reported updated results from the BRIM3 study at the American Society of Clinical Oncology's annual meeting. Based on a longer follow-up, median overall survival for Zelboraf-treated patients was 13.6 months compared to 9.7 months for those in the chemotherapy arm. This was cited as a significant improvement in outcomes for metastatic melanoma patients who were previously expected to survive for between six to nine months.


Caris Adds ROS1, MGMT Methylation Testing to Profiling Service

Caris Life Sciences has begun offering ROS1 and MGMT methylation testing to its molecular profiling service.

According to the company, it is among the few diagnostic testing shops to provide these tests commercially. Caris will test for ROS1 via fluorescence in situ hybridization in non-small cell lung cancer patients and for MGMT methylation levels by pyrosequencing in glioblastoma patients.

ROS1 rearrangements have been shown in clinical studies to impact non-small cell lung cancer patients' response to Xalkori, a drug that is marketed by Pfizer. Currently, Xalkori is only indicated for advanced NSCLC patients with ALK rearrangements, but early studies have shown that patients with ROS1-positive tumors have a robust response to the drug (PGx Reporter 6/6/2012).

Following preliminary data presented at the American Society of Clinical Oncology's annual meeting in June, Pfizer said it was working to better understand how ROS1 arrangements impact Xalkori response in NSCLC patients. The company at the time did not say whether it would try to expand Xalkori's indication to this population, however many academic physicians at the meeting were excited by the data and said they would prescribe the drug to patients with ROS1 positive tumors at major cancer centers.

Meanwhile, Caris hopes to use pyrosequencing to gauge disease prognosis in glioblastoma patients, as well as predict likelihood that they will respond to temozolomide.

"The additions of these genes to our molecular profiling service further aid oncologists in determining the appropriate therapeutic regimen for their NSCLC and glioblastoma patients," said Sandeep Reddy, clinical professor of medicine at the University of California, Los Angeles, and senior medical director at Caris.

The company claims that it has tested more than 40,000 patients through its molecular profiling service, which provides comprehensive tumor biomarker analyses and assesses potential therapies that patients are most likely to respond to.