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MDx/CDx Focus: Positive Data for Trastuzumab Emtansine; Veracyte Gets NY OK for Afirma Thyroid Dx

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With Positive Survival Data, Genentech Crossing over EMILIA Patients on Lapatinib/Capecitabine Combo to T-DM1

The latest results from a late-stage clinical trial show that breast cancer patients receiving Genentech's trastuzumab emtansine, or T-DM1, lived "significantly" longer than those treated with a combination of Genentech's Xeloda (capecitabine) and GlaxoSmithKline's Tykerb (lapatinib).

In the confirmatory analysis of the Phase III EMILIA trial involving nearly 1,000 advanced breast cancer patients whose tumors overexpress the HER2 protein, "overall survival … crossed the pre-specified boundary that showed trastuzumab emtansine significantly extended [patients'] lives" compared to the lapatinib/capecitabine combination, researchers from Genentech and elsewhere reported this week.

Roche subsidiary Genentech hasn't yet released the final data from EMILIA, which are slated for in early 2014. The company has submitted a biologics license application with the US Food and Drug Administration, and is planning to file for marketing authorization with the European Medicines Agency.

Based on the updated overall survival results, Genentech will give patients in the Tykerb/capecitabine arm of EMILIA the option to receive trastuzumab emtansine. While the drug is being reviewed by health regulators, the company will offer patients with HER2 expressing metastatic breast cancer the chance to receive the second-generation HER2-targeting oncologic via an expanded access program.

Trastuzumab emtansine is an antibody drug conjugate in which Genentech's Herceptin and the chemotherapy DM1 are bonded via a stable linker. The two bonded agents attach to HER2-positive cancer cells, block abnormal signaling pathways driving tumor growth, and induce the body's immune system to destroy malignant cells. In EMILIA, enrolled patients have previously been treated with Herceptin and a taxane-based chemotherapy.

Researchers in EMILIA are investigating whether T-DM1 extends progression-free survival and overall survival better than the lapatinib/capecitabine regimen. Study investigators will also be tracking patients' one-year and two-year survival rates, safety profile, progression-free survival, objective response rate, duration of response, and quality of life.

"A previous interim analysis of overall survival demonstrated a trend towards improved overall survival in people receiving trastuzumab emtansine compared to those who received lapatinib plus Xeloda. However, the data were not considered statistically significant at that time," Genentech said in a statement.

Those receiving T-DM1 experienced progression-free survival of 9.6 months compared to 6.4 months for those in the lapatinib/capecitabine arm, which indicates a 35 percent reduction in the risk of disease worsening for patients treated with the trastuzumab-containing regimen.

Severe adverse reactions were lower in the T-DM1 arm than in the lapatinib/capecitabine arm, 40.8 percent versus 57 percent. Common side effects associated with T-DM1 treatment were low platelet count, increased liver enzymes, and anemia.


Veracyte Gets NY License to Market Afirma Gene Expression Test for Thyroid Cancer Prognosis

The New York State Department of Health has issued a license allowing molecular diagnostics firm Veracyte to market to patients in the state its Afirma Gene Expression Classifier, a test that analyzes the expression of 142 genes to gauge whether thyroid nodules are benign or at high risk of cancer after testing by fine needle hasn't yielded definitive results.

A clinical validation study, published in the New England Journal of Medicine in June, showed that when FNA cytology yields inconclusive results, Veracyte's genetic test is able to discern which samples are at low risk of thyroid cancer with up to a 95 percent negative predictive value (PGx Reporter 6/27/2012).

Veracyte markets the Afirma Gene Expression Classifier as part of its comprehensive Afirma Thyroid FNA Analysis, which provides specialized cytopathology assessment services for the initial assessment of thyroid nodule FNAs as well as genetic testing to classify inconclusive results. The company has garnered Medicare coverage for the gene expression test, which it is marketing in partnership with Sanofi subsidiary Genzyme.

According to Veracyte, Memorial Sloan-Kettering Cancer Center will be among the first medical institutions in New York to offer testing with the Afirma Gene Expression Classifier.

The American Cancer Society estimates that more than 56,000 people will be diagnosed with thyroid cancer this year. Veracyte suggested that doctors need greater prognostic guidance through a test like the Afirma Gene Expression Classifier since around 30 percent of the approximately 450,000 FNA cytology analyses performed each year come up inconclusive as to whether patients are at heightened risk of thyroid cancer. The next step after FNA cytology testing is thyroid surgery, but after the invasive procedure between 70 percent and 80 percent of patients discover they had benign nodules.

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