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New Study Shows Circulating Tumor Cell Enumeration – as Part of Composite Biomarker Panel – May Serve as a Surrogate for Efficacy Response in Metastatic Castration-Resistant Prostate Cancer

Janssen Diagnostics, LLC recently announced results from a study presented at the European Cancer Congress in Amsterdam, Netherlands, that demonstrated circulating tumor cell (CTC) enumeration using CELLSEARCH®, along with lactate dehydrogenase (LDH) as part of a composite biomarker panel, was an efficacy-response surrogate for survival in managing patients with metastatic castration-resistant prostate cancer (mCRPC). The results show mCRPC patients with greater than or equal to five CTCs and an abnormal LDH level at 12 weeks of treatment have a poorer prognosis than those with lower CTC counts and normal LDH values, with a one- and two-year survival probability of 25 percent and 2 percent compared to 82 percent and 46 percent, respectively. Findings suggest therapeutic alternatives should be considered for patients in the high-risk category at 12 weeks.

KineMed Awarded NIH Contract to Identify Biomarkers for Myocardial Fibrosis

KineMed, Inc. (www.kinemed.com) recently announced that the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), awarded the company a Phase I SBIR (Small Business Innovation Research) contract to develop biomarkers for the detection of early myocardial fibrosis. Biomarkers for myocardial fibrosis will guide disease interventions that block the progression of this disease which is risk factor for heart failure and arrhythmias.

Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG CYP2C19 Kit

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit. This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.

FDA Advisory Committee Recommends Accelerated Approval of Genentech’s Perjeta for Neoadjuvant Use in HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. The FDA will make a decision on whether or not to approve Perjeta for this use by October 31, 2013. If approved, the Perjeta regimen will be the first neoadjuvant breast cancer treatment approved in the United States and the first treatment approved based on pathological complete response (pCR) data, meaning there is no tumor tissue detectable at the time of surgery.

Perjeta is already approved in a number of countries including the United States for people with HER2-positive metastatic breast cancer (an advanced form of the disease in which the cancer has spread to other parts of the body).

The Perjeta application for neoadjuvant use follows a proposed new FDA pathway designed to more quickly bring promising medicines to people with earlier stages of breast cancer, where treatment may have a greater impact.

“More than 6,000 people in the United States die of HER2-positive breast cancer each year,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “The ODAC’s recommendation is a step toward bringing Perjeta to people with HER2-positive early stage breast cancer, where treatment can potentially prevent the disease from returning and spreading.”

Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working and may also reduce a tumor’s size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect in breast cancer and can be assessed more quickly than traditional endpoints in early stage breast cancer.

The ODAC recommendation was based on a review of results from NEOSPHERE and TRYPHAENA, two Phase II studies of Perjeta in high-risk, HER2-positive early stage breast cancer, as well as on longer-term safety data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer.

The ongoing Phase III APHINITY study will further evaluate Perjeta in the adjuvant setting (after surgery) and compares Perjeta, Herceptin® (trastuzumab) and chemotherapy with Herceptin and chemotherapy in people with HER2-positive early stage breast cancer. The study has completed enrollment with approximately 4,800 people, and the primary endpoint is invasive disease-free survival (IDFS). Genentech has proposed this study as a confirmatory study to the FDA. Data are expected in 2016.

Source: Genentech

Analysis Published In New England Journal of Medicine Highlights Discovery of New Predictive Biomarkers for Vectibix (Panitumumab)

Amgen (NASDAQ: AMGN) recently announced the publication of a biomarker analysis of Vectibix® (panitumumab) in combination with FOLFOX, a type of oxaliplatin-based chemotherapy, for the first-line treatment of patients with metastatic colorectal cancer (mCRC). Published in the New England Journal of Medicine, the analysis found that RAS mutations, beyond the known KRAS exon 2 mutations, predict lack of response to Vectibix in combination with FOLFOX. RAS mutations are mutations occurring in exons 2, 3 and 4 of KRAS and NRAS.