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GSK's Cancer Vaccine Fails its Late-Stage NSCLC Trial


Today, GlaxoSmithKline (GSK) announced that its cancer vaccine MAGE-A3 failed to meet its two primary endpoints in a late stage trial.

The company said that its Phase III MAGRIT trial, evaluating its MAGE-A3 cancer immunotherapeutic in non-small cell lung cancer (NSCLC) patients, did not meet its first or second co-primary endpoint as it did not significantly extend disease-free survival (DFS) when compared to placebo in either the overall MAGE-A3-positive population, which was the first co-primary endpoint, or in those MAGE-A3-positive patients who did not receive chemotherapy, which was the second co-primary endpoint.

The company intends to continue the trial in order to assess the third co-primary endpoint, designed to identify a subset of MAGE-A3 positive patients that may benefit from the treatment with the cancer vaccine. Results from a final analysis are expected in 2015.

MAGE-A3 is a tumor-specific antigen expressed in several cancers but not in normal cells. The antigen is expressed in approximately one third of tumors in patients diagnosed with Stage IB-IIA NSCLC. The vaccine is unlike traditional preventive vaccines. It is designed for people with established disease, helping their immune systems prevent the return of disease after surgery.

“We want to thank all patients, their families and healthcare workers for their involvement in the MAGRIT trial. We are disappointed that the trial did not demonstrate a benefit for overall MAGE-A3 positive patient population, but we remain committed to the effort to identify a sub-population of NSCLC patients who may benefit from this investigational treatment,” said Vincent Brichard, Senior Vice-President & Head of Immunotherapeutics, GSK Vaccines.

GSK had a similar setback in September, when its drug did not extend disease-free survival in melanoma patients when compared to placebo in mid-stage trials. The company will continue to evaluate the vaccine in another Phase III clinical study DERMA to determine if a sub population of melanoma patients would benefit from MAGE-A3.

Source: GlaxoSmithKline plc

Last updated: 3/20/14; 12:30pm EST

Heat Biologics Submits Revised Protocol to FDA for Phase II Clinical Trial of HS-110

Heat Biologics

Today, Heat Biologics, Inc. announced that it has submitted its revised Phase II clinical trial protocol to the US Food and Drug Administration (FDA) for its non-small cell lung cancer candidate.

The revised protocol is for its HS-110 product candidate, entering mid-stage development for the treatment of patients with non-small cell lung cancer (NSCLC). HS-110 is Heat’s first product candidate in a series of its proprietary Immune Pan Antigen Cytotoxic Therapy (imPACT) based allogenic cell lines designed to direct T cells to attack cancer. HS-110 utilizes genetically modified lung cancer cells to stimulate a patient’s immune system to activate a robust cytotoxic T cell response against several lung cancer antigens.

The Phase II NSCLC clinical trial in the third line setting will evaluate overall survival and response rates, as well as immune response to HS-110 in combination with low dose cyclophosphamide versus chemotherapy alone. The trial will include approximately 120 patients expected to be enrolled in 20-30 clinical trial centers. Patient enrollment and dosing for the Phase II NSCLC study is expected in the third quarter of 2014.

“With the latest groundbreaking advancements being made in studying immune checkpoint inhibitors for treating cancer, it is clear where oncology treatment is heading,” said Justin Stebbing, MD, PhD, Clinical Advisory Board Chairman and Chief Medical Advisor at Heat. “We specifically designed Heat’s NSCLC Phase 2 trial to continue our exploration of the potential of HS-110 therapeutic vaccine and to expand its utility for future combination regimens with checkpoint inhibitors as they come to the market.”

In the Phase II trial, Heat also plans on evaluating the potential of this novel immune therapy to sensitize patient tumors to subsequent chemotherapy treatments. The company said that it will collect obtain biopsy specimens pre- and post-treatment to correlate tumor infiltrating lymphocytes and T-cell receptor sequencing with patient outcomes.

“There have been some advances in late stage lung cancer treatment options in the last several years but NSCLC remains the most common of all lethal cancers, with approximately 228,000 cases reported in 2013 in the US and approximately 160,000 deaths,” Heat’s Chief Executive Officer Jeff Wolf, said. “Heat’s allogeneic, off-the-shelf HS-110 vaccine therapy has the potential to improve the lung cancer treatment landscape and address an unmet need by offering patients access to investigational agents in the 3rd-line setting where there are currently very few approved options.”

Source: Heat Biologics, Inc.

Last updated: 3/19/14; 3:45pm EST

NeoGenomics Launches Two of its Next Generation Sequencing Tests for Cancer


NeoGenomics, Inc. recently announced that it has validated and launched the first two of a series of next generation cancer profiling tests.

The tests are designed for profiling myelodysplastic syndrome (MDS) and solid tumor cancers. Currently, the company is validating additional cancer-type specific next generation tests, which are scheduled for launch over the next several months.

The MDS next generation sequencing (NGS) test can be performed on bone marrow and peripheral blood and plasma samples. Plasma-based testing for MDS may be used to avoid bone marrow biopsies. It has the potential to quantify and monitor tumor load and to detect the emergence of subclones. The MDS next generation profiling test covers 16 genes that are involved in various pathways of MDS, including epigenomics, signal transduction, transcription regulation and spliceosomes. The test is especially important for confirming and defining the diagnosis of MDS, a disease that can be extremely difficult in early stages of the disease.

NeoGenomics’ solid tumor cancer NGS profiling test covers 48 genes and is performed on paraffin-embedded tissue. The solid tumor profile is extensive and covers the driver genes involved in various types of solid tumor cancers.

“NeoGenomics is committed to developing and using cutting edge technology to provide efficient and reliable clinical tests. We believe that targeted next generation sequencing technology has advanced sufficiently to be offered more routinely in high-throughput clinical laboratory testing for cancer patients. Importantly, our NGS tests focus on the actionable genes justified medically and financially at this time. Our NGS profiles are designed for precision testing in order to generate actionable data. Each of these tests is relevant for diagnosis, predicting prognosis, determining or monitoring therapy, and exploring clinical trials options,” said NeoGenomics’ Chairman and CEO Doug VanOort.

According to Dr Maher Albitar, Chief Medical Officer and Director of Research and Development, NeoGenomics, targeted NGS provides significant advantages over conventional technology. The NGS testing is more reliable with a limited number of genes analyzed.

“Our panel of 16 genes for MDS provides remarkable precision, reliability and sensitivity for the diagnosis, monitoring and management of patients with MDS, especially when performed on peripheral blood plasma. Next generation sequencing is allowing us to further establish plasma-based testing as a practical and more routine testing in hematologic neoplasms,” Dr. Albitar.

Source: NeoGenomics, Inc.

Last updated: 3/19/14; 12:50pm EST

Exact Sciences' Colon Cancer Screening Test Demonstrates High Sensitivity in Detecting Tumors

Exact Sciences

Exact Sciences Corp. and the Mayo Clinic’s novel colon cancer test demonstrated high sensitivity in detecting the disease in a pivotal study.

Results from the DeeP-C pivotal clinical study, “Multi-Target Stool DNA Testing for Colorectal-Cancer Screening”, were published in the New England Journal of Medicine, showing that the test is almost as sensitive in detecting colon cancer as a colonoscopy.

The DeeP-C study was designed to determine the performance characteristics of Exact Sciences’ multi-target stool DNA-based screening test, Cologuard, for colorectal cancer and to compare the performance to the fecal immunochemical test (FIT), a commonly used non-invasive colorectal cancer screening test. The study included 10,000 patients and took place at 90 centers throughout the US and Canada.

Cologuard scans for traces of tumor DNA, genetic mutations and blood in a stool sample. It detected 92 percent of patients with colorectal cancer compared to 74 percent detected by FIT. In patients with colorectal cancers in Stages I-III, Cologuard detected 93 percent compared to 73 percent detected by FIT. Patients with colorectal cancers in Stages I-III are determined to be associated with an increased rate of being cured, according to the American Joint Committee on Cancer. Cologuard detected 42 percent of advanced pre-cancerous lesions compared to 24 percent detected by FIT. For patients with polyps with high-grade dysplasia, Cologuard detected 69 percent versus 46 percent for FIT. Additionally, Cologuard achieved a specificity of 87 percent compared to 95 percent specificity by FIT.

An approximately 13 percent increase in false positives occurred with Cologuard compared to FIT, leading patients to undergo a colonoscopy that found no signs of cancer.

“We know that colorectal cancer can be prevented and can be highly treatable if found early through screening,” said lead author Thomas F. Imperiale, MD, of the Indiana University School of Medicine, Regenstrief Institute Inc., the IU Simon Cancer Center, and the Roudebush VA Medical Center in Indianapolis. “Sensitivity is the most important characteristic for screening tests because the primary role of such testing is to rule out diseases such as cancer. In our clinical study, the data show that Cologuard, the multi-target stool-based DNA test, is highly sensitive in detecting colorectal cancer and higher risk pre-cancerous polyps in a large, diverse average-risk patient population and has the potential to be an important screening tool.”

Colorectal cancer is considered one of the most preventable, yet least prevented cancers. One of three adults age 50 years and older has nto been screened as recommended. It is the second-leading cancer killer in the US. If found early, colorectal cancer is highly treatable, therefore detecting pre-cancerous polyps is critical.

“We are very pleased with the data published today in the New England Journal of Medicine,” said Kevin T. Conroy, president and chief executive of Exact Sciences. “We believe Cologuard could be an important tool in the early detection of colorectal cancer. This is an important milestone for Exact Sciences and Cologuard.”

Cologuard is an investigational device that is currently being reviewed by the US Food and Drug Administration (FDA). The agency’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to review the application on March 27, 2014.

Source: Exact Sciences Corp.

Last updated: 3/19/14; 11:30am EST

Astellas and Medivation Seek New Indication for Prostate Cancer Drug Xtandi


Today, Astellas Pharma Inc. and partner Medivation Inc. announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Xtandi.

The companies said that they have filed the application seeking approval of Xtandi (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. Xtandi is already approved by the FDA for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.

The sNDA application is based on results from a late-stage trial comparing Xtandi to placebo. The Phase III PREVAIL trial included 1,700 chemotherapy-naïve patients with metastatic prostate cancer whose disease progressed on a luteinizing hormone-release analogue or after bilateral orchiectomy. The trial’s co-primary endpoints were overall survival and radiographic progression free survival (PFS). In the trial, treatment with Xtandi demonstrated a statistically significant overall survival benefit, reducing the risk of death by 29 percent compared to placebo. Additionally, the drug significantly reduced the risk of radiographic progression PFS or death by 81 percent compared to treatment with placebo.

According to the companies, the marketing authorization application is expected to be submitted to the European Medicines Agency (EMA) later this year.

“The PREVAIL study results demonstrate for the first time a statistically significant reduction both in the risk of death and a delay in cancer progression in men with metastatic prostate cancer who have a rising PSA and few, if any, symptoms,” said co-principal investigator of the PREVAIL study Tomasz M. Beer, MD, FACP, professor of medicine and deputy director of the Knight Cancer Institute at Oregon Health & Science University. “The scope of the efficacy endpoints and safety profile in PREVAIL, including the length of time that chemotherapy can be delayed, would represent a step forward for men with prostate cancer.”

Source: Medivation Inc.

Last updated: 3/18/14; 4:05pm EST