“The American Society of Clinical Oncology (ASCO) today announced it has begun recruiting patients with advanced cancer for its first-ever clinical trial, the Targeted Agent and Profiling Utilization Registry (TAPUR) study. The trial will evaluate molecularly-targeted cancer drugs and collect data on clinical outcomes to help learn additional uses of these drugs outside of indications already approved by the Food and Drug Administration (FDA). Patients enrolled in the study will have access to these cancer drugs at no cost.
“The trial will initially enroll participants at 30 clinical sites located in Michigan, North Carolina, South Carolina, and Idaho and ASCO plans to expand to other areas of the country by the end of the year. Because of its unique design and purpose, TAPUR will include a broader patient population than in most clinical trials. Eligible participants include those who have an advanced solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma who are no longer benefitting from standard anti-cancer treatments or for whom no acceptable standard treatment is available.”
“That was the situation Angie Watts, 44, faced after she walked into a radiation oncologist’s office last June expecting to discuss the radiation therapy she was about to begin after a lumpectomy for breast cancer. Instead, Dr. Timothy M. Zagar of the University of North Carolina looked down at a sheet of test results and delivered some shocking news.
“A genetic test showed she had inherited an alteration in a gene needed to repair DNA. Radiation breaks DNA, so the treatment might actually spur the growth of her cancer, he said. He urged her not to take the risk and to have a double mastectomy instead.”
“Afatinib (Giotrif, EU; Gilotrif, US) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with advanced squamous cell non–small cell lung cancer (NSCLC) following progression on platinum-based chemotherapy, according to Boehringer Ingelheim, the manufacturer of the irreversible EGFR inhibitor.
“The CHMP opinion, which recommends that the treatment should gain approval from the European Medicines Agency in this setting, is based on data from the phase III LUX-Lung 8 trial. In the study, second-line afatinib reduced the risk of both disease progression and death by 19%, compared with erlotinib (Tarceva) in patients with advanced squamous cell carcinoma of the lung.”
“The team behind the Lung Cancer Master Protocol (Lung-MAP), a groundbreaking clinical trial for patients with advanced squamous cell lung cancer, is announcing exciting new changes and enrolling more patients as it adapts to the latest science and treatments. The nation-wide precision medicine trial now includes nivolumab, the immunotherapy treatment recently approved by the U.S. Food and Drug Administration
“Lung-MAP tests several new treatments for patients with advanced stage squamous cell lung cancer. In advanced stage squamous patients, cancer has usually spread from the lungs to other organs. The trial is for these patients, whose cancer has continued to grow – even after being treated with standard therapy.
“Lung-MAP gives these patients access to innovative therapies. The trial design allows several drugs to be tested simultaneously. Currently, the trial has four trial options for patients. Here’s how it works. All qualifying patients enrolled in Lung-MAP get free genomic profiling. Based on results of that DNA tumor tissue test, patients can be assigned to one of three biomarker-driven sub-studies, each evaluating a promising new drug. If there is no genomic match, patients can enroll in a fourth sub-study, which is testing the FDA-approved nivolumab, an immunotherapy made by Bristol Myers Squibb, against a nivolumab combination therapy. Regardless of their genomic profile, all Lung-MAP patients receive a treatment – not a placebo.”
“Determining the next step for a patient with melanoma who has failed or is not a candidate for existing targeted therapies or immunotherapies can be a challenge.
“However, there is hope, says Omid Hamid, MD, chief of Translational Research and Immunotherapy, and director of Melanoma Therapeutics at The Angeles Clinic.
“ ‘There are times when you throw your hands in the air and say, “I’ve run out of options,” ‘ he says. ‘But, all you need to do is look in another direction, open another cabinet, and realize that there are a ton of new options for our patients. These are nontraditional agents that maybe would not come to mind, but can be very effective in first-line, second-line, or any line.’
“Currently, several new checkpoint inhibitors and costimulatory molecules are being explored. These include those that target glucocorticoid-induced tumor necrosis factor receptor (GITR)—which is expressed on CD4- and CD8-positive T cells—in addition to T-regulatory cells, NK cells, and dendritic cells.”
Fred Hutchinson Cancer Research Center | Feb 29, 2016
“Metastatic prostate cancer presents an appealing target for precision oncology, according to new work from scientists at Fred Hutchinson Cancer Research Center and the University of Washington. In a study published Monday in the journal Nature Medicine, the researchers showed that though metastases from different patients varied widely in their genetic characteristics, metastases within a single patient were remarkably similar. These results suggest not merely that patients with metastatic prostate cancer may benefit from treatment tailored to their particular tumors, but also that a single biopsy may provide enough information to oncologists to guide such therapy.
“ ‘If you look in multiple metastases within a given patient, they’re actually very, very similar,’ said Dr. Pete Nelson, the study’s lead author and a prostate cancer researcher at Fred Hutch and oncologist at Seattle Cancer Care Alliance, the Hutch’s treatment arm. Unlike initial tumors in the prostate, in which molecular characteristics can vary by location, the tumor cells that break free and travel to distant locations within the body, forming metastases, appear to share characteristics. ‘They’re not identical, but they are very similar… We can feel generally confident, at least with prostate cancer, that if you did sample a single tumor, you could make clinical decisions based on what you find.’ “
“While still in its early stages, integrative genomic testing could be the future for personalizing therapy for patients with castration-resistant prostate cancer (CRPC), according to Tomasz M. Beer, MD, FACP.
“In an interview with Targeted Oncology, Beer, deputy director, Knight Cancer Institute, Oregon Health and Science University, explained that understanding the genetic makeup of CRPC could lead to new treatments, both single-agents and combinations. One of the most recent examples was the discovery of BRCA genetic mutations within CRPC, he said. While BRCA mutations are mostly associated with breast and ovarian cancers, this discovery could provide a new avenue for treating men with CRPC.
“In the interview, Beer discussed the current state of genetic testing for prostate cancer and changes on the horizon that are currently being explored in clinical trials.”
“Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
“The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.
“ ‘We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib,’ said Patrick J. Mahaffy, President and CEO of Clovis Oncology. ‘New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.’ “
“A huge federal trial of personalized cancer medicine has run into an unexpected roadblock: Many of the tumor samples aren’t robust enough to be put through genetic analysis.
“The samples, taken from patients with advanced cancer, were collected by doctors in hundreds of clinics nationwide. When researchers checked them, they found as many as 1 in 5 didn’t have enough malignant cells to analyze, in most cases because the biopsy had been poorly done.
“The glitch raises troubling questions about the new era of precision medicine.”