Palbociclib Showed Antiproliferative Activity in Early-stage Breast Cancer

Excerpt:

“The molecularly targeted therapeutic palbociclib (Ibrance), which is used to treat advanced breast cancer, was effective in slowing the multiplication of cancer cells in patients diagnosed with early-stage breast cancer who received no prior therapy, according to data from a phase II clinical trial presented here at the AACR Annual Meeting 2016, April 16-20.

” ‘The use of targeted therapies has been increasing in the last few years. It is crucial to determine that these drugs do hold activity against tumor cells,’ said the study’s lead author, Monica Arnedos, MD, an assistant professor at Gustave Roussy Cancer Campus in Villejuif, France. ‘In the case of palbociclib, no predictive biomarkers have been identified to date, and there are still no data about its potential efficacy in the early setting.’ ”

“Palbociclib, an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, was approved by the U.S. Food and Drug Administration (FDA) in February 2015 for use in combination with the anti-estrogen therapeutic letrozole for treating postmenopausal women with a specific subtype of breast cancer: estrogen receptor-positive, HER2-negative, metastatic breast cancer.”

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US Widens Use of Boehringer's Lung Cancer Drug Gilotrif

Excerpt:

“US health officials have expanded the approved indications for Boehringer Ingelheim’s Gilotrif, clearing its use in patients with squamous cell carcinoma of the lung.

“Gilotrif (afatinib), an oral, once-daily EGFR-directed therapy, is currently cleared in the US for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.

“Approval for squamous cell carcinoma of the lung, a disease linked with a particularly bleak poor prognosis of one-year survival post diagnosis, was based on data from the head-to-head LUX-Lung 8 trial in patients whose tumours progressed after first-line chemotherapy.”

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UCSF Center Adds to Revolution of Care for BRCA Carriers

Excerpt:

“A new center at University of California, San Francisco, is designed to provide comprehensive and integrated care for patients with cancer who carry BRCA and other mutations.

“The Center for BRCA Research at UCSF Helen Diller Family Comprehensive Cancer Center joins Basser Center for BRCA in Philadelphia as the only facilities solely devoted to BRCA–related cancers.

“HemOnc Today spoke with Pamela N. Munster, MD, leader of the developmental therapeutics program and co-director of the Center for BRCA Research, about how the center came about, how she became involved, and what she hopes the center will do for BRCA mutation carriers and their families.”

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ASCO Kicks off Ground-Breaking Clinical Trial to Learn from Use of Approved Targeted Cancer Therapies Matched to Tumor Genomics

“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.”


When Gene Tests for Breast Cancer Reveal Grim Data but No Guidance

“At a time when genetic testing and genetically personalized treatments for cancer are proliferating, buoyed by new resources like President Obama’s $215 million personalized medicine initiative, women with breast cancer are facing a frustrating reality: The genetic data is there, but in many cases, doctors do not know what to do with it.

“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.”


CHMP Recommends Afatinib for Second-Line NSCLC

“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.”


Lung-MAP Precision Medicine Trial Makes Exciting Changes

“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 . 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.”


Novel Checkpoints Offer Hope After Standard Melanoma Immunotherapies Fail

“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.”


Is Metastatic Prostate Cancer Tailor-Made for Precision Oncology?

“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.’ “