“In a new study by Yale Cancer Center, scientists suggest that as the number of clinical trials in cancer immunotherapy grows exponentially, some caution should be exercised as we continue to better understand the biology of these new therapeutic targets. The findings are published today in the journal Cell.
“Researchers around the world have been racing to create therapies that unleash the power of our immune systems against cancer. The most successful of these immunotherapies, which target a molecular pathway known as PD-1/PD-L1, have brightened the landscape for many people suffering with lung cancer and other types of tumors.”
“ASCO and Friends of Cancer Research (Friends) applaud the National Cancer Institute’s (NCI) recent revision of its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials. The protocol template was expanded to help increase the opportunity for participation in NCI-funded clinical trials for patients with certain health-care conditions, as well as to provide an opportunity for patients younger than age 18 to participate in adult clinical trials in certain circumstances.”
“Cancer has an insidious talent for evading the natural defenses that should destroy it. What if we could find ways to help the immune system fight back?
“It has begun to happen. The growing field of immunotherapy is profoundly changing cancer treatment and has rescued many people with advanced malignancies that not long ago would have been a death sentence.”
“In recent years, many Americans have embraced vitamin D and fish oil pills, their enthusiasm fueled by a steady trickle of suggestive research studies linking higher levels of vitamin D with lower rates of cancer and other ills, and fish consumption with reduced heart disease.
“Now a large and rigorous government-funded randomized trial — the only such study of omega-3 fish oils ever carried out in healthy adults, and the largest trial ever done of high-dose vitamin D — has found the supplements do not lower cancer rates in healthy adults. Nor do they reduce the rate of major cardiovascular events, a composite of heart attacks, strokes and deaths from cardiovascular disease. The trial is of the kind considered the gold standard in medicine.”
“ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.”
“Midgut neuroendocrine tumors are a rare type of cancer that develops in the small intestine and colon. Roughly 12,000 people are diagnosed with this disease each year. In January, the United Stated Food and Drug Administration approved Lutathera, a first-of-its-kind peptide receptor radionuclide therapy. The injection consists of a somatostatin analog combined with a radioactive isotope that directly targets neuroendocrine tumor cells.
“Dr. Jonathan Strosberg, head of Neuroendocrine Tumor Program at Moffitt ‘Treatment options have been limited for patients with neuroendocrine tumors and toxicities of treatment can often outweigh the benefit. Our studies have shown Lutathera is an effective option to treat tumor progression and also provide patients with a better quality of life,’ said Jonathan R. Strosberg, M.D., head of the Neuroendocrine Tumor Program at Moffitt Cancer Center.”
“Healthcare informatics firm Massive Bio has enrolled its first patient in a global registry it launched as part of a new clinical trial matching system that seeks to connect patients to appropriate biomarker-based clinical trials using information such as clinical history and genomic testing results.
“Previously, Massive Bio offered its clinical trial matching capability as part of a broader oncology clinical decision support system through which it provides treatment guidance and expert recommendations primarily to oncologists working in community practices. By separating the clinical trial matching component, the company hopes to broaden its market reach, said Massive Bio CEO and Cofounder Selin Kurnaz. The company also hopes the new tool will appeal to contract research organizations, molecular diagnostics companies, and patients themselves.”
“At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind.
“Known as the “Right to Try” legislation, it would allow terminally ill patients access to experimental drugs without the approval of the Food and Drug Administration.
“But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.”
“The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations. The news is a boost for companies like Foundation Medicine and Thermo Fisher Scientific, who are among the few firms with such tests on the market.
“Late Friday, the CMS said that, going forward, it will start to reimburse for tests that use DNA sequencing technology to map the tumors of patients with advanced cancers once approved by the FDA. Two of the already-approved tests fitting this description are FoundationOne CDx, from Cambridge, MA-based Foundation, and Oncomine Dx Target Test, from Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO). FoundationOne CDx looks for 324 cancer-related alterations in patients’ DNA. Foundation amasses a report based on the results and sends it to doctors, who use the data to suggest possible treatments. Oncomine detects 23 genetic alterations associated with non-small cell lung cancer.”