Most Popular News Stories on OBR Daily
(ECCO) Nov 15, 2018 - A combination of two drugs, which prompt the body’s immune system to identify and kill cancer cells, is a safe treatment for patients with advanced non-small cell lung cancer and has shown some signs of efficacy. Results from a phase I/II clinical trial in 25 patients, presented at the 30th EORTC-NCI-AACR  Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland, today (Thursday), identified the maximum tolerated doses at which NIR178 (PBF-509) and spartalizumab (PDR001) could be given to patients whose disease had either failed to respond or stopped responding to previous treatments. The disease shrank or disappeared in two patients and it remained stable, without progressing, in 14 patients.
(Reuters) Nov 28, 2018 - Merck & Co Inc said on Wednesday it raised U.S. prices on five of its drugs earlier in November by between 1.5 percent and 6 percent, including its top-selling cancer treatment Keytruda. The list price increases are the first that the U.S. drugmaker has made since pledging in July that it would not raise the average net price of all of its medicines by more than the inflation rate.
(ProPublica/New York Times) Dec 8, 2018 - One is dean of Yale’s medical school. Another is the director of a cancer center in Texas. A third is the next president of the most prominent society of cancer doctors. These leading medical figures are among dozens of doctors who have failed in recent years to report their financial relationships with pharmaceutical and health care companies when their studies are published in medical journals, according to a review by ProPublica and The New York Times and data from other recent research. Dr. Howard A. “Skip” Burris III, the president-elect of the American Society of Clinical Oncology, for instance, declared that he had no conflicts of interest in more than 50 journal articles in recent years, including in the prestigious New England Journal of Medicine.
(MSK/OnCancer Blog) Nov 26, 2018 - Larotrectinib is the first cancer drug to be FDA approved based on its effect on a specific mutation in a tumor. The US Food and Drug Administration has approved the drug larotrectinib (Vitrakvi®; LOXO-101) for cancers caused by a genetic mutation called a TRK fusion. This groundbreaking targeted therapy is the first to be developed and approved based solely on its effect on a specific genetic change in a tumor, regardless of where in the body the tumor originated.
(Nature.com) Nov 19, 2018 - The stunning failure of a once-promising cancer drug has got some researchers arguing that the field has moved too fast in its embrace of therapies that unleash the immune system. The drug, epacadostat, blocks a protein called IDO that hobbles immune cells if left unchecked. Early trials suggested that the drug could be a powerful weapon against some advanced cancers when paired with existing therapies that bolster the body’s immune response to tumours. But a large, controlled study of epacadostat was halted in April after the drug failed to show benefits.
(AstraZeneca) Nov 16, 2018 - AstraZeneca and MedImmune, its global biologics research and development arm, today announced final overall survival (OS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy and the combination of Imfinzi and tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) platinum-based chemotherapy in previously-untreated patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). In the primary analysis population of patients, whose tumours express PD-L1 on 25% or more of their cancer cells as determined by the VENTANA PD-L1 (SP263) Assay, Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving OS compared to SoC chemotherapy. While the OS result did not meet statistical significance, a hazard ratio (HR) of 0.76 (97.54% CI 0.564-1.019; nominal p=0.036) was observed with Imfinzi monotherapy. The combination therapy had an HR of 0.85 (98.77% CI 0.611-1.173; nominal p=0.202); the data support further analysis in exploratory subgroups.
(StreetInsider) Nov 26, 2018 - The Centers for Medicare & Medicaid Services (CMS) proposal to allow Medicare Part D and Medicare Advantage plans to dictate access to drugs in the “six protected classes” is a potential nightmare for vulnerable patients with cancer. For the first time ever, Medicare patients with cancer and other serious diseases that rely on drugs in these protected therapeutic categories, will no longer have guaranteed access to potentially life-saving drugs. Instead, they will be subjected to “fail first” step therapy and formulary restrictions that potentially restrict them from receiving the evidence-based therapies that their trained physicians prescribe as first line cancer treatment.
(FDA.gov) Nov 21, 2018 - The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy. “Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities. Today’s approval gives health care providers another tool to use in the treatment of AML patients with various, unique needs. Clinical trials showed that overall survival was improved using Daurismo in combination with LDAC compared to LDAC alone for patients who would not tolerate intensive chemotherapy,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
(New York Times) Nov 19, 2018 - 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. “Patients with advanced cancer are increasingly living for years not months,” a recent editorial in the journal JAMA said. It added that longer survival means that health workers in just about every specialty — not just oncologists — will be taking care of people who are living with cancer or recovered from it.
(Penn Medicine) Nov 28, 2018 - Drug is the first to target common mutation associated with relapse, short survival in AML. The U.S. Food and Drug Administration (FDA) has approved the first ever inhibitor drug specifically approved for treating patients with relapsed or refractory acute myeloid leukemia (AML) with a mutation in the Fms-like tyrosine kinase 3 (FLT3) gene. Patients with these mutations who have relapsed or refractory AML have very low response rates to chemotherapy at the time of relapse and their survival is poor as a result.