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Targeted Oncology - Herbst Explains the Potential for TMB Use as a Biomarker for Immunotherapy Response in NSCLC Trials

Tumor mutational burden (TMB) has generated interest as a potential biomarker of response to immunotherapy and has already been examined in the context of several lung cancer trials to gauge its utility.

 

One such analysis, which was presented at the 2019 European Society of Medical Oncology (ESMO) Congress, explored the association between tissue TMB and efficacy of immunotherapy from patient samples taken from 2 completed trials of pembrolizumab (Keytruda) monotherapy in patients with non–small cell lung cancer (NSCLC).

 

The ASCO Post - Friends of Cancer Research Launches ctDNA Pilot Project

Friends of Cancer Research (Friends) recently announced the launch of its latest project, ctMoniTR. This pilot project will aim to harmonize the use of circulating tumor DNA (ctDNA) to monitor treatment response in patients with cancer and test the feasibility of data comparison from different clinical studies.

 

The ASCO Post - Confirmation Hearing for FDA Commissioner Nominee Stephen Hahn, MD

On November 20, 2019, Stephen Hahn, MD, President Trump’s nominee to be the next Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the Senate Health, Education, Labor, and Pension Committee and answered wide-ranging questions relating to the many important roles the Commissioner must oversee. In a statement released by Friends of Cancer Research (Friends), Ellen Sigal, PhD, Chair and Founder, offered the following remarks.

Regulatory Focus - FDA’s Project Orbis May Expand to Singapore and Switzerland

The US Food and Drug Administration (FDA) may expand a pilot project that allows for simultaneous drug approval decisions from US, Canadian and Australian regulators to include Singapore and Switzerland, Richard Pazdur, director of FDA’s Oncology Center of Excellence, said Tuesday at the Friends of Cancer Research's annual meeting in Washington, DC.

 

AJMC - Data Collaborations Are Driving Improvements to the Use of Real-World Evidence

The number of expedited FDA approvals for cancer drugs that are based on surrogate end points is increasing, leading many to search for new ways to uncover efficacy and safety data to justify the costs associated with these treatments. With the growth of data innovations and collaborations, the answer might be found in real-world evidence (RWE), according to presentations at the 9th Annual Research Symposium held in conjunction with the AMCP Nexus 2019 meeting,

 

Science Magazine - Ph.D.–turned–policy insider takes over world’s largest science society

Sudip Parikh has helped shape U.S. science policy as a staffer on a powerful congressional spending panel. He’s been a senior health care executive for a large nonprofit organization that manages several federal research facilities. And in January 2020, the 46-year-old structural biologist will become the new CEO of AAAS (which publishes Science) as the 171-year-old association pursues its mission to advance science and serve society.

 

The ASCO Post - Friends of Cancer Research Hosts Annual Leadership Awards

On September 24, 2019, Friends of Cancer Research (Friends) hosted its 23rd Annual Cancer Leadership Awards Reception. The event honored individuals who have been champions of cancer research and steadfast advocates for patients: Anna Barker, MA, PhD, Professor and Director, Transformative Healthcare Networks, Arizona State University, who was awarded this year’s Ellen V.

OncLive - Dr. Kim on Clinical Trial Eligibility Criteria in Lung Cancer

Edward S. Kim, MD, chair, Department of Solid Tumor Oncology, Levine Cancer Institute, discusses clinical trial eligibility criteria in lung cancer.

 

JAMA - Older Patients (Still) Left Out of Cancer Clinical Trials

A decade before he became the US Surgeon General, Vivek Murthy, MD, published a 2004 study in JAMA about participants in cancer clinical trials. Among other findings, Murthy and his coauthors concluded that from 2000 to 2002, people aged 65 years or older were “strikingly underrepresented” in a set of National Cancer Institute–funded drug trials. Fifteen years later, a JAMA Oncology study suggests that not much has changed for older people with cancer. In fact, things appear to be getting worse.

 

Precision Oncology News - Q&A: The Parker Institute's Theresa LaVallee on the Path Forward for Precision Immuno-Oncology

Theresa LaVallee joined the Parker Institute for Cancer Immunotherapy in 2017 and is currently VP of translational medicine and regulatory affairs. As part of the institute's efforts to bring precise and powerful immunotherapies to cancer patients, LaVallee and colleagues are on the front lines of both drug and biomarker development for a new class of therapies that are challenging the models of precision medicine established with the emergence of genomically targeted therapies.

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