FDA-AACR Workshop Examines the Practice and Promise of Real-world Evidence in Oncology

Building on advances in technology and analytical tools, real-world data (RWD) sources have attracted increasing interest as means to efficiently answer important clinical, research, and regulatory questions around oncology treatments and outcomes. RWD can come from a variety of sources, including medical claims data, electronic health records, patient-reported outcomes, and product or disease registry data. Real-world evidence (RWE) is clinical evidence generated from these data.

While the randomized controlled trial remains the gold standard for gathering clinical evidence for regulatory use, RWE can provide critical insights in situations where such trials may be difficult to complete. This is especially relevant in oncology, where personalized medicine approaches are leading to increasingly smaller patient populations that necessitate new strategies for efficient drug development.

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The Net Widens for Research on Rare Cancer

Rare cancers, when taken all together, make up an estimated 20 to 25 percent of all cancers diagnosed. With more than 1.7 million people in the U.S. expected to be diagnosed with cancer this year, that could mean as many as 400,000 people will learn they have a rare cancer. Often, these patients have few treatment options.

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AACR Annual Meeting 2019: A Record Year for Clinical Trials Presentations

Over the course of AACR Annual Meeting 2019, there were 213 presentations on incredibly exciting clinical trials. This is a record number of clinical trial presentations for an AACR Annual Meeting. The trials presented covered the continuum of cancer treatment, from surgery, to radiotherapy and chemotherapy, to the two newest pillars of cancer care—molecularly targeted therapy and immunotherapy. The final clinical trials plenary session of the Annual Meeting epitomized this diversity by showcasing clinical trials reporting new ways to combine radiotherapy with other types of treatment, and new advances in immunotherapy and molecularly targeted therapy.

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AACR Annual Meeting 2019: Patients as Partners in the Research Process

In the past couple of decades, progress against cancer has created a new generation of survivors. Today, more than 16.9 million people in the United States are cancer survivors. While their experiences are incredibly diverse, many are living well. They work, they tend to their families, they travel … and many are inspired to play a role in the cancer research community.

The Presidential Select Symposium at the AACR Annual Meeting 2019 addressed these crucial roles in a session titled “Engaging Cancer Patients as Partners in the Research Process.” The session was moderated by outgoing AACR President Elizabeth M. Jaffee, MD, Deputy Director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

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AACR Annual Meeting 2019: New Approaches to Treating Drug-resistant Non-small Cell Lung Cancer

About 80 percent of lung cancers are non-small cell lung cancers (NSCLC), and about 15 to 20 percent of NSCLCs harbor epidermal growth factor receptor (EGFR)-activating mutations.
Treatment for EGFR-mutant NSCLC improved dramatically with the introduction of EGFR tyrosine kinase inhibitors (TKIs). Several TKIs targeting this receptor have been developed, including the U.S. Food and Drug Administration (FDA)-approved first-generation EGFR TKIs gefitinib (Iressa) and erlotinib (Tarceva); second-generation EGFR TKIs, such as the FDA-approved afatinib (Gilotrif) and dacomitinib (Vizimpro), and the investigational therapeutic neratinib; and third-generation EGFR TKIs, including the FDA-approved osimertinib (Tagrisso), and the investigational therapeutics olmutinib and nazartinib.

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AACR Annual Meeting 2019: PD-1 Pandemonium

“Do you want to have fun?” Richard Pazdur, MD, director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, asked the audience as he opened the “PD-1 Pandemonium: FDA Speaks with Industry on the Past, Present, and Future of PD-1 Drugs” regulatory science and policy session at the American Association for Cancer Research (AACR) Annual Meeting 2019 on Monday, April 1.

Pazdur explained that he and AACR staff in the Science Policy and Government Affairs Office thought that it would be informative to convene representatives from all the companies who have an FDA-approved PD-1– or PD-L1–targeted immunotherapeutic for a heart-to-heart conversation about the past, present, and future of this group of revolutionary cancer treatments.

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AACR Annual Meeting 2019: Promising Data from CAR T-cell Clinical Trials for Advanced Solid Tumors

A pair of studies presented at the AACR Annual Meeting 2019 demonstrated encouraging clinical outcomes with two different chimeric antigen receptor (CAR) T-cell therapies for patients with advanced solid tumors.

CAR T-cell therapy is a type of immunotherapy in which T cells are removed from a patient’s body and genetically modified so that they can recognize the patient’s cancer cells. The modified T cells, when reintroduced into the patient’s body, multiply and attack cancer cells. The U.S. Food and Drug Administration has approved two CAR T-cell therapies for blood cancers so far: tisagenlecleucel (Kymriah) for treating certain patients with acute lymphoblastic leukemia or non-Hodgkin lymphoma (NHL), and axicabtagene ciloleucel (Yescarta) for treating certain adults with NHL.

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How Can We Use Technology to Advance Population Science Research?

There has been a rapid expansion of technology in recent years, from artificial intelligence to intensive genetic sequencing to wearable trackers of fitness and health. How all of this technology can be effectively incorporated into population sciences research is an area of active inquiry.

To facilitate discussion and showcase research in this area, the American Association for Cancer Research (AACR) is hosting a conference, Modernizing Population Sciences in the Digital Age, in San Diego from Feb. 19-22. This four-day meeting will include discussions about the best use of mobile technology, how to best leverage large datasets, and how to incorporate modern technologies into existing and upcoming studies.

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Research Highlights from the San Antonio Breast Cancer Symposium 2018

The 41st San Antonio Breast Cancer Symposium, held Dec. 4-8, drew more than 7,500 attendees from more than 90 countries. The Symposium offered the latest clinical, translational, and basic research, providing a forum for interaction and communication among researchers, health professionals, and those with a special interest in breast cancer.

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How Can We Turn “Cold” Pancreatic Tumors “Hot”?

Pancreatic cancer remains a challenging disease to treat, with a five-year survival rate of less than 9 percent, according to recent statistics. Unlike many other cancers, which can now be treated with checkpoint blockade immunotherapy, pancreatic cancer often does not respond to this type of treatment. One potential reason for this lack of efficacy is that pancreatic tumors tend to be nonimmunogenic, meaning that the cancer fails to elicit a strong immune response.

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