Penn Researchers Tap into Roche’s Flatiron Database for Study Revealing Oncologists Effectively Responding to FDA Safety Alerts

Sep 25, 2019 | Adverse Events, Oncology, Safety Alerts

University of Pennsylvania Abramson Cancer Center researchers conducted a study to assess just how nimble are oncologists to FDA safety alerts. The study found that once the FDA moved to restrict the label of two immunotherapies, usage by oncologists dropped by 50%.

TrialSite News follows up with question and answer summary of this study.

Who sponsored the study?

Abramson Cancer Center at the University of Pennsylvania (Penn Medicine).

Who Funded the Study?

The study was funded by 1) the Conquer Cancer Foundation and 2) the National Cancer Institute of The National Institutes of Health

Why is the study timely?

As the world of cancer medicine grapples with the rapid pace of approval for new therapies, particularly as it relates to the FDA’s accelerated approval (AA) program. There are so many new treatments available it is hard to keep up as many physicians have incredibly busy schedules.

What are the concerns with the FDA accelerated approval (AA) program when it comes to cancer drugs?

The FDA’s AA program has come under significant scrutiny in recent months. There are plenty of supports of course—as the program does in fact bring promising drugs into the clinic more expeditiously, which can benefit millions of patients and even save lives. However, critics counter that these drugs shouldn’t come to market prior to undergoing extensive randomized Phase III clinical trials, which is considered the gold standard in medical and drug development research.

How was the Study Conducted?

The study, published in JAMA, examined usage rates of two immunotherapies approved for first-line use in advanced bladder cancer patients who are not eligible for standard cisplatin-based chemotherapy: the PD-1 inhibitor pembrolizumab and the PD-L1 inhibitor atezolizumab. The FDA approved both therapies in 2017 based on phase II studies. However, data from ongoing phase III studies showed patients had decreased survival when taking these drugs compared to undergoing first-line platinum-based chemotherapy. This led the FDA to restrict the label indications compared to the original approval. The restrictions went into effect in June 2018.

Using a de-identified data set from the Flatiron Health database, which is derived from the health records from more than 280 oncology clinics across the United States, Penn researchers initiated a study to examine the treatments for 1,965 patients with advanced bladder cancer. Between May 2018 and January 2019, the rate of immunotherapy usage among these patients decreased from 51.9 percent to 30.3 percent per 100 patients. The rate of chemotherapy usage increased from 37 percent to 60.6 percent per 100 patients. Rates of PD-L1 testing also increased from 9.3 percent to 21.2 percent per 100 patients.

Brief Summary

The Penn Medicine researchers found that the findings offer reassurance that oncologists can be nimble enough to quickly incorporate the latest guidelines into their practices when new safety data comes to light. However, the researchers caution that there are other factors that could be contributing to the trends observed. Further study is needed to continue to assess the effect of label changes on clinical practice.

Lead Research/Investigator

Ronac Mamtani, MD, MSCE, assistant professor of Hematology-Oncology, Perelman School of Medicine, University of Pennsylvania

Ravi B. Parikh, MD, MPP, Medical Ethics and Health Policy, University of Pennsylvania

Blythe Adamson, PhD, senior qualitative scientist, Flatiron Health

Aaron Cohen, MD, MSCE, associate medical director of Flatiron Health

About Penn Medicine

Penn Medicine is one of the world’s leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System, which together form a $7.8 billion enterprise.

The Perelman School of Medicine has been ranked among the top medical schools in the United States for more than 20 years, according to U.S. News & World Report’s survey of research-oriented medical schools. The School is consistently among the nation’s top recipients of funding from the National Institutes of Health, with $425 million awarded in the 2018 fiscal year.

The University of Pennsylvania Health System’s patient care facilities include: the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center–which are recognized as one of the nation’s top “Honor Roll” hospitals by U.S. News & World Report–Chester County Hospital; Lancaster General Health; Penn Medicine Princeton Health; and Pennsylvania Hospital, the nation’s first hospital, founded in 1751. Additional facilities and enterprises include Good Shepherd Penn Partners, Penn Home Care and Hospice Services, Lancaster Behavioral Health Hospital, and Princeton House Behavioral Health, among others.

Penn Medicine is powered by a talented and dedicated workforce of more than 40,000 people. The organization also has alliances with top community health systems across both Southeastern Pennsylvania and Southern New Jersey, creating more options for patients no matter where they live.

Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2018, Penn Medicine provided more than $525 million to benefit our community.

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