• Groups ask FDA to issue five guidance documents to increase clinical trial eligibility for cancer patients
• Trials could open to patients with HIV, spread of brain cancer, teenagers

New cancer therapies could reach patients more quickly under a proposal by two cancer groups to increase access to the clinical trials that are essential for FDA approval.

The proposal, which the groups sent Aug. 9 to the Food and Drug Administration, would allow patient populations that typically have been excluded from participating in cancer clinical trials, including adolescents, HIV patients, and those whose cancers have spread, or metastasized, to the brain. The brain metastases proposal alone would open up cancer trials to the patients with the 70,000 diagnoses of brain metastases that occur each year in the U.S.

Clinical trial recruitment has been an ongoing challenge for researchers who want to test new therapies, and fewer than 5 percent of adult cancer patients enroll in clinical trials. Without enough patients to run a clinical trial, drug and device companies can’t demonstrate the safety and effectiveness that’s required to bring new products to market, which could affect the 1.7 million Americans who will receive a new cancer diagnosis this year.

“One of the challenges that has always been a problem for the clinical trials enterprise as a whole is accrual,” Jeff Allen, president and chief executive officer of Friends of Cancer Research, told Bloomberg Law in an Aug. 9 interview. The Friends group submitted the proposal jointly with the American Society of Clinical Oncology (ASCO).

The groups hope the FDA will use these proposals to lay out in formal guidance documents ways to allow greater participation in studies by re-examining or modifying the exclusion criteria, Allen said. “It’s a good thing for patients in terms of having greater access to trials as a option in their care,” he said. “And I think it’s a good thing for the conduct of trials as well.”

FDA spokeswoman Sandy Walsh told Bloomberg Law the agency will carefully review and consider these recommendations. “We’ll continue to work with the community on better access to experimental therapies being tested in clinical trials by modernizing eligibility criteria and look forward to continuing to work together on these efforts,” she wrote in an Aug. 9 email.

FDA Modernizing Clinical Trials System

The submission from ASCO and Friends comes as the FDA wants to overhaul the current clinical trial system. “FDA is committed to advancing new policies to make the drug development and review process more modern, more scientifically rigorous and more efficient,” Walsh told Bloomberg Law.

Friends and ASCO submitted to the FDA recommended language for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations build on two years of work to modernize eligibility criteria to promote greater patient participation in cancer clinical trials. Their proposal would open up cancer trials to patient populations who typically have been excluded, including patients with:

• brain metastases;
• HIV/AIDS, hepatitis B, and hepatitis C;
• organ dysfunction; and
• prior and concurrent malignancies

They also propose lowering the minimum age below 18 for first-in-human studies and all adult clinical trials.

ASCO President Monica M. Bertagnolli said in an Aug. 9 statement, “Eligibility criteria ensure patient safety, but if they are overly strict, they can jeopardize accrual for clinical trials and reduce the ability to apply trial results to treating patients with cancer in clinical practice.”

Advances in HIV treatment have changed the disease from a death sentence in the 1980s to a more chronically managed condition, which means an HIV infection won’t necessarily interfere with a cancer treatment, Allen said. As HIV patients are living longer, they also may be more likely to develop other diseases including cancer. People infected with HIV are about 500 times more likely to be diagnosed with Kaposi’s sarcoma, a cancer that develops from the cells that line lymph or blood vessels, according to the National Cancer Institute, part of the National Institutes of Health.

FDA Leader’s Openness

FDA Commissioner Scott Gottlieb indicated during ASCO’s annual meeting last month he wants to modernize eligibility criteria for clincal trials.

Draft guidance issued this summer by the FDA indicates the agency may particularly be open to the proposal to allow more adolescents to enroll in clinical trials, which Gottlieb also referenced.

“Although most cancers in children and adults are distinctly different entities, there are some diseases that occur in both and span the adolescent age groups,” Gottlieb said. “If there’s no evidence that an investigational drug might have exaggerated toxicity in younger patients, then we’re encouraging sponsors to enroll adolescents into disease appropriate trials.”

https://news.bloomberglaw.com/pharma-and-life-sciences/cancer-clinical-…;

Reproduced with permission. Published Aug. 9, 2018. Copyright 2018 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com&gt;