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An effective and more affordable treatment for lung cancer may not gain approval after the Food and Drug Administration (FDA) complained about the lack of black people in its clinical trial, with a top FDA cancer official repeatedly noting in a meeting that it is Black History Month.
Eli Lilly and a Chinese partner called Innovent believe the drug, known as Tyvyt or sintilimab, could extend the lives of those suffering with late-stage non-squamous non-small cell lung cancer (NSCLC), and be more affordable than other treatments. The clinical trial patients were Asian because the trial was conducted in China.
But at a meeting Thursday to decide whether the drug’s application for U.S. approval was satisfactory, Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said “We just had a meeting yesterday with external groups to celebrate Black History Month and the primary thing that many people said, and I’m sure all of you on this call have heard it, that our clinicians, that our clinicians, we want people that look like us on this trial, okay.”
“I’m very unhappy to have this conversation on this month which is obviously Black History Month. I think we really have to do a better job of this. We have several programs at the FDA on this, including Project Equity, trying to address this issue,” he said.
In the study, called the Orient-11 trial, patients receiving Tyvyt along with chemo reduced disease progression by 52% compared to chemo alone, and reduced the risk of death by 35%. Fierce Pharma noted prior to the meeting that Eli Lilly has made the drug’s affordability a prime selling point, boasting of its “disruptive pricing strategy.”
Padzur said the trial “does not reflect the ethnic and racial make up of a U.S. population notably with regard to groups traditionally underrepresented in clinical trials.”
If there is harm from a trial being done with people of a different race, though, by far the biggest group affected would seem to be whites, not blacks who are “traditionally underrepresented.” In the U.S., 79% of patients with non-squamous NSCLC are white.
An Innovent official said “There’s no reason to suggest that the safety in the U.S. patients would differ from the results observed in ORIENT-11.”
But Pazdur said “the representation of ethnic and racial minority groups is not just a biological reason we want people on these trials, it’s to build confidence in the clinical trials and a confidence after these drugs are approved that they should be used in these groups,” he said. An FDA presentation added that non-biological “ethnic factors” may impact drug efficacy, such as smoking, alcohol, food habits, and “drug compliance.”
In 2019, Pazdur encouraged Chinese companies to conduct drug trials in order to bring lower-cost medicine to the U.S., as Fierce Pharma reported. Pazdur alluded to that comment Thursday, but said “Over the past two to three years, especially since the pandemic, this country has experienced significant social change and there has been a tremendous outcry for diversity in clinical trial and representation. We as a public agency, the FDA have to adhere to what patients want in the United States… So we have a huge commitment to diversity.”
The FDA presented its concerns to a panel of experts who were charged with voting on how to deal with the request to proceed with approval in the U.S. One panelist, Dr. Jorge Nieva, critiqued their logic, arguing that bringing a low-cost, life-saving drug to market would help all groups, especially impoverished ones.
“This drug works,” he said. “Regarding the need for resolving health equity issues in the U.S., health equity I think will improve when there are fewer cost barriers to care. And having more drugs competing for those same patients will have, I think, greater impact on equity than the need for diversity in clinical trial enrollment.”
But after the negative presentation from the FDA and Pazdur’s comments, all the other panelists voted “no.” The vote could have an effect on many more drugs. The presentation asked: “Should additional clinical trials demonstrating applicability to U.S. patients and U.S. medical care be required prior to a final regulatory decision?”
Some information in the FDA presentation appeared to provide support that the trial was well-designed. “ORIENT-11 trial design, enrollment criteria, and statistical assumptions closely resemble landmark NSCLC trials which changed treatment paradigm to include immune checkpoint inhibitors,” it said.
The FDA presentation said there was no reason to think the way the drug worked on Chinese people was different from the way it would work on white Americans. “Population pharmacokinetic (PopPK) analyses compared pharmacokinetic (PK) characteristics of Chinese (n=475) and U.S. patients… Modeling and simulation data suggest no clinically significant difference in PK between White and Chinese patients, or significant effect of body weight on PK.”
It added: “However, limited U.S. patients do not represent ethnic and racial diversity of U.S.” It omitted that the same Innovent study actually appears to show blacks’ PK characteristics to be more similar to Asians’ than whites are.
Clinical trial participants are volunteers, and many drugs approved by the FDA have clinical trial pools consisting of many highly educated white males, because those are the people who volunteered. Increased hurdles to creating a satisfactory pool of participants could block or slow drugs’ entrance to market.
A 2020 medical paper said “Recruitment of participants takes up to 30% of development timelines, and ~1.2 billion USD is spent on this activity… [w]ith 11% of clinical research sites failing to enroll even a single participant, and 37% of sites under-enrolling.”
Female participants often must use appropriate birth control during the trial. It is difficult for people with hourly jobs to participate because it can involve going to repeated appointments during the day. People who are unhealthy beyond the illness being studied cannot serve. And those who are selected must remain reliably in touch in order to complete the trial.
A 1995 paper said that people are not interested in participating in clinical trials for many reasons, including “does not value clinical research,” “belief that investigator is more interested in the research than in patient wellbeing,” fearful of being a “guinea pig.”
It said blacks are particularly uninterested in participating because one of the most famous medical experiments, the Tuskegee Syphilis Experiment, deliberately let its black participants suffer for years. The paper also cites “low level of education.”
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