Use of biomarkers, biologics ups success rate of clinical trials in gastric cancer
Success rates of clinical trials in gastric cancer tend to improve with the use of implementing biomarkers, receptor-targeted therapies, and biologics in clinical development, suggests a recent study.
A team of investigators assessed clinical trial success rates for new drug developments in gastric cancer since 1998 and explored trial design features that could lessen the risk of clinical trial failure. They obtained data from clinicaltrials.gov.
Drugs that entered testing between 1 January 1998 and 1 January 2022 were included, while those that did not have a completed phase I trial or treated secondary effects of gastric cancer were excluded.
The investigators calculated transition probabilities for each phase and compared these with industry averages. They then determined success rates based on biomarker usage, drug target, type of therapy, and drug chemistry.
A total of 1,990 trials were identified, of which 219 were eligible for analysis. The likelihood that a drug would complete all phases of testing and obtain FDA approval was 7 percent, which is below the industry average of 11 percent.
Using biomarkers in clinical development was associated with nearly a twofold increase in the cumulative success rate. Biologics also resulted in greater success rates when compared with small molecules (17 percent vs 1 percent). This finding persisted when comparing both drug types that shared the same target.
In comparisons of receptor-targeted therapies only, biologics remained superior to small molecules (62 percent vs 18 percent). Likewise, biologics continued to perform better when compared with drugs targeting solely HER2 receptors (64 percent vs 24 percent).
“Thus, physicians should prioritize the enrollment of gastric cancer patients in clinical trials that incorporate the aforementioned features,” the investigators said.