A recent study revealed the impact of biomarker analyses on oncology trial success and clinical development timelines, with patterns varying by cancer type. The study’s findings were reported in The Oncologist.1

The researchers noted that, in a prior study, “biomarker usage in oncology trials was associated with higher rate of success in clinical trials, with effects seen in breast, melanoma, and lung cancer.”2  

However, incorporating biomarkers adds complexity to trial design and the interpretation of results, so the researchers aimed to characterize the effects of biomarkers on the speed of clinical trials and the clinical development timeline.1


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The researchers used the ClinicalTrials.gov registry to collect timeline data for clinical trials in 4 cancer indications involving drugs that completed phase 1 trials between 1998 and 2020. The 4 indications were non-small cell lung cancer (NSCLC), metastatic breast cancer, metastatic melanoma, and metastatic colorectal cancer. 

The study included 1224 trials that encompassed 671 drugs. The researchers found no significant differences in mean durations between biomarker trials and nonbiomarker trials. 

However, the timing of biomarker inclusion in clinical development timelines varied somewhat by cancer type. In trials of NSCLC, colorectal cancer, and breast cancer, biomarker trials appeared to be conducted later in the timelines, compared with nonbiomarker trials. This pattern was strongest in trials for NSCLC. 

In melanoma, however, biomarker trials appeared to be more prevalent earlier in the clinical development timeline, while nonbiomarker trials dominated later.

The researchers also evaluated time to clinical trial failure by trial phase. In phase 3, trials using biomarkers were less likely to fail at a particular time point than nonbiomarker trials (hazard ratio [HR], 0.50; 95% CI, 0.29-0.87; P <.05). 

However, the time to failure did not differ between biomarker and nonbiomarker trials in phase 1 (HR, 1.06; 95% CI, 0.52-2.15; P =.88) or in phase 2 (HR, 0.77; 95% CI, 0.42-1.40; P =.41).

Other patterns were evident according to cancer type, with some exceptions for particular trial phases. Overall, biomarker use was associated with longer gaps in time between trial phases for colorectal and breast cancer. Such gaps were not evident in nonbiomarker trials in these indications or in biomarker trials for NSCLC and melanoma. 

In NSCLC and melanoma, biomarker trials more often ran concurrently over somewhat shorter periods of time than nonbiomarker trials did (excepting phase 3 for melanoma).

The researchers concluded that biomarker use may affect some aspects of clinical trial timing and failure risk, with some indication-specific patterns. 

“[C]linicians deciding on clinical trial participation need to consider whether the indication under consideration risks facing potential delays when biomarkers are included,” the researchers wrote. 

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

  1. Mohamed L, Manjrekar S, Ng DP, Walsh A, Lopes G, Parker JL. The effect of biomarker use on the speed and duration of clinical trials for cancer drugs. Oncologist. Published online August 22, 2022. doi:10.1093/oncolo/oyac130
  2. Hayashi K, Masuda S, Kimura H. Impact of biomarker usage on oncology drug development. J Clin Pharm Ther. 2013;38(1):62-67. https://doi.org/10.1111/jcpt.12008