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Biomarker Identification a Challenge and Opportunity in Cancer Drug Development, Survey Finds

NEW YORK – A survey of professionals developing cancer drugs found that while precision oncology is a major area of focus at pharmaceutical companies, there are varying views as to the extent these therapeutic advances will benefit patients.

Dublin-based contract research organization Icon surveyed 104 drug development professionals at small and large pharma companies in North America and Europe about their areas of focus and how precision medicine approaches are changing development strategies.

When Icon asked how these companies categorize the cancers they are trying to develop drugs for, more than half of the respondents (65 percent) said they do so using both pathological and molecular genetic features or just molecular genetic features.

The top three therapeutic categories for which respondents said their employers had development programs include cell and gene therapies (30 percent), targeted therapies (24 percent), and immunotherapies (23 percent). The top five types of therapies under development within these categories that respondents cited were targeted small molecules, mRNA-based cancer vaccines, gene therapies, antibody-drug conjugates, and immunomodulatory cytokines.

When asked about the disadvantages drug developers faced in developing these therapies, the limitation that more than half of respondents (53 percent) noted was biomarker identification and predicting patient response. The respondents also cited gauging harmful or toxic side effects, limited efficacy in a subset of patients, potency control, and off-target effects and inflammation as the most common challenges within drug development programs.

Despite the challenges of identifying response predictive biomarkers, respondents also said that biomarkers were key to improving the drug development process. Nearly half of respondents (47 percent) said using predictive biomarkers was a primary way to improve R&D for oncology drugs while 41 percent cited early biomarker identification, and 45 percent cited innovative clinical trial designs as beneficial.

Icon also probed drug development professionals about how they're employing artificial intelligence tools to advance cancer drugs. While only 16 percent said they were currently using AI or machine learning to detect or assess biomarkers, 49 percent said using AI and ML to support such work could accelerate oncology drug development the most.

In the future, nearly half of respondents (49 percent) said cancer treatment will mostly involve care that is personalized based on molecular genetic characteristics or other precision approaches, but respondents had varying expectations about how much patients will benefit from these approaches. About a third of respondents (37 percent) said they expect patient outcomes in 10 years to almost always be favorable or to dramatically improve with these new approaches. A higher proportion of respondents (43 percent) expect the outcome improvements will be moderate or minimal, and 20 percent predicted that patients' outcomes will not change or will worsen.

"Encouragingly, this survey illustrates the continued investment sponsors are making to develop new oncology treatments. The outlook with regards to future impact is varied given considerations around stage of development, likely clinical benefit, treatment accessibility, and implementation into current standard of care treatments," Andreas Dreps, senior VP and head of oncology and immunology drug development at Icon, said in a statement, adding that the challenges identified through the survey highlight "the need for robust clinical development programs that address the complexity sponsors face — from a scientific, regulatory and commercial perspective."