The long and winding road to market
Clinical trials in oncology are more time-consuming than in other therapeutic areas. Trials planners need to take into account a complex set of factors including tumor heterogeneity (including disease staging), biomarkers, patient eligibility criteria, clinical endpoints that best mimic readouts for efficacy, as well as follow-up timelines. As a result, oncology clinical trials often rely on novel designs: basket trials, for example, test one drug in several tumor indications (this is the approach that invIOs has taken with its APN401 cell therapy candidate).
For precision cancer treatments such as invIOs’s novel cell therapies, which are personalized to each patient, success involves working closely with multiple stakeholders. Trial protocols must be well designed; trial sponsors have to comply with the specifications of regulatory bodies, as well as common standards such as GCP, to ensure that the highest standards are maintained. Drug developers must develop robust processes and structure the trial design to ensure that the data gathered during the trial is consistent and clear. Finally, trial execution must be efficient and effective, with accurate data collection, monitoring and analysis.
The future of clinical oncology trials
Despite these challenges, oncology is one of the leading areas for innovation in the growing global therapies market. A record 30 oncological novel active substances were launched globally in 2021, and a total of 159 since 2012. And the pace of innovation shows no sign of slowing, with the trial pipeline for immune oncology therapies growing by 233% in 2017-2020[5].
This staggering growth has been driven by years of fundamental cancer research that have yielded pioneering discoveries such as immune checkpoints – like the well-known PD-!/PD-L1 axis or Cbl-b, which invIOs targets with APN401 and INV441 – and other advances in cell engineering including chimeric antigen receptors (CARs)[6].
The revolution in cancer treatment is being paralleled by similarly seismic shifts in the design, pre-authorization and execution of clinical trials. In immune oncology, greater patient stratification and more nuanced efficacy measurements are becoming the norm. As treatment strategies and trial design continue to advance, it is vital that regulatory approaches and education of medical staff, hospital workforces and key opinion leaders (KOLs) also evolve so that patients can benefit from safe, well tolerated and highly effective treatments.
With more and more novel treatments entering clinical trials, the potential for finding treatments for rare and complex cancers continues to increase. Precision and individualized therapies such as those being developed by invIOs have the potential to transform the lives of patients, offering new tools to fight cancers. Optimal clinical trial design and execution will be key to making these breakthroughs possible.
