Leading global life sciences consulting firm Trinity today released a new white paper analyzing the oncology clinical trial pipeline to determine the extent to which basket trials are being utilized and, in particular, how many are likely to be registrational studies resulting in tissue-agnostic indications. Historically, basket trials have been used to explore multiple tumor types in one trial in order to prioritize the ones with the greatest response for further research. However, with Keytruda’s MSI-H and dMMR approval, basket trials have now become a viable registrational strategy to pursue a tissue-agnostic indication. Key findings from the whitepaper include:
- Only 2 trials appear to clearly be pursuing a tissue-agnostic regulatory filing; there are no basket trials currently in Phase III.
- Although many of the trials identified are not clearly linked to a planned regulatory filing for a tissue-agnostic indication, the authors expect that the results of these trials, if positive in the broad indication, could lead to future registrational trials in the next 1-3 years.
- Across the 37 basket trials identified for analysis, 16+ types of biomarkers or genetic mutations are currently being studied. This broad scope verifies the growing trend of tumor-agnostic research across oncologic agents, regardless of biomarker studied.
“In the near term, pending the results of these trials, interest in tissue-agnostic basket trial development is likely to grow, especially as next-generation genomic sequencing continues to become more widespread in oncology,” said Jillian Godfrey Scaife, principal at Trinity. “Whether the number of tissue-agnostic indication approvals will ever be substantial enough to drive a significant shift in treatment approaches remains an open question.”
“With this research, we sought to better understand whether and when there will be a tipping point in the oncology treatment paradigm,” added Vivian DeWoskin, engagement manager. “The growing pool of mid-phase/exploratory tissue-agnostic trials suggests we could be headed in that direction, leading to many long-term implications on the clinical application, commercialization and development of targeted oncolytics in the next several years.”
Trinity works with more than 100 clients annually, including 18 of the top 25 global biopharmaceutical companies and dozens of leading medical device and diagnostic companies. Trinity has over 150 professionals on staff that focus solely on the life sciences industry.