This year marked Phesi’s first attendance as an exhibitor at ASCO, the annual meeting of professionals and exhibitors, held by the American Society of Clinical Oncology. At the event, we announced the news that Phesi has created a new digital twin for Cytokine Release Syndrome (CRS) patients following Chimeric Antigen Receptor (CAR)-T therapy, based on our analysis of 5,473 CAR-T treated patients. The news opened up some insightful conversations at the event and has created opportunities to fundamentally transform clinical research.
CAR-T immunotherapies have become widely used in the treatment of aggressive lymphomas, leukemia, and multiple myeloma. However, CAR-T can cause severe side effects, including CRS, an acute systemic inflammatory syndrome caused by the cytokines released by infused CAR-T cells. The condition affects more than 54-91% of CAR-T patients, and is characterized by fever and multiple organ dysfunction, as well as neurological side effects. CRS is one of the most frequent and serious side effects of CAR-T therapy, yet to date only one treatment for the condition has been approved by the FDA: Tocilzumab.
A decade has passed since the discovery of the first immunotherapies, and new treatments are only becoming more essential: CAR-T is now being prescribed for more indications, particularly for blood cancers. However, the industry’s endeavors to find more treatments for CRS have been largely held back so far. Due to the relative scarcity of CRS patients, the search for new therapies is effectively akin to evaluating a rare disease.
The use of a placebo control arm already raises ethical questions in other areas of clinical development – but because of the rapid onset and often life-threatening nature of CRS, double-blind trials for this indication are not feasible. In place of a placebo arm, the industry must embrace a new approach, utilizing artificial intelligence and big data analysis.
Phesi’s new digital twin will function as a synthetic control arm, eliminating the need for a placebo setting. This will greatly accelerate the search for new CRS therapies and allow sponsors to better model and predict outcomes. The digital twin approach also makes clinical development far more patient-centric, reducing both patient and investigator site burden by eliminating the need for placebo treatments.
To learn more about Phesi’s new digital twin for CRS patients, visit: https://www.phesi.com/news/digital-twins-car-t-in-cancer-treatment/.