Scandion Oncology announced final data from its CORIST trial, revealing promising results for SCO-101 in overcoming drug resistance in metastatic colorectal cancer (mCRC). The data supports the advancement of SCO-101 into a randomized phase II proof-of-concept trial.
The CORIST trial, involving 71 patients who received at least one dose of SCO-101, demonstrated a good safety and tolerability profile across 534 cycles, representing 20 patient years of treatment. The maximal tolerated dose (MTD) was defined for both 4-day and 6-day schedules, with no long-term safety issues observed.
Clinical Activity and Biomarker Identification
In CORIST part 2 (N=25), clinical activity was observed, with a median Progression Free Survival (mPFS) of 2 months, median Overall Survival (mOS) of 10.4 months, and a Clinical Benefit Rate (CBR) of 42%. Analysis based on the bilirubin index (BI) showed a statistically significant increase in mOS from 6.66 to 13.35 months.
CORIST part 3 (N=28) evaluated two dosing schedules, identifying the RP2D of 250mg SCO-101 in the 4-day schedule. Notably, two patients receiving the RP2D achieved partial responses (PR) with over 30% tumor reduction and continued treatment until the end of the study (44 weeks), subsequently offered compassionate use.
The mPFS for all evaluable patients (N=24) in CORIST part 3 was 3.76 months. UGT1A1 genotype was identified as a potential biomarker, with a statistically significant mPFS of 7.04 months in patients with wild-type UGT1A1 compared to 3.32 months in those with non-wild-type UGT1A1 genotypes.
Overall Survival Benefits
Similarly, the mOS for evaluable patients was 7.92 months. Patients with wild-type UGT1A1 had an mOS that was not yet reached, while those with non-wild-type UGT1A1 had an mOS of 6.94 months, a statistically significant difference. Eight patients from CORIST part 3 remain in survival follow-up, ranging from 6.0 to 24.5 months.
Next Steps
"With the finalization of CORIST, we can conclude that we are ready with an optimal dose and schedule to move forward into the next steps of the clinical development of SCO-101 which will entail a randomized phase II Proof of Concept trial," said Lars Damstrup, CMO at Scandion Oncology. He added, "Implementing a useful biomarker is a crucial tool in the development of any new drugs in oncology. With our impressive increase in OS and PFS based on UGT1A1 we will implement this potential biomarker in future studies."
