Final Data from Phase IIa CORIST Part 2 Trial Shows Promising Median Overall Survival of 10.4 Months

Patients participating in part 2 of the CORIST trial demonstrated a median Overall Survival (OS) of 10.4 months, a significant improvement over the historical median OS range of 5-7 months for similar patient populations treated with placebo or best supportive care. This trial involved 25 heavily pretreated patients with metastatic colorectal cancer (mCRC) who had no other active treatment options available.

A notable finding from the trial was the identification of unconjugated bilirubin as a potential biomarker for predicting patient response to the treatment. A subset of 17 out of 25 patients exhibited a transient increase in unconjugated bilirubin, correlating with a median OS of 13.4 months, compared to 8.0 months in patients with a persistent increase.

The trial also evaluated Progression Free Survival (PFS) and Clinical Benefit Rate (CBR) as secondary endpoints. The median PFS was 2.0 months, and the CBR after 16 weeks was 21%, with an increase to 42% after 8 weeks. Tumor shrinkage was observed in four patients, although it did not meet the trial's primary endpoint threshold of +30%.

These results are encouraging for the continued development of SCO-101, especially for patients with hard-to-treat refractory cancer. The identification of a potential biomarker could significantly impact the selection of patients most likely to benefit from SCO-101 treatment, highlighting the importance of further research in this area.

The findings from the CORIST part 2 trial represent a significant step forward in the treatment of cancer resistant to current therapies, offering hope for improved survival rates and quality of life for patients with mCRC.