The updated Part 3 interim data confirm the rationale for the optimized dosing schedule in terms of pharmacokinetic data, biomarker potential, early signs of efficacy and interim OS data.
Early signs of efficacy have been reported in terms of long Progression Free Survival (PFS), Clinical Benefit Rate and partial tumor responses in two patients. In alignment with the Part 2 data, a low Bilirubin Index (BI) was also in Part 3 found to be clearly associated to increased PFS and improved OS with 6 of 9 patients still alive in the “low BI” group. The UGT1A1 genotype was investigated and patients with UGT1A1 wildtype had both longer PFS and OS than patients with mutated UGT1A1. Noteworthy, in the UGT1A1 wildtype patients the current mPFS is 7.04 months and the mOS is 13.74 months. These interim data are very promising, and final data are expected in H2 2024.
“These encouraging results confirm the rationale behind our optimized dosing strategy and highlight the significant potential of SCO-101 and our innovative mechanism of action to enhance treatment outcomes in this challenging patient population,” said
The optimized dosing schedules resulted in the expected changes in PK and data demonstrated a slight decrease (app. 20%) in the maximum peak value (Cmax) of the active chemotherapy (SN-38) and an increase in the maximum peak value of SCO-101. The overall exposure to SN-38 and SCO-101 remained largely unchanged compared to CORIST Part 1. Additionally, SCO-101 caused a clear increase in the plasma levels of SN-38, caused a 5-fold shift in the ratio between active SN-38 and inactive SN-38 and an increase in unconjugated bilirubin. This is in full alignment with the PK data from CORIST Part 1.
“Altogether, the updated Part 3 interim data is very positive. Based on the current, still preliminary, overall survival data and based on data from Part 2 of the trial, we have data to support that these early signs of efficacy have the potential to translate into clinical meaningful improvement in overall survival, especially for the patients with positive biomarkers,” said Lars Damstrup, CMO at
The updated data is planned to be further explored by increasing the irinotecan component of FOLFIRI in a 4-days schedule with 250 mg SCO-101 to establish the MTD in this schedule and to define the Recommended Phase 2 Dose (RP2D) for the subsequent randomized Phase IIb study.
The topline data for mPFS included censored patients and was reported to 4.6 months. Un-censoring changed the mPFS to a final value of 3.8 months for the 21 evaluable patients.
For further information please contact:
Johnny Stilou, CFO
Phone: +45 2960 3532
E-mail: jos@scandiononcology.com
This information is information that
Drug resistance remains a massive problem in cancer treatment and in the development of new medicines. Scandion’s lead compound SCO-101 is currently studying metastatic colorectal cancer (mCRC) in its Phase 2 CORIST trial, while the PANTAX Phase 1 program is developing SCO-101 for pancreatic cancer.
Scandion is based in
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