Scandion Oncology has announced positive topline results from Part 3 of its CORIST Phase IIa trial, evaluating SCO-101 in combination with FOLFIRI chemotherapy for metastatic colorectal cancer (mCRC) patients who have developed resistance to FOLFIRI. The trial demonstrated promising signs of efficacy, including tumor reduction, improved Progression Free Survival (PFS), and a high Clinical Benefit Rate (CBR). These results support the continued clinical development of SCO-101 as a potential treatment option for this challenging patient population.
Encouraging Efficacy Data
The CORIST Part 3 trial involved 25 heavily pre-treated mCRC patients with no other active treatment options available. A preliminary analysis revealed a partial response (PR), defined as a tumor reduction of more than 30%, in one patient out of 21 evaluable patients. This observation supports the rationale for combining SCO-101 with chemotherapy to overcome drug resistance.
The study also reported a median PFS of 4.6 months in Part 3, which is superior to the 2.0 months reported in CORIST Part 2 and historical data ranging from 1.7 to 1.8 months. In one cohort within Part 3, the median PFS reached as high as 5.0 months.
Furthermore, the Clinical Benefit Rate (CBR) was 76% after eight weeks of treatment, a significant increase from the 46% CBR observed in CORIST Part 2. In the cohort where the Maximum Tolerated Dose (MTD) was established, the CBR reached 100% after eight weeks. Historical controls have reported CBRs of 11-16% after 6 weeks.
Optimal Dosing and Tolerability
Part 3 of the CORIST trial was designed to establish the optimal dosing schedule and MTD for SCO-101 in combination with FOLFIRI. The MTD of SCO-101 was determined to be 150mg administered in a six-day schedule. The trial also confirmed previous findings suggesting unconjugated bilirubin as a potential biomarker for identifying patients most likely to benefit from SCO-101 treatment. The treatment was generally safe and well-tolerated.
Implications for mCRC Treatment
Metastatic colorectal cancer remains a significant clinical challenge, with high mortality rates and limited treatment options for patients who develop resistance to standard therapies like FOLFIRI. These topline results from the CORIST Part 3 trial suggest that SCO-101, in combination with chemotherapy, may offer a new approach to overcoming drug resistance and improving outcomes for these patients.
"We are very encouraged by the promising topline results reported today, not only establishing a maximum tolerated dose for this indication and drug combination, but also demonstrating impressive progression free survival for the participating patients and tumor shrinkage in a number of them," said Francois Martelet, CEO of Scandion Oncology. "These results strongly support the potential of SCO-101 as a combination treatment of mCRC, a disease which is today characterized by high mortality rates and massive problems with addressing drug resistance."
Scandion Oncology plans to conduct a thorough analysis of the complete dataset from CORIST Part 3 to determine the next steps in the clinical development of SCO-101. The company will host an Investor/R&D Event on February 5th to present the data in detail.
