BioStock contacted Mads Kronborg, Head of Communications, to find out more.
Scandion Oncology The goal is to become the first biotechnology company to offer a combination treatment for treatment-resistant, metastatic cancers. Drug resistance is found in approximately 90 percent of patients with metastatic cancer. The leading project CHORUS evaluates the candidate SCO-101 in metastatic colon cancer and is in part two of a phase II study. At the end of last week, the company communicated topline results from the study, which failed to meet the primary outcome measure regarding efficacy. However, the results are sufficiently positive in terms of safety and tolerability, for the company to choose to take the project to the next part, which involves dose escalations.
PoC not yet achieved
Part two of CORIST's four planned parts included 25 patients with metastatic colorectal cancer, all of whom had acquired resistance to treatment and were RAS wild-type. Patients were treated with the established dose of SCO-101 in combination with current standard of care FOLFIRI. The results showed several positive signals; tumor reduction was seen in some patients, but below the defined threshold reduction of at least 30 percent. This means that the primary outcome measure of the study is not met. Other positive signals were seen in the secondary outcome measures, which showed signs of prolonged progression-free survival and stable disease.
Scandion's acting CEO Johnny Stilou commented on the results in a press release:
»While we do not achieve a clinical proof of concept for efficacy through these topline results, we are encouraged by the signals observed in the trial, confirming the rationale for combining SCO-101 and FOLFIRI in this indication.«
The company emphasizes that the majority of the difficult-to-treat patient population was only treated for eight weeks – and since patients are still receiving continued treatment within the framework of the study, the released topline data is not final. The results could, the company believes, look different after a longer period of treatment.
In addition to efficacy parameters, the results further provide understanding of the candidate's pharmacokinetics as well as confirmation of safety and tolerability in combination with FOLFIRI in the indication.
Part three continues as planned
Based on the increased knowledge of how the candidate is handled by the body, Scandion plans to enroll up to 36 patients in a dose-escalation schedule, which constitutes part three of CORIST. By testing higher doses of SCO-101 in combination with FOLFIRI, Scandion aims to the company to investigate the full potential of the candidate, as the current dose selection was not sufficient to achieve the primary objective of the study. Part three will include patients with RAS wild-type as well as patients with RAS mutations. Read more about this here.
Scandion Oncology comments
BioStock contacted Mads Kronborg, Head of Communications, to find out more.
The topline data from part two of CORIST phase II could not provide Scandion with Proof-of-Concept. Could you specify what is required in order to obtain PoC in this particular study?
- The primary endpoint of this study is responses observed in treated patients, which may occur as late as after 9-12 months of treatment. So technically we could not reach proof of concept at the current time point as we did not observe responses so far, but things may change as some patients are still treated.
One could debate whether eight weeks of treatment is enough to show PoC. Could you elaborate on why most of the patients had only been treated for 8 weeks?
– This time point was chosen as potentially meaningful and it is identified in the study protocol. Eventually it proved non conclusive and possibly waiting for 16 or 24 weeks could have been more useful, but this can only be said with hindsight. In any case it was always specified and clear that this was a topline communication only, even more so after the recent study amendment that expanded the study.
Can we expect an update on the final outcome of part two of CORIST phase II, or will it automatically transition to part three?
- We will not be reporting further since that would be intermediate results patient by patient and that is not how clinical trials are conducted and reported. The CORIST protocol foresees another topline assessment when part 4 patients will have received the 8 week scan. Further to this, we expect to report the results of part 3 and the final dose we will use for part 4.