Alchemia enters analysis stage for mCRC trial

Alchemia (ASX:ACL) has entered the endpoint analysis phase for its pivotal phase III trial of HA-Irinotecan in metastatic colorectal cancer.

The trial has achieved its primary endpoint analysis threshold for a minimum of 350 progression-free survival (PFS) events, paving the way for statistical analysis.

The database lock means that no further changes to the trial data will occur and that the validated dataset has been finalised and sent to Alchemia’s statisticians for analysis. Results are now expected to be released by the end of October.

The randomised, double-blinded, active controlled trial enrolled 415 patients across 76 clinical centres. The patients all had mCRC and were candidates for second- or third-line chemotherapy.

Patients were administered HA-Irinotecan - a formulation of popular chemotherapeutic irinotecan using Alchemia’s HyACT technology - as part of the conventional FOLFIRI regimen. The primary goal is to demonstrate improved PFS in HA-Irinotecan compared to irinotecan.

“We are excited to reach the final stage of the phase III trial process, and we look forward to the results of this trial, which has the potential to substantially impact the current second- and third-line treatment regimen for patients with metastatic colorectal cancer,” Alchemia CEO Thomas Liquard commented.

“A successful trial would be transformational for Alchemia as our further validated HyACT platform could then be applied to many different chemotherapy agents used against a broad range of solid tumours.”

Alchemia (ASX:ACL) shares were trading 1.56% higher at $0.650 as of around 2 pm on Monday.