Alchemia Phase III trial misses the mark
THE ROADHOUSE PHARMACY: Alchemia Limited (ASX: ACL) announced its pivotal Phase III trial of HA-Irinotecan in the treatment of patients with metastatic colorectal cancer (mCRC) did not meet its primary endpoint of statistically significant improvement in progression-free survival (PFS).
The Phase III trial enrolled 415 patients across 76 clinical centers worldwide as a randomised, double-blinded, active controlled study of Alchemia’s proprietary HyACT technology formulated with the well-known chemotherapeutic drug, irinotecan.
HA-Irinotecan or irinotecan were administered as part of the conventional FOLFIRI chemotherapy regimen (combination of folinic acid, fluorouracil and irinotecan) in patients with mCRC who were candidates for second-or third-line chemotherapy.
The company explained the primary objective of this trial was to demonstrate superiority in progression-free survival (PFS) of its HA-Irinotecan over irinotecan.
The trial demonstrated a median PFS of 5.5 months for patients treated with HA-Irinotecan as part of the FOLFIRI chemotherapy regimen.
Patients treated with the FOLFIRI regimen containing standard irinotecan also achieved a median PFS of 5.5 months.
A planned interim analysis of overall survival was performed and the FOLFIRI and HA-Irinotecan arms demonstrated an equivalent overall survival of approximately 14 months.
The safety profile was equivalent between both arms of the study.
“We are extremely disappointed in the outcome of this trial and extend our appreciation to trial investigators, the clinical sites and the hundreds of patients who participated in this study,” Alchemia Limited chief executive officer Thomas Liquard said in the company’s announcement to the Australian Securities Exchange.
“We will undertake further analysis of this trial.
“We expect to report back to the scientific community and the market with further details on our data reviews and corporate strategy early in 2015.”
The company’s chief scientific officer, Dr Tracey Brown said Alchemia will be conducting an in-depth review of the data to identify the possible reasons for an unexpectedly high median PFS outcome in the irinotecan control group.
“We will also investigate the impact of other variables, including potential regional and country-specific differences, in outcomes of our Phase III study,” Dr Brown said.
“With these additional analyses in hand, we will be in a better position to formulate the next steps for the HA-Irinotecan development programs.”
Website: www.alchemia.com.au