US-based biopharmaceutical firm CytRx has reported updated results from its ongoing Phase IIb clinical trial, evaluating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas (STS).
New data from the multicenter, randomised, open-label trial showed that aldoxorubicin significantly increases progression-free survival (PFS), PFS at six months, overall response rate (ORR) and tumour shrinkage, compared with doxorubicin, the current standard-of-care, as a first-line treatment in patients with STS.
Sarcoma Oncology Center director and principal investigator of the trial Sant Chawla said the results indicate that aldoxorubicin is well-tolerated and may improve clinical outcomes in patients compared with doxorubicin therapy, the current standard-of-care in this indication.
"This includes promising improvements in progression-free survival, tumour shrinkage and overall response rates in patients with a wide variety of soft tissue sarcomas," Chawla said.
"We are hopeful that the next stage of development for aldoxorubicin, a well-tolerated single agent that lacks the cardiotoxicity associated with doxorubicin therapy, will demonstrate its potential to meaningfully extend survival, and will lead to a new treatment option for patients fighting this aggressive, life-threatening cancer."
A total of 123 patients with advanced soft tissue sarcomas were enrolled in the 31-centre Phase IIb trial and they were randomised 2:1 to receive either 350mg/m2 of aldoxorubicin or 75mg/m2 of doxorubicin every three weeks for up to six cycles.
These patients were then followed every six weeks with CT scans to monitor tumour size.
Two approaches were used to evaluate the efficacy of aldoxorubicin compared with doxorubicin in these patients, which include evaluation by the study investigators, as well as assessment by a blinded central laboratory review.
The trial’s primary endpoint was PFS and secondary endpoints included PFS at six months for each group, ORR and overall survival, which will be reported when the clinical trial is complete.
CytRx president and chief executive officer Steven Kriegsman said these results were selected for presentation at the 2014 American Society for Clinical Oncology (ASCO) Annual Meeting.
"We look forward to discussing the data with the oncology community and to reporting the full overall survival results from this trial in the second half of 2014," Kriegsman said.
"In parallel, we continue to actively enroll patients in our pivotal global Phase III trial in second-line STS. In that Phase III clinical trial, we are permitted to dose until progression, which could substantially enhance the benefit for sarcoma patients."
Image: Undifferentiated soft tissue sarcoma in left lung of young child. Photo: courtesy of ThatPeskyCommoner.