CytRx Corporation (NASDAQ:CYTR) released positive updated data from its pivotal Phase III clinical trial assessing aldoxorubicin versus investigator’s choice in subjects with relapsed or refractory STS. The trial, which registered 433 patients, showed a statistically considerable improvement in PFS between aldoxorubicin and investigator’s select therapy in 246 subjects with liposarcoma and leiomyosarcoma, (p=0.007).
The hazard ratio was 0.62, representing a 38% decline in the tumor progression risk for patients getting aldoxorubicin versus investigator’s choice. Liposarcoma and Leiomyosarcoma are the two most popular types of STS and comprised for 57% of the subjects enrolled in the study.
Aldoxorubicin showed a statistically considerable improvement in PFS compared to investigator’s choice in 312 subjects cured in North America. Notably, aldoxorubicin fared better than investigator’s choice for the complete trial population and barely missed statistical significance. All responses were decided by an independent, blinded central laboratory assessment of scans.
The expert view
Sant Chawla, the Principal Investigator for the Phase III trial, said that this report shows a vital measure taken forward for STS, a rare, very difficult-to-treat and highly complex group of cancers. This data is important as they show that treatment with aldoxorubicin can spread the time to development in a clinically significant way. The study design applied was more stringent compared to any prior clinical study in STS as it assessed aldoxorubicin to real world options.
The control arm enabled investigators to choose any one of the 5 most popularly used treatments best matched for their subjects’ specific type of STS. Contrasting other clinical studies for refractory or relapsed STS which used either placebo or dacarbazine as the control, this trial was biased in favor of selecting the best treatment for the patients, a truly innovative study design.
CytRx intends to submit the report of this clinical study for presentation at an imminent major scientific meeting. In the inclusive study population, aldoxorubicin reported a statistically considerable improvement in the DCR; defined as ORR plus stable disease for minimum 4 months of 29.4% compared to 20.5% for the subjects cured with investigator’s choice.