Soft Tissue Sarcoma

February 9, 2015

CytRx reported results of a phase IIb study of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas (STS). In this randomized, open-label, 123-subject, 31-center, phase IIb trial, subjects with advanced soft tissue sarcomas were randomized 2:1 to receive either 350mg/m2 of aldoxorubicin (83 subjects) or 75mg/m2 of doxorubicin (40 subjects) every three weeks for up to six cycles. Subjects were then followed every six weeks with CT scans to monitor tumor size. The OS results in 123 patients showed aldoxorubicin-treated patients demonstrated a 27% reduction in the risk of death compared to patients treated with doxorubicin (HR 0.73: 95% confidence interval 0.44-1.20), the current standard-of-care in this indication. In addition, aldoxorubicin-treated patients demonstrated a 41% likelihood of surviving more than two years, a two-fold increase, compared to a 20% probability for doxorubicin- treated patients. Median overall survival was 16 months (95% confidence interval 13.1-not reached) for aldoxorubicin-treated patients v. 14.4 months (95% confidence interval 8.7-20.9) for doxorubicin-treated patients (p=0.21). For treatment-naive patients, representing 90% of the patients in the clinical trial, median overall survival was 16 months (95% confidence interval 13.1-not reached) for aldoxorubicin-treated patients v. 14 months (95% confidence interval 8.7-20.1) for doxorubicin treated patients (p=0.14). Progression-free survival (PFS) results demonstrated treatment with aldoxorubicin increased median PFS approximately 79% to 8.4 months, compared to 4.7 months with doxorubicin, meeting the study’s primary endpoint (HR=0.419; p=0.0007). In blinded central radiology review, PFS results demonstrated treatment with aldoxorubicin increased median PFS approximately 104% to 5.7 months, compared to 2.8 months with doxorubicin, also meeting the study’s primary endpoint (HR=0.584; p=0.024).

January 24, 2011

ARIAD Pharmaceuticals and Merck released positive results from a phase III trial of ridaforolimus, for the treatment of soft-tissue or bone sarcomas. This randomized, placebo-controlled, double-blind study, SUCCEED (Sarcoma Multi-Center Clinical Eval. of the Efficacy of Ridaforolimus), enrolled 711 subjects with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. The subjects received placebo or oral ridaforolimus administered at 40 mg a day for five consecutive days, followed by two days off, until disease progression. The primary endpoint of improved progression-free survival (PFS) compared to placebo was reached. Based on the full analysis of 552 PFS events, determined by an independent review committee, there was a statistically significant (p≡0.0001) 28% reduction by ridaforolimus in the risk of progression compared to placebo. Ridaforolimus treatment resulted in a statistically significant 21% (3.1 week) improvement in median PFS (ridaforolimus, 17.7 weeks versus placebo, 14.6 weeks). Based on the full analysis determined by the investigative sites, there was a statistically significant (p<0.0001) 31% reduction in the risk of progression compared to placebo. Ridaforolimus resulted in a statistically significant 52% (7.7 week) improvement in median PFS (ridaforolimus, 22.4 weeks versus placebo, 14.7 weeks).

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