Ridaforolimus Shows Promise as Maintenance Therapy for Patients With Advanced Sarcoma

Oncology & Biotech News
Published: Wednesday, Aug 03, 2011
ASCO attendeesPatients with metastatic soft-tissue sarcoma had statistically significant improvement in progression-free survival (PFS) when treated with mTOR inhibitor ridaforolimus, results of a multicenter trial showed.

Median PFS improved from 14.6 weeks with placebo to 17.7 weeks among patients treated with ridaforolimus. The 3- and 6-month PFS also showed advantages for the active treatment, according to a report presented in June at the ASCO annual meeting.

“The study met the primary endpoint in progression-free survival improvement,” said Sant Chawla, MD, a medical oncologist at the Sarcoma Oncology Center in Santa Monica, California. “There was a trend toward a benefit for overall survival, with a hazard ratio of 0.88 for ridaforolimus compared with placebo.

“Ridaforolimus provided better tumor control, and the treatment had no adverse impact on survival following disease progression. We observed no major unexpected adverse events and toxicities, which were similar to other mTOR inhibitors.”

Multiples types of sarcomas exhibit dysregulated mTOR signaling. Ridaforolimus is a rapamycin analog that possesses potent mTOR inhibition, and phase I/II clinical trials demonstrated clinical activity in sarcomas.

Table. SUCCEED Trial: Progression-Free Survival Rates


 
Independent Radiology Review
HR = 0.72; P = .0001
 
 
Median PFS
3-Month PFS Rate
6-Month PFS Rate
 
Ridaforolimus
17.7 weeks
70%
34%
 
Placebo
14.6 weeks
54%
23%
 

 
Investigator Assessment
HR = 0.69; P = .0001
 
 
Median PFS
3-Month PFS Rate
6-Month PFS Rate
 
Ridaforolimus
22.4 weeks
72%
37%
 
Placebo
14.7 weeks
55%
23%
 
HR indicates hazard ratio; PFS, progression-free survival.
Adapted from Chawla et al. J Clin Oncol. 2011;29(suppl; abstr 10005).
Chawla presented results of a phase III trial involving 711 patients with metastatic sarcomas that had progressed after initial benefit (response or stable disease) during treatment with as many as 3 prior chemotherapy regimens. Patients were randomized to ridaforolimus or placebo and treated until disease progression. Response was assessed by an independent radiology review.


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