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TGF-beta2 inhibitor has clinical benefit in high-grade gliomas
A phase-3 study of the drug, SAPPHIRE, is currently enrolling patients.
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AACR 101st Annual Meeting
WASHINGTON, D.C. — The use of trabedersen, a TGF-beta2 specific phosphorothioate antisense oligonucleotide, in patients with high-grade gliomas resulted in a clear clinical benefit with an acceptable safety profile. Trabedersen was especially beneficial in patients with anaplastic astrocytoma.
Piotr Jachimczak, MD, senior scientific advisor at Antisense Pharma, the company developing the drug, presented the phase-2b data by phone at the American Association for Cancer Research 101st Annual Meeting in Washington, D.C.
One hundred and forty-five patients with refractory or recurrent high-grade glioma were randomly assigned standard chemotherapy, 10 mcM trabedersen or 80 mcM trabedersen. The study was designed to evaluate response rate, survival and treatment safety.
“In order to deliver this molecule efficiently, we used convection enhanced delivery,” Jachimczak said. The drug is delivered via single multihole catheter using a portable pump and subcutaneous infusion line. “This allows us to treat our patients for a longer time without the need of additional surgical procedures at each treatment cycle,” he said.
In addition, this delivery method circumvents the blood-brain-barrier, and places few restrictions on patient activity, according to Jachimczak.
Trabedersen had the most activity in patients with anaplastic astrocytoma assigned the 10 mcM dose. At a follow-up of 24 months, survival was 83.3% in patients assigned 10 mcM trabedersen compared with 53.3% in patients assigned 80 mcM and 41.7% in patients on standard chemotherapy.
These patients had a duration of response of 29.1 months vs. eight months on standard chemotherapy.
However, any patient assigned trabedersen had a longer OS than those assigned chemotherapy. Patients on chemotherapy had a median OS of 21.7 months; those assigned 10 mcM trabedersen had a median OS of 39.1 months, for a survival benefit of 17.4 months.
Finally, in those patients with glioblastoma, trabedersen was as effective as standard chemotherapy. However, in a subgroup of patients with glioblastoma aged 55 years or younger, the two-year survival rate was 44% compared with 13.3% in patients assigned standard chemotherapy. - by Leah Lawrence
For more information:
- Jachimczak P. #3716. Presented at: AACR 101st Annual Meeting; April 17-21, 2010; Washington, D.C.
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