ATIM-11. PHASE 2 TRIAL OF SL-701, A NOVEL IMMUNOTHERAPY COMPRISED OF SYNTHETIC SHORT PEPTIDES AGAINST GBM TARGETS IL-13Rα2, EphA2, AND SURVIVIN, IN ADULTS WITH SECOND-LINE RECURRENT GBM: INTERIM RESULTS
Year: 2016
Type: conference-abstract
Abstract: SL-701 is a novel immunotherapy comprised of synthetic short peptides designed to elicit an immune response against three overexpressed GBM targets: interleukin-13 receptor alpha-2 (IL-13Rα2), EphrinA2 (EphA2), and Survivin. We report preliminary data from an ongoing multicenter, 2-stage Phase 2 clinical trial of SL-701 in HLA-A2 positive adults with first recurrence of GBM. Patients had to have KPS > 60, age > 18, and failed standard RT/TMZ. In Stage 1, SL-701 with adjuvants GM-CSF and imiquimod is administered biweekly for 6 months, then every 28 days thereafter. In Stage 2, SL-701 with the adjuvant poly-ICLC is administered biweekly with bevacizumab (10 mg/kg). Primary objectives: 1) safety and tolerability 2) investigator assessed objective response rate (ORR) using RANO criteria and 3) survival rate at 12 months. As of 5/17/16, 58 patients (46 in Stage 1 and 12 in Stage 2) received SL-701. Accrual for Stage 1 is complete. Stage 2 accrual is ongoing. Median age is 55 years (range: 23–74), median KPS is 90, and 67% are male. Patients received a median of 4 doses. The most frequent grade 3–4 treatment-related adverse events (TRAEs) were fatigue (n = 1; 1.7%) and altered mental status (n = 1, 1.7%). Among 30 evaluable patients in Stage 1, there was 1 partial response (PR) (33+ weeks duration, ongoing) and 15 stable diseases (SD) (median duration: 8 weeks; range: 8–42+ weeks, ongoing). Of the 4 evaluable patients in Stage 2 to date, there has been 1 PR (8+ weeks duration, ongoing) and 3 SD (median duration: 8 weeks; range: 5–8+ weeks, ongoing). SL-701 plus adjuvants GM-CSF/imiquimod or poly-ICLC and bevacizumab is well-tolerated. Patients are being followed for response, SD, PFS, and OS. Updated study data will be presented.
Source: Neuro-Oncology
Authors: David Reardon, David Peereboom, Burt Nabors, Karen Fink, Surasak Phuphanich, Tom Mikkelsen, Erin Dunbar, Michael Badruddoja, David Schiff, Frank Lieberman, David Tran, Michael Schulder, Nicholas Butowski, Lynn Ashby, Christopher Moertel, Fabio Iwamoto, Jonathan Sherman, Janice Chen, Peter McDonald, Enrique Poradosu, Christopher Brooks, Shay Shemesh, Jeffrey Raizer
Institutions: Harvard University, Dana-Farber Cancer Institute, Cleveland Clinic, University of Alabama at Birmingham, Baylor University Medical Center, Cedars-Sinai Medical Center, Henry Ford Hospital, Piedmont Atlanta Hospital, Center for Neurosciences, University of Virginia, University of Pittsburgh Medical Center, Hofstra University, University of California, San Francisco, Barrow Neurological Institute, University of Minnesota, Columbia University, George Washington University, Stemline Therapeutics (United States), Northwestern University
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2558730841