On June 5, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that positive data from the SL-701 and SL-801 clinical trials were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, IL (Press release, Stemline Therapeutics, JUN 5, 2018, View Source [SID1234527186]). The presentations are available on Stemline’s website (www.stemline.com) under the Scientific Presentations tab.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
SL-701 – Clinical Highlights
The Phase 2 trial of SL-701 in previously treated GBM patients met its primary endpoint of 12-month overall survival (OS-12)
Long-term survivors: 50% OS-12 with SL-701 + bevacizumab
Major responses, including complete responses (CRs), in second-line GBM
Well-tolerated, with very manageable side effect profile
Long-term survivors were comprised largely of patients with target-specific CD8+ T-cell responses
Median OS of target-specific CD8+ T cell responders not reached
Given the major unmet medical need in GBM and promising safety and efficacy data generated to date with SL-701 + bevacizumab, Stemline is considering next steps including leveraging potential immune-related biomarker in registration-directed trial designs
SL-801 – Clinical Highlights
Manageable safety and tolerability profile, largely grade 1-2 adverse events (AEs), to date
Multiple cases of stable disease (SD) in a heavily pretreated solid tumor patient population
Pharmacokinetic (PK) analyses suggest dose-dependent increases in exposure
Ideal therapeutic dose not yet determined as dose escalation continues
Ivan Bergstein, M.D., Stemline’s CEO, commented, "Our BPDCN disease awareness campaign is kicking into high gear as we approach the end of ASCO (Free ASCO Whitepaper), and we believe that our key messages around BPDCN and CD123 are resonating. Our SL-401 regulatory and pre-launch activities continue to progress, and our timelines remain on track." Dr. Bergstein continued, "Additionally, our SL-701 and SL-801 clinical presentations were very well-received at the conference, and our investigators are excited and engaged. The SL-701 + bevacizumab combination has been well-tolerated and has shown activity, including the emergence of long-term survivors comprised largely of target-specific CD8+ T cell responders. Given the major unmet medical need in GBM and SL-701’s promising safety and efficacy data, we are considering next steps, including applying these immune data in registration-directed trial designs. Additionally, we are encouraged by SL-801’s tolerability profile as we continue to dose escalate in a heavily pretreated solid tumor patient population of unmet medical need. Enrollment is ongoing, and we look forward to further updates later this year."