Stemline Therapeutics (STML) Announces Presentation of SL-701 Phase 2 Data in 2nd-Line GBM

November 21, 2016 7:32 AM EST

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Stemline Therapeutics, Inc. (Nasdaq: STML) announced the oral presentation of clinical data from its ongoing Phase 2 trial of SL-701 in patients with second-line glioblastoma (GBM). The Phase 2 results were delivered by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School, at the Society for Neuro-Oncology (SNO) annual meeting in Scottsdale, AZ this past Friday, November 18, at 6:20 PM ET. SL-701 is a subcutaneously delivered immunotherapy designed to generate a long-term T cell response against GBM.

David A. Reardon, M.D., the lead investigator of the study, commented, “We are observing encouraging clinical activity, including major responses, some with promising durability, from the combination of SL-701 and bevacizumab.” Dr. Reardon continued, “These preliminary findings are consistent with a potential long-term immunotherapeutic benefit of SL-701 as a large majority of treated patients remain alive and the trial has not reached a median overall survival.” Dr. Reardon concluded, “We look forward to following our patients and reporting longer-term survival and response data as the trial matures. In parallel, we are evaluating additional combination regimens and the design of a potential pivotal trial.”

SL-701 Phase 2 TrialThe SL-701 Phase 2 trial enrolled second-line GBM patients and was comprised of a single-agent stage (Stage 1; n=46) and a combination stage which evaluated SL-701 with bevacizumab (Stage 2; n=28).

SL-701 was found to be safe and well-tolerated, and demonstrated clinical activity, including major responses, in second-line GBM when used alone or in combination with bevacizumab.

Key efficacy outcomes observed to date with the overall program include:

  • Combination activity in second-line GBM
    • SL-701 + poly-ICLC + bevacizumab (Phase 2 trial, Stage 2; n=21 evaluable)
      • Major responses (n=7; 2 complete responses [CR] and 5 partial responses [PR])
        • 4 confirmed with 2nd response assessment
        • 2 with pending 2nd response assessment
        • 1 progressed prior to 2nd response assessment
      • Response duration encouraging, with several responses of 6 months-plus in duration, all ongoing
      • Overall survival appears promising; median not reached and data continue to mature
  • Single agent activity in relapsed/refractory GBM
    • SL-701 + GM-CSF + Imiquimod (Phase 2 trial, Stage 1; n=42 evaluable)
      • 1 partial response (PR) of 13+ months duration, ongoing
      • 2 stable diseases (SD) of 18+ and 20+ months duration, both ongoing
    • Earlier versions of SL-701 + poly-ICLC (Phase 1 trial)
      • Major responses in second- and third-line GBM

Patients continue to be followed for response and survival, and additional clinical data updates are expected next year, as well as immunocorrelative analyses.

The full presentation is now available on the Stemline website, under the “Scientific Presentations” tab (see link: http://www.stemline.com/scientific-presentations.asp).



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