On February 27, 2018 SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (SELLAS), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported that data from the Phase 2 trial of its lead candidate, galinpepimut-S (GPS), in acute myeloid leukemia (AML) have been published in the current issue of Blood Advances (Press release, Sellas Life Sciences, FEB 27, 2018, View Source [SID1234524259]). GPS met its pre-specified primary endpoint of ≥34% actual overall survival (OS) rate at three years with a GPS-induced OS rate of 47.4%. Median disease-free survival (DFS) from first complete response was 16.9 months, while the overall survival (OS) from diagnosis has not yet been reached, but is predicted to be > 67.6 months. GPS targets the antigen, Wilms tumor 1 (WT1) protein, which has been ranked by the National Cancer Institute as the leading target for cancer immunotherapy.
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"These data follow on prior positive data in AML and various cancer indications, supporting the development of GPS as an important potential therapy in the treatment of AML and other cancers," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS. "We are encouraged by the collective supporting evidence generated by our Phase 1 and Phase 2 AML studies. We wholeheartedly appreciate the participation of patients and their families in all our clinical studies, as well as the exceptional physicians and study teams. We look forward to advancing GPS into a Phase 3 trial in AML."
For patients in the older cohort (age >60; n=13), median OS post-diagnosis was 35.8 months. Historical controls for comparable patients over sixty years of age who reach first complete remission (CR1) show median OS since initial diagnosis of 9.5-15.8 months.
"We were especially pleased with the findings in AML patients over sixty years of age, which are important considering the poor prognosis particularly for those patients, even with optimal use of current care standards" stated Peter Maslak, M.D., Chief, Immunology Laboratory Service at Memorial Sloan Kettering Cancer Center and Principal Investigator of the study.
The open-label Phase 2 study evaluated GPS in 22 adult patients with AML (median age – 64 years) in CR1. Patients received 6 vaccinations administered over 10 weeks with the potential to receive 6 additional monthly doses if they remained in CR1. Immune responses (IR’s) were evaluated after the sixth and twelfth vaccinations by CD4+ T-cell proliferation, CD8+ T cell interferon-γ secretion (ELISPOT) or the CD8-relevant WT1 peptide MHC tetramer assay (HLA-A*02 patients only).
"Older adults with AML who achieve complete remission (CR) are in critical need of new treatment options to prevent emerging relapses, especially in cases where allogeneic stem cell transplant is infeasible or is not predicted to improve outcome," stated Gert Ossenkoppele, M.D., Ph.D., professor of Hematology at the VU University Medical Center in Amsterdam, The Netherlands, and chair of the AML working party of HOVON (Dutch-Belgian Hematology Trial Group). "Results from this GPS Phase 2 study reinforce the potential of this innovative WT1-targeting immunotherapy in the post-CR maintenance setting. I look forward to co-leading the Phase 3 study in AML patients older than 60 years, currently being planned by SELLAS." Dr. Ossenkoppele did not participate in the GPS Phase 2 study.
In the study, GPS was well tolerated, with the most common side effects being Grade 1/2 injection site reactions (46%), fatigue (32%), and skin induration (32%). Fourteen patients (64%) completed more than six vaccinations, and nine (41%) received all 12 vaccine doses. Nine of 14 tested patients (64%) had an immune response (IR) in more than one of three assays used (one for CD4 or two for CD8).
The article, "Phase 2 trial of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia," is available in the current issue of Blood Advances, a peer-reviewed medical journal published by the American Society of Hematology (ASH) (Free ASH Whitepaper). The complete article can be accessed here (View Source).