On December 14, 2021 Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage biopharmaceutical company focused on research and development for novel cancer therapeutics, reported that the Phase 3 WIZARD 201G study will terminate following its second interim analysis after determining there is a low probability of meeting the primary endpoint of overall survival at the final analysis (Press release, Sumitomo Dainippon Pharma, DEC 14, 2021, View Source [SID1234597152]). This study evaluated the safety and efficacy of Ombipepimut-S Emulsion (DSP-7888)*, an investigational WT1 immunotherapeutic cancer vaccine, in combination with bevacizumab versus bevacizumab alone in patients with recurrent or progressive glioblastoma (GBM) following initial therapy.

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"Patients with recurrent or progressive glioblastoma have a high unmet medical need and we intended to develop a new treatment option for this population," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "We are disappointed with the results of this Phase 3 trial and would like to express gratitude to the trial’s participants, investigators, and staff for their efforts and contributions to the study. SDP Oncology is committed to continuing our pursuit of advancing our pipeline to bring forward innovative treatments for patients with cancer."

The multicenter, open-label, randomized Phase 3 WIZARD 201G study evaluated the efficacy and safety of Ombipepimut-S Emulsion in combination with bevacizumab versus bevacizumab alone at 185 events in the second interim analysis of a pivotal trial with an enrollment planned for 338 patients. Patients were randomized one-to-one in the study. The study’s primary endpoint was overall survival with an adaptive design and two planned interim analyses. The overall safety profile was generally tolerable. The most common adverse events occurring in patients in the Ombipepimut-S Emulsion in combination with bevacizumab arm were injection site reactions, hypertension, headache and fatigue. Final data and analyses of this study will be published for the oncology community.

The study of Ombipepimut-S Emulsion in combination with checkpoint inhibitors in solid tumors with an expansion arm in platinum-resistant ovarian cancer (NCT03311334) will continue as planned.

*Adegramotide/nelatimotide is assigned as the international nonproprietary name (INN).

About Ombipepimut-S Emulsion (DSP-7888)

Ombipepimut-S Emulsion (DSP-7888) is an investigational WT1 immunotherapeutic cancer vaccine containing two peptides that induce WT1-specific cytotoxic T-lymphocytes (WT1-CTL) and helper T-cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that adding a peptide to induce helper T cells may improve outcomes compared to a treatment regimen based on a killer peptide alone.1

Ombipepimut-S Emulsion is in a Phase 1/2 study (estimated enrollment number of patients: 84; NCT03311334) in the United States in combination with nivolumab or pembrolizumab in patients with advanced solid tumors with a Phase 2 expansion arm in platinum-resistant ovarian cancer in combination with pembrolizumab. In 2017, the U.S. Food and Drug Administration granted Orphan Drug Designations for Ombipepimut-S Emulsion in brain cancer and in myelodysplastic syndrome (MDS).

About Glioblastoma

Glioblastoma multiforme (GBM) is the most aggressive form of primary brain cancer.2 In 2018, approximately 11,000 men and women in the U.S. were diagnosed with GBM.3 GBM is a highly infiltrative form of cancer and is not surgically curable, which leads to a high recurrence rate and poor prognosis. The overall 5-year survival rate is approximately 5.7%.3 Treatment barriers to GBM include its ability to create an immunosuppressive tumor microenvironment (TME) that is further protected by the confines of the blood-brain-barrier.4