In April, MesotheliomaHelp reported on the success of the Wilms Tumor-1 (WT1) vaccine, also known as galinpepimut-S, in its orphan designations in both the United States and the European Union. At the Annual Meeting of the American Society of Clinical Oncology (ASCO) in early June, representatives from Sellas, the maker of galinpepimut-S, announced “exciting results” from two separate phase 2 clinical trials for the drug, for the treatment of acute myeloid leukemia and malignant pleural mesothelioma.
According to a June 6 press release from Sellas Life Sciences Group, the “exciting results” of the drug trials have cleared the way for the company to move forward with “a pivotal Phase 2b/3 trial in patients with MPM [malignant pleural mesothelioma], later this year,” as well as a Phase 3 trial acute myeloid leukemia patients.
“Galinpepimut-S has continued to demonstrate outstanding results and updated findings in regard to survival, immunological responses, and safety in AML and MPM,” said Dr. Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS.
Mesothelioma is a rare, aggressive form of cancer primarily caused by past exposure to airborne asbestos fibers. Each year close to 3,000 Americans are diagnosed with the incurable cancer. While there is currently no known cure for the disease, the clinical trials and studies that are underway bring hope to mesothelioma patients with each discovery for new approaches to treating the disease.
WT1 is over-expressed in many human cancers, including mesothelioma, and the National Cancer Institute recently ranked WT1 as the top target for cancer immunotherapy, according to Sellas. The WT1 vaccine is a late clinical-stage cancer immunotherapy that targets the WT1 antigen in certain cancers including acute myeloid leukemia (AML), mesothelioma (MPM), multiple myeloma, ovarian cancer. Sellas reports that WT1 has not been druggable by traditional approaches, but it can be targeted by the immune system making this research critical to these cancers with few treatment options.
- The trial showed a median overall survival of 24.8 months for galinpepimut-S-treated MPM patients versus a median 16.6 month overall survival for patients in the control arm after the most recent patient follow-up as of May 2016.
- Patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit.
- Galinpepimut-S demonstrated a favorable safety and tolerability profile in MPM patients and was well-tolerated by patients in the trial.
In a separate press release announcing these same results at the International Mesothelioma Interest Group in May, Sellas announced the Phase 2b/3 study of WT1 vaccine in mesothelioma patients will commence by 3Q 2016.
“We have seen a great deal of excitement about the study, which, in addition to the US, will enroll patients at sites internationally,” said Andres Gutierrez, M.D., Ph.D., SELLAS’s Chief Medical Officer. “The clinicians have been very pleased as we’ve started to roll out our careful and scientifically rigorous clinical plan, which will ultimately provide the foundations for a strong regulatory path forward.”