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Clinical Trials

Date: 2016-06-06

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago

Company: SELLAS Life Sciences (Switzerland)

Product: galinpepimut-S (human Wilms tumor protein 1 peptides - WT1 vaccine)

Action mechanism:

peptide/vaccine. This vaccine is comprised of four modified peptide chains that induce a strong adaptive T-cell immune response (CD4+/CD8+ T-cells) against the WT1 antigen.  The WT1 vaccine is administered in combination with an adjuvant and an immune modulator to improve the immune response to the target. Based on its mechanism and the accumulating evidence of activity in mid-stage trials, the WT1 vaccine may have the potential to complement currently available therapies by destroying residual tumor cells of cancers in remission and providing ongoing immune surveillance for recurrent tumors. The WT1 vaccine has been originally developed by Memorial Sloan Kettering Cancer Center and licensed to Sellas. 

Disease: malignant pleural mesothelioma

Therapeutic area: Cancer - Oncology - Rare diseases

Country:

Trial details:

SELLAS’ Phase 2 double-blinded, randomized (1:1) study compared WT-1 analog peptides vaccine in combination with Montanide-adjuvant + Granulocyte-macrophage colony-stimulating factor (GM-CSF), versus Montanide-adjuvant + GM-CSF in patients with MPM who had previously completed combined modality therapy. Thirty-nine patients were to be enrolled in each arm at two centers, MSK and M.D. Anderson Cancer Center. However, in May 2015, the trial’s independent Data Monitoring Committee requested discontinuation of the control arm due to futility while leaving open the WT1 cancer vaccine arm. This change led to unblinding the study earlier than planned: total enrollment has reached 40 patients, with 19 patients in WT1 cancer vaccine arm and 21 in the control arm.

Latest news:

* On June 6, 2016, SELLAS™ Life Sciences Group announced that  a poster was presented at the ASCO meeting detailing positive Phase 2 results of galinpepimut-S for the treatment of patients with malignant pleural mesothelioma (MPM).  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.

* On May 4, 2016, SELLAS Life Sciences Group announced that results from a Phase 2 trial of the Company’s WT1 cancer vaccine in patients with malignant pleural mesothelioma (MPM) were presented at the plenary session of the iMig 2016 Conference, being held May 1-4, 2016, in Birmingham, UK. As reported in an oral plenary session presentation at this week’s iMig Conference, treatment with galinpepimut-S in a randomized, double-blind, placebo-controlled Phase 2 trial conducted at Memorial Sloan Kettering Cancer Center (MSK) and M.D. Anderson Cancer Center resulted in improved overall survival in patients with MPM and doubling of progression-free survival:The trial showed a median overall survival of 21.4 months for WT1 vaccine-treated patients versus a median 16.6 months overall survival for patients in the placebo control arm. The WT1 cancer vaccine also resulted in a median progression-free survival of 11.4 months, double that of the control arm, 5.7 months, in patients with MPM.
The WT1 vaccine demonstrated a favorable safety and tolerability profile in MPM patients.
Patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit
Patients who mounted an immune-response with galinpepimut-S had a significant survival benefit
Galinpepimut-S was very well tolerated by patients in this trial.

Based on these results, SELLAS is preparing to initiate a pivotal Phase 2b/3 trial of its WT1 vaccine in patients with MPM by the third quarter of 2016.

* On October 12, 2015, SELLAS Life Sciences Group  announced top-line data from the Company’s Phase 2 clinical study of its WT1 cancer vaccine in patients with malignant pleural mesothelioma (MPM). The study showed clinically meaningful greater median overall survival (OS) in patients receiving the WT1 cancer vaccine: 39 months OS versus 18 months OS for patients in the control arm. Typical median overall survival in patients with MPM receiving currently available treatment options ranges from 15-18 months. In addition, the WT1 cancer vaccine resulted in a median progression-free survival (PFS) of 11.5 months, more than double that of the control arm (5.5 months). The investigators continue to track patient outcomes. As the study was unblinded sooner than expected due to the discontinuation of the control arm for futility, there was a smaller patient cohort and shorter follow-up than originally planned. During the trial, the WT1 vaccine was shown to have a favorable safety and tolerability profile.

These and other top-line clinical results from the ongoing WT1 Phase 2 trials will be presented by David A. Scheinberg, M.D., Ph.D., in Kyoto, Japan, at the upcoming 8th International WT1 Conference on November 19-20, 2015. Dr. Scheinberg is Chairman of MSK’s Pharmacology program and the Center for Experimental Therapeutics; and he is an inventor of the WT1 vaccine.

 

Is general: Yes