Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Galinpepimut-S · 4 trials · 8 indications
Interval between randomization and death from any cause
OS at 3 years, measured from first treatment with GPS to patient's survival status at 3 years or more
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirements). Best overall response is defined as the best overall visit response in the following order: CR, PR, SD, PD, or UE as measured by RECIST 1.1
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirement). Overall response rate is defined as the proportion of participants with a best overall response of CR or PR as defined by RECIST 1.1
Number and percentage of participants with CD4 and/or CD8 immune responses against WT1m measured 12-14 weeks after first GPS administration (6 x administrations)
| Arm | Type | Description |
|---|---|---|
| Galinpepimut-S + Montanide + GM-CSF | EXPERIMENTAL | Galinpepimut-S injections will be administered as follows, until disease relapse: 1. First 6 galinpepimut-S injections: every 2 weeks (Weeks 0 - 10) followed by a 4-week period of no treatment. The first series of 6 injections of galinpepimut-S define the initial immunization induction phase. 2. Injections 7 to 12: every 4 weeks (Weeks 14 - 34) followed by a 6-week period of no treatment. The second series of injections of galinpepimut-S define the early immune booster phase. 3. Injections 13 to 15: every 6 weeks (Weeks 40 - 52). The third series of injections of galinpepimut-S define the late immune booster phase. 4. Injections 16-20: every 2 months (in Year 2). 5. Injection 21 and thereafter: every 3 months (in Year 3). Y2 and Y3 define the maintenance phase. Note: Galinpepimut-S is admixed with Montanide adjuvant before administered as a subcutaneous injection. GM-CSF is administered two days before and on the same day as the galinpepimut-S + Montanide injection. |
| Best Available Therapy | ACTIVE_COMPARATOR | Four options, as monotherapy or as combination of agents listed below, (per treating investigator's choice): 1. Observation (whereby palliative management with hydroxyurea is allowed), or 2. HMA (decitabine or azacitidine), and/or 3. Venetoclax, and/or 4. Low-dose ara-C |
| Colorectal Cancer (CRC) - opened but since only one subject enrolled, not included for analyses | EXPERIMENTAL | * N=20 (planned); * Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab |
| Ovarian Cancer (OvC) | EXPERIMENTAL | * N=20 (planned); * Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab |
| Small Cell Lung Cancer (SCLC) - not opened | EXPERIMENTAL | * N=20 (planned); * Advanced SCLC previously treated with one line of prior systemic chemotherapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab |
| Triple Negative Breast Cancer (TNBC) - not opened | EXPERIMENTAL | * N=15 (planned); * TNBC previously treated with one line of prior systemic chemotherapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab |
| Acute Myelogenous Leukemia (AML) - not opened | EXPERIMENTAL | * N=15 (planned); * AML (any age) who are not eligible for allogeneic hematopoietic stem cell transplant and have been able to achieve partial response (PR) while receiving frontline therapy with hypomethylating agents (HMAs) * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab |
| Name | Type | Description |
|---|---|---|
| Galinpepimut-S | BIOLOGICAL | Galinpepimut-S admixed with the adjuvant Montanide following specified schedule |
| Azacitidine | DRUG | injection |
| Venetoclax | DRUG | tablet |
| Decitabine | DRUG | injection |
| Cytarabine | DRUG | injection |
| Observation | OTHER | palliative management |
| GM-CSF | BIOLOGICAL | subcutaneous injection |
| Montanide | OTHER | adjuvant |
| pembrolizumab | BIOLOGICAL | Pembrolizumab is administered at a dose of 200 mg intravenously every 3 weeks on Day 1 of each cycle (3-week cycles) starting on Study Week 6 and continuing for up to 2 years thereafter (Study Week 108). Pembrolizumab is to be administered no earlier than 30 minutes after the administration of GPS on Day 1 of each cycle. |
| lenalidomide | DRUG | optional post-ASCT therapy |
| bortezomib | DRUG | optional post-ASCT therapy |
Inclusion Criteria: 1. Willing and able to understand and provide signed informed consent for the study that fulfills Institution Review Board (IRB) guidelines. 2. Male or female patients ≥18 years of age on the day of signing informed consent. 3. Must have a diagnosis of AML according to the WHO c...
Galinpepimut-S is an investigational cancer immunotherapy being studied for multiple myeloma, acute myelogenous leukemia, acute myeloid leukemia, and malignant pleural mesothelioma. It is being evaluated as a maintenance treatment in acute myeloid leukemia and in other oncology settings.
Galinpepimut-S is a WT1 (Wilms tumor 1) analog peptide vaccine. It is designed to stimulate the immune system to target cells expressing the WT1 antigen, which is overexpressed in several cancers including leukemia and mesothelioma.
Galinpepimut-S is being developed by SELLAS Life Sciences Group, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SLS.
Galinpepimut-S is in Phase 3 clinical development for acute myeloid leukemia. It has also completed Phase 1 and Phase 2 trials in multiple myeloma, acute lymphoblastic leukemia, and malignant pleural mesothelioma. It is investigational and not yet approved by the FDA.
Galinpepimut-S is being studied in the Phase 3 trial NCT04229979 for acute myeloid leukemia maintenance, which is active but not recruiting. Completed trials include NCT01265433 in malignant pleural mesothelioma, NCT01266083 in acute myeloid leukemia and acute lymphoblastic leukemia, and NCT01827137 in multiple myeloma.
Yes, Galinpepimut-S is also known as a WT1 analog peptide vaccine. It is designed to target the WT1 antigen, and some clinical trial titles refer to it as the WT1 vaccine.