Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SLS-001, GPS, WT1 Analog Peptide Vaccine
Galinpepimut-S · 5 trials · 9 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
Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
Median progression free survival (PFS) is where PFS are assessed from the time of randomization to first evidence of disease recurrence or death of any cause.
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 |
| Montanide + GM-CSF | PLACEBO_COMPARATOR | Montanide adjuvant 1 mL and GM-CSF 70 mcg |
| 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 |
| Galinpepimut-S + Montanide + GM-CSF | BIOLOGICAL | Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self administered) subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. |
| Montanide + GM-CSF | BIOLOGICAL | Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self-administered)subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. |
| 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 vaccine being studied for Acute Myeloid Leukemia, Malignant Pleural Mesothelioma, and Multiple Myeloma. It is also known as Galinpepimut-S plus Montanide plus GM-CSF. The vaccine is designed to stimulate an immune response against WT1-expressing tumors.
Galinpepimut-S targets WT1, a protein often overexpressed in certain cancers. As a vaccine antigen, it aims to elicit an immune response against WT1-positive tumor cells. This targeted approach is being explored in several malignancies, including Acute Myeloid Leukemia and Multiple Myeloma.
Galinpepimut-S is being developed by SELLAS Life Sciences Group, Inc., which trades under the ticker SLS. The company is advancing the vaccine in clinical trials for multiple cancer indications.
Galinpepimut-S is in Phase 1 development according to the overall program status, but it has been tested in a Phase 3 trial (NCT04229979) that is active but not recruiting. It is an investigational agent and has not been approved by the FDA.
Galinpepimut-S has been studied in several clinical trials, including NCT04229979, a Phase 3 trial in Acute Myeloid Leukemia; NCT03761914, a Phase 1 trial in advanced cancers; NCT01827137, a Phase 1 trial in Multiple Myeloma; and NCT01266083, a Phase 2 trial in Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia.