Zeltherva (galinpepimut-S)

Clinical trial registration: https://clinicaltrials.gov/study/NCT04229979. The clinical trial identifier is NCT04229979.

P1/2, N=26, Completed, Sellas Life Sciences Group | Active, not recruiting --> Completed | N=90 --> 26

P1, N=10, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Nov 2024 | Trial primary completion date: Jul 2025 --> Nov 2024

P2, N=41, Completed, Sellas Life Sciences Group | N=31 --> 41

P1/2, N=20, Completed, Sellas Life Sciences Group | Unknown status --> Completed | Phase classification: PN/A --> P1/2

P1, N=15, Active, not recruiting, 3D Medicines | Trial primary completion date: May 2024 --> Dec 2024

P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025

P3, N=126, Active, not recruiting, Sellas Life Sciences Group | Recruiting --> Active, not recruiting

P1, N=15, Active, not recruiting, 3D Medicines | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> May 2024

Safety: N=25, GPS alone=8 (due to disease progression); >1 dose of combination =17. Median age: 64-yrs; median number of prior lines: 2. Five patients experienced 11 SAEs, one of which was drug related.

P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Jul 2023 --> Jul 2024

Therapy included six (every two weeks) subcutaneous inoculations of galinpepimut-S vaccine adjuvanted with Montanide, low-dose subcutaneous sargramostim at the injection site, with intravenous nivolumab over 12 weeks, and up to six additional doses until disease progression or toxicity. Coadministration of galinpepimut-S and nivolumab demonstrated a tolerable toxicity profile and induced immune responses, as indicated by immunophenotyping and WT1-specific IgG production. Exploratory analysis for efficacy yielded a promising 1-year PFS rate.

P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting

P1, N=15, Recruiting, 3D Medicines | Not yet recruiting --> Recruiting | Trial completion date: Jun 2024 --> Dec 2024

P1, N=15, Not yet recruiting, 3D Medicines

The patient was on a clinical trial with Galinpepimut-S, a Wilms’ tumor 1 peptide vaccine, and pembrolizumab, an immune checkpoint inhibitor, and she had received six cycles when she developed the symptoms. To the best of our knowledge, this is the first case reported for acute onset, rapidly progressive anti-Yo positive paraneoplastic cerebellar degeneration associated with an immune checkpoint inhibitor, pembrolizumab use. Early recognition of the condition and timely discontinuation of an immune checkpoint inhibitor is crucial for the neurological outcome.

P1/2, N=90, Active, not recruiting, Sellas Life Sciences Group | Recruiting --> Active, not recruiting | Trial completion date: Apr 2024 --> Apr 2023 | Trial primary completion date: Jan 2024 --> Nov 2022

P1, N=10, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2023

P1, N=11, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=20 --> 11 | Trial completion date: Apr 2022 --> Apr 2023 | Trial primary completion date: Apr 2022 --> Apr 2023

Introduction: Acute myeloid leukemia (AML) is a disorder wherein clonal expansion of undifferentiated myeloid precursors results in compromised hematopoiesis and bone marrow failure. GPS has been shown to be safe and tolerable in phase 1 and phase 2 studies and is now being evaluated in a phase 3 study.Expert opinion: Given the unmet need in the treatment of relapsed and refractory AML, especially among the elderly and patients with comorbidities who are not fit enough to undergo traditional salvage treatments, GPS could potentially fill the gap for this subset of patients. Future clinical trials utilizing GPS in second complete remission 2 (CR2) compared to best available therapy in AML and in combination with other immunotherapeutic agents (like pembrolizumab) for treatment for various malignancies are underway.

P3, N=116, Ongoing, Sellas Life Sciences

P1/2, N=90, Recruiting, Sellas Life Sciences Group | Trial completion date: Apr 2023 --> Apr 2024 | Trial primary completion date: Dec 2020 --> Jan 2024

P1, N=20, Recruiting, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Recruiting | N=11 --> 20 | Trial completion date: Apr 2021 --> Apr 2022 | Trial primary completion date: Apr 2021 --> Apr 2022

P1/2, N=90, Recruiting, Sellas Life Sciences Group | Trial completion date: Jul 2021 --> Apr 2023