GS-0189 / Gilead - LARVOL DELTA

A phase 1 first-in-human study of GS-0189, an anti-signal regulatory protein alpha (SIRPα) monoclonal antibody, in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). (PubMed, EJHaem) - P1 | "Here we report: (1) clinical safety, preliminary activity, and pharmacokinetics of GS-0189 as monotherapy and in combination with rituximab from a phase 1 clinical trial in patients with relapsed/refractory NHL (NCT04502706, SRP001); (2) in vitro characterization of GS-0189 binding to SIRPα; and (3) in vitro phagocytic activity. In vitro phagocytosis induced by GS-0189 was also SIRPα variant-dependent. Although clinical development of GS-0189 was discontinued, the CD47-SIRPα signaling pathway remains a promising therapeutic target and should continue to be explored."

Journal • P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • SIRPA

Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Gilead Sciences | Trial completion date: Mar 2024 ➔ Mar 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2023 ➔ Mar 2022; Sponsor's decision to discontinue development of this molecule

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • SIRPA

"$GILD discontinues Ph1a SIRPa program (GS-0189) and still not a single data update in 2+ yrs on Magrolimab in NHL...shaking my head..." (@DrPaulyDeSantis)

SIRPA

Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Gilead Sciences | Recruiting ➔ Active, not recruiting | N=81 ➔ 9 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Combination therapy • Enrollment change • Enrollment closed • Monotherapy • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • SIRPA

Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1; N=81; Recruiting; Sponsor: Gilead Sciences; Trial completion date: Aug 2023 ➔ Mar 2024; Trial primary completion date: Mar 2022 ➔ Sep 2022

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • SIRPA

Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1; N=75; Recruiting; Sponsor: Gilead Sciences; Trial primary completion date: Dec 2021 ➔ Mar 2022

Clinical • Combination therapy • Monotherapy • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Study of FSI-189 as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1; N=63; Recruiting; Sponsor: Gilead Sciences; Not yet recruiting ➔ Recruiting; Trial completion date: Sep 2022 ➔ Aug 2023

Clinical • Combination therapy • Enrollment open • Monotherapy • Trial completion date • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Study of FSI-189 as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1; N=63; Not yet recruiting; Sponsor: Gilead Sciences

Clinical • Combination therapy • Monotherapy • New P1 trial • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Forty Seven announces 2020 strategic priorities and expected milestones (GlobeNewswire) - "The company expects to achieve the following milestones in 2020:...File an investigational new drug application with the FDA for FSI-189 in the first quarter; Initiate a Phase 1 clinical trial evaluating the safety and tolerability of FSI-189 for the treatment of cancer in the second quarter."

NDA • Trial initiation date