LY3022855 / Eli Lilly - LARVOL DELTA

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma (clinicaltrials.gov) - P1/2 | N=5 | Completed | Sponsor: Dana-Farber Cancer Institute | Active, not recruiting ➔ Completed

Trial completion • Melanoma • Oncology • Solid Tumor

Safety and immunologic impact of neoadjuvant/adjuvant GM-CSF-secreting allogenic pancreatic tumor cell vaccine (GVAX) combined with cyclophosphamide, pembrolizumab, and macrophage-targeting CSF1R inhibitor IMC-CS4 in pancreatic adenocarcinoma (AACR 2024) - P2 | "The triplet was safe and significantly increased activated CD8+ T cells suggesting the combination can induce an effector T cell response. Decreased granulocyte levels correlated with PR."

Clinical • Tumor cell • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD8 • CEACAM8 • CSF1R • CSF2 • GZMB • PD-L1

Safety and immunologic impact of neoadjuvant/adjuvant GM-CSF-secreting allogenic pancreatic tumor cell vaccine (GVAX) combined with cyclophosphamide, pembrolizumab, and macrophage-targeting CSF1R inhibitor IMC-CS4 in pancreatic adenocarcinoma (AACR 2024) - "Abstract is embargoed at this time."

Clinical • Tumor cell • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CSF2

Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b | N=72 | Completed | Sponsor: Eli Lilly and Company | N=178 ➔ 72

Combination therapy • Enrollment change • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

A phase I/II study of LY3022855 with BRAF/MEK inhibition in patients with Melanoma. (PubMed, Invest New Drugs) - "CSF1R inhibition with LY3022855 in combination with BRAF/MEK inhibition with vemurafenib and cobimetinib was difficult to tolerate in a small melanoma population. One response was observed in this small sample of patients suggesting this combination might be worthy of further exploration."

IO biomarker • Journal • P1/2 data • Immune Modulation • Melanoma • Oncology • Solid Tumor

Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma (clinicaltrials.gov) - P1/2 | N=5 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial primary completion date: Jun 2022 ➔ Dec 2022

Trial primary completion date • Melanoma • Oncology • Solid Tumor

Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Phase 1 study of LY3022855, a colony-stimulating factor-1 receptor (CSF-1R) inhibitor, in patients with metastatic breast cancer (MBC) or metastatic castration-resistant prostate cancer (MCRPC). (ASCO 2019) - P1; "LY3022855 was well tolerated and showed evidence of target engagement. Clinically meaningful SD > 9 months was observed in 2 MBC pts. Tumor biomarker analyses are underway."

P1 data

Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Trial completion date: Sep 2021 ➔ Dec 2021; Trial primary completion date: Sep 2021 ➔ Dec 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma (clinicaltrials.gov) - P1/2; N=5; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Trial completion date: Dec 2022 ➔ Dec 2023; Trial primary completion date: Jun 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • MRI

A phase 1a/1b trial of CSF-1R inhibitor LY3022855 in combination with durvalumab or tremelimumab in patients with advanced solid tumors. (PubMed, Invest New Drugs) - P1a/1b | "The RP2D was LY3022855 100 mg QW with durvalumab 750 mg Q2W. ClinicalTrials.gov ID: NCT02718911 (Registration Date: May 3, 2011)."

Clinical • Combination therapy • Journal • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CSF1R

Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

LY3022855, an anti-colony stimulating factor-1 receptor (CSF-1R) monoclonal antibody, in patients with advanced solid tumors refractory to standard therapy: phase 1 dose-escalation trial. (PubMed, Invest New Drugs) - P1 | "Conclusions LY3022855 was well tolerated and showed dose-dependent pharmacokinetics-pharmacodynamics and limited clinical activity in a heterogenous solid tumor population. ClinicalTrials.gov ID NCT01346358 (Registration Date: May 3, 2011)."

Journal • Acute Kidney Injury • Anorexia • Cardiovascular • Fatigue • Heart Failure • Hematological Disorders • Nephrology • Oncology • Pancreatitis • Renal Disease • Solid Tumor

Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Trial completion date: Sep 2020 ➔ Sep 2021; Trial primary completion date: Sep 2020 ➔ Sep 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Immunomodulatory Activity of a Colony-Stimulating Factor-1 Receptor Inhibitor in Patients With Advanced Refractory Breast or Prostate Cancer: A Phase 1 Study. (PubMed, Clin Cancer Res) - "LY3022855 was well tolerated and showed evidence of immune modulation. Clinically meaningful stable disease >9 months was observed in two MBC patients."

Journal • P1 data • Breast Cancer • Fatigue • Genito-urinary Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Prostate Cancer • Solid Tumor

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma (clinicaltrials.gov) - P1/2; N=5; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Trial completion date: Dec 2020 ➔ Dec 2022; Trial primary completion date: Apr 2019 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma (clinicaltrials.gov) - P1/2; N=5; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Recruiting ➔ Active, not recruiting; N=43 ➔ 5; Trial completion date: Oct 2023 ➔ Dec 2020; Trial primary completion date: Oct 2020 ➔ Apr 2019

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1a/1b; N=178; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion