liposomal gemcitabine (FF-10832) / Fujifilm Holdings - LARVOL DELTA

KEYNOTE-B57: A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

Fujifilm’s FF-10832 Granted Orphan Drug Designation for the Treatment of Biliary Tract Cancer (Contract Pharma) - "The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Fujifilm’s FF-10832, an investigational liposomal formulation of gemcitabine, for the treatment of biliary tract cancer (BTC)....Phase 1 study (NCT03440450) results presented at ASCO 2025 suggest FF-10832 is well tolerated and has anti-tumor activity in patients with advanced BTC."

Orphan drug • Biliary Tract Cancer

FF-10832 Granted FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer (Businesswire) - "FUJIFILM Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Fujifilm’s FF-10832 - an investigational liposomal formulation of gemcitabine - for the treatment of biliary tract cancer (BTC). Phase 1 study (NCT03440450) results presented at ASCO 2025 suggest FF-10832 is well tolerated and has anti-tumor activity in patients with advanced BTC."

Orphan drug • Biliary Tract Cancer

Sarah Cannon Research Institute to Showcase Cancer Insights at 2025 ASCO Annual Meeting (Businesswire) - "Today, Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, announced that it will showcase its latest research highlights through more than 155 accepted abstracts and presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from May 30-June 3, 2025. Over 75 investigators from more than 20 research sites in SCRI’s network are first authors and co-authors on the clinical trial updates featured at the Annual Meeting, including findings from 55 early-phase clinical trials."

Clinical data • Platinum resistant • Biliary Tract Cancer • Colorectal Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor

Phase 1 expansion study of FF-10832 (liposomal gemcitabine) antitumor activity in patients with advanced biliary carcinomas. (ASCO 2025) - P1 | "FF-10832 is well-tolerated and has anti-tumor activity in pts with advanced BTC who progressed on prior GEM. Although preliminary, these results of a single agent therapy compare favorably to those reported for 2nd line combination therapies. This warrants further investigation of FF-10832 efficacy and safety in BTC patients."

Clinical • Metastases • P1 data • Anemia • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Infectious Disease • Oncology • Septic Shock • Solid Tumor • CD8

Improving the tumor microenvironment with liposomal gemcitabine, FF-10832, enhances the effects of immune checkpoint blockade (AACR 2025) - P1, P2 | "Cancer immunotherapy, including immune checkpoint blockade (ICB), is a type of cancer treatment that achieves tumor regression in various types of cancer. These results suggest that FF-10832 is a promising immunomodulator for TAM-targeted cancer immunotherapy. Combination therapy of FF-10832 and pembrolizumab is under investigation for non-small cell lung cancer and urothelial cancer in a phase 2a clinical trial (NCT05318573)."

Biomarker • Checkpoint block • Checkpoint inhibition • Tumor microenvironment • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. | Trial completion date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Sep 2024 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

A phase 2a safety run-in and preliminary efficacy study of liposomal gemcitabine (FF-10832) in combination with pembrolizumab in patients with advanced solid tumors. (ASCO 2024) - P2 | "The safety and preliminary efficacy of FF832+PEM was demonstrated in heavily pre-treated pts with solid tumors whose disease progressed on prior GEM and/or PEM. Continuous GEM exposure from FF832 along with immune checkpoint blockade may improve antitumor activity. Evaluation of FF832 at the RP2D/schedule of 40 m/gm 2 Q 21 days alone and in combination with PEM is ongoing in a randomized expansion study in pts with metastatic NSCLC and UC with prior disease progression on PD-1/L1 therapy."

Clinical • Combination therapy • IO biomarker • Metastases • P2a data • Tumor mutational burden • Anemia • Fatigue • Genito-urinary Cancer • Hematological Disorders • Lung Cancer • Musculoskeletal Pain • Non Small Cell Lung Cancer • Oncology • Pain • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer • CD4 • CD8 • PD-L1 • TMB

ProGenier signs a material transfer agreement with FUJIFILM Pharmaceuticals in the U.S. [Google translation] (Medifonews) - "Progenier...signed a Material Transfer Agreement with FUJIFILM Pharmaceuticals USA Inc...Fujifilm's global center for new drug development, to explore the synergy effects of the materials of both companies. announced that it had signed a contract...Under this contract, Progenier will receive FF-10832 and FF-10850, liposomal chemotherapy drugs in clinical trials from FFPU, and explore the effects of combination with ProLNG-001, an immunomodulator that Progenier is developing....ProLNG-001 was developed as an existing vaccine adjuvant, but when injected with an in-situ vaccine, that is, a treatment that induces cell death, in a non-clinical tumor model, it showed high efficacy and was also confirmed to have an immunity acquisition effect, so it will be scheduled for clinical trial 1 in 2025."

Licensing / partnership • New P1 trial • Preclinical • Biliary Tract Cancer • Bladder Cancer • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Solid Tumor

KEYNOTE-B57: A Study to Evaluate Safety, Efficacy of FF-10832 in Combination With Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. | N=10 ➔ 120

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

KEYNOTE-B57: A Study to Evaluate Safety, Efficacy of FF-10832 in Combination With Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. | Phase classification: P2a ➔ P2

Combination therapy • Metastases • Monotherapy • Phase classification • Oncology • Solid Tumor

Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread (clinicaltrials.gov) - P2; N=184; Recruiting; Sponsor: ECOG-ACRIN Cancer Research Group; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

A phase 1, first-in-human, dose-escalation and biomarker trial of liposomal gemcitabine (FF-10832) in patients with advanced solid tumors. (ASCO 2022) - P1 | "FF-10832 was well-tolerated in heavily pre-treated pts with solid tumors, with evidence of anti-tumor activity in pts who progressed on prior GEM. Prolonged, continuous exposure and enhancement of anti-tumor immunity may contribute to improved efficacy. Expansion is ongoing in biliary tract cancer pts treated at the RP2D/schedule of 40 mg/m2 Day 1 of a 21-day cycle."

Biomarker • Clinical • P1 data • Biliary Cancer • Biliary Tract Cancer • Dermatology • Gallbladder Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Inflammation • Oncology • Pancreatic Cancer • Pneumonia • Solid Tumor • Thrombocytopenia • CD4 • CD8

A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. | Trial completion date: Mar 2023 ➔ Mar 2025 | Trial primary completion date: Sep 2022 ➔ Sep 2024

Trial completion date • Trial primary completion date • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A physiologically based pharmacokinetic and pharmacodynamic model for disposition of FF-10832. (PubMed, Int J Pharm) - "The sensitivity analysis of the PBPK/PD model revealed the critical factors affecting antitumor efficacy, which included the total and intratumor tissue uptake clearances for liposomal formulation and the cytidine deaminase and deoxycytidine deaminase activities in tumors. Thus, these parameters are potential biomarkers for predicting the efficacy of the liposomal formulation of dFdC."

Journal • PK/PD data • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, the INSPIRE Study (clinicaltrials.gov) - P2; N=114; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Study to Evaluate Safety, Efficacy of FF-10832 in Combination With Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P2a | N=10 | Recruiting | Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Oncology • Solid Tumor

Fujifilm Begins U.S. Clinical Phase 2a Study of FF-10832 in Combination with KEYTRUDA (pembrolizumab, Merck & Co., Inc., Rahway, N.J., U.S.A.) for Patients with Advanced Solid Tumors (Fuji Pharma Press Release) - "FUJIFILM Corporation...announced that it has begun implementation of a phase 2a study in the U.S. to evaluate safety, tolerability, and preliminary efficacy of FF-10832, a liposomal drug candidate, in combination therapy with Merck & Co., Inc., Rahway, N.J., U.S.A.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for patients with advanced solid tumors....The primary focus of the trial is to establish the safety and tolerability of FF-10832 in combination with KEYTRUDA in patients with advanced solid tumors, and evaluate its preliminary efficacy in non-small cell lung cancer (NSCLC) and urothelial cancer (UC) patients who have progressed after standard therapy, including immune checkpoint inhibitor therapy."

Trial status • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer

Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer (clinicaltrials.gov) - P3; N=249; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P3 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Study to Evaluate Safety, Efficacy of FF-10832 in Combination With Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P2a | N=10 | Not yet recruiting | Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.

Combination therapy • Monotherapy • New P2a trial • Oncology • Solid Tumor

Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P2; N=163; Recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Recruiting

Clinical • Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P2; N=163; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended

Clinical • Trial suspension • Bladder Cancer • Cervical Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P2; N=163; Recruiting; Sponsor: National Cancer Institute (NCI); N=72 ➔ 163

Clinical • Enrollment change • Bladder Cancer • Cervical Cancer • Oncology • Solid Tumor • Urothelial Cancer

Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P2; N=72; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Bladder Cancer • Cervical Cancer • Oncology • Solid Tumor • Urothelial Cancer