Abstract 1530P
Background
Pancreatic cancer (PC) is an aggressive malignancy with limited treatments and poor outcomes. Claudin 18.2 (CLDN18.2) antigen, a gastric-specific tightjunciton protein has been described frequently expressed in malignant gastrointestinal cancers including pancreatic cancer. FG-M108 is a human monoclonal antibody specifically targeting CLDN18.2 with optimal affinity and enhanced antibody-dependent cellularcytotoxicity (ADCC) activity.
Methods
with one cohort of an ongoing phase 1 study of FG-M108, eligible PC patients with positive CLDN18.2 expression (IHC 1+/2+/3+≥10%) were enrolled. The patients received FG-M108 (intravenous, 300 mg/m2, day1) plus gemcitabine (intravenous, 1000 mg/m2, day1,8) and nab-paclitaxel (intravenous, 125 mg/m2, day1,8) of each 3-week cycle. Primary endpoints included the incidence of adverse events (AEs) and preliminary clinical efficacy (ORR, DCR, DOR, PFS, OS, et al.).
Results
As of April 19, 2024, 35 patients received FG-M108 plus chemotherapy. Of 30 patients who received at least once tumor evaluation, ORR was 30.0% (9/30) and DCR was 100% (30/30), with one patient is still on treatment for 13.5 months. The most common M108-related AEs were nausea (54.3%), emesis (51.4%) and hypoalbuminemia (42.9%). Serious M108-related AEs occurred in 5 (5/35) participants. No M108-related grade 4 or 5 AEs and no treatment-related deaths were reported.
Conclusions
FG-M108 plus gemcitabine and nab-paclitaxel as first-line treatment in patients with Claudin-18.2+ advanced PC showed promising clinical efficacy with manageable safety. the safety and efficacy, especially PFS and OS will be further evaluated.
Clinical trial identification
CTR20210508.
Editorial acknowledgement
Legal entity responsible for the study
FutureGen Biopharm.
Funding
FutureGen BioPharm.
Disclosure
F. Liu, J. Gong, M. Zhang, X. Liang, J. Wang: Non-Financial Interests, Institutional, Local PI: FutureGen Biopharm. Y. Zhang, S. Zhang: Financial Interests, Institutional, Local PI: FutureGen Biopharm. Y. LI, Z. Jin, Y. Yang: Financial Interests, Institutional, Full or part-time Employment: FutureGen Biopharm. L. Shen: Non-Financial Interests, Institutional, Coordinating PI: FutureGen Biopharm.
Resources from the same session
1525P - Nab-paclitaxel/gemcitabine with or without epigenetic targeting followed by consolidating immune targeting with durvalumab and lenalidomide in patients with advanced pancreatic ductal adenocarcinoma: Results from the SEPION/AIO-PAK-0118 phase I/II study
Presenter: Jens Siveke
Session: Poster session 18
1527P - GnP vs mFOLFIRINOX or S-IROX in metastatic pancreatic cancer: 1-year follow-up updated data from the GENERATE (JCOG1611)
Presenter: Satoshi Kobayashi
Session: Poster session 18
1528P - TCOG T5221 trial: A phase II randomized study of gemcitabine and nab-paclitaxel in combination with S- 1/LV (GASL) or oxaliplatin (GAP) as first-line treatment for metastatic pancreatic cancer
Presenter: Yung-yeh Su
Session: Poster session 18
1531TiP - TWINPEAK phase I/II study, PT886 a bispecific antibody targeting claudin 18.2 and CD47 in combination with chemotherapy and/or pembrolizumab in gastric/GEJ-carcinomas or PDAC
Presenter: Michael Overman
Session: Poster session 18
1532TiP - Zolbetuximab with gemcitabine + nab-paclitaxel (GN) in first-line treatment of Claudin 18.2–positive metastatic pancreatic cancer (mPC): Phase II, open-label, randomized study
Presenter: Wungki Park
Session: Poster session 18
1533TiP - A multicenter, open-label phase II study to evaluate the efficacy and safety of pimicotinib (CSF-1R inhibitor) in combination with chemotherapy with or without toripalimab in patients (pts) with advanced pancreatic ductal adenocarcinoma (aPDAC)
Presenter: Xiaofei Zhang
Session: Poster session 18
1534TiP - Valproic acid combinEd with Simvastatin and gemcitabine/nab-paclitaxel-based regimens in untreated metastatic Pancreatic Adenocarcinoma patients-VESPA trial
Presenter: Alfredo Budillon
Session: Poster session 18