Document Type
Article
Publication Date
1-22-2026
Abstract
BACKGROUND: Cysteine-cysteine chemokine receptors 2 (CCR2) and 5 (CCR5) contribute to immune suppression in tumor microenvironments. CCR2 and CCR5 antagonists have demonstrated antitumor activity in pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), respectively. This phase 1b/2, open-label study evaluated BMS-813160, a CCR2/5 dual antagonist, in combination with chemotherapy±nivolumab in advanced PDAC or metastatic CRC.
METHODS: Part 1 included patients with metastatic untreated (first-line (1L)) PDAC, 1L CRC, or previously treated (second or third line (2/3L)) microsatellite stable (MSS) CRC. Patients received 2 weeks of BMS-813160 monotherapy (300 mg two times a day, 600 mg once daily, 300 mg once daily, or 150 mg once daily) and then BMS-813160+chemotherapy (gemcitabine+nab-paclitaxel (gem/nabP; 1L PDAC), 5-fluorouracil+leucovorin+irinotecan (FOLFIRI; 1L CRC)), or nivolumab (2/3L MSS CRC).Part 2 included patients with metastatic 1L PDAC or 2L CRC. Patients received BMS-813160 300 mg two times a day+gem/nabP±nivolumab (1L PDAC), BMS-813160 300 mg two times a day or 150 mg once daily+FOLFIRI (2L CRC), or chemotherapy alone. Primary endpoints were safety and pharmacodynamics (Part 1) and efficacy (Part 2).
RESULTS: In Part 1, 22 of 75 (29%) and 54 of 72 (72%) patients experienced a treatment-related adverse event during monotherapy lead-in and overall, respectively. Two dose-limiting toxicities (rash and pericardial effusion with pericarditis, both grade 3) occurred. In Part 2, patients with 1L PDAC who received BMS-813160 300 mg two times a day+gem/nabP+nivolumab achieved an overall response rate (ORR) of 37% (13/35); the median duration of response (DOR) was 45 weeks (95% CI 26.1 to not evaluable). ORRs with BMS-813160 300 mg two times a day+gem/nabP and gem/nabP alone were 26% (9/35) and 28% (9/32), respectively; median DORs were 121 and 31 weeks, respectively. Progression-free survival rates at 24 weeks were 56% (BMS-813160 300 mg two times a day+gem/nabP+nivolumab), 56% (BMS-813160 300 mg two times a day+gem/nabP), and 50% (gem/nabP). ORRs in 2L CRC were 19% (6/32; BMS-813160 300 mg two times a day+FOLFIRI), 13% (4/32; BMS-813160 150 mg once daily+FOLFIRI), and 27% (7/26; FOLFIRI).
CONCLUSIONS: In 1L PDAC, BMS-813160 300 two times a day+gem/nabP±nivolumab demonstrated durable antitumor response and was well tolerated. BMS-813160 combination regimens were tolerable in other cohorts, but clinical efficacy was not demonstrated.
TRIAL REGISTRATION NUMBER: NCT03184870.
Recommended Citation
Le, Dung T.; Folprecht, Gunnar; Varghese, Anna M.; Gutierrez, Martin; Noel, Marcus; Trikalinos, Nikolaos A.; Chen, Eric; Dayyani, Farshid; Davis, S. Lindsey; Ma, Wen Wee; Basu Mallick, Atrayee; Garrido-Laguna, Ignacio; Osawa, Mayu; O'Brien, Shaun; Novosiadly, Ruslan D.; Xu, Ke; Greenawalt, Danielle M.; Dutta, Santanu; Twyman Saint Victor, Christina; and Lenz, Heinz-Josef, "Phase 1b/2 study of BMS-813160, a CCR2/5 Dual Antagonist, in Combination With Chemotherapy or Nivolumab in Patients With Advanced Pancreatic or Colorectal Cancer" (2026). Department of Medical Oncology Faculty Papers. Paper 325.
https://jdc.jefferson.edu/medoncfp/325
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License
PubMed ID
41571299
Language
English
Included in
Immunotherapy Commons, Oncology Commons, Therapeutics Commons
Comments
This article is the author’s final published version in Journal for ImmunoTherapy of Cancer, Volume 14, Issue 1, 2026, Article number e011284.
The published version is available at https://doi.org/10.1136/jitc-2024-011284. Copyright © Author(s) (or their employer(s)) 2026.