A phase Ib/II study of cancer stemness inhibitor napabucasin (BB608) combined with weekly paclitaxel in platinum-resistant ovarian cancer
Abstract
5578 Background: Napabucasin (BBI-608, BB608) is a first-in-class cancer stemness inhibitor targeting the STAT3 pathway that has shown potent synergistic anti-tumor activity with paclitaxel in vivo. In a dose escalation study, BB608 plus weekly paclitaxel was well tolerated in patients (pts) with advanced solid tumors. RP2D expansion included accrual of pts with platinum resistant ovarian cancer (PROC). Methods: Pts with advanced epithelial ovarian, fallopian, or peritoneal cancer who have progressed on a prior taxane-based regimen and who were platinum resistant or refractory were enrolled. BB608 240-480 mg twice daily was administered orally with paclitaxel 80 mg/m2 IV weekly 3 of every 4 weeks. A sample size of 40 set the bounds of the 90% CI at ±10% to 14%, assuming a disease control rate (DCR) of 60% to 80%. DCR is the proportion with stable disease (SD) at least 8 weeks or ,partial (PR) or complete response (CR) per RECIST 1.1. Results: 56 pts were enrolled after a median 4 prior lines of therapy, including prior taxanes (92% paclitaxel only, 4% docetaxel only, 4% both). Treatment was tolerated without dose-limiting toxicity or unexpected adverse events (AE). Grade 3 AE included rapidly-reversible diarrhea (18%), vomiting (7%), abdominal pain (7%), nausea (5%), dehydration and fatigue ( < 4% each). 80% of pts with grade 3 AE continued study at a reduced dose. In evaluable pts (n = 40), DCR was 68%, tumor regression occurred in 40%, and ORR (PR+CR) was 25%, including 1 w…
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Phase I and II clinical studies demonstrated promising antitumor efficacy when napabucasin was combined with standard chemotherapy agents.
“Phase I and II clinical studies demonstrated promising antitumor efficacy when napabucasin was combined with standard chemotherapy agents (Garcia et al., 2016).”
From Targeting Janus Kinases and Signal Transducer and Activator of Transcription 3 To Treat Inflammation, Fibrosis, and Cancer: Rationale, Progress, and Caution (2020) · cites this paper as Garcia et al., 2016
Preclinical studies in mouse models of several cancers show that napabucasin was effective both as monotherapy and in combination with other agents, particularly paclitaxel where synergy was observed.
“Preclinical studies in mouse models of several cancers show that napabucasin was effective both as monotherapy and in combination with other agents, particularly paclitaxel where synergy was observed.”
From Targeting Janus Kinases and Signal Transducer and Activator of Transcription 3 To Treat Inflammation, Fibrosis, and Cancer: Rationale, Progress, and Caution (2020) · cites this paper as Garcia et al., 2016
No new AE or pharmacokinetic interactions were observed when napabucasin was combined with paclitaxel.
“Notably, no new AE or pharmacokinetic interactions were observed when napabucasin was combined with paclitaxel.”
From Targeting Janus Kinases and Signal Transducer and Activator of Transcription 3 To Treat Inflammation, Fibrosis, and Cancer: Rationale, Progress, and Caution (2020) · cites this paper as Garcia et al., 2016
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Bharadwaj, U., Kasembeli, M. M., Robinson, P., & Tweardy, D. J. (2020) · Pharmacological Reviews · doi:10.1124/pr.119.018440 · Cited by 314 · see citing works
- Authors
- Garcia, A. A., Hays, J. L., Cote, G. M., Becerra, C., Langleben, A., Lau, S. K., Roman, L. D., McCormick, C. C., Richards, D. A., Braiteh, F. S., Yimer, H. A., Richey, S. L., Edenfield, W. J., Kossler, K., Hume, S., Li, Y., Hitron, M., & Li, C.
- Affiliations
- Los Angeles County Hospital/University of Southern California, Los Angeles, CA;
- The Ohio State University Wexner Medical Center (US)
- Massachusetts General Hospital (US)
- Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX;
- St. Mary's Hospital, Westmount, QC, Canada;
- McGill University (CA)
- University of Southern California (US)
- The John Hopkins Hospital, Portland, OR;
- Tyler Cancer Center, US Oncology Research, McKesson Specialty Health, Houston, TX;
- The US Oncology Network (US)
- Texas Oncology (US)
- Prisma Health (US)
- Boston Biomedical (United States) (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2016-05-20
- Volume
- 34
- Issue
- 15_suppl
- Pages
- 5578-5578
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2889685701
- Cited by
- 7
- References
- 0
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2022: 1 · 2020: 1 · 2017: 2
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Oncology › Cancer Cells and Metastasis
- Keywords
- napabucasin, STAT3 pathway, paclitaxel, platinum-resistant ovarian cancer, recurrent epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, combination chemotherapy, disease control rate, progression-free survival, dose-limiting toxicity, taxane-refractory disease
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