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Poster display session

2089 - Phase 1b/2 Study to Assess the Safety, Tolerability, and Clinical Activity of BGB-290 in Combination with Temozolomide in Patients with Locally Advanced or Metastatic Solid Tumors


11 Sep 2017


Poster display session


Melissa Johnson


Annals of Oncology (2017) 28 (suppl_5): v122-v141. 10.1093/annonc/mdx367


M. Johnson1, B. Benson2, R. Wei3, R. Brachmann2, M.D. Galsky4

Author affiliations

  • 1 Tennessee Oncology, Sarah Cannon Research Institute, 37203 - Nashville/US
  • 2 Clinical Development, BeiGene USA, Inc, 94608 - Emeryville/US
  • 3 Biostatistics, BeiGene USA, Inc, 94608 - Emeryville/US
  • 4 Medical Oncology, Icahn School of Medicine at Mount Sinai, 00 - New York/US


Abstract 2089


Poly (ADP-ribose) polymerase (PARP) proteins are a family of DNA binding and repair proteins and are thought to play a key role in the base excision repair of DNA damage generated by temozolomide (TMZ), a DNA-alkylating agent. PARP inhibitors (PARPis) represent a class of antitumor agents that exert their cytotoxic effects by inhibiting PARP activity. Some PARPis are capable of trapping PARP proteins on DNA, further augmenting cell death. BGB-290 is a potent and selective inhibitor of PARP1/2 and has demonstrated PARP trapping capacity. Synergistic cytotoxicity has been observed in vitro and in vivo when BGB-290 is combined with low dose TMZ.

Trial design

This open-label, Phase 1b/2 dose-escalation/dose-expansion study is designed to evaluate BGB-290 at the recommended Phase 2 dose (60 mg administered orally twice daily [PO BID]) in combination with TMZ in patients with locally advanced and metastatic solid tumors. The phase 1b dose-escalation component will follow a 3 + 3 design to establish the maximum tolerated dose (MTD) of TMZ in combination with BGB-290 in ∼50 patients with solid tumors. Dose escalation will evaluate the safety, tolerability and pharmacokinetics of BGB-290 (60 mg BID) plus escalating doses of TMZ administered once daily (QD) either on Days 1-7 (Arm A) or continuously (Arm B) of each 28-day cycle. The phase 2 component will further evaluate the safety, tolerability and antitumor activity of the recommended combination dose and schedule in ∼20 patients with one of five different tumor types (Table). Enrollment into these expansion cohorts will occur simultaneously and independent of each other. Subjects will continue to receive treatment in 28-day cycles until confirmed disease progression, intolerable toxicity, or discontinuation/withdrawal.Table:


Treatment armTumor typeEstimated sample size
Cohort 1Platinum-sensitive high grade epithelial, non-mucinous, ovarian cancer, fallopian cancer or primary peritoneal cancer with either known deleterious or suspected deleterious germline or somatic BRCA1/2 mutation or with DNA HRD20
Cohort 2Triple negative breast cancer with either known deleterious or suspected deleterious germline or somatic BRCA1/2 mutation or with DNA HRD20
Cohort 3Metastatic castration-resistant prostate cancer with either known deleterious or suspected deleterious germline or somatic BRCA1/2 mutation or with documented HRD20
Cohort 4Extended stage small cell lung cancer who have been treated with ≤2 prior regimens20
Cohort 5Gastric or gastroesophageal junction cancer who have been treated with ≤ 2 prior regimens20

Clinical trial identification

Legal entity responsible for the study

Beigene Ltd.


Beigene Ltd


M. Johnson: Research funding compensation for consulting to the institution from OncoMed, BerGenBio, Lilly, and various Pharm/Biotech companies. Spouse is a contract lobbyist for Astellas and Otsuka Pharmaceuticals. B. Benson, R. Wei: Employee and stock holder of BeiGene USA. R. Brachmann: Employee of BeiGene USA. M.D. Galsky: Consulting fees from Genentech, Merck, Novartis, Astellas, Astra Zeneca, and Bristol-Myers Squibb outside the submitted work; stock options in Dual Therapeutics outside the submitted work.

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