Date: 2018-02-09
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at 2018 Genitourinary Cancers Symposium
Company: BeiGene (China)
Product: tislelizumab (BGB-A317)
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor/immunomodulator. Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
- BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).
Disease: advanced solid tumors - urothelial carcinoma (UC)
Therapeutic
area: Cancer - Oncology
Country: Australia, New Zealand, Republic of Korea, Taïwan, USA
Trial
details:
- The multi-center, open-label Phase 1 trial of tislelizumab as monotherapy in advanced solid tumors is being conducted in Australia, New Zealand, the United States, Taiwan, and South Korea and consists of dose escalation, schedule expansion, fixed dose expansion, and indication expansion in disease-specific cohorts. (NCT02407990)
Latest
news:
- • On February 9, 2018, BeiGene presented preliminary clinical data from patients with urothelial carcinoma (UC) enrolled in an ongoing Phase 1 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, at the 2018 Genitourinary Cancers Symposium in San Francisco. The preliminary Phase 1 data suggest that tislelizumab was generally well tolerated and exhibited objective responses in patients with UC.
- Data presented at the Genitourinary Cancers Symposium included 16 patients with urothelial carcinoma. Of these, 12 had one or more prior systemic anticancer treatment for metastatic disease and the remaining four had progressed after receiving platinum-based regimen in the neoadjuvant or adjuvant setting. In addition, five patients had prior radiotherapy. At the time of the data cutoff on August 28, 2017, median treatment duration was 4.3 months (range of 0.7 to 18.3 months). A total of six patients remained on treatment.
- Adverse events (AEs) assessed by the investigator to be related to treatment occurred in 14 patients (88%). Of those, fatigue (31%), rash (19%), infusion related reactions (13%), nausea (13%), pain in extremity (13%), and proteinuria (13%) occurred in more than one patient. All of the treatment-related AEs were grade 1 or 2 except one case each of fatigue, hyperglycemia, and diabetes mellitus. One adverse event of muscle weakness, which was associated with disease progression and occurred more than one month after the last dose of the study drug, had a fatal outcome; this event was considered not related to treatment.
- At the time of the data cutoff, 15 patients were evaluable, defined as having a measurable baseline tumor assessment and at least one evaluable post-baseline tumor response assessment, or had progressed or died prior to the initial tumor assessment. One patient had a confirmed complete response (CR), four achieved a confirmed partial response (PR), and three achieved stable disease (SD). Nine evaluable patients had PD-L1 status determined. There was one CR, two PR and one SD among six PD-L1 high patients, and one PR among three PD-L1 low or negative patients.
Is
general: Yes
