BeiGene Announces Clinical Data on Tislelizumab Presented at European Society for Medical Oncology (ESMO) Asia 2019 Congress
Nov 23, 2019 5:00 AM
“In this trial, the combination treatment of tislelizumab and chemotherapy demonstrated durable responses and was generally well-tolerated in patients with G/GEJ adenocarcinoma or ESCC,” said
Updated Results of Tislelizumab in Combination with Chemotherapy in Patients with G/GEJ Adenocarcinoma or ESCC
Poster 128P
This open-label, multi-center Phase 2 trial (NCT03469557) of tislelizumab in combination with standard chemotherapy as a potential first-line treatment is being conducted in
As of
At the time of data cutoff, eight patients remained on treatment, including four with G/GEJ adenocarcinoma and four with ESCC. Results included:
- As of data cutoff, seven patients (46.7%) with G/GEJ adenocarcinoma achieved a confirmed partial response (PR), and the objective response rate (ORR) (consisting of the aggregate of complete responses and PRs) in this cohort was 46.7%. In the cohort of patients with ESCC, seven patients (46.7%) achieved a confirmed PR, and the ORR in this cohort was 46.7%;
- Median duration of response (DoR) was not mature in the G/GEJ adenocarcinoma cohort; median DoR was estimated as 12.8 months in the ESCC cohort;
- Median progression-free survival (PFS) was 6.1 months and 10.4 months in the G/GEJ adenocarcinoma and ESCC cohorts, respectively;
- Despite the long median follow up in both the G/GEJ adenocarcinoma cohort (15.4 months) and ESCC cohort (13.0 months), median overall survival (OS) had not been reached; in the G/GEJ adenocarcinoma cohort, the OS rate was 85% at six months and 62% at 12 months; in the ESCC cohort, the OS rate was 71% at six months and 50% at 12 months;
- Treatment with tislelizumab in combination with the standard first-line chemotherapy was generally well tolerated in patients with G/GEJ adenocarcinoma and ESCC. Adverse events (AEs) reported were consistent with the known tolerability profile of PD-1 inhibitors in combination with chemotherapy;
- Treatment-emergent adverse events (TEAEs) occurred in all patients and most TEAEs were mild or moderate in severity;
- The most common TEAEs (≥ 40%) of any grade in all patients were anemia (60%), decreased appetite (56.7%), nausea (53.3%), asthenia (50%), leukopenia (43.3%), vomiting (43.3%), decreased neutrophil count (40%), and decreased platelet count (40%);
- Grade 3-4 TEAEs occurred in 11 patients (G/GEJ adenocarcinoma, n=6; ESCC, n=5), with the most common being vomiting (16.7%), hyponatremia (13.3%), and increased aspartate aminotransferase (AST), decreased weight, decreased appetite, hypokalemia, anemia, leukopenia, neutropenia, and thrombocytopenia (one patient each);
- Serious adverse events (SAEs) were reported in 13 patients (G/GEJ adenocarcinoma, n=5; ESCC, n=8); serious TEAEs reported in ≥2 patients in either cohort were increased blood bilirubin (G/GEJ adenocarcinoma, n=2), dysphagia (ESCC, n=3), and fatigue (ESCC, n=2); and
- One patient with ESCC experienced a fatal AE of hepatic dysfunction mainly attributed to progressive disease, which may possibly have been related to study treatment or confounded by underlying HBV infection.
About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologics program and 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.
Ongoing clinical trials of tislelizumab include a Phase 3 clinical trial in patients with second-line or third-line non-small cell lung cancer (NSCLC); a Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a Phase 3 clinical trial in first-line patients with gastric / gastroesophageal junction (G/GEJ) cancer; a Phase 3 clinical trial in first-line patients with ESCC; and a Phase 2 clinical trial in second- or third-line patients with HCC. The aforementioned trials are enrolling patients in multiple countries, including
In addition to a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) classical Hodgkin’s lymphoma (cHL) and a pivotal Phase 2 clinical trial in patients with locally advanced or metastatic urothelial cancer,
New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with previously treated locally advanced or metastatic UC have been accepted and granted priority review by the
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from ongoing clinical trials of tislelizumab, the mechanism of action of tislelizumab, BeiGene’s advancement of, and anticipated clinical development, regulatory milestones and commercialization of tislelizumab. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including
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1 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.
2 GLOBOCAN. Cancer incidence and mortality worldwide in 2019. http://globocan.iarc.fr/. Accessed
3 ABRAXANE®, REVLIMID® and VIDAZA® are registered trademarks of Celgene Corporation.
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