Abstract 128P
Background
Tislelizumab, an investigational monoclonal antibody with high affinity and specificity for PD-1, was engineered to minimize binding to FcγR on macrophages in order to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. In prior reports, tislelizumab, as a single agent and in combination with various chemotherapies, was generally well tolerated and had antitumor activity in pts with advanced solid tumors. This phase 2 study (NCT03469557) assessed tislelizumab plus chemotherapy as first-line therapy in pts with inoperable, locally advanced, or metastatic GC/GEJC or ESCC.
Methods
Patients with GC/GEJC received tislelizumab (200 mg IV Q3W) + oxaliplatin (130 mg/m2 IV Q3W for ≤6 cycles) and capecitabine (1000 mg/m2, Days 1-15 orally BID Q3W); pts with ESCC received tislelizumab + cisplatin (80 mg/m2 IV Q3W for ≤6 cycles) and 5FU (800 mg/m2/d, Days 1-5 IV Q3W for ≤6 cycles). Response was assessed using RECIST v1.1, Kaplan-Meier analysis estimated survival, and adverse event (AE) monitoring examined safety/tolerability.
Results
As of 31 Mar 2019, 30 pts with GC/GEJC and ESCC (n = 15 each) were enrolled. Median age was 61 yr; most pts were male (n = 25). Clinical responses were observed during treatment (Table). In pts with ESCC, treatment-emergent AEs (TEAEs) of grade ≥3 occurring in ≥ 2 pts were vomiting and dysphagia (n = 4 each), hyponatremia (n = 3), and anemia, leukopenia, fatigue, lung infection, and decreased weight (n = 2 each). No grade ≥3 TEAEs occurred in ≥ 2 pts with GC/GEJC. One pt with ESCC had a fatal AE (hepatic dysfunction) attributed to treatment by the investigator, but which may have been confounded by progressive disease and underlying hepatitis.Table:
128P
GC/GEJC (n = 15) | ESCC (n = 15) | |
---|---|---|
PR, n (%) | 7 (46.7) | 7 (46.7) |
SD, n (%) | 3 (20.0) | 5 (33.3) |
PD, n (%) | 1 (6.7) | 0 (0.0) |
Non-CR/non-PD, n (%)* | 2 (13.3) | 0 (0.0) |
NE, n (%) | 2 (13.3) | 3 (20.0) |
ORR, % (95% CI) | 46.7 (21.3, 73.4) | 46.7 (21.3, 73.4) |
Median DoR, (95% CI) | NR (3.0, NR) | 12.8 (3.5, 12.8) |
Median PFS, mo (95% CI) | 6.1 (3.8, NR) | 10.4 (5.6, 15.1) |
Median OS, mo (95% CI) | NR (7.0, NR) | NR (5.6, NR) |
Median follow-up, mo (95% CI) | 15.4 (14.7, 17.2) | 13.0 (12.3, 14.0) |
Patients who have non-target lesions at baseline.
Abbreviations: CI, confidence interval; CR, complete response; DoR, duration of response; ESCC, esophageal squamous cell carcinoma; GC/GEJC, gastric/gastroesophageal junction cancer; mo, month; NE, not evaluable; NR, not reached; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.
Conclusions
Tislelizumab plus chemotherapy was generally well tolerated and antitumor activity was observed in pts with advanced GC/GEJC or ESCC.
Clinical trial identification
NCT03469557.
Editorial acknowledgement
Writing and editorial support for this abstract was provided by Agnieszka Laskowski, PhD, and Elizabeth Hermans, PhD, of OPEN Health Medical Communications (Chicago, IL).
Legal entity responsible for the study
BeiGene Co., Ltd., Beijing, China.
Funding
BeiGene (Beijing) Co., Ltd., Beijing, China.
Disclosure
X. Li: Full / Part-time employment: BeiGene (Beijing) Co., Ltd. Y. Li: Full / Part-time employment: BeiGene (Beijing) Co., Ltd. X. Wang: Full / Part-time employment: BeiGene (Beijing) Co., Ltd. S. Yang: Full / Part-time employment: BeiGene (Beijing) Co., Ltd. All other authors have declared no conflicts of interest.
Resources from the same session
304P - Survival outcomes and survival predictors in recurrent and metastatic head and neck squamous cell cancer (R/M-HNSCC) patients treated with chemotherapy (CT) plus cetuximab as first-line therapy in a real-world study
Presenter: Filipa Pontes
Session: Poster display session
Resources:
Abstract
305P - A retrospective study to evaluate patient characteristics for recurrent head and neck cancer after definitive treatment
Presenter: Tetsuro Wakasugi
Session: Poster display session
Resources:
Abstract
306P - Efficacy and safety of apatinib in heavily pretreated metastatic adenocarcinoma of the head and neck
Presenter: Lin Gui
Session: Poster display session
Resources:
Abstract
307P - Lacrimal gland tumours: Clinical and epidemiological patterns in the United States
Presenter: Mahmoud KhalafAllah
Session: Poster display session
Resources:
Abstract
308P - Dental prophylaxis and 5-fluorouracil related oral mucositis in head and neck cancer patients: A population-based cohort study
Presenter: Yi-Fang Huang
Session: Poster display session
Resources:
Abstract
309P - Evaluation of a pharmacist-led opioid de-escalation (PLODE) program after chemoradiotherapy completion in head and neck cancer patients
Presenter: Ai Horinouchi
Session: Poster display session
Resources:
Abstract
310P - Laser and PDT for the oral leukoplakia
Presenter: Sadykov Rasul
Session: Poster display session
Resources:
Abstract
311P - Incidence of thyroid carcinoma in the Philippines: A retrospective study from a tertiary university hospital
Presenter: Priscilla Caguioa
Session: Poster display session
Resources:
Abstract
312P - Oral health disparities among privileged and underprivileged tribes of south India - A study on precancerous oral lesions prevalence
Presenter: Shanavas Palliyal
Session: Poster display session
Resources:
Abstract
313P - Immunotherapy application for advanced cancers: One institution experiences since 2016 to 2019
Presenter: Jo Pai Chen
Session: Poster display session
Resources:
Abstract