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Lin Shen *, Yi-Long Wu *, Ying Yuan , Yuxian Bai , Qingyuan Zhang , Qing Zhou , Tianshu Liu , Jun Zhao , Siyang Wang , Xiaoming

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Lin Shen *, Yi-Long Wu *, Ying Yuan , Yuxian Bai , Qingyuan Zhang , Qing Zhou , Tianshu Liu , Jun Zhao , Siyang Wang , Xiaoming SAFETY AND EFFICACY OF LONG-TERM EXPOSURE (LTE) TO TISLELIZUMAB IN CHINESE PATIENTS WITH ADVANCED SOLID TUMORS Lin Shen1*, Yi-Long Wu2*, Ying Yuan3, Yuxian Bai4, Qingyuan Zhang4, Qing Zhou2, Tianshu Liu5, Jun Zhao1, Siyang Wang6, Xiaoming Huang7, Hongming Pan8, Aiping Zhou9, Ting Sun10, Jie Wang9, Yujuan Gao11, Silu Yang11, Yanjun Li11, Juan Zhang11, Jun Guo1 1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, China; 2Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China; 3The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; 4Harbin Medical University Cancer Hospital, Harbin, China; 5Zhongshan Hospital, Fudan University, Shanghai, China; 6The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, China; 7Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China; 8Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China; 9Tumor Hospital of Chinese Medical Science Institute, Beijing, China; Poster: 522P 10The First Affiliated Hospital of Nanchang University, Nanchang, China; 11BeiGene (Beijing) Co., Ltd., Beijing, China European Society of Medical Oncology *Contributed equally September 19-21, 2020, Virtual Congress Table 1: Demographics and Baseline Characteristics (ITT Analysis Set) Tumor reductions were reported regardless of PD-L1 expression status or number Continued tumor reduction was observed in patients who were treated beyond BACKGROUND of prior lines of systemic therapy and 6 patients experienced a 100% reduction in progression (Figure 3) CONCLUSIONS Patients With LTE target lesions (Figure 1) The programmed cell death protein-1/programmed death-ligand 1 (PD-1/PD-L1) axis (N=70) 4 patients (NPC, n=1; melanoma, n=1, NSCLC, n=2) had an increase of >50% in the Tislelizumab remained generally well tolerated plays a central role in suppressing antitumor immunity; dysregulation of the axis can be sum of target lesion diameters – Adverse events reported across these cohorts were generally of mild or moderate 1 Figure 1: Maximum Tumor Reduction in Patients Treated With Tislelizumab used by cancer cells to evade the immune system Median age, years (range) 54 (33, 75) – Of the two patients with NSCLC, one is receiving ongoing tislelizumab treatment and severity and were consistent with prior reports for tislelizumab monotherapy 30 the other is alive, but discontinued treatment due to progressive disease – Monoclonal antibodies against PD-1 have demonstrated antitumor activity in a Patients treated beyond progression demonstrated long treatment duration and 2 Male 52 (74.3) multitude of tumor types, and patients receiving PD-(L)1 therapy for less than Sex, n (%) 20 – The patients with NPC and melanoma died six months after discontinuation of treatment tumor reductions were observed in patients treated beyond progression 12 months have been associated with higher rates of relapse3 Female 18 (25.7) 10 With a median follow-up of 32.1 months, median OS was not reached for patients with LTE Based on these data, tislelizumab is being investigated in multiple ongoing pivotal Tislelizumab, an anti-PD-1 antibody, was engineered to minimize binding to FcγR on clinical trials 0 25 (35.7) 0 Figure 3: Change in Sum of Target Lesion Diameters in Patients Treated Beyond macrophages to abrogate antibody-dependent phagocytosis, a potential mechanism of ECOG status, n (%) T-cell clearance and resistance to anti-PD-1 therapy4,5 Progression With Tislelizumab 1 45 (64.3) -10 Immune-mediated AEs were reported in 26 patients (37%); and the incidence of 150 Tislelizumab is approved in China for previously treated relapsed/refractory classical First progressive disease grade ≥3 immune-mediated AEs was low (Table 4) Non-small cell lung cancer 16 (22.9) Hodgkin lymphoma and locally advanced/metastatic urothelial carcinoma with PD-L1– -20 Ongoing treatment No patients with LTE reported a TRAE or immune-mediated TRAE leading to death high expression; supplemental new drug applications were accepted for review of Nasopharyngeal cancer 8 (11.4) -30 Prior lines of systemic therapy Table 4: Immune-mediated Adverse Events in LTE Patients tislelizumab plus chemotherapy as first-line treatment for advanced squamous and 0 nonsquamous non-small cell lung cancer (NSCLC), as well as second-line treatment for MSI-H/dMMR 7 (10.0) -40 100 1 LTE Patients 2 hepatocellular carcinoma a (N=70) -50 3 Category, n (%) In a global first-in-human (FIH) study, the approved clinical dose of tislelizumab (200 mg Melanoma 7 (10.0) every 3 weeks [Q3W]) demonstrated antitumor activity, and adverse events (AEs) were -60 Prior lines of Any Grade Grade ≥3 manageable6 Renal cell carcinoma 7 (10.0) systemic therapy 50 Tumor type, n (%) -70 0 (N=5) Any immune-mediated adverse event 26 (37.1) 6 (8.6) – Patients treated with tislelizumab for more than 12 months (median treatment Hepatocellular cancer 6 (8.6) 1 (N=31) 7 exposure: 21.7 months) reported that AEs were generally of mild or moderate severity -80 2 (N=18) Hypothyroidism 14 (20.0) 0 (0.0) Change from Baseline in Target Lesions %) Change from Baseline in Target 3 (N=16) – Single-agent tislelizumab elicited durable responses in patients with a variety of tumor Urothelial cancer 6 (8.6) -90 PD-L1 ≥10% types, regardless of PD-L1 status 0 Pneumonitis 6 (8.6) 3 (4.3) Gastric cancer 4 (5.7) Ongoing treatment -100 Data from the current phase 1/2 dose-verification/indication-expansion study conducted Skin adverse reaction 4 (5.7) 1 (1.4) 8 Abbreviation: PD-L1, programmed death-ligand 1. in China (BGB-A317-102; NCT04068519) confirmed the recommended dose and clinical Esophageal squamous cell carcinoma 3 (4.3) Change from Baseline %) outcomes reported in the FIH study Hyperthyroidism 3 (4.3) 0 (0.0) Other 6 (8.6) Many patients were receiving ongoing treatment at the time of data cutoff (Figure 2) – Among evaluable patients (n=251), the objective response rate (ORR) was 18% and -50 Median duration of response was 30.4 months, with a median follow-up of 26.6 months Hepatitis 2 (2.9) 2 (2.9) responses were observed in multiple tumor types regardless of PD-L1 expression 0 5 (7.1) – Median overall survival (OS) for all patients was 11.5 months (95% CI: 9.1, 15.0) and Figure 2: Time to and Duration of Response in Patients Treated With Tislelizumab Adrenal insufficiency 1 (1.4) 0 (0.0) median progression-free survival was 2.6 months (95% CI: 2.2, 4.0) Prior lines of 1 31 (44.3) systemic therapies, -100 Here, we present the clinical effects and safety of long-term exposure (LTE; >12 months) Thyroiditis 1 (1.4) 0 (0.0) n (%)a 2 18 (25.7) 0 5 10 15 20 35 30 35 40 to tislelizumab in Chinese patients from BGB-A317-102 Time from Treatment Start Months) aPatients may have had more than one immune-mediated adverse event. ≥3 16 (22.9) Abbreviation: LTE, long-term exposure. METHODS Median time from locally advanced/metastasis to first dose, Safety and Tolerability b 13.6 (0.3, 120.8) Overall Design and Study Objectives months (range) Long-term exposure to tislelizumab was generally well tolerated A full description of the design, patient population, and treatment administration for this Commonly reported treatment-related AEs (TRAEs) included increased alanine REFERENCES 8 PD-L1 ≥10% 18 (25.7) aminotransferase (ALT; n=24, 34.3%) and increased aspartate aminotransferase study is presented in the primary publication 1. Mahoney KM, Freeman GJ, McDermott DF. 5. Zhang T, Song X, Xu L, et al. The binding PD-L1 expression, (AST; n=22, 31.4%) (Table 3) Briefly, adult patients (aged ≥18 years) with histologically or cytologically confirmed c PD-L1 <10% 45 (64.3) The next immune-checkpoint inhibitors: of an anti-PD-1 antibody to FcγRΙ has n (%) advanced/metastatic disease, who had progressed on, or were unable to tolerate, – Treatment-related AEs across the entire study were mostly of grade ≤2 severity PD-1/PD-L1 blockade in melanoma. Clin a profound impact on its biological standard antitumor treatment received tislelizumab 200 mg intravenously (IV) Q3W Unknown/missing 7 (10.0) – The only grade ≥3 TRAEs occurring in more than 5% of patients were increased ALT Ther. 2015;37(4):764-782. functions. Cancer Immunol Immunother. until patients had no evidence of continued clinical benefit, unacceptable toxicity, or aPrior systemic treatment included neoadjuvant, adjuvant, and palliative therapies. (n=4, 5.7%) and increased AST (n=4, 5.7%) 2. Naidoo J, Page DB, Li BT, et al. Toxicities 2018;67(7):1079-1090. withdrawal of consent bTime reported represents whichever came first. c Three patients (4.3%) had TRAEs leading to treatment discontinuation (interstitial lung of the anti-PD-1 and anti-PD-L1 immune 6. Desai J, Deva S, Lee JS, et al. Phase IA/ PD-L1 expression represents the percent of tumor cells with PD-L1 membrane staining at any intensity. checkpoint antibodies. IB study of single-agent tislelizumab, an – Enrolled patients had no available standard treatment or refused standard therapy Abbreviations: dMMR, defective mismatch repair; ECOG, Eastern Cooperative Oncology Group; ITT, intention-to-treat; disease, pneumonia, and malaise; n=1 each) Ann Oncol. LTE, long-term exposure; MSI-H, microsatellite instability-high; PD-L1, programmed death-ligand 1. 2015;26(12):2375-2391. investigational anti-PD-1 antibody, in solid Disease assessment by radiographic imaging (enhanced CT or MRI) was performed Table 3: Treatment-Related Adverse Events in ≥10% of LTE Patients tumors. J Immunother Cancer. 2020;8(1). approximately every 9 weeks during the first 12 months and approximately every 12 weeks Antitumor Activity 3. Gauci ML, Lanoy E, Champiat S, et al.
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