Abstract: Background: The Bruton tyrosine kinase (BTK) inhibitor zanubrutinib has demonstrated greater selectivity for BTK versus other TEC- and EGFRfamily kinases in biochemical assays, and favorable pharmacokinetic/pharmacodynamic properties in preclinical studies. In a phase 1 clinical trial, zanubrutinib showed complete and sustained 24-hour BTK occupancy in both peripheral blood mononuclear cells and lymph node biopsies from patients treated with 160 mg twice daily (Tam et al. Blood 2016;128:642). Zanubrutinib was also associated with high and durable responses in patients with WaldenstrC6m macroglobulinemia (WM) (Tam, ASCO 2020, abstract 8007; Dimopoulos, EHA 2019, abstract PF487; Trotman, EHA 2019, abstract PF481). Here we present initial safety and efficacy data from a phase 2 trial of zanubrutinib in patients with relapsed or refractory (R/R) WM. Methods: BGB-3111-210 (ClinicalTrials.gov: NCT03332173) is a pivotal, single-arm, open-label, multicenter, phase 2 study conducted in China. Patients with R/R WM aged b %18 years and with b %1 prior line of standard chemotherapy-containing regimen (with completion of b %2 continuous treatment cycles) receive zanubrutinib 160 mg twice daily until disease progression or unacceptable toxicity. The primary objective is to evaluate the efficacy of zanubrutinib as measured by major response rate (MRR), defined as the proportion of patients achieving complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by an independent review committee (IRC) according to an adaptation of the 6th International Workshop on WM response criteria. Secondary endpoints include progression-free survival (PFS), overall response rate (ORR), duration of major response, and safety. The safety analysis set includes all patients who received b %1 dose of zanubrutinib. All efficacy endpoints are analyzed in patients with pathologically confirmed WM and with baseline immunoglobulin M (or M-protein) b %5 g/L. Adverse event (AE) severity is graded according to NCI CTCAE v4.03. Results: As of August 31, 2019, a total of 44 patients with R/R WM were enrolled and treated, with a median follow-up of 18.58 months. Baseline characteristics are summarized in Table 1. For the 43 patients evaluable for efficacy (1 patient was excluded from the efficacy analysis due to baseline immunoglobulin M & lt;5g/L), MRR per IRC was 69.8% (n=30, Table 1), with b % VGPR achieved in 32.6% of patients (n=14). As of data cutoff date, median PFS and median duration of major response were not reached. The most frequently reported (b %20%) treatment-emergent AEs (TEAEs) included neutrophil count decreased (56.8%), platelet count decreased (29.5%), white blood cell count decreased and upper respiratory tract infection (27.3% each), diarrhea (25.0%), weight increased and arthralgia (20.5% each). Grade 3 or higher AEs reported in b %5% of patients included neutrophil count decreased (31.8%), platelet count decreased (20.5%), lung infection (13.6%), white blood cell count decreased (11.4%), pneumonia (9.1%), anemia and upper respiratory tract infection (6.8% each). Most bleeding events were grade 1 or 2 originating in skin or mucous membranes. Major hemorrhage (serious or grade b %3 bleeding, or central nervous system bleeding of any grade) was reported in 2 patients (4.5%). No cases of atrial fibrillation/flutter or tumor lysis syndrome were reported. Two patients died within 30 days of last study treatment: one due to acute hepatitis B and multiple organ dysfunction syndrome, both of which were related to study drug per investigator's judgment, the other due to unknown reason, which was unlikely to be related to study drug as assessed by the investigator. TEAEs leading to discontinuation of zanubrutinib (n=1 each) included lung infection, laryngeal cancer, WM (investigator reported WM as AE due to unexpected rapid progression and suspected it to be a transformation), intracranial mass, acute hepatitis B (grade 5), and multiple organ dysfunction syndrome (grade 5). Conclusions: Zanubrutinib was shown to be highly active in patients with R/R WM, as demonstrated by a high MRR, b %VGPR rate. Zanubrutinib was generally well tolerated, consistent with previous reports of zanubrutinib treatment in patients with various B-cell malignancies. Disclosures Zhou: Henan Cancer Hospital: Current Employment. Guo:BeiGene Co., Ltd.: Current Employment, Current equity holder in private company. Du:BeiGene Co., Ltd.: Current Employment, Current equity holder in private company. Huang:BeiGene: Current Employment, Current equity holder in publicly-traded company, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company). Novotny:BeiGene USA, Inc.: Current Employment, Current equity holder in private company. Zhong:BeiGene Co., Ltd.: Current Employment, Current equity holder in private company. OffLabel Disclosure: Zanubrutinib is a small molecule inhibitor of Bruton's tyrosine kinase (BTK) that is being evaluated as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Zanubrutinib is approved in the United States to treat adult patients with MCL who have received at least one prior therapy and in China for the treatment of MCL in adult patients who have received at least one prior therapy and CLL or SLL in adult patients who have received at least one prior therapy. Zanubrutinib is not approved for use outside of the United States and China.

Abstract: Although Bruton tyrosine kinase (BTK) inhibitors have demonstrated promising efficacy in patients with Waldenström macroglobulinemia (WM), data in Asian populations are scarce. This trial is the first to investigate the effect of a BTK inhibitor in Chinese patients with relapsed/refractory (R/R) WM. Patients and Methods: Patients with R/R WM with at least one prior regimen were enrolled into this single-arm, multicenter, phase II study (NCT03332173) and received zanubrutinib 160 mg twice daily until disease progression or unacceptable toxicity. The primary endpoint was major response rate (MRR), as assessed by an independent review committee. Secondary endpoints included progression-free survival, overall response rate, duration of major response, and safety. Results: Forty-four patients were enrolled. After a median follow-up of 33.0 (range, 3.2–36.5) months, MRR in all patients was 69.8%, with very good partial response or better in 32.6% of patients. All mutation groups benefited from zanubrutinib treatment (MRR in patients with MYD88L265P mutation, 73%; MRR in patients with MYD88 wild type mutation, 50%). A higher response rate was seen in the MYD88L265P/CXCR4WT population, compared with the other populations. Median progression-free survival and median duration of major response were not reached. The most frequently reported grade ≥3 treatment-emergent adverse events (AEs) were neutrophil count decreased (31.8%), and platelet count decreased and pneumonia (20.5% each). No case of atrial fibrillation/flutter occurred. Conclusions: Zanubrutinib achieved a high rate of response that was durable and deep in patients with R/R WM across all subgroups, and potentially confers a positive benefit–risk profile for WM.

Abstract: Introduction Zanubrutinib is a highly specific, potent BTK inhibitor with minimal off-target inhibition of other kinases such as EGFR, JAK3, TEC and ITK. Zanubrutinib has shown 100% BTK occupancy, sustained over 24-hours, in both the peripheral blood and lymph node biopsies from patients treated at 160 mg twice daily and achieves durable responses in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) (Tam 2019). In a phase 2 study conducted in patients with relapsed/refractory (R/R) CLL/SLL, treatment with zanubrutinib resulted in an overall response rate (ORR) of 85%. In addition, duration of response (DOR), progression free survival (PFS) and overall survival (OS) of zanubrutinib monotherapy at 12 months were 93%, 87% and 96%(Xu 2020). Here, we present the pooled analysis to evaluate the impact of number of prior lines of therapy on outcomes of zanubrutinib treatment for CLL/SLL patients. Methods Our analysis was based on a pooled data including CLL/SLL patients treated with zanubrutinib monotherapy in two phase 1 studies (ClinicalTrials.gov NCT02343120, and ClinicalTrials.gov NCT03189524) and one phase 2 study (ClinicalTrials.gov NCT03206918), with median study follow-up time of 29.2, 21.1 and 15.1 months, respectively. Firstly, efficacy and safety outcomes were compared between the treatment naïve (TN) and relapsed/refractory (R/R) groups. Secondly, patients with 1 prior therapy were compared to patients with ≥ 2 prior therapies within the R/R setting. To control confounding in each analysis, entropy balancing was used to create a weighted sample where the baseline covariates were balanced between groups (Hainmueller 2012). In each weighted sample, the efficacy outcomes of zanubrutinib included complete response rate (CRR), ORR (defined as the achievement of complete response [CR], or CRi, partial response [PR] , nodular PR, PR with lymphocytosis), PFS and OS. The difference between groups in CRR and ORR was investigated by logistic regression, and those in PFS and OS by Cox proportional hazards models and log-rank test. The 24-month PFS and OS rates were calculated by the Kaplan-Meier method. The extent of exposure and safety profile of each group were summarized. Results The analysis data consisted of 19 TN patients, 93 patients with 1 prior therapy, and 99 patients with ≥ 2 prior therapies. Seven patients were excluded due to missing baseline covariates. In the weighted samples, all baseline covariates were balanced between groups. After weighting, the effective sample sizes were 19 and 31 for the TN and the R/R groups respectively. The median follow-up times were 31.3 and 20.9 months for the TN and R/R group, respectively; 54.4%, 18.8% and 26.8% of the patients in the R/R group had 1, 2 and & gt;2 prior lines of therapy. The ORR and CRR were higher in TN group, compared with R/R groups (100% vs. 92.1% in ORR [p & lt;0.001] and 21.05% vs. 6.7% in CRR [p=0.09] ). PFS of the TN group was superior to the R/R group (p = 0.13; HR 0.33 [95% CI: 0.10, 1.09]; Figure 1a). The 24-month PFS rate was 100% in the TN group and 79.1% in the R/R group. The OS was comparable between two groups. And safety profile was similar for both groups. After weighting, the effective sample sizes were 77 and 85 for the 1 prior therapy and the ≥ 2 prior therapies groups respectively. The median follow-up times were 17.1 and 15.8 months for the 1 prior therapy and the ≥ 2 prior therapies groups; 56.5%, 20.6% and 22.9% of the patients in the ≥ 2 prior therapies group were treated with 2, 3 and & gt;3 prior lines of therapy. The ORR was numerically higher in the 1 prior therapy group, compared with ≥ 2 prior therapies group (97.0% vs. 88.3%; p=0.05). The CRR was comparable in two groups (9.8% vs. 8.4%; p=0.75). The PFS of 1 prior therapy group was significantly longer than that in ≥ 2 prior therapies group (p & lt;0.001; HR 0.15 [95% CI: 0.05, 0.45]; Figure 1b), and 24-month PFS rates were 94.6% and 75.3%, respectively. The OS was comparable between two groups. And safety profile was similar for both groups. Conclusion Zanubrutinib administered in the early lines, including treatment of naïve patients and patients with 1 prior therapy, led to higher overall response rates and greater durability of therapeutic benefit. Safety profile was similar across all lines of therapy. References Tam CS, et al. Blood. 2019; 134 (11): 851-859. Xu W, et al. J Hematol Oncol. 2020; 13 (1): 48. Hainmueller, J. Political Analysis. 2012; 20(1): 25-46. Disclosures Tam: BeiGene: Honoraria; AbbVie: Honoraria, Research Funding; Janssen: Honoraria, Research Funding. Seymour:Morphosys: Consultancy, Honoraria; Mei Pharma: Consultancy, Honoraria; Gilead: Consultancy; AstraZeneca: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Research Funding; F. Hoffmann-La Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Nurix: Honoraria. Zhou:Henan Cancer Hospital: Current Employment. Opat:Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; BeiGene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZenca: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; CSL Behring: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Epizyme: Research Funding. Trotman:Celgene: Research Funding; Takeda: Research Funding; BeiGene: Research Funding; F. Hoffmann-La Roche: Research Funding; PCYC: Research Funding. Huang:BeiGene: Current Employment, Current equity holder in publicly-traded company. Lu:BeiGene: Current Employment, Current equity holder in publicly-traded company. OffLabel Disclosure: Zanubrutinib in treatment-naive CLL/SLL

Abstract: Mantle cell lymphoma (MCL) is a mature B-cell neoplasm with a high initial response rate followed almost invariably by relapse. Here we report the pooled data from 2 studies, BGB-3111-AU-003 and BGB-3111-206, to explore the efficacy of zanubrutinib monotherapy in relapsed/refractory (R/R) MCL. A total of 112 patients were included. Median follow-up durations were 24.7 and 24.9 months for BGB-3111-AU-003 and BGB-3111-206, respectively. Overall response rate (ORR) and complete response (CR) rate were 84.8% and 62.5%, and median duration of response, progression-free survival (PFS) and overall survival (OS) were 24.9, 25.8 and 38.2 months, respectively. After weighting, the PFS (median: NE vs. 21.1 months, P  = 0.235) and OS (median: NE vs. 38.2 months, P  = 0.057) were similar but numerically better in the second-line than later-line group. Zanubrutinib was well-tolerated with treatment discontinuation and dose reduction for adverse events in 12.5% and 2.7% of patients, respectively. Hypertension, major hemorrhage and atrial fibrillation/flutter rates were 11.6%, 5.4% and 1.8%, respectively. Zanubrutinib is efficacious in R/R MCL, with a favorable safety profile.

Abstract: Chidamide has demonstrated significant clinical benefits for patients with relapsed/refractory (R/R) PTCL in previous studies. This multi-center observational study was aimed to evaluate the objective response rate (ORR), overall survival (OS), and safety of chidamide. From February 2015 to December 2017, 548 patients with R/R PTCL from 186 research centers in China were included in the study. Among the 261 patients treated with chidamide monotherapy, ORR was 58.6% and 55 patients (21.1%) achieved complete response (CR). Among the 287 patients receiving chidamide-containing combination therapies, ORR was 73.2% and 73 patients (25.4%) achieved CR. The median OS of all patients was 15.1 months. The median OS of patients receiving chidamide monotherapy and combination therapies was 433 and 463 days, respectively. These results demonstrate a significant survival advantage of chidamide treatments as compared with international historical records. Common adverse effects (AEs) were hematological toxicities. Most AEs in both monotherapy and combined treatments were grade 1–2. No unanticipated AEs occurred. In conclusion, chidamide-based therapy led to a favorable efficacy and survival benefit for R/R PTCL. Future studies should explore the potential advantage of chidamide treatment combined with chemotherapy.

Abstract: Background: The Bruton tyrosine kinase (BTK) inhibitor zanubrutinib,has demonstrated greater selectivity for BTK versus other TEC- and EGFR-family kinases in biochemical assays and favorable pharmacokinetic/pharmacodynamic properties in preclinical studies. In a phase 1 clinical trial, zanubrutinib showed complete and sustained 24-hour BTK occupancy in both blood and lymph node biopsies from patients treated at 160 mg twice daily (bid; Tam et al. Blood 2016;128:642), and was associated with durable responses in patients with non-Hodgkin lymphoma (Tam et al. Blood 2017;130:152). Here, we present initial safety and efficacy data from a phase 2 trial of zanubrutinib in patients with relapsed or refractory mantle cell lymphoma (R/R MCL). Methods: Conducted in China, BGB-3111-206 (clinicaltrials.gov NCT03206970) is a pivotal, single-arm, open-label, multicenter phase 2 study. Patients with R/R MCL aged 18-75 years and with 1-4 prior treatment regimens received zanubrutinib 160 mg bid until disease progression (PD) or unacceptable toxicity. The primary objective is to evaluate the efficacy of zanubrutinib as measured by overall response rate (ORR) assessed by an Independent Review Committee (IRC). Response was assessed with PET-CT scans (in subjects with FDG-avid disease) and CT or MRI scans (in subjects with FDG non-avid disease) at each response assessment and for confirmation of complete response (CR) per the International Conference on Malignant Lymphoma (Lugano) criteria (Cheson, 2014). Key secondary endpoints included progression free survival (PFS), time to response (TTR), duration of response (DOR) and safety. Treatment-emergent adverse events (TEAEs) were assessed according to NCI CTCAE v4.03. Results: As of 27 March 2018, 86 patients with R/R MCL were enrolled and treated. Patient characteristics are summarized in the Table. Over one-half (52.3%) of patients were refractory to their last prior therapy. Median follow-up was 36 weeks (range,1-56) at the data cut. Twenty-one patients discontinued zanubrutinib (13 for PD; 6 for TEAEs; 1 withdrew consent; and 1 per investigator's discretion). One patient was not evaluable for response due to a lack of central pathologic confirmation of MCL. Of the 85 evaluable patients, ORR per the IRC was 84% (n=71; Table), with CR reported in 59% of patients (n=50). The estimated event-free rate for responders was 90% at 24 weeks after response. In total, 12 patients have progressed; the estimated PFS rate was 82% at 24 weeks. The most frequent (≥15%) TEAEs due to any cause included decreased neutrophil count (31.4%), upper respiratory tract infection (29.1%), rash (29.1%), decreased platelet count (22.1%), and decreased white blood cell (WBC) count (17.4%). Grade ≥3 TEAEs due to any cause reported in 〉 2 patients included decreased neutrophil count (11.6%), lung infection (5.8%), anemia (4.7%), and decreased WBC count (3.5%). Petechia/purpura/contusion and hematuria were each reported in 4 patients (4.7%, all grade 1/2); major hemorrhage (serious or grade ≥3 bleeding or central nervous system bleeding of any grade)was reported in 1 patient (1.2%); no cases of atrial fibrillation/flutter or tumor lysis syndrome were reported. Six patients died within 30 days of last study treatment, 1 from PD, 4 due to Grade 5 TEAEs and 1 due to a Grade 5 event that was not treatment emergent. TEAEs leading to discontinuation of zanubrutinib included (n=1 each): infection, pneumonia, lung infection, interstitial lung disease, and twoGrade 5 TEAEs (cerebral hemorrhage and road traffic accident). Conclusions: Zanubrutinib was shown to be highly active in patients with R/R MCL, as demonstrated by a high rate of CR documented by PET-based imaging. Zanubrutinib was generally well-tolerated, consistent with previous reports of zanubrutinib treatment in patients with various B-cell malignancies. Disclosures Song: Peking University Cancer Hospital (Beijing Cancer Hospital): Employment. Zhou:Affiliated Cancer Hospital of Zhengzhou University: Employment; Health and Family Planning Commission of Henan Province: Patents & Royalties: Scientific and technological innovative talents "51282" Project leaders; Henan Cancer Hospital: Consultancy, Employment; Natural Science Foundation of China: Research Funding. Jin:College of Medicine, Zhejiang University: Employment; The National Natural Science Foundation of China: Research Funding. Guo:BeiGene (Shanghai) Co., LTD: Employment. Wang:BeiGene (Shanghai) Co., LTD: Employment. Hilger:BeiGene (Beijing) Co., Ltd.: Employment, Equity Ownership. Huang:BeiGene (Beijing) Co., Ltd.: Employment, Equity Ownership. Novotny:BeiGene (Beijing) Co., Ltd.: Employment, Equity Ownership. Osman:BeiGene USA: Employment, Equity Ownership. Zhu:Beijing Cancer Hospital: Employment.

Abstract: Bruton tyrosine kinase (BTK) inhibitors have demonstrated a high degree of efficacy in the treatment of B cell malignancies characterized by constitutive B cell receptor activation, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Methods The efficacy and safety of zanubrutinib, an investigational highly selective BTK inhibitor, was evaluated in this single-arm, phase 2 study of Chinese patients with relapsed/refractory CLL/SLL. The primary endpoint was overall response rate as assessed by an independent review committee. Results Of the 91 evaluable patients, 77 (84.6%) achieved a response, with three (3.3%), 54 (59.3%), and 20 (22%) patients achieving a complete response, partial response, and partial response with lymphocytosis, respectively, after a median follow-up of 15.1 months. The estimated 12-month event-free rate for duration of response was 92.9%. The most commonly reported grade ≥ 3 adverse events (AEs) were neutropenia (44%), thrombocytopenia (15.4%), lung infection/pneumonia (13.2%), upper respiratory tract infection (9.9%), and anemia (8.8%). The 12-month overall survival rate was 96%. Eight (9.0%) patients discontinued zanubrutinib due to AEs, and seven (8.0%) patients required at least one dose reduction. Conclusion Treatment of patients with relapsed/refractory CLL/SLL with zanubrutinib was generally well tolerated and resulted in a high overall response rate, thereby conferring a favorable benefit-risk profile. Trial registration Prospectively registered in China public registry (CTR20160890) on December 7, 2016: http://www.chinadrugtrials.org.cn/ . Retrospectively registered in ClinicalTrials.gov ( NCT03206918 ) on July 2, 2017.

Abstract: Introduction Prognosis for relapsed and refractory large B-cell lymphoma (r/r LBCL) is poor, and treatment remains challenging. Relmacabtagene autoleucel (relma-cel) is a CD19-directed 4-1BB/CD3z chimeric antigen receptor T cell (CAR-T) product manufactured in China. RELIANCE study is the first CAR-T study with CD19 as target that got IND approved by the authority in China. Initial findings of the pivotal Phase 2 single-arm, multicenter RELIANCE trial demonstrated high response rates and low rates of CAR-T-associated toxicity with relma-cel treatment in heavily pretreated patients (pts) with r/r LBCL (NCT04089215; Ying et al. Cancer Med 2020;10:999-1011). Long-term follow-up data for the RELIANCE study are presented. Materials & Methods Fifty-nine adults (age ≥18 years) with heavily pretreated (≥2 prior therapies), measurable and histologically confirmed r/r LBCL were randomized to receive lymphodepletion chemotherapy (LDC: fludarabine 25 mg/m 2 + cyclophosphamide 250 mg/m 2 daily×3) followed by a single infusion of autologous CAR+ T cells at a dose of 100×10 6 or 150×10 6. Pts were evaluated for efficacy using Lugano criteria and for toxicity using Common Terminology Criteria for Adverse Events v4.03 and for cytokine release syndrome (CRS) using Lee et al. (Blood 2014;124(2):188-95). Primary endpoint was 3-month objective response rate (ORR); key secondary endpoints included complete response rate (CRR) at 3 months, duration of response (DOR), progression-free survival (PFS), overall survival (OS) and treatment-emergent adverse event (TEAE) profile. The data cutoff date was December 31, 2020. Results At the time of analysis, all 59 pts (median age 56.0 years, range 18-75 years) were at least 15 months post-treatment with relma-cel (7 pts completed trial, 34 pts on study, 18 pts withdrew). Among the modified intent-to-treat (mITT) population of 58 efficacy-evaluable pts, best ORR was 77.6%, with a best CRR of 51.7%; ORR and CRR at 3-month-postdose landmark were 60.3% and 44.8%, respectively. With a median follow-up of 17.9 months (range 0.3-25.6 months), median PFS (mITT) was 7.0 months (95% CI 4.8-not reached [NR]). Median PFS was NR (95% CI 8.8 months-NR) for pts with compete response (CR) at 3 months, the 6-, 12-, 18- and 24-month PFS rates were 80.8%, 69.2%, 69.2% and 69.2%, respectively (Figure). PFS was associated with objective response or CR at 1, 3, 6, and 12 months (log-rank test, p≤0.002). Median OS was NR (95% CI NR-NR) for both the mITT population and pts with CR at 3 months (12-month OS rate, 76.8% and 92.3%, respectively). Median DOR was NR (95% CI 4.9 months-NR) for the mITT population and (95% CI 8.0 months-NR) for pts with CR at 3 months. Levels of CAR-T cells declined to below the level of quantification (BLQ) in 41 (69.5%) pts, among whom nearly 40% had sustained response. Median time from documentation of CAR-T BLQ to disease progression was 6.1 months (95% CI 1.8-NR). Treatment-related TEAEs were reported in 93.2% of pts and were primarily grade 1-2 (89.8% pts); 54.2% of pts had grade ≥3 TEAEs. Pyrexia was the most common TEAE, reported in 59.3% of pts (all grade 1-2). The most common grade ≥3 treatment-related TEAEs were neutrophil count decrease (30.5%) and white blood cell (WBC) count decrease (13.6%). Presence of cytopenia at day 29 (78.0%) was significantly associated with WBC count after LDC, change in serum albumin between days 1 and 4 and serum interleukin 8 after LDC (p & lt;0.05). The incidence of CRS and neurotoxicity (NT) was 47.5% and 20.3%, respectively, both primarily grade 1-2. There were no CRS- or NT-related deaths. Occurrence of grade ≥2 CRS or NT (11.9% and 6.8%, respectively) was significantly associated with fold-change of platelet count on day 4 compared with baseline and day 1 absolute neutrophil count (p & lt;0.03). There were no treatment-related deaths. Conclusions These are the first data of long-term follow-up CD19 CAR-T study with IND approval in China reported. With nearly 18 months of median follow-up, the RELIANCE pivotal registered study demonstrated durable responses, high rates of OS and PFS, and no new safety profile found in r/r LBCL pts. Based on these data, relma-cel is undergoing approval in China. Figure: Kaplan-Meier estimates of (A) PFS and (B) OS by 3-month tumor response PR, partial response Figure 1 Figure 1. Disclosures Zhang: JW Therapeutics: Current Employment. Yang: JW Therapeutics: Current Employment. Zhou: JW Therapeutics: Current Employment. Zheng: JW Therapeutics: Current Employment.