Beqalzi (sonrotoclax) / BeOne Medicines - LARVOL DELTA

Cases and Conversations: Sequencing Strategies in Relapsed and Refractory CLL (ASH 2026) - "Pivotal phase 3 readouts — AMPLIFY (acalabrutinib + venetoclax ± obinutuzumab), CLL17, BRUIN CLL-313/-314 (pirtobrutinib), CELESTIAL-TN (sonrotoclax + zanubrutinib), and MAJIC — have reshaped both the treatment armamentarium and the decision framework around fixed-duration vs continuous therapy. Real-world data show persistent gaps in molecular testing, treatment selection, and toxicity management. This Medical Crossfire® session uses focused didactic primers paired with moderated expert debate to examine the frontline decision points clinicians face every day, with attention to molecular testing, fixed-duration vs continuous therapy, MRD-guided approaches, and proactive AE management."

Clinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia

CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL. (ASCO 2024) - P3 | "Background: The combination of venetoclax (ven), the first-generation BCL2 inhibitor, and ibrutinib, a BTK inhibitor, has demonstrated efficacy in patients with CLL (Wierda et al. Other secondary endpoints include PFS as assessed by investigator (INV); CRR by INV; rate of uMRD4 based on flow cytometry; overall response rate by IRC and INV; duration of response by IRC and INV; patient-reported outcomes; and safety and tolerability. Recruitment is ongoing."

Clinical • IO biomarker • P3 data • Chronic Lymphocytic Leukemia • Hematological Disorders • Neutropenia • TP53

A Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in People With Mantle Cell Lymphoma (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

New P2 trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Transplantation • CD4

Zanubrutinib + obinutuzumab + sonrotoclax in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL/SLL): Initial results from an ongoing phase 1/1b study, BGB-11417-101 (ASH 2025) - P1 | "Introduction: Combination therapy with zanubrutinib, obinutuzumab, and venetoclax has demonstratedefficacy in patients with TN CLL/SLL, including those with high-risk disease features. Combination therapy with zanubrutinib + obinutuzumab + sonrotoclax 320 mg was welltolerated by patients with TN CLL/SLL. No deaths or discontinuations of any study drug due to TEAE wereobserved and no laboratory or clinical TLS occurred during sonrotoclax ramp-up. Substantial efficacy wasobserved, with a 100% ORR and 60% CR + CRi rate."

Clinical • IO biomarker • P1 data • Chronic Lymphocytic Leukemia • CNS Disorders • Hematological Malignancies • Insomnia • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Sleep Disorder • Small Lymphocytic Lymphoma • Thrombocytopenia • IGH

MRD-guided therapy of sonrotoclax (BGB-11417) + obinutuzumab (O) in patients with treatment-naive CLL: Initial results from an ongoing phase 1/1b study, BGB-11417-101 (ASH 2025) - P1 | "Introduction: The first-generation BCL2 inhibitor, venetoclax, is an effective treatment for CLL/SLL, but itsusage may be limited by toxicity. Sonrotoclax + obinutuzumab was generally well tolerated in patients with TN CLL/SLL, withno sonrotoclax discontinuations or deaths due to TEAEs. No laboratory or clinical TLS events occurredduring sonrotoclax ramp-up. Encouraging antitumor activity was observed with sonrotoclax 320 mg."

Clinical • IO biomarker • P1 data • Chronic Lymphocytic Leukemia • Genito-urinary Cancer • Hematological Malignancies • Neutropenia • Prostate Cancer • Richter's Syndrome • Solid Tumor • Thrombocytopenia • IGH

Surzetoclax: A Potentially Best-In-Class BCL-2 Inhibitor for the Treatment of Multiple Myeloma with T(11;14) Translocation or High BCL-2 Expression (IMS 2026) - P1/2 | "TGI of the RS4;11 model was superior to that achieved with clinically relevant BCL-2 inhibitors venetoclax, sonrotoclax or lisaftoclax at equivalent doses and schedules...Importantly, surzetoclax combined effectively with daratumumab and dexamethasone in the KMS-27 and the BCL-2 high RPMI-8226 MM xenograft models. These data identify surzetoclax as a potential best-in-class, next-generation BCL-2 inhibitor that is in a phase-1/-2 clinical trial for the treatment of patients with R/R MM (ClinicalTrials.gov ID: NCT06953960)."

IO biomarker • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Small Lymphocytic Lymphoma • ANXA5 • BCL2L1 • BCL2L2 • MCL1

A Study of Sonrotoclax Combined With Glofitamab and GemOx for Relapsed or Refractory Large B-Cell Lymphoma (ChiCTR) - P2 | N=39 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University

New P2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

A Phase 1 Study with the Novel B-Cell Lymphoma 2 (Bcl-2) Inhibitor Bgb-11417 As Monotherapy or in Combination with Zanubrutinib (ZANU) in Patients (Pts) with CLL/SLL: Preliminary Data (ASH 2022) - P1a/1b | "Background/introduction: The effectiveness of Bcl-2 inhibitors as a treatment for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was established by the approval of venetoclax in pts with CLL/SLL across all lines of therapy. These preliminary data show BGB-11417, alone or in combination with ZANU, was well-tolerated in most patients. Grade ≥3 neutropenia was uncommon and manageable. Efficacy is supported by the rapid reduction in ALC during ramp-up, and early response data are promising."

Clinical • Combination therapy • IO biomarker • Monotherapy • P1 data • Chronic Lymphocytic Leukemia • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia

PRELIMINARY SAFETY AND ANTILEUKEMIC ACTIVITY OF SONROTOCLAX (BGB-11417), A POTENT AND SELECTIVE BCL2 INHIBITOR, IN PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (EHA 2024) - P1/2, P1b/2 | "Although treatment with the BCL2 inhibitor venetoclax has improved outcomes in some patients (pts) withnewly diagnosed acute myeloid leukemia (AML), it is not approved in relapsed/refractory (R/R) AML. In this ongoing dose escalation phase 1b/2 trial, sonrotoclax + azacitidine was generally well tolerated. Thiscombination demonstrated promising antileukemic activity in pts with R/R AML including in the lowest dosecohorts. Further evaluation in pts with R/R AML is ongoing."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Anemia • Bone Marrow Transplantation • Febrile Neutropenia • Infectious Disease • Lymphoma • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Neutropenia • Thrombocytopenia • Transplantation

Combination Treatment with Sonrotoclax (BGB-11417), a Second-Generation BCL2 Inhibitor, and Zanubrutinib, a Bruton Tyrosine Kinase (BTK) Inhibitor, Is Well Tolerated and Achieves Deep Responses in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (TN-CLL/SLL): Data from an Ongoing Phase 1/2 Study (ASH 2023) - P1 | "The combination of venetoclax, a BCL2 inhibitor, and ibrutinib, a BTK inhibitor, is an effective treatment for CLL/SLL. Sonrotoclax (160 mg and 320 mg) in combination with zanubrutinib was well tolerated in patients with TN CLL/SLL. Only one patient discontinued treatment and three patients had dosage reductions. No TLS was seen with either ramp-up schedule."

Clinical • P1/2 data • Atrial Fibrillation • Cardiovascular • Chronic Lymphocytic Leukemia • CNS Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Small Lymphocytic Lymphoma

Effect of first-line treatment of CLL/SLL with the all-oral combination of sonrotoclax (sonro) and zanubrutinib (zanu) on minimal residual disease (uMRD) rates, including in patients with del(17p)/TP53. (ASCO 2026) - P1, P3 | "We hypothesize that upgrading the BCL2i component of BTKi-BCL2i with sonro, a next generation BCL2i with ~14x pharmacological potency compared with venetoclax, may lead to improved uMRD rates. Sonro+zanu was well tolerated and achieved uMRD rates of >90%, including in patients with high-risk cytogenetics. The depth and kinetics of uMRD achieved with sonro+zanu highlights the improved potency and differentiated profile of this combination vs available combination therapies in first-line CLL. Sonro+zanu is being evaluated in two phase 3 clinical trials (NCT06073821, NCT07277231)."

Clinical • Minimal residual disease • Residual disease • Chronic Lymphocytic Leukemia • Hematological Disorders • Infectious Disease • Neutropenia • Novel Coronavirus Disease • Respiratory Diseases • Small Lymphocytic Lymphoma • TP53

BCL-2 inhibition in North American adult T-cell leukemia/lymphoma: Preclinical insights and early clinical outcomes (ASH 2025) - "Hence, we evaluated thepreclinical efficacy of BCL-2 inhibitors in NA ATLL cells and explored clinical outcomes in chemotherapy-refractory ATLL patients.Preclinical:A panel of well-characterized North American patient-derived ATLL cell lines [Pt-4a, Pt-5a, Pt-6a, Pt-15a]along with Japanese patient-derived ATLL cell lines [ATL43T (−)] (J-ATLL) were used to evaluate the efficacyof different BCL-2 inhibitors, including Venetoclax, Sonrotoclax, and Lisaftoclax. Both North American and Japanese ATLL cell lines have shown preclinical sensitivity to BCL-2inhibition using Venetoclax and other emerging inhibitors. Distinct molecular dependencies identifiedthrough BH3 profiling and transcriptional analyses. Venetoclax induces mitochondrial apoptosis anddownregulates key HTLV-1 viral oncogenes, targeting both survival pathways and viral factors."

Clinical data • IO biomarker • Preclinical • Adult T-Cell Leukemia-Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • BCL2L1 • CASP3 • CD4 • MCL1 • NOTCH1 • TP53

Sonrotoclax and Zanubrutinib as Frontline Treatment for CLL Demonstrates High MRD Clearance Rates with Good Tolerability: Data from an Ongoing Phase 1/1b Study BGB-11417-101 (ASH 2024) - P1 | "Introduction : The combination of venetoclax, a BCL2 inhibitor, with ibrutinib, a BTK inhibitor, is effective in CLL/SLL, but their clinical use can be limited by toxicity. With a median follow-up of 18.3 mo, only 1 PFS event occurred in the 160-mg cohort, and none occurred in the 320-mg cohort. A registrational phase 3 study (CELESTIAL-TNCLL, BGB-11417-301) assessing this combination with sonrotoclax 320 mg is recruiting."

IO biomarker • P1 data • Chronic Lymphocytic Leukemia • CNS Disorders • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Neutropenia • Novel Coronavirus Disease • Oncology • IGH • TP53

Accessing BTK Inhibitors and Other Novel Therapies for Mantle Cell Lymphoma: Are We All Invited to the Party? (SOHO 2024) - "In the phase 3 RAY trial,2 ibrutinib led to better responses and significant improvements in progression-free survival (PFS) and tolerability versus temsirolimus in patients with R/R MCL...In the SHINE trial,3 the combination of ibrutinib with bendamustine and rituximab for 6 cycles, followed by rituximab maintenance and ibrutinib until progression, led to an unprecedented PFS of 80.6 months in patients not eligible for ASCT...Second-generation BTK inhibitors have also been approved for R/R MCL, including acalabrutinib and zanubrutinib with a more favorable safety profile. In first line therapy, the results of bendamustine, rituximab, and acalabrutinib are expected to be presented soon...Pirtobrutinib, a third-generation non-covalent BTK inhibitor has shown promising activity in MCL after exposure to covalent BTK inhibitors. Moreover, the BCL-2 inhibitors, venetoclax and sonrotoclax, have also shown activity in the post-BTK inhibitor scenario, and sonrotoclax is..."

Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

COMBINATION TREATMENT WITH NOVEL BCL2 INHIBITOR SONROTOCLAX (BGB-11417) AND ZANUBRUTINIB INDUCES HIGH RATE OF COMPLETE REMISSION FOR PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA (EHA 2025) - P1, P3 | "The phase 3 SYMPATICO study showed that combination therapy with venetoclax, a BCL2 inhibitor (BCL2i), and ibrutinib, a Bruton tyrosine kinase inhibitor (BTKi), had efficacy in patients (pts) with relapsed/refractory (R/R) MCL; however, treatment intolerance may impact its use. Sonrotoclax + zanu combination therapy was well tolerated and demonstrated encouraging antitumor activity, with a CR rate of 62.2%, and responses in pts previously treated with a BTKi. A registrational phase 3 study (NCT06742996) further assessing this combination with sonrotoclax 320mg is recruiting."

Clinical • Atrial Fibrillation • Cardiovascular • CNS Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Myelodysplastic Syndrome • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock

Frontline treatment of sonrotoclax (BGB-11417) and zanubrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) demonstrates high undetectable minimal residual disease (uMRD) rates with favorable tolerability: Updated data from BGB-11417-101, an ongoing phase 1/1b study (ASH 2025) - P1 | "Introduction: Frontline CLL/SLL treatments with venetoclax and a Bruton tyrosine kinase (BTK) inhibitorhave emerged as important therapy options with limited undetectable MRD rates...Zanubrutinib, a next-generation BTKinhibitor, is highly effective in CLL, including in patients with high-risk disease features, and showedsuperior progression-free survival (PFS) with fewer cardiac adverse events (AEs) vs ibrutinib in arandomized study in patients with CLL/SLL... Sonrotoclax (160 and 320 mg) + zanubrutinib was well tolerated in patients with TN CLL/SLL,with low rates of treatment discontinuation due to TEAE and no TLS. Efficacy was substantial, with a 100%ORR in assessed patients and a best uMRD4 rate of 94%. High blood uMRD4 rates occurred early anddeepened over time, including in patients with high-risk disease factors, such as unmutated IGHV, TP53mutation, and del(17p)."

IO biomarker • Minimal residual disease • P1 data • Residual disease • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Chronic Myelomonocytic Leukemia • CNS Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Otorhinolaryngology • Respiratory Diseases • Richter's Syndrome • Sinusitis • Small Lymphocytic Lymphoma • IGH • TP53

UPDATED SAFETY AND EFFICACY OF ALL‑ORAL SONROTOCLAX + ZANUBRUTINIB IN RELAPSED/REFRACTORY (R/R) CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL), INCLUDING PATIENTS WITH DEL(17P)/TP53 (EHA 2026) - P1 | "Sonrotoclax (BGB-11417; sonro), a next-generation BCL2 inhibitor, is a more selective and pharmacologically potent inhibitor of BCL2 than venetoclax, with a shorter half-life and no drug accumulation. Zanubrutinib (zanu), a next-generation BTK inhibitor, has shown superior progression-free survival (PFS) with fewer cardiac adverse events vs ibrutinib in R/R CLL/SLL...No pt with uMRD4 reverted to MRD4+. Summary/Conclusion In pts with R/R CLL/SLL, sonro 320 mg + zanu was well tolerated, with low rates of tx discontinuation due to TEAEs, and continued to demonstrate substantial antitumor activity (ORR 100%; CR 52%; uMRD4 86%), including in BTK inhibitor-pretreated pts."

Clinical • IO biomarker • Cardiovascular • Cerebral Hemorrhage • Chronic Lymphocytic Leukemia • CNS Disorders • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Lymphoma • Meningococcal Infections • Multiple Myeloma • Musculoskeletal Pain • Myelodysplastic Syndrome • Neutropenia • Non-Hodgkin’s Lymphoma • Pneumonia • Respiratory Diseases • Septic Shock • Small Lymphocytic Lymphoma • IGH • TP53

SAFETY AND EFFICACY RESULTS OF A PHASE 1 STUDY OF THE NOVEL BCL2 INHIBITOR SONROTOCLAX (BGB-11417) FOR RELAPSED/REFRACTORY WALDENSTRÖM'S MACROGLOBULINEMIA (EHA 2024) - P1 | "In previous studies, theBCL2 inhibitor venetoclax demonstrated antitumor activity in patients with WM (Castillo 2022), but it is notapproved for the treatment of this disease. Sonrotoclax monotherapy was well tolerated in patients with R/R WM, and the preliminary antitumor activity isencouraging in this heavily pretreated R/R WM population. Based on findings of this study, further evaluationof sonrotoclax monotherapy in patients with R/R WM is ongoing in a potentially pivotal phase 2 study."

Clinical • P1 data • Anemia • Cardiovascular • CNS Disorders • Dermatology • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Lymphoplasmacytic Lymphoma • Neutropenia • Novel Coronavirus Disease • Oncology • Pneumonia • Pruritus • Respiratory Diseases • Waldenstrom Macroglobulinemia

UPDATED INTERIM RESULTS OF SONROTOCLAX + DEXAMETHASONE IN PATIENTS WITH T(11; 14)-POSITIVE RELAPSED/REFRACTORY MULTIPLE MYELOMA: AN ALL-ORAL TREATMENT (EHA 2025) - P1/2 | "Sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, is a more selective and pharmacologically potent inhibitor of BCL2 than venetoclax, with a shorter half-life and no drug accumulation. The all-oral combination of sonrotoclax + dex continued to show a tolerable safety profile, with low rates of infection and hematologic toxicity, and promising efficacy, with an ORR of 81% in the 640-mg cohort, in this t(11; 14)-positive R/R MM population. The study is ongoing; additional tx combinations with sonrotoclax are being investigated."

Clinical • CNS Disorders • Fatigue • Hematological Malignancies • Infectious Disease • Insomnia • Multiple Myeloma • Oncology • Pancreatic Cancer • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections • Sleep Disorder • Solid Tumor

SONROTOCLAX PLUS DEXAMETHASONE IS TOLERABLE AND DEMONSTRATES ANTIMYELOMA ACTIVITY IN PATIENTS WITH RELAPSED/REFRACTORY (R/R) MULTIPLE MYELOMA HARBORING T(11; 14) (EHA 2024) - P1/2 | "Background: BCL2 is an attractive therapeutic target in multiple myeloma (MM) with t(11; 14), in that MM cells are primedfor BCL2 and responsive to oral BCL2 inhibitors, such as venetoclax, a first-generation BCL2 inhibitor. With longer follow-up, sonrotoclax plus dexamethasone continues to demonstrate** a manageable safetyprofile, with low rates of hematologic toxicities and infections. The combination provided deep and durableresponses in this R/R population. The study is ongoing, and other combination treatments with sonrotoclax arebeing investigated."

Clinical • CNS Disorders • Fatigue • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Hepatocellular Cancer • Hepatology • Infectious Disease • Insomnia • Liver Failure • Multiple Myeloma • Neutropenia • Novel Coronavirus Disease • Oncology • Pancreatic Cancer • Sleep Disorder • Solid Tumor • Thrombocytopenia

Venetoclax Alone or in Combination Shows Promising Activity in Preclinical Models and Clinical Cases of Relapsed/Refractory North American Adult T-Cell Leukemia Lymphoma (ASH 2024) - "Venetoclax has shown activity in other T-cell malignancies, alone or in combination with hypomethylating agents (HMA), AZT (Zidovudine) with Interferon-alpha has been the backbone of acute ATLL treatment for the past three decades...Results : Preclinical : We observed that both the J-ATLL and NA-ATLL cells are sensitive to BCL-2 inhibitors (Venetoclax & Sonrotoclax) with IC50s in the 1-10uM range...To determine synergy between drugs we tested the combination of Decitabine (hypomethylating agent)-Venetoclax as well as between Biktarvy-Venetoclax...TP53 mutated patients had poorer responses. Given the encouraging preclinical and clinical activity of this agent, a prospective clinical trial is being developed using these agents."

IO biomarker • Preclinical • Adult T-Cell Leukemia-Lymphoma • Endocrine Disorders • Fatigue • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Leukemia • Lymphoma • Metabolic Disorders • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock • IFNA1

Sonrotoclax (BGB-11417) in Combination with Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma with t(11; 14): Safety, Efficacy, and Determination of Recommended Phase 2 Dose (ASH 2023) - P1/2 | "In patients with relapsed/refractory (R/R) MM harboring t(11; 14) for whom multiple prior lines of therapy failed, single-agent venetoclax, a first generation BCL2 inhibitor, demonstrated antimyeloma activity (Kumar S, et al. Sonrotoclax plus dexamethasone was generally well tolerated in patients with R/R MM harboring t(11; 14) at doses up to 640 mg, and initial safety and efficacy results are promising. The SMC has recommended 640 mg in combination with dexamethasone as the RP2D. Recruitment is ongoing for the sonrotoclax in combination with dexamethasone and carfilzomib dose-finding arms and the sonrotoclax plus dexamethasone indication expansion cohort."

Clinical • Combination therapy • IO biomarker • P2 data • B Cell Lymphoma • Cataract • CNS Disorders • Fatigue • Hematological Malignancies • Infectious Disease • Insomnia • Lymphoma • Multiple Myeloma • Musculoskeletal Pain • Oncology • Ophthalmology • Pain • Retinal Disorders • Sleep Disorder

Sonrotoclax (BGB-11417) + zanubrutinib (SZ) vs venetoclax + acalabrutinib (AV) in treatment-naive chronic lymphocytic leukemia (TN CLL): A phase 3 randomized trial design (CELESTIAL-TNCLL-2). (ASCO 2026) - P1, P3 | "Other secondary endpoints are ORR and complete response assessed by IRC and investigator (INV), uMRD5 rate (clonoSEQ), PFS-INV, duration of response by IRC and INV, time to next tx, pt-reported outcomes, and safety/tolerability. Enrollment in BGB-11417-304 is currently ongoing."

Clinical • IO biomarker • P3 data • B Cell Lymphoma • Chronic Lymphocytic Leukemia • CNS Disorders • Hematological Disorders • Hematological Malignancies • Hypertension • Leukemia • Lymphoma • Neutropenia • Prolymphocytic Leukemia • Rare Diseases • Richter's Syndrome • IGH • TP53

COMBINATION TREATMENT WITH NOVEL BCL2 INHIBITOR SONROTOCLAX (BGB-11417) AND ZANUBRUTINIB INDUCES HIGH RATE OF COMPLETE REMISSION FOR PATIENTS WITH RELAPSED/REFRACTORY (R/R) MANTLE CELL LYMPHOMA (MCL) (SIE 2025) - P1, P3 | "Sonrotoclax (sonro; BGB-11417), a next-generation BCL2 inhibitor, is a more selective and pharmacologically potent inhibitor of BCL2 than venetoclax. Sonro + zanu was well tolerated and had encouraging antitumor activity, with a CR rate of 62.2%, and responses in pts with prior BTKi tx. A registrational phase 3 study (NCT06742996) with sonro 320mg + zanu is recruiting."

Clinical • Atrial Fibrillation • Cardiovascular • CNS Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Myelodysplastic Syndrome • Neutropenia • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Septic Shock

Sonic: Escalated inpatient ramp-up of sonrotoclax in CLL/SLL and MCL (ASH 2025) - P2 | "Sonrotoclax (BGB-11417) is apromising next generation Bcl-2 inhibitor with better potency and specificity than venetoclax, a firstgeneration Bcl-2 inhibitor, in pre-clinical studies...Patients with a prior othermalignancy within the past 2 years are excluded.Objectives:Primary Objectives:To examine the safety and tolerability of an escalated ramp-up of sonrotoclax (BGB-11417) followinginitial debulking with zanubrutinib or rituximab in patients with treatment-naïve or R/R CLL/SLL andpatients with R/R MCL.To assess safety by measuring the frequency of adverse events (AEs), including episodes of laboratoryand clinical TLS.To evaluate the feasibility of reaching a target dose of sonrotoclax 320mg daily on day 12 +/- 2 daysfollowing a 4-day inpatient ramp-up of sonrotoclax.Secondary Objective:To estimate the efficacy of an escalated ramp-up of sonrotoclax followed by 1 year of combinationtherapy (with either zanubrutinib or rituximab) by assessing the overall..."

Clinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Richter's Syndrome • Small Lymphocytic Lymphoma