sonrotoclax (BGB-11417) / BeOne Medicines - LARVOL DELTA

Bgb-11417: A novel BCL2 inhibitor with robust antileukemic activity in T-cell acute lymphoblastic leukemia, alone or with vincristine (ASH 2025) - "T-cell acute lymphoblastic leukemia (T-ALL) is a malignant disorder characterized by the abnormal proliferation of immature T lymphocytes. Both as a single agent and in combination with VCR, BGB-11417 shows superior efficacy compared to ABT-199. These results demonstrate that BGB-11417 as a promising therapeutic agent for T-ALL and should be considered in future clinical trials."

IO biomarker • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • T Acute Lymphoblastic Leukemia • Targeted Protein Degradation • T-cell Acute Lymphoblastic Lymphoma • BCL2L1 • CASP3 • MYC • NOTCH1

Primary analysis of a multicenter, open-label, phase 2 study of sonrotoclax (BGB-11417) monotherapy in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) (ASH 2025) - P1, P2 | "Sonrotoclax monotherapy demonstrated promising efficacy in heavily pretreated Chinesepts with R/R CLL/SLL, with an IRC-assessed ORR of 76%, and deep, rapid responses regardless of riskstatus, including subgroups with unmutated IGHV, del(17p) and/or TP53 mutations, and BTK mutations.Sonrotoclax monotherapy was well tolerated, and toxicities were manageable with low rates of dosereduction and treatment discontinuation. These data support the potential of sonrotoclax as a promisingtherapeutic option for pts with R/R CLL/SLL."

Clinical • IO biomarker • Monotherapy • P2 data • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Disorders • Infectious Disease • Leukemia • Lymphoma • Pneumonia • Respiratory Diseases • Small Lymphocytic Lymphoma • IGH • TP53

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

Harnessing BCL2 inhibition with BTK inhibition in follicular lymphoma: A translational trial with mechanistic insights from single cell analysis (ASH 2025) - "We hypothesized that the tumor microenvironment (TME) contributes to the activation ofalternative survival mechanisms and dual inhibition of BTK and BCL2 may overcome TME-mediatedresistance and improve therapeutic response. This study investigates the therapeutic potential of combining the BTK inhibitor zanubrutinib(zanu) with the potent BCL2 inhibitor sonrotoclax (sonro) in FL, leveraging a novel ex vivo co-culturemodel (iNHL-TME) that mimics the lymph node microenvironment. This study integrates functional drug testing with high-resolution molecular profiling. Functional phenotypic studies suggest that the combination of BTK and BCL2 inhibitors deliver effectivecell killing. The mechanistic study also suggests that most tumor cells are under drug-induced stress andundergo apoptosis."

Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

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

Other cancers in patients with chronic lymphocytic leukemia/SMALL lymphocytic lymphoma (ASH 2025) - "Among patients treated with targetedtherapies, 950 (50%) received ibrutinib, 381 (20%) received acalabrutinib, 164 (9%) received zanubrutinib,4 (<1%) received orelabrutinib, 280 (15%) received venetoclax, and 3 (<1%) received sonrotoclax. In this large dataset of newly diagnosed patients with CLL/SLL in the past ten years,approximately 10% patients developed OC at 5 years. Receipt of CLL directed therapy was associatedwith a 40% increased risk of development of OC compared to those patients who did not receive therapy.The risk was highest among patients who received CIT with or without targeted therapy and was stillelevated in those who received CIT only or targeted therapy only."

Clinical • IO biomarker • Chronic Lymphocytic Leukemia • Gastrointestinal Disorder • Hematological Malignancies • Leukemia • Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Solid Tumor • IGH

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

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

Sonrotoclax (BGB-11417) monotherapy in patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) previously treated with a bruton tyrosine kinase (BTK) inhibitor: Early results from A phase 1/2 study (ASH 2025) - P1/2 | "Sonrotoclax (BGB-11417), a next-generation B-cell lymphoma 2 (BCL2) inhibitor, is a more selective and pharmacologically potent inhibitorof BCL2 than venetoclax, with a shorter half-life and no drug accumulation. Preliminary results indicate that once daily sonrotoclax 320 mg monotherapy is welltolerated in patients with R/R MCL previously treated with a BTK inhibitor. Clinically meaningful benefits,including median DOR of 15.8 months, were seen in patients with high unmet needs and advanced,aggressive disease. These results support sonrotoclax as a promising treatment option for patients withR/R MCL."

Clinical • Monotherapy • P1/2 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Disorders • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Pneumonia • Respiratory Diseases

CaDAnCe-104, an ongoing, open-label, phase 1b/2 master protocol study of Bruton tyrosine kinase degrader BGB-16673 in combination with other agents in patients with relapsed/refractory B-cell malignancies (ASH 2025) - P1/2 | "Thecurrent master protocol includes four substudies with their prioritized histologies evaluating BGB-16673in combination with: sonrotoclax (substudy 1: CLL/SLL, WM, MCL, and MZL), zanubrutinib (substudy 2:CLL/SLL, WM, MCL, and MZL), mosunetuzumab (substudy 3: FL and CLL/SLL), and glofitamab (substudy 4:non-GCB DLBCL and MCL). In addition, several exploratoryanalyses to assess predictive, prognostic, and pharmacodynamic biomarkers may be performed usingpatient samples. Recruitment is ongoing."

Clinical • Combination therapy • P1/2 data • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia • BTK

Trium study: Exploring MRD-guided triplet therapy with sonrotoclax, zanubrutinib, and CD20mab in Untreated Mantle Cell Lymphoma: A prospective, multicenter, Phase II Study (ASH 2025) - P2 | "Sonrotoclax (BGB-11417), a next-generation BCL-2 inhibitor, exhibits higher selectivity andpharmacological potency than venetoclax, with a shorter half-life and no drug accumulation.Zanubrutinib, a next-generation BTK inhibitor, has shown favorable safety and efficacy profiles intreatment-naïve (TN) MCL patients.ObjectiveTo evaluate the efficacy and safety of sonrotoclax-containing, chemotherapy-free triplet inductiontherapy in TN MCL.MethodsThis open-label, single-arm, multicenter trial (NCT06463691) enrolled treatment-naïve MCL patients.Patients received zanubrutinib (160 mg BID) plus zuberitamab, a novel CD20mab with enhancedantibody-dependent cellulal cytotoxicity, for 2 cycles as lead-in treatment. ConclusionsThe preliminary results indicate sonrotoclax combined with zanubrutinb and zuberitamab showedpromising efficacy, with manageable toxicity and tolerability. The study is ongoing, and further resultsand details will be updated."

Clinical • P2 data • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Thrombocytopenia • TP53

A phase 3, randomized, open-label, multicenter study of sonrotoclax (BGB-11417) plus anti-CD20 antibody therapies vs venetoclax plus rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL-RR1/CELESTIAL-RRCLL) (ASH 2025) - P1, P3 | "Obinutuzumab, a type II anti-CD20 antibody, has showngreater efficacy than rituximab as first-line CLL treatment, but randomized data are currently lacking forR/R CLL.Sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, is a more selective and morepharmacologically potent inhibitor of BCL2 than venetoclax, with a shorter half-life and no drugaccumulation. Further exploratory analyses will evaluate baseline molecular and cytogenetic features, MRDdynamics, and potential predictors of response or resistance.The study is enrolling at approximately 150 sites across North America, Europe, Asia-Pacific, includingAustralia/New Zealand and China/Korea, and Latin America. Recruitment began in June 2025 and iscurrently ongoing."

Clinical • IO biomarker • P3 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Richter's Syndrome • Small Lymphocytic Lymphoma • TP53

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

Initial phase 1b/2 study results with sonrotoclax (BGB-11417) in combination with carfilzomib and dexamethasone in patients with t(11; 14)-positive relapsed/refractory multiple myeloma (ASH 2025) - P1/2 | "Sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, is a more selective and pharmacologically potent inhibitor ofBCL2 than venetoclax, with a shorter half-life and no drug accumulation. Sonrotoclax + K + dex combination therapy demonstrated a tolerable safety profile andencouraging antimyeloma activity, with an 84% ORR and a 32% CR/sCR rate in heavily pretreated patientswith t(11; 14)-positive R/R MM. Enrollment in BGB-11417-105 is ongoing, and additional treatmentcombinations with sonrotoclax are being investigated."

Clinical • Combination therapy • P1/2 data • Acute Kidney Injury • Back Pain • Cardiovascular • CNS Disorders • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Insomnia • Multiple Myeloma • Musculoskeletal Pain • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases • Sleep Disorder • Thrombocytopenia

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: BeOne Medicines

New P3 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

Advances in the Management of Relapsed/Refractory CLL and Richter Transformation (ICML 2025) - P=N/A, P2, P3 | "BRUIN CLL-321 is a phase 3, registrational study that evaluated pirtobrutinib compared to the investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) [23]...Nemtabrutinib is now being evaluated in the registrational, phase 3 BELLWAVE-010 trial (NCT05947851) for patients with R/R CLL, comparing nemtabrutinib plus venetoclax to venetoclax plus rituximab...An ongoing, open-label, first-in-human phase 1/2 study is evaluating the BTK degrader BGB-16673 as monotherapy in patients with R/R CLL [27, 28]...NX-2127 is an investigational, first-in-class BTK degrader currently being evaluated in a phase 1 trial for patients with relapsed or refractory B-cell malignancies, CLL [29, 30]...NX-5948 is another investigational and more selective BTK degrader in an ongoing Phase 1a/1b clinical trial...This trial aims to establish lisaftoclax plus acalabrutinib as a potential alternative to venetoclax-based BTKi combination..."

IO biomarker • Acute Myelogenous Leukemia • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • BCL2L1 • TP53

The Development of Novel Therapies for Chronic Lymphocytic Leukaemia in the Era of Targeted Drugs. (PubMed, J Clin Med) - "Over the past decade, chronic lymphocytic leukaemia (CLL) treatment has shifted from chemoimmunotherapy to targeted oral agents, predominantly Bruton's tyrosine kinase inhibitors (BTKis) and the BCL-2 inhibitor venetoclax...This has driven the development of novel therapeutic strategies, including non-covalent BTKis such as pirtobrutinib and nemtabrutinib, which retain activity in BTK C481-mutated disease. Next-generation BCL-2 inhibitors (sonrotoclax, lisaftoclax) and BTK degraders are promising in early clinical trials...Minimal residual disease (MRD)-guided, fixed-duration regimens represent a significant paradigm shift toward personalised treatment and potentially deeper remissions. Ongoing clinical studies are expected to introduce new effective therapies that may further transform the management of CLL in the coming years."

IO biomarker • Journal • Review • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Sonrotoclax monotherapy achieves an ORR by IRC of 76%, with a CR/CRi of 19%, in patients with R/R CLL/SLL, demonstrating rapid and deep responses (Poster Presentation: 5666) (Businesswire) - "These data were featured at the 67th American Society of Hematology (ASH) Annual Meeting....BGB-11417-202 (NCT05479994) is an open-label, phase 2, and a potential registrational study evaluating the efficacy and safety of sonrotoclax in 100 heavily pretreated patients with R/R CLL/SLL. At a median follow-up of 14.4 months (range, 0.2-27.5 months), primary analysis results show: Similar ORR and CR responses were seen in patients with unmutated IGHV, del(17p) and/or TP53 mutation, and BTK mutation. Median TTR was 3.7 months (range, 1.3-11.1 months). The best blood uMRD rate was 49.0% (n=49/100). Median time to blood uMRD4 was 5.8 months (range, 3-12 months)."

P2 data • Chronic Lymphocytic Leukemia • Small Lymphocytic Lymphoma

Sonrotoclax plus zanubrutinib and obinutuzumab (Poster Presentation: 3890) (Businesswire) - "These data were featured at the 67th American Society of Hematology (ASH) Annual Meeting....In 15 efficacy-evaluable patients, the ORR was 100%, with a CR/CRi rate of 40%. Of the MRD-evaluable patients (n=10), 100% achieved uMRD4, discontinued treatment as mandated by the protocol, and remain in remission; 80% of patients achieved uMRD6. With a median study follow-up of approximately 18.0 months, no PFS events have occurred."

P1 data • Chronic Lymphocytic Leukemia • Small Lymphocytic Lymphoma

Sonrotoclax plus obinutuzumab (Oral Presentation: 793) (Businesswire) - "These data were featured at the 67th American Society of Hematology (ASH) Annual Meeting....In the 320 mg efficacy-evaluable cohort (n=30), the ORR was 93%, with CR/CRi in 43% of patients. The median time from reaching sonrotoclax target dose to uMRD was 2.3 months (range, 1.4-5.6 months) in the 320-mg cohort. The combination was generally well tolerated, with no sonrotoclax discontinuations or deaths due to TEAEs."

P1 data • Chronic Lymphocytic Leukemia • Small Lymphocytic Lymphoma

Sonrotoclax plus zanubrutinib (Poster Presentation: 3891) (Businesswire) - "These data were featured at the 67th American Society of Hematology (ASH) Annual Meeting....In 135 efficacy-evaluable patients, ORR was 100%, with CR/CR with incomplete count recovery (CRi) in 55% of the 320-mg cohort. Median TTR was 2.6 months (range, 1.5-10.8 months). At 48 weeks of combination treatment, the uMRD4 rate in the 320-mg cohort was 91% and uMRD rates continue to increase over time, with 98% of patients achieving uMRD4 by 96 weeks. Median time from the initiation of the combination to uMRD4 was 4.5 months."

P1 data • Chronic Lymphocytic Leukemia • Small Lymphocytic Lymphoma

Sonrotoclax could become the first BCL2 inhibitor indicated for R/R MCL in the U.S., based on data showing an overall response rate (ORR) of 52.4%. (Oral Presentation: 663; December 7 from 5:00-5:15 PM EST) (Businesswire) - "These data were featured at the 67th American Society of Hematology (ASH) Annual Meeting....In this Phase 1/2, global, multicenter, single-arm, open-label study (NCT05471843), ORR by IRC was 52.4% (95% CI, 42.4-62.4) with a complete response (CR) rate of 15.5% (95% CI, 9.1-24.0) in patients with R/R MCL post-treatment with anti-CD20 therapy and a BTK inhibitor treated with 320 mg of sonrotoclax (n=103). Notably, ORR by IRC benefit was consistent across patients with high-risk disease subtypes, including patients with TP53 mutation, a key prognostic marker for MCL. In this patient group, ORR by IRC was 59.1% (95% CI, 36.3-79.3)."

P1/2 data • Mantle Cell Lymphoma

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

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

CELESTIAL-TNCLL: An Ongoing, Open-Label, Multiregional, Phase 3 Study of Sonrotoclax (BGB-11417) + Zanubrutinib vs Venetoclax + Obinutuzumab for Treatment-Naive CLL (ASH 2024) - P3 | "Introduction : The combination of venetoclax, the first-generation BCL2 inhibitor, and ibrutinib, a BTK inhibitor, has demonstrated efficacy in patients with chronic lymphocytic leukemia (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 at approximately 230 study sites in 20 countries, including 50 sites in the US, 6 in Brazil, and 15 in Canada."

Clinical • IO biomarker • P3 data • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53