RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC49H59N7O7S

InChIKeyZQTKOYMWCCSKON-XKXNWSITSA-N

CAS Registry2383086-06-2

Clinical Trials associated with Sonrotoclax

NCT06859008

/ RecruitingPhase 1IIT

Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities

This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.

Start Date07 Feb 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07277231

/ Not yet recruitingPhase 3

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia

The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).

Start Date31 Jan 2026

Sponsor / Collaborator

BeOne Medicines Ltd.

NCT07141511

/ RecruitingPhase 1

A Phase 1, Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Participants to Evaluate Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332)

The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet containing zanubrutinib and sonrotoclax (BG-71332) compared to a zanubrutinib capsule and sonrotoclax tablet administered simultaneously and the effect of food on how the body processes the fixed-dose combination tablet.

Start Date24 Sep 2025

Sponsor / Collaborator

BeOne Medicines Ltd.

100 Clinical Results associated with Sonrotoclax

100 Translational Medicine associated with Sonrotoclax

100 Patents (Medical) associated with Sonrotoclax

Literatures (Medical) associated with Sonrotoclax

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Biotransformation and disposition of C14-labeled sonrotoclax ([14C]BGB-11417) in preclinical safety species and characterization of unique contribution from gut microbiome

Article

Author: Su, Dan ; Tang, Zhiyu ; Liu, Jianmei ; Cai, Tingting ; Wang, Fan ; Wu, Yue ; Tang, Wei

INTRODUCTION:

Sonrotoclax (BGB-11417), a second-generation B-cell lymphoma-2 (BCL-2) inhibitor currently in clinical development, requires comprehensive verification of its biotransformation and disposition profiles in safety species.

METHODS:

[¹⁴C]BGB-11417 was employed to assess its pharmacokinetics, excretion, tissue distribution and metabolite profiles in mice and dogs. Radioactivity in plasma and excreta were analyzed to determine pharmacokinetics and mass balance. The metabolite profiles were generated by the chromatographic separation coupled with radioactivity detector/ mass spectrometry. Quantitative whole-body autoradiography (QWBA) was performed to assess tissue distribution in both pigmented or albino mice. Anaerobic human fecal incubation was conducted to evaluate the biotransformation contribution of gut microbiome.

RESULTS:

T_max of [¹⁴C]BGB-11417 radioactivity was observed at 4 h, with a T_1/2 ranging 6.5-7.2 h in both species. The highest tissue exposure was noted in metabolic and excretory organs, with 90% of the administered radioactivity eliminated through mouse excreta within 48 h. Prolonged excretion kinetics accompanied by marked inter-individual variability were observed in dog excreta. A distinct nitro-reduction pathway was detected exclusively in dogs. These metabolites were also detected in anaerobic incubations of [¹⁴C]BGB-11417 with human feces. Aerobic incubation of the nitro-reduction metabolite with dog feces directly yielded lipid-conjugated products, confirming that conjugation occurs spontaneously post-reduction rather than on the parent drug.

CONCLUSION:

The concordance between dog fecal metabolites and human fecal incubations underscored cross-species gut microbiome similarities. These findings offer a mechanistic insight into the fate of sonrotoclax in organisms and guide the interpretation of metabolic clearance in human.

01 Oct 2025·Advanced Science

Inhibition of FOXM1 Synergizes with BH3 Mimetics Venetoclax and Sonrotoclax in Killing Multiple Myeloma Cells through Repressing MYC Pathway

Article

Author: Wen, Zhi ; Springstroh, Kelsey ; Kitchner, Terrie E. ; Wang, Yidan ; Fox, Kathryn C. ; Bissonnette, Adam M. ; Tanawattanacharoen, Patcharon ; Hebbring, Scott J. ; Moat, Luke F. ; Sheerar, Dagna S. ; Onitilo, Adedayo A. ; Katzenellenbogen, Benita S. ; Kim, Sung Hoon ; Fagbemi, Seth O. ; Katzenellenbogen, John A. ; Janz, Siegfried ; Leon, Chady A.

Abstract:

Relapsed and refractory multiple myeloma (RRMM) remains the leading cause of MM mortality. FOXM1 is strongly associated with RRMM, making it a compelling therapeutic target. Through three low‐throughput screenings, we have identified nine FDA‐approved drugs, including the BH3 mimetic Venetoclax, that synergize with FOXM1 inhibitor NB73 in killing MM cells. Venetoclax has shown effects in 6% of non‐t(11;14) and 27% of t(11;14) MM cases. The NB73‐Venetoclax combination barely induces acute toxicity in vivo and represses MM cells in vivo and ex vivo. NB73 enhances the ubiquitination and proteasomal degradation of FOXM1, an effect further amplified by Venetoclax. The NB73‐Venetoclax combination abolishes FOXM1's binding to promoters of key MYC pathway genes, such as PLK1, leading to significant downregulation of their expression. Furthermore, the PLK1‐specific inhibitor GSK461364 synergizes with NB73 to inhibit MM cell growth. Interestingly, NB73 does not sensitize U266 cells, a Venetoclax‐resistant t(11;14) MM cell line expressing high FOXM1, to Venetoclax treatment, which is corrected by a new‐generation BH3 mimetic Sonrotoclax and ALK inhibitor Ceritinib. Collectively, targeting FOXM1 demonstrates significant potential for enhancing the efficacy of FDA‐approved drugs in RRMM. These findings shed new light on the discouraging outcomes of the Phase‐III CANOVA study centering Venetoclax with an encouraging molecular clue.

01 Aug 2025·CANCER LETTERS

Sonrotoclax (BGB-11417) synergistically amplifies the radiotherapy-elicited anti-tumor immune response

Article

Author: Liu, Xu ; Yu, Jinming ; Ma, Mengmeng ; Wu, Meng ; Chen, Dawei ; Tian, Chen ; Zhang, Zengfu ; Yuan, Jupeng

Escape from apoptosis is one of the main hallmarks of cancer. The imbalance of BCL-2 family members is a key factor leading to radiotherapy resistance. Targeting BCL-2 can overcome radiotherapy resistance by promoting apoptosis. Nevertheless, the function of BCL-2 in regulating the tumor immune microenvironment (TIME) is still not well understood. Herein, we discovered that the specific BCL-2 inhibitor sonrotoclax (BGB-11417) boosted the effectiveness of radiotherapy in an immune-mediated manner. Using flow cytometry, we found that sonrotoclax combined with radiotherapy polarized tumor-associated macrophages (TAMs) toward the M1-type and promoted the infiltration of Gzmb⁺ CD8⁺ T cells into the tumor. Mechanistically, we demonstrated that the combination of sonrotoclax and radiotherapy induced immunogenic ferroptosis of cancer cells by inhibiting GPX4 expression, released tumor-associated damage-associated molecular patterns (DAMPs) and subsequently activated the NF-κB pathway in TAMs. Moreover, the combination therapy also led to aberrant cytosolic DNA abundance and activated the cGAS-STING pathway in cancer cells, leading to the release of type I interferons and enhanced activation of CD8⁺ T cells. Meanwhile, the activation of cGAS-STING pathway also led to the upregulation of PD-L1 expression. Further combination of sonrotoclax and radiotherapy plus anti-PD-L1 exerted the most significant anti-tumor effects. Overall, our study indicated that sonrotoclax enhanced the anti-tumor immune response of radiotherapy through non-apoptotic roles of BCL-2, and shed light on the further clinical evaluation of the triple combination therapy of sonrotoclax, radiotherapy and immunotherapy.

News (Medical) associated with Sonrotoclax

27 Nov 2025

·www.pharmaceutical-technology.com

BeOne’s sonrotoclax gains priority FDA review for mantle cell lymphoma

Sonrotoclax has also secured breakthrough therapy status from the US regulator for R/R mantle cell lymphoma in adults. Credit: MY STOCKERS/Shutterstock.com. The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for BeOne Medicines’ B-cell lymphoma 2 (BCL2) inhibitor, sonrotoclax, and granted it priority review for use in treating adults with relapsed or refractory mantle cell lymphoma (R/R MCL). The decision is intended for those who have previously been treated with a Bruton’s tyrosine kinase (BTK) inhibitor. This application is based on data from a global, open-label, multicentre Phase I/II study (BGB-11417-201) involving 125 R/R MCL patients who had already received BTK inhibitor therapy. The therapy met its main goal of overall response rate, as determined by an independent review committee, and showed clinically meaningful responses in this patient group. The company has indicated plans to submit the Phase I/II data to additional regulatory agencies worldwide, including the European Medicines Agency, to pursue further approvals for sonrotoclax in R/R MCL. NDAs for the therapy in both R/R MCL and R/R chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) are also being reviewed by the China National Medical Products Administration’s Center for Drug Evaluation, for potential accelerated approval. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Lab studies in early development showed that the therapy is a potent and selective BCL2 inhibitor, characterised by a short half-life and lack of drug accumulation. The therapy has demonstrated promising clinical activity across several B-cell malignancies and is being investigated as a standalone treatment as well as in conjunction with other therapeutics, such as Brukinsa. Sonrotoclax has also secured breakthrough therapy status from the US regulator for R/R MCL in adults. It has fast track status for MCL and Waldenström macroglobulinemia, and orphan drug status for adults with MCL, multiple myeloma, Waldenström macroglobulinemia, acute myeloid leukaemia and myelodysplastic syndrome. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Priority ReviewNDAOrphan DrugBreakthrough TherapyFast Track

26 Nov 2025

·www.businesswire.com

U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. “Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window,” said Lai Wang, Ph.D., Global Head of R&D at BeOne. “That pace reflects both the strength of the data and the urgency of the need for patients with R/R MCL. With rapid, deep, and durable responses and a manageable safety profile, sonrotoclax is emerging as a potential best-in-class BCL2 inhibitor, alongside our two other transformative hematology assets – BTK inhibitor BRUKINSA, and investigational BTK degrader BGB-16673.” The NDA is supported by data from the global, multicenter, single-arm, open-label, Phase 1/2 study, BGB-11417-201 (NCT05471843), which enrolled 125 adult patients with R/R MCL who received prior treatment with a BTK inhibitor. Sonrotoclax achieved its primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), demonstrating clinically meaningful responses in this heavily pretreated population. The study also showed promising results across several secondary efficacy endpoints, including complete response (CR) rate, duration of response (DOR), and progression-free survival (PFS). The treatment was well-tolerated, and the risks were manageable. BeOne will present the full results for the first time at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6-9, in Orlando, Florida. (Oral Presentation: 663; December 7 from 5:00-5:15 PM EST). Supporting efforts to rapidly advance global review and potential access, BeOne will participate in the FDA’s Project Orbis for sonrotoclax, an initiative that provides a framework for concurrent submission and review of oncology products among international partners. BeOne also intends to submit the Phase 1/2 data to other global regulatory bodies for the potential approval of sonrotoclax in R/R MCL, including the European Medicines Agency. New drug applications for sonrotoclax for the treatment of R/R MCL and R/R chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) have also been accepted and are under review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for potential accelerated approval. About Mantle Cell Lymphoma Mantle cell lymphoma (MCL) is a rare subtype of aggressive non-Hodgkin lymphoma (NHL)1 that originates in B-cells located in the mantle zone of the lymph nodes. MCL accounts for approximately 5% of all NHL cases globally2, affecting an estimated 28,000 people3. MCL is often diagnosed at advanced stages4 and nearly all MCL patients will eventually develop refractory or relapsed (R/R) disease.5 The five-year survival rate for MCL is approximately 50%, reflecting the urgent need for new therapeutic options.6 About Sonrotoclax (BGB-11417) Sonrotoclax is a next-generation and potentially best-in-class investigational B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Laboratory studies during early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies and is in development as a monotherapy and in combination with other therapeutics, including BRUKINSA. Notably, in early clinical trials, sonrotoclax plus BRUKINSA has demonstrated rapid and unprecedented rates of undetectable minimal residual disease (uMRD) in treatment-naïve patients with CLL. To date, more than 2,200 patients have been enrolled across the broad sonrotoclax global development program. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for sonrotoclax for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). In addition, the FDA has granted sonrotoclax Fast Track Designation for MCL and Waldenström macroglobulinemia, as well as Orphan Drug Designation for the treatment of adult patients with MCL, WM, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of nearly 12,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential benefits of sonrotoclax; BeOne’s expectations regarding sonrotoclax’s clinical development, regulatory milestones, submissions and approvals; BeOne’s plans to present the full data at an upcoming medical meeting; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom. 1 Jain, P., and Wang, M. L. (2022). Mantle cell lymphoma: 2022 update on diagnosis, risk stratification, and clinical management. American Journal of Hematology, 97(5), 638–656. https://doi.org/10.1002/ajh.26523 2 Ferlay, J., et al. (2024). Global Cancer Observatory: Non-Hodgkin Lymphoma. International Agency for Research on Cancer. https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf 3 Association of Community Cancer Centers. Relapsed/Refractory Mantle Cell Lymphoma. https://www.accc-cancer.org/home/learn/cancer-types/hematologic-malignancies/mcl 4 Cencini, E., et al. (2024). Survival outcomes of patients with mantle cell lymphoma: A retrospective, 15-year, real-life study. Hematology Reports, 16(1), 50–62. https://doi.org/10.3390/hematolrep16010006 5 Burkart, M., and Karmali R. (2022). Relapsed/refractory mantle cell lymphoma: Beyond BTK inhibitors. Journal of Personalized Medicine, 12(3), 376. https://doi.org/10.3390/jpm12030376 6 Cleveland Clinic. (2023). Mantle cell lymphoma. https://my.clevelandclinic.org/health/diseases/24030-mantle-cell-lymphoma

Priority ReviewFast TrackOrphan DrugASHBreakthrough Therapy

21 Nov 2025

·www.prnewswire.com

Hackensack Meridian John Theurer Cancer Center Unveils Research at the 67th American Society of Hematology Annual Meeting

Advances span leukemia, lymphoma, myeloma, myeloproliferative neoplasms, sickle cell disease, and AI-enabled diagnostics HACKENSACK, N.J., Nov. 21, 2025 /PRNewswire/ -- Investigators from Hackensack Meridian John Theurer Cancer Center (JTCC)—a leading research partner of the NCI-designated Lombardi Comprehensive Cancer Center at Georgetown University, and number one Cancer Center in New Jersey—will present 65 studies at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6–9, 2025, in Orlando. This represents one of JTCC's largest and most diverse scientific contributions to ASH to date, highlighting innovations in cell therapy, targeted agents, AI-driven diagnostics, stem cell transplantation, and real-world evidence across virtually every hematologic disease area. "John Theurer Cancer Center continues to help shape the future of blood cancer care," said André Goy, MD, chair, physician-in-chief and vice president of oncology at Hackensack Meridian Health. "Our teams are redefining transplantation, advancing CAR-T science, and co-leading trials testing next-generation targeted therapies and immunotherapies. The depth and breadth of our ASH presentations underscore our mission: to bring transformational science rapidly to the clinic for patients with blood cancers and other serious blood disorders." Highlights of JTCC Research to be presented at ASH 2025 can be found here. Leukemia High event-free (EFS) and overall survival (OS) after non-total body irradiation (TBI) conditioning and allogeneic hematopoietic cell transplantation (HCT) in next-generation-sequencing minimal residual disease (NGS-MRD) negative B-acute lymphoblastic leukemia (B-ALL): Results from the EndRAD trial (PTCTC ONC1701) (ABSTRACT 25-12959) A phase 2 dose confirmation trial of oral ASTX030, a combination of oral azacitidine with cedazuridine among patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia (ABSTRACT 25-7509) Ziftomenib in combination with venetoclax and azacitidine in relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b safety and clinical activity results from KOMET-007 (ABSTRACT 25-3910) 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 (ABSTRACT 25-7489) Real world outcomes of bispecific T-cell engagers in plasma cell leukemia (ABSTRACT 25-4651) Etoposide can be safely removed from induction chemotherapy without impacting survival for pediatric acute myeloid leukemia – a report from the Children's oncology group study AAML1831 (ABSTRACT 25-12270) Updated response and safety analyses from a Phase 1 study of ivosidenib combined with intensive chemotherapy in patients with newly diagnosed (ND) Acute Myeloid Leukemia with isocitrate dehydrogenase (IDH)1 mutation (ABSTRACT 25-421) AI-derived prediction of response and relapse to venetoclax plus hypomethylating agent based therapy in Acute Myeloid Leukemia (ABSTRACT 25-14588) TSC-101 eliminates recipient hematopoietic cells and demonstrates potential for improved relapse-free survival in patients with AML, ALL, or MDS undergoing allogeneic HCT: Updated results from the Phase 1 (ALLOHA) trial (ABSTRACT 25-12098) Trials in progress: Design of a registrational Phase 2 trial (ALLOHA) using an external control arm for TSC-101 for prevention of relapse post allogeneic HCT in patients with ALL, AML, or MDS (ABSTRACT 25-13827) Developing artificial intelligence-based transcriptomic signature for selecting patients with HOXA-MEIS1 pathway abnormalities for the treatment with menin inhibitors (ABSTRACT 25-4126) Evaluation of ventoclax initiation prophylaxis and monitoring outcomes at each dose level and time point in patients with chronic lymphocytic leukemia: A real-world experience (ABSTRACT 25-2129) Developing transcriptomic signature for IDH1 and IDH2 acute leukemia and the demonstration of high prevalence of these signatures in mutation-negative leukemia (ABSTRACT 25-4127) Impact of DUSP22 and TP63 rearrangements in patients with ALK-negative ALCL treated with frontline BV-CH(E)P (ABSTRACT 25-1798) Harnessing repressive LEF1/ β-catenin complexes to overcome drug resistance in chronic lymphocytic leukemia (ABSTRACT 25-14485) Reducing Acute Myeloid Leukemia resistance to CAR T cell therapy by epigenetic activation of the tumor inflammasome-pyroptosis signaling (ABSTRACT 25-13458) Lymphoma Epcoritamab + R-mini-CHOP results in 2-year remissions and high MRD negativity rates in elderly patients with newly diagnosed DLBCL: Results from the EPCORE NHL-2 trial (ABSTRACT 25-3828) Epcoritamab with rituximab + lenalidomide (R2) and epcoritamab maintenance deliver deep and durable remissions in previously untreated (1L) follicular lymphoma (FL): 3-year outcomes from epcore NHL-2 arms 6 and 7 (ABSTRACT 25-2787) Liquid-biopsy mutation landscape and its concordance with skin biopsies in cutaneous T-cell lymphoma (ABSTRACT 25-2858) ZUMA-25 preliminary analysis: A Phase 2 study of brexucabtagene autoleucel (brexu-cel) in patients (Pts) with relapsed/refractory (R/R) Burkitt lymphoma (BL), substudy C (ABSTRACT 25-2841) Final results of a phase 1 trial with soquelitinib (SQL), a selective interleukin-2-inducible T cell kinase (ITK) inhibitor for treatment of relapsed/refractory (R/R) T cell lymphomas (TCL) (ABSTRACT 25-2574) Acalabrutinib plus venetoclax and rituximab in patients with treatment-naive (TN) mantle cell lymphoma (MCL): Results from the Phase 2 TrAVeRse study (ABSTRACT 25-7289) Two-year update of ZUMA-2 Cohort 3: Brexucabtagene autoleucel (Brexu-cel) in patients (pts) with relapsed/refractory mantle cell lymphoma (R/R MCL) who had not received prior Bruton tyrosine kinase inhibitor (BTKi) therapy (ABSTRACT 25-2240) Phase 2 bellwave-003 cohort f: Updated clinical outcomes of nemtabrutinib in participants with relapsed or refractory marginal zone lymphoma (ABSTRACT 25-2322) A real-world analysis of safety and outcomes with first line nivolumab in combination with doxorubicin, vinblastine, and dacarbazine (NAVD) in patients with classic Hodgkin lymphoma (cHL) – a multicenter cohort study (ABSTRACT 25-2368) Safety and efficacy of brexucabtagene autoleucel in elderly patients with relapsed or refractory Mantle Cell Lymphoma: A retrospective, multicenter, international study (ABSTRACT 25-2034) Developing artificial intelligence-based transcriptomic signature for the diagnosis of dark zone lymphoma in patients without MYC gene rearrangement (ABSTRACT 25-7855) A multicenter real-world analysis of combined chemotherapy followed by consolidative radiation versus chemotherapy alone in the management of early-stage Hodgkin lymphoma – the HODGKIN25 study (ABSTRACT 25-1471) Nivolumab with doxorubicin, vinblastine, and dacarbazine (NAVD) in older adults with classic Hodgkin lymphoma: Do S1826 results hold up in the real world? (ABSTRACT 25-7840) First-line salvage therapies in relapsed/refractory large B-cell lymphoma after second- or third-line CD19-directed CAR T-cell therapy (ABSTRACT 25-3402) Multicenter, randomized Phase II study of epcoritamab for patients with large B-cell lymphomas achieving a partial response after CD19-directed CAR T-cell therapy: Trial in progress (ABSTRACT 25-15528) 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 (ABSTRACT 25-4113) Sustained remissions beyond 4 years with epcoritamab monotherapy: Long term follow-up results from the pivotal EPCORE NHL-1 trial in patients with relapsed or refractory large B-cell lymphoma (ABSTRACT 25-7543) Multiple Myeloma Real-world outcomes with elranatamab in multiple myeloma: A multi-center analysis from the United States multiple myeloma immunotherapy consortium (ABSTRACT 25-2557) Phase 1 study of ktx-1001, a first-in-class oral MMSET/NSD2 inhibitor, demonstrates clinical activity in relapsed/refractory multiple myeloma (ABSTRACT 25-2077) Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Updated results from iMMagine--1 (ABSTRACT 25-4541) Alterations in the gut microbiome and the association of butyrate producers with progression-free survival in multiple myeloma patients undergoing autologous stem cell transplantation (ABSTRACT 25-14794) Talquetamab outcomes in relapsed/refractory myeloma with extramedullary and paraskeletal soft tissue plasmacytomas (ABSTRACT 25-7804) Safety and efficacy of talquetamab in patients with relapsed and refractory multiple myeloma (RRMM) with and without renal impairment (ABSTRACT 25-7724) Enhancing the safety of ciltacabtagene autoleucel in relapsed multiple myeloma (MM): Identification of potentially modifiable risk-factors associated with delayed neurotoxicity and non-relapse mortality (ABSTRACT 25-2357) An open-label, multi-center Phase 2 study to assess the safety and efficacy of burixafor (GPC-100) and propranolol with G-CSF for the mobilization of hematopoietic progenitor cells in patients with multiple myeloma (ABSTRACT 25-14982) Prospective real-world evaluation of SKY92 for risk stratification in multiple myeloma: Comparison with updated ims/IMWG criteria in the prommis study (ABSTRACT 25-8818) Pomalidomide salvage in T-cell engager monotherapy failures: Real-world experience with talquetamab or elranatamab with pomalidomide combinations in heavily pretreated multiple myeloma (ABSTRACT 25-10539) Prolonged elranatamab treatment interruption in patients with relapsed or refractory multiple myeloma (RRMM) is feasible: A retrospective analysis from MagnetisMM-3 (ABSTRACT 25-8338) Talquetamab, a GPRC5D×CD3 bispecific antibody, in combination with pomalidomide in patients with Relapsed/Refractory multiple myeloma: Updated safety and efficacy results from the Phase 1b monumental-2 study (ABSTRACT 25-11949) Prospective study of fluoroquinolone resistance colonization in patients undergoing autologous hematopoietic stem cell transplantation in the treatment of multiple myeloma (ABSTRACT 25-13625) Identifying high-risk profiles and adverse prognoses in relapsed/refractory multiple myeloma treated with bispecific antibodies: A real-world analysis of 943 treatment initiations (ABSTRACT 25-8860) Intratumoral cellular immunotherapy with autologous hyperactivated M1 SIRP α -low macrophages in non-Hodgkin lymphoma: Clinical results from a first-in-human Phase 1 study (ABSTRACT 25-8309) Real-world disease burden and treatment patterns among triple-class–exposed patients with relapsed/refractory multiple myeloma and extramedullary disease in the US: A retrospective analysis using Flatiron Health electronic medical records (ABSTRACT 25-9053) Shared immune features correspond to high-risk multiple myeloma across multiple human subtypes and murine models (ABSTRACT 25-13910) Real-world efficacy and safety of teclistamab in relapsed or refractory multiple myeloma: Results from 87 patients treated by the polish myeloma group (ABSTRACT 25-11305) Myeloproliferative Neoplasms Preliminary data from the Phase I/II study of nuvisertib, an oral investigational selective PIM1 inhibitor, in combination with momelotinib showed clinical responses in patients with relapsed/refractory myelofibrosis (ABSTRACT 25-3882) Safety and efficacy results from A phase 1b study of R289, a dual irak 1/4 inhibitor, in patients with Relapsed/Refractory (R/R) lower risk myelodysplastic syndrome (LR-MDS) (ABSTRACT 25-13480) Nuvisertib, an oral investigational selective PIM1 kinase inhibitor, showed clinical responses strongly correlating with cytokine modulation in patients with relapsed/refractory myelofibrosis in the ongoing global phase I/II study (ABSTRACT 25-2614) Bone marrow microenvironment overlap between vexas and myelodysplastic syndrome demonstrated by targeted transcriptomic and artificial intelligence (ABSTRACT 25-7376) Noncancerous Blood Disorders Reduced intensity haploidentical bone marrow transplantation in children with severe sickle cell disease (SCD): BMT CTN 1507 (ABSTRACT 25-11982) End-of-study results from the ICON3 pines trial, a phase 3, randomized trial of eltrombopag vs. standard first-line treatment for newly diagnosed immune thrombocytopenia in children (ABSTRACT 25-4324) The real-world safety and efficacy of BCMA-directed chimeric antigen receptor T-cell therapy in systemic AL amyloidosis (ABSTRACT 25-2732) Robust HbF induction and improvement of anemia and hemolysis with base editing in sickle cell disease: Safety and efficacy findings from the ongoing BEACON study (ABSTRACT 25-2531) Children and adolescents with sickle cell disease demonstrate improved health-related quality of life and low decisional regret after hematopoietic cell transplantation: A sickle cell transplant advocacy and research alliance (STAR) study (ABSTRACT 25-12128) Increased age-adjusted mortality rates from hemophagocytic lymphohistiocytosis (HLH), 2010-2023 (ABSTRACT 25-7365) Rapid decrease in age-adjusted mortality rates associated with ITP following eltrombopag and romiplostim approvals, but not in TMA following eculizumab approval, 1999-2023 (ABSTRACT 25-9103) Technology B- and T-cell clonality using peripheral blood cell-free RNA (cfRNA) in liquid biopsy (ABSTRACT 25-7865) Not so exclusive: Co-mutations in JAK2, MPL and CALR define distinct hematologic and clonal signatures (ABSTRACT 25-10661) Temporal control of CAR expression enables thymic generation of autoreactive T cells targeting tumor-associated antigens (ABSTRACT 25-8390) About Hackensack Meridian John Theurer Cancer Center Hackensack Meridian John Theurer Cancer Center at Hackensack University Medical Center is recognized as New Jersey's #1 cancer center in New Jersey by U.S. News & World Report. They are also the largest and most comprehensive center dedicated to diagnosis, treatment, management, research, screening, and preventive care as well as survivorship of patients with all types of cancers. The 16 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. John Theurer Cancer Center is part of the NCI-designated Lombardi Comprehensive Cancer Center at Georgetown University. Housed within a 781-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities. The center expanded to Jersey Shore University Medical Center, serving patients in southern New Jersey and parts of Pennsylvania. Toms River Regional Cancer Center and Saint Joseph's Health are affiliated with the cancer center. For additional information, please visit . SOURCE Hackensack Meridian John Theurer Cancer Center 21% more press release views with Request a Demo

Clinical ResultPhase 2Phase 1ImmunotherapyASH

100 Deals associated with Sonrotoclax

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Mantle cell lymphoma recurrent	NDA/BLA	United States	BeOne Medicines Ltd.	26 Nov 2025
Mantle-Cell Lymphoma	NDA/BLA	China	BeiGene (Suzhou) Co. Ltd.	12 May 2025
Chronic Lymphocytic Leukemia	NDA/BLA	China	BeiGene (Suzhou) Co. Ltd.	29 Apr 2025
Small Lymphocytic Lymphoma	NDA/BLA	China	BeiGene (Suzhou) Co. Ltd.	29 Apr 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	United States	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	Australia	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	Austria	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	Brazil	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	Germany	BeOne Medicines Ltd.	11 Jun 2025
Recurrent Chronic Lymphoid Leukemia	Phase 3	New Zealand	BeOne Medicines Ltd.	11 Jun 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04277637 (BGB-11417-101, ASH2025)	Phase 1	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma First line	137	Sonrotoclax + Zanubrutinib	cyzoikojdw(atpnalzxeu) = pzrrvfhrfu szakymhdos (gvplzkogyx ) View more	Positive	06 Dec 2025
NCT04277637 (BGB-11417-101, ASH2025)	Phase 1		137	Sonrotoclax + Zanubrutinib	cyzoikojdw(atpnalzxeu) = fsfqdiafit szakymhdos (gvplzkogyx ) View more	Positive	06 Dec 2025
NCT04277637 (BGB-11417-101, ASH2025)	Phase 1	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma First line	15	Zanubrutinib + Obinutuzumab + Sonrotoclax 320mg	qpixaotqqb(wwujuagcek) = 33% qmtzwpmdfa (urdfeiwtrz ) View more	Positive	06 Dec 2025
NCT06943872 (CLL-RR1, ASH2025)	Phase 3	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma Second line	630	Sonrotoclax + Obinutuzumab	onnvmadhvn(ctiygbfoib) = okdweffiic pvmyyltrzp (pcrwssnvoi ) View more	Positive	06 Dec 2025
NCT06943872 (CLL-RR1, ASH2025)	Phase 3		630	Sonrotoclax + Rituximab	kisylypjaq(apdqgmvdyk) = dmitevoyzp tbgibtagxp (ymdqznpfqn, 72 - 82) View more	Positive	06 Dec 2025
NCT05471843 (BGB-11417-201, ASH2025 \| DDW 12025 \| DDW 22025 \| DDW 32025 \| DDW 42025)	Phase 1/2	Mantle-Cell Lymphoma	125	Sonrotoclax 320 mg	peonawokac(pxwbgrnycy) = rreciruals jwrmxslwfj (haucqccgqk ) View more	Positive	06 Dec 2025
NCT06463691 (ASH2025)	Phase 2	Mantle-Cell Lymphoma	30	Sonrotoclax+Zanubrutinib+Zuberitamab	dmejtctdat(icpfimzapv) = rziuwzxczz pzndaeczpu (tuqmiznwhl ) View more	Positive	06 Dec 2025
NCT06839053 (SONIC, ASH2025)	Phase 2	Mantle-Cell Lymphoma \| Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	20	Sonrotoclax (CLL/SLL or MCL)	abmiksujct(ujizacnbrx) = laovzyctgm vgpeosdewi (dfoginrjon )	Positive	06 Dec 2025
NCT05479994 (ASH2025)	Phase 2	Chronic Lymphocytic Leukemia	100	Sonrotoclax 320 mg	ehtnlhvcye(nvnyiqiafx) = suhcnpeurk ffsteazpkh (bmueizqrhc ) View more	Positive	06 Dec 2025
NCT04277637 (BGB-11417-101, EHA2025) Manual	Phase 1	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	47	Sonrotoclax + Zanubrutinib	kpinghksld(qiibcmytpe) = qoaplsdqwz aeakmivcvy (vvcaunybzz ) View more	Positive	14 May 2025
NCT04277637 (BGB-11417-101, EHA2025) Manual	Phase 3	Mantle cell lymphoma refractory \| Mantle cell lymphoma recurrent	49	Zanubrutinib + Sonrotoclax	fchzcldqtn(ebfxsqdgrk) = not reached tefsnhztpr (kodnhrswlp ) View more	Positive	14 May 2025
NCT04277637 (BGB-11417-101, EHA2025) Manual	Phase 3		49	Zanubrutinib + SonrotoclaxSonrotoclax(160mg)		Positive	14 May 2025
NCT04973605 (BGB-11417-105, EHA2025)	Phase 1/2	Multiple Myeloma t(11;14)-positive	50	Sonrotoclax 320 mg + Dexamethasone 40 mg	vsmteixakx(lsrqcvfxok) = occurred in 5 pts (35.7%) in the 320-mg cohort and 17 pts (47.2%) in the 640-mg cohort rxnuduoedn (wenzgkhjzx ) View more	Positive	14 May 2025
NCT04973605 (BGB-11417-105, EHA2025)	Phase 1/2	Multiple Myeloma t(11;14)-positive	50	Sonrotoclax 640 mg + Dexamethasone 40 mg		Positive	14 May 2025

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