On December 7, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, reported the initial data of the first-in-human trial of IBI3003, a novel trispecific antibody targeting G protein-coupled receptor C5D (GPRC5D), B-cell maturation antigen (BCMA), and CD3 for the treatment of relapsed or refractory multiple myeloma (R/R MM), in an oral presentation at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. IBI3003 demonstrated favorable tolerability and a manageable safety profile. Despite the relatively short follow-up duration, IBI3003 has shown encouraging efficacy signals, particularly in high-risk patients with extramedullary disease (EMD) or those who have previously received anti-BCMA and/or anti-GPRC5D targeted therapies.

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IBI3003 is a novel trispecific antibody targeting GPRC5D, BCMA and CD3 simultaneously. Its dual-targeting design against BCMA and GPRC5 aims to overcome single antigen escape in multiple myeloma (MM). In preclinical studies, IBI3003 exhibited superior in vivo anti-tumor activity over marketed benchmark bispecific antibodies in mouse models, with particularly prominent tumor-killing efficacy in in vitro cell models with low expression of BCMA and GPRC5D. Currently, Innovent is conducting a Phase 1/2 clinical trial (NCT06083207) of IBI3003 in China and Australia to evaluate its safety, tolerability, and efficacy in patients with R/R MM.

The first phase of the study enrolled eligible R/R MM patients who had failed ≥2 lines of previous anti-myeloma therapies that included at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 mAb; and must be relapsed or refractory to their last anti-myeloma regimen. Prior BCMA- or GPRC5D-targeting therapy was allowed.

IBI3003 was administered subcutaneously once weekly (QW). For patients who have received continuous treatment for ≥6 months and achieved partial response (PR) or better for ≥2 months could switch to Q2W as maintenance. To reduce the risk of cytokine release syndrome (CRS), 1 to 3 priming doses were included in the study design.

A total of 39 patients were enrolled in this phase in China and Australia, with a dose range of 0.1 μg/kg to 800 μg/kg. The median age of patients was 62 years (range: 40-79), 64.1% of whom were classified as high-risk per mSMART criteria, and 46.2% had ≥1 EMD. The median number of prior lines of therapy was 4 (range: 1-10). All patients had received at least three classes of drugs (PI, IMiD, and anti-CD38 antibody), 51.3% had received at least five classes of drugs (at least 2 PIs, 2 IMiDs, and 1 anti-CD38 antibody), 41% had previously received anti-BCMA and/or anti-GPRC5D therapies, and 76.9% were refractory to the last treatment. As of the data cutoff date, November 7, 2025, the median follow-up duration was 3.25 months (range: 0.4-7.4), and the median treatment duration was 12.14 weeks (range: 1.0-33.0).

Manageable Safety Profile of IBI3003 in R/R MM Patients

Dose-limiting toxicity (DLT) only occurred in 2 patients, both of whom experienced Grade 4 platelet count decreased and recovered.
97.4% of patients experienced treatment-emergent adverse events (TEAEs). Common TEAEs included CRS, neutrophil count decrease, anemia, lymphocyte count decrease, white blood cell count decrease, and platelet count decrease.
Hematological disorders were the most common Grade ≥3 TEAEs that mainly occurred during step-up dosing and were manageable and recoverable.
The incidences of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) were 64.1% and 6.1%, respectively, all of which were Grade 1-2 and resolved with treatment. Prophylactic use of tocilizumab may reduce incidence, severity, and duration CRS.
The incidence of all-grade infections was 48.7%, with Grade ≥3 infections reported in 28.2% of patients.
For GPRC5D target-related TEAEs involving the oral cavity, skin, and nails, no Grade ≥3 oral TEAEs were observed. Most skin and nail TEAEs were Grade 1-2, with only 2 patients experiencing Grade 3 rash.
Encouraging Efficacy and Depth of Response Observed with IBI3003 at Doses ≥120 μg/kg

Encouraging efficacy was observed with a median follow-up of 3.25 months: Among patients treated with ≥120 μg/kg (n=24), the overall response rate (ORR) was 83.3%, including 4 cases of stringent complete response (sCR), 7 cases of very good partial response (VGPR), and 9 cases of partial response (PR).
Among patients treated with ≥120 μg/kg, the ORR was 80% in 10 patients with EMD and 77.8% in 9 patients who had previously received anti-BCMA and/or anti-GPRC5D therapies.
Among patients who achieved CR or better as assessed by central laboratory next-generation sequencing (NGS) testing, the minimal residual disease (MRD) negativity rate was 100% (n=4).
Potent and Sustained Pharmacodynamic Responses Observed with IBI3003 in R/R MM Patients

Biomarker analysis showed that baseline soluble BCMA (sBCMA) levels were high and variable in R/R MM patients (median level: 198 ng/mL, range: 10-3010 ng/mL).
A profound and durable decline in serum sBCMA across 120, 360 and 540 μg/kg groups was observed, demonstrating a strong pharmacodynamic response.
IBI3003 has demonstrated favorable tolerability and a manageable safety profile in R/R MM patients, with encouraging efficacy signals observed at doses ≥120 μg/kg. Efficacy responses were also observed in high-risk patients, including those with EMD or prior anti-BCMA and/or anti-GPRC5D therapies. Current follow-up remains relatively short, and deeper anti-tumor responses are expected with continued treatment and observation. Dose optimization for IBI3003 is ongoing in the Phase 1 study.

Professor Peng Liu, Zhongshan Hospital Affiliated to Fudan University, stated, "Patients with R/R MM have a poor prognosis after failing standard treatments, including PI, IMiD, and anti-CD38 therapies, with an ORR of only 29.8%, a median progression-free survival of 4.6 months, and a median overall survival of 12.4 months[1]. Therefore, there is an urgent unmet clinical need for these patients, particularly those with high-risk features such as EMD or prior anti-BCMA and/or anti-GPRC5D therapies. The dual-target coverage of BCMA and GPRC5D by IBI3003 addresses the issues of antigen expression heterogeneity and treatment resistance associated with single-target drugs, reducing tumor escape. Meanwhile, its optimized CD3 affinity enables precise T-cell activation for tumor killing while also improving safety. In the disclosed Phase 1 study results, IBI3003 showed a manageable safety profile and impressive efficacy data at doses ≥120 μg/kg, with an ORR of 83.3%. It also demonstrated significant efficacy in high-risk patients with EMD or prior anti-BCMA and/or anti-GPRC5D therapies, fully reflecting its potential in overcoming R/R MM. We look forward to the long-term follow-up survival data with continuous IBI3003 treatment."

About IBI3003 (Anti-GPRC5D/BCMA/CD3 Trispecific Antibody)

IBI3003 is a tri-specific TCE developed using Innovent’s proprietary Sanbody platform to target both GPRC5D and BCMA. Designed to overcome drug resistance driven by single-antigen tumor escape, IBI3003 has exhibited superior in vivo antitumor activity in preclinical studies compared with marketed benchmark TCEs, especially in cell models with low BCMA and GPRC5D expression. Innovent is currently conducting a Phase 1/2 clinical trial (NCT06083207) of IBI3003 in China and Australia to evaluate its safety, tolerability, and efficacy in patients with R/R MM.

(Press release, Innovent Biologics, DEC 7, 2025, View Source [SID1234661219])

On December 7, 2025 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company", Stock Code: 9887.HK) reproted an oral presentation on the opening day of the conference featuring the Phase I/II clinical results of LBL-034, a GPRC5D/CD3 bispecific antibody with a unique 2:1 structure and conditional activation, independently developed using the proprietary LeadsBody platform, for the treatment of relapsed/refractory multiple myeloma (RRMM) at the 67th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") held in Orlando, Florida, USA.

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The study, led by Professor Jin Lu of Peking University People’s Hospital and conducted across 17 centers in China, demonstrated that LBL-034 achieved favorable safety and highly encouraging anti-tumor activity, including in high-risk refractory subgroups, highlighting its potential as a best-in-class therapeutic candidate.

The key clinical highlights of LBL-034

Safe escalation to 1200 μg/kg with no DLTs or MTD reached.
Adverse events impacting quality of life were predominantly Grade 1–2 and occurred mainly during Cycle 1, with markedly lower incidence thereafter. Taste, skin, and nail toxicities were infrequent and generally self-resolving.
Strong efficacy across dose levels 400–1200 μg/kg (n=40).
ORR reached 82.5%, with ≥CR at 52.5%, ≥VGPR at 72.5%, and MRD negativity at 80.0%.
At 800 μg/kg, ORR and ≥CR were 90.9% and 63.6%, respectively.
Robust activity in difficult-to-treat RRMM subgroups.
Extramedullary disease (EMD): ORR 75.0%, including two sCRs. At 1200 μg/kg, ORR in EMD patients reached 100%, with rapid EMD lesion regression observed.
Prior BCMA-treated patients: ORR 85.7%, with CR/sCR 57.1%.
Durable clinical benefit.
Across the 400–1200 μg/kg range, the 12-month PFS rate was 61.2% (median follow-up: 9.6 months). At 400 μg/kg (n=11), median follow-up reached 13.1 months, with a 12-month PFS rate of 56.8%.
Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:

"We are delighted that the strong efficacy and clinical potential of LBL-034 have been recognized by the international scientific community. A Phase II trial evaluating the safety and efficacy of LBL-034 with a RP2D at 1200 μg/kg in 4 populations, including 4L+RRMM, 2L+RRMM with EMD, 4L+RRMM with prior BCMA therapy, and R/R Plasma Cell Leukopenia (PCL) is currently ongoing. With our focused and efficient clinical development strategy, we aim to deliver new treatment options to patients with multiple myeloma, particularly those who are refractory or have extramedullary disease, as quickly as possible."

About LBL-034

LBL-034 is a bispecific T-cell engager (TCE) that targets both GPRC5D and CD3, developed using the Company’s proprietary LeadsBody platform. Designed with a 2:1 binding format—two sites for GPRC5D and one for CD3—LBL-034 can selectively target GPRC5D+ cancer cells, conditionally activate T cells, reduce the risk of cytokine release, minimize the risk of systemic toxicity, and lower the risk of T cell exhaustion, thereby exerting anti-tumor effects in an efficient, low-toxic, and long-term stable manner.

In preclinical studies, LBL-034 has demonstrated strong efficacy signals, comparable to or exceeding those of leading competitors. The molecule is currently being evaluated in a Phase I/II clinical trial for relapsed or refractory multiple myeloma (RRMM) in China. According to Frost & Sullivan, as of November 2024, LBL-034 is the second most clinically advanced GPRC5D-targeted CD3 T-cell engager globally. In October 2024, LBL-034 received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of multiple myeloma.

(Press release, Nanjing Leads Biolabs, DEC 7, 2025, View Source [SID1234661218])

On December 7, 2025 ImCheck Therapeutics reported updated results from its Phase I/II EVICTION study evaluating ICT01, a first-in-class γ9δ2 T-cell activator, in combination with azacitidine and venetoclax in newly diagnosed AML patients ineligible for intensive chemotherapy. The data were presented by Dr. Sylvain Garciaz (Institut Paoli-Calmettes, Marseille, France) in an oral session at the 67th ASH (Free ASH Whitepaper) Annual Meeting, taking place December 6-9, in Orlando, Florida. The data presentation follows ImCheck’s recently announced agreement to be acquired by Ipsen, pending transaction close.

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The ASH (Free ASH Whitepaper) 2025 dataset builds on the promising efficacy signals previously shared at ASCO (Free ASCO Whitepaper) [2] 2025, highlighting rapid, deep, and durable responses with a favorable safety profile and encouraging early overall survival. Notably, responses were strongest at the 10mg ICT01 dose, which has now been endorsed by the FDA for further development. In 2025, ICT01 also received Orphan Drug Designation from both the FDA[3] and EMA.

"ICT01 continues to demonstrate rapid and durable responses across AML subtypes. The updated ASH (Free ASH Whitepaper) data further strengthens our confidence in ICT01’s ability, when added to Aza-Ven, to deliver deep, lasting remissions that have the potential to translate into meaningful overall survival improvement for patients" said Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics. "We see an early onset of complete remissions, consistently strong efficacy at the selected dose across molecular subtypes, and signs of durable responses even in adverse-risk patients. These findings together with the encouraging early survival signal create a compelling case as we advance toward late-stage development."

Key Highlights:
Patient population: At the data cut-off on October 6, 2025, 57 patients aged 51 to 87 had been enrolled. Of these, 41 received 10 mg ICT01 and 16 received 75 mg ICT01, each in combination with Aza-Ven.
Rapid responses: More than 90% of patients treated with ICT01 (10 mg) achieved CRc4 as their best response already by end of Cycle 2.
Broad molecular activity: The 10 mg dose selected for future studies produced higher CR/CRc rates across molecular subtypes, including favorable-, intermediate-, and adverse-risk AML (e.g., TP53-mutated) versus the 75 mg dose.
Durability emerging: At a median follow-up of 10.8 months median DoR[5] was not yet reached for the 10 mg ICT01 dose.
Early survival signal: A 12-month OS[6] rate of 62% was observed, which is numerically higher than the ~54% reported for the Aza-Ven regimen in recent Phase 3 trials.
Favorable benefit–risk profile: Safety of the novel triplet regimen ICT01-Aza-Ven remains well manageable, with a 30-day mortality rate of 4%, and no deaths attributed to ICT01.
Regulatory momentum: ICT01 received Orphan Drug Designation from both FDA and EMA. The 10 mg ICT01 dose has been endorsed by FDA for further clinical development of the triplet regimen.
"ImCheck has in hand the alignment of strong clinical activity, a favorable safety profile, Orphan Drug Designations on both sides of the Atlantic, and now a clear regulatory-endorsed dose for ICT01 for accelerated late-stage development," added Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics. "These results arrive at a transformative moment for ImCheck, following the announced acquisition agreement with Ipsen. We remain deeply grateful to the patients, investigators, and our team for bringing ICT01 to this important inflection point."

(Press release, ImCheck Therapeutics, DEC 7, 2025, View Source [SID1234661217])

On December 7, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that clinical data from its ongoing Phase 2 study of SLS009, a highly selective CDK9 inhibitor, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment were presented today at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 6 – 9, 2025, in Orlando, Florida.

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In this Phase 2 expansion study, R/R AML-MR patients (N = 35 evaluable) were studied in three separate cohorts (cohorts 3-5) who were previously treated with VEN-based regimens and either relapsed and/or were refractory to VEN and were then treated with SLS009 plus AZA/VEN. The median age of participating patients was 69 years, and 98% of patients had ELN adverse-risk AML, with the most frequent mutations being ASXL1, RUNX1, TP53, and SRSF2.

SLS009 in combination with AZA/VEN demonstrated clinically meaningful activity in patients with R/R AML-MR, and among the 35 evaluable patients, the overall response rate (CR+CRi+MLFS) was 46%, including 29% achieving CR/CRi. Patients harboring ASXL1 or TP53 mutations achieved response rates of 48% (19% CR/CRi) and 57% (29% CR/CRi), respectively. The median overall survival (mOS) was exceedingly higher than the expected 2.6 months in this R/R AML patient population, and in the least pretreated cohort, mOS reached 8.9 months. Across all cohorts, patients with one prior line of therapy experienced the greatest benefit, with a 58% response rate and mOS not yet reached. No dose-limiting toxicities (DLTs) or treatment-related deaths were observed, and the combination was well tolerated.

"These results further reinforce the therapeutic potential of SLS009 to overcome resistance to venetoclax-based regimens by suppressing the expression of MCL-1, a key mechanism of resistance to BCL-2 inhibition in AML," said Dr. Dragan Cicic, Senior Vice President and Chief Development Officer of SELLAS. "The combination of SLS009 with azacitidine and venetoclax demonstrates encouraging activity in a heavily pretreated population with adverse-risk AML-MR, including those harboring ASXL1 and TP53 mutations. We are particularly encouraged by the strong responses in patients with limited prior therapy and look forward to expanding this combination regimen into newly diagnosed AML with high-risk features."

Presentation Details:

Title: Phase 2 Study of SLS009 in Combination with Azacitidine and Venetoclax for Relapsed/Refractory AML with MDS-Related Changes (AML-MR) After Prior Venetoclax Treatment

Session Date and Presentation Time: Sunday, December 7, 2025, 6:00 – 8:00 PM EST

Session Title: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II

Location: Orange County Convention Center (OCCC) – West Halls B3-B4

Lead Author: Joshua F. Zeidner, MD, University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC

Publication Number: 3423

(Press release, Sellas Life Sciences, DEC 7, 2025, View Source [SID1234661216])

On December 7, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies. These data were featured at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida. The five presentations highlight durable responses in heavily pretreated patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and additional studies showing deep, rapid, and sustained undetectable minimal residual disease (uMRD) rates with sonrotoclax-based combinations in patients with treatment-naive chronic lymphocytic leukemia (CLL), highlighting the foundational potential of this medicine.

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"The data we’re presenting at ASH (Free ASH Whitepaper) 2025 are redefining what physicians can expect from sonrotoclax as a next-generation BCL2 inhibitor," said Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne. "Our data demonstrates that sonrotoclax has succeeded where others have failed, achieving deep and durable responses as a monotherapy in both R/R CLL and MCL and notably fast kinetics as a combination therapy in treatment-naïve CLL. With these results, we believe sonrotoclax will become a foundational medicine in B-cell malignancies, potentially transforming outcomes for patients worldwide."

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)

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).

At a median study follow-up of 14.2 months (range, 0.3-24.9 months), the median duration of response (DOR) by IRC was 15.8 months (95% CI, 7.4 months-NE) and has yet to reach full maturity. The median time to response (TTR) was 1.9 months (range 1.6-6.5 months), and the median progression-free survival (PFS) was 6.5 months (95% CI: 4.0-10.4).

Treatment with sonrotoclax monotherapy was generally well tolerated, and adverse events were manageable. The most common grade ≥3 treatment-emergent adverse events (TEAEs) in greater than 10% of patients were neutropenia (19.1%), infections (16.5%), and pneumonia (10.4%).

These data are under Priority Review by the U.S Food and Drug Administration for potential accelerated approval.

"Achieving deep and durable responses in relapsed or refractory mantle cell lymphoma after BTK inhibitor therapy has been a long-standing challenge," said Michael Wang, M.D., Professor, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, and presenting author of the study. "In this analysis, sonrotoclax monotherapy demonstrated meaningful and lasting responses in heavily pretreated patients, including those with high-risk disease. These findings are highly encouraging and suggest this next-generation BCL2 inhibitor could play a foundational role in improving outcomes for patients with limited treatment options."

Sonrotoclax combinations demonstrate fast responses with unmatched uMRD rates and notably better kinetics than current options

BGB-11417-101 (NCT04277637) is an ongoing, phase 1/1b, dose-escalation/expansion study in patients with B-cell malignancies. Results presented at ASH (Free ASH Whitepaper) showcase data from sonrotoclax combinations in patients with treatment-naive (TN) CLL/SLL. Notable highlights include:

Sonrotoclax plus zanubrutinib (Poster Presentation: 3891)
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.
With a median study follow-up of 30.9 months, no progression events have been observed in the 320-mg cohort, including in the 40% of patients (34 patients) who had electively discontinued treatment.
The combination was generally well tolerated, with no TEAEs leading to death, or clinical or laboratory tumor lysis syndrome (TLS).
Sonrotoclax plus obinutuzumab (Oral Presentation: 793)
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.
Updated efficacy and safety data will be presented on Monday, December 8, 10:30 AM–10:45 AM EST.
Sonrotoclax plus zanubrutinib and obinutuzumab (Poster Presentation: 3890)
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.
The combination was generally well tolerated, and no deaths or discontinuations of any study drug due to TEAEs were observed.
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)

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).
Sonrotoclax monotherapy was well tolerated, and toxicities were manageable and no clinical TLS occurred.
Updated data from the abstract will be presented on Monday, December 8, 6:00-8:00 PM EST. Additionally, these data are under review by China’s National Medical Products Administration (NMPA) for potential accelerated approval.
For more information about our presence at the 2025 ASH (Free ASH Whitepaper) Annual Meeting and Exposition, please visit our meeting hub: congress.beonemedicines.com.

About Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is a rare subtype of aggressive B-cell non-Hodgkin lymphoma (NHL)1 that develops 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 Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia (CLL) is a life-threatening cancer of adults. It is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues.7,8 CLL is the most common type of leukemia in adults, accounting for about one-third of new cases.2,9

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.

The information provided in this press release is intended for a global audience.

(Press release, BeOne Medicines, DEC 7, 2025, View Source [SID1234661215])