RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Special Review Project (China)

Structure/Sequence

Sequence Code 577079733L

Source: *****

Sequence Code 616719194H

Source: *****

664

Clinical Trials associated with Tislelizumab

NCT06883552

/ Not yet recruitingPhase 2IIT

An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer

This is a single-arm study evaluating the efficacy and safety of Stapokibart Injection in combination with Tislelizumab Injection in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy.

Start Date01 Oct 2025

Sponsor / Collaborator

Sichuan University

NCT06364904

/ Not yet recruitingPhase 3IIT

A Multicenter, III Stage, Randomized Controlled Trail on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma.

The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.

Start Date01 Oct 2025

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

NCT05982522

/ Not yet recruitingPhase 1/2

A Multicenter, Open-Label, Randomized, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Taxane and Anti-PD-1/L1 Monoclonal Antibody in Previously-treated Solid Tumors

This is a phase Ib/II, randomized, open-label, multicenter clinical trial to evaluate the antitumor activities, safety, tolerability and pharmacokinetics (PK) of IN10018 in combination with taxane and anti-PD-1/L1 monoclonal antibody in patients with locally advanced or metastatic solid tumors who have failed in or been intolerant to at least one line of standard therapy. This study will be firstly carried out in previously-treated non-small cell lung cancer (NSCLC) population,

Start Date13 Aug 2025

Sponsor / Collaborator

Inxmed (Shanghai) Co., Ltd

100 Clinical Results associated with Tislelizumab

100 Translational Medicine associated with Tislelizumab

100 Patents (Medical) associated with Tislelizumab

526

Literatures (Medical) associated with Tislelizumab

31 Dec 2025·Human Vaccines & Immunotherapeutics

Durable response to third-line combination therapy in a metastatic colorectal cancer patient with BRAF V600E mutation: A case report

Article

Author: Li, Li ; Qian, Xiaoping ; Zhang, Qun

In metastatic colorectal cancer (mCRC), the BRAFV600E mutation subtype is one of the subtypes with the worst prognosis. The long-term abnormal activation of multiple signaling pathways caused by the BRAF V600E mutation is closely related to the formation of BRAF inhibitor resistance and drug-resistant tumor cell subpopulations. These factors significantly impact the survival and prognosis of CRC patients. Therefore, treating mCRC patients with the BRAFV600E mutation, particularly in later stages, is challenging. We reported a case of an mCRC patient with the BRAF V600E mutation in the primary and metastatic tumors. After the failure of second-line treatment, this patient received a combination therapy including immunotherapy (tislelizumab), radiotherapy, and targeted therapy (fruquintinib). Through comprehensive imaging evaluations and continuous monitoring of tumor markers, we were astonished to observe that the patient has achieved and maintained a complete response (CR) for over 12 months. This case supports the efficacy of combination therapy in mCRC patients with the BRAF V600E mutation.

01 Aug 2025·Current Drug Safety

Treatment of Tislelizumab-Induced Toxic Epidermal Necrolysis and Agranulocytosis: A Case Report and Literature Review

Article

Author: Xu, Xiangqian ; Xue, Honghao ; Lu, Chenghua ; Guo, Xiaoyan ; Zhang, Yemin ; Zhou, Yanshi ; Zhang, Jun ; Wu, Qingyuan ; Xie, Shiyun

Background::

Non-small Cell Lung Cancer (NSCLC) makes up about 85% of lung cancer cases, mainly adenocarcinoma and squamous cell carcinoma. Recently, PD-1 inhibitors have become crucial in NSCLC treatment, significantly enhancing survival for some. However, side effects, like skin reactions and hematotoxicity, limit their use, with drug-induced TEN and immunotherapy-induced agranulocytosis as severe adverse effects.

Case Presentation::

Herein, we have reported the case of a 75-year-old male diagnosed with metastatic Lung Squamous cell Carcinoma (LUSC) in the left lung. He received first-line treatment with one cycle of tislelizumab in combination with nab-paclitaxel and carboplatin, after which he developed Toxic Epidermal Necrolysis (TEN) and granulocytopenia. To address these two serious immune-related Adverse Events (irAEs), the patient was administered methylprednisolone in combination with gamma globulin for TEN and dexamethasone in combination with G-CSF for agranulocytosis. Antibiotics were also administered according to the patient’s medication regimen. After treatment, the patient recovered and was discharged from the hospital. It was also noted that the lung tumor condition improved.

Conclusion::

Effective management of severe immune-related side effects from tislelizumab, including TEN and agranulocytosis, can be partly achieved through steroids, gamma globulin, GCSF, and antibiotics. This strategy not only alleviates these adverse effects, but also potentially improves tumor conditions, highlighting the crucial role of vigilant monitoring and management in immunotherapy.

01 Jun 2025·JOURNAL OF UROLOGY

A Phase 2 Study of Tislelizumab as Neoadjuvant Treatment of Cisplatin-Ineligible High-Risk Upper Tract Urothelial Carcinoma

Article

Author: Zhang, Wei ; Zhang, Jin ; Xue, Wei ; Zhang, Dadong ; Luo, Yuansheng ; Cai, Xingyun ; Chen, Qiong ; Wang, Zaoyu ; Chen, Yonghui ; Zhang, Jiyang ; Chen, Haige ; Wu, Guangyu ; Qiao, Keying ; Huang, Jiwei ; Kong, Wen ; Ng, Cheoklong

PURPOSE:

We investigated the efficacy and safety of tislelizumab as neoadjuvant therapy in patients with cisplatin-ineligible high-risk upper tract urothelial carcinoma (UTUC).

MATERIALS AND METHODS:

In this single-arm phase 2 trial (NCT04672330), 20 patients with high-risk UTUC were enrolled. Eligibility criteria included high-risk UTUC (defined as high-grade UTUC confirmed by endoscopic biopsy or urinary cytology, radiographic evidence of invasion [cT2-T4N0-2M0], and/or hydronephrosis), an Eastern Cooperative Oncology Group performance status of 0 to 2, no previous systemic therapy, and cisplatin ineligibility. Patients received neoadjuvant tislelizumab before radical surgery. Contrast-enhanced MRI was performed before the third dose and again before surgery. The primary end point was pathological complete response rate (ypT0N0). Secondary end points included pathological response rate (≤ypT1N0), objective response rate, disease-free survival, safety profile, and perioperative complications. Multiplex immunofluorescence assessed immune cell populations in the tumor microenvironment.

RESULTS:

Among the 20 patients, 13 underwent radical nephroureterectomy, 1 received endoscopic ablation, and 3 had segmental ureteral resection. Three patients declined surgery because of disease progression or adverse events. The pathological complete response rate was 20%, with 45% of patients restaged to ≤ pT1. Median disease-free survival and overall survival were not reached. Grade 3/4 treatment-related adverse event occurred in 15% of patients. MRI analysis revealed higher apparent diffusion coefficient entropy in patients with partial response. Exploratory analysis showed increased PD-L1⁺CD68⁺ macrophages and PD-1⁺CD8⁺ T cells in the tumor stroma of partial and complete responders.

CONCLUSIONS:

Neoadjuvant tislelizumab showed promising efficacy and manageable toxicity in patients with high-risk, cisplatin-ineligible UTUC. Increased apparent diffusion coefficient entropy on MRI and the presence of PD-L1⁺CD68⁺ macrophages in the tumor stroma may serve as potential predictors of response to neoadjuvant tislelizumab.

TRIAL REGISTRATION NO.:

NCT04672330.

477

News (Medical) associated with Tislelizumab

20 May 2025

·www.biospace.com

Pfizer Puts $6B on the Line For 3SBio’s PD-1/VEGF Antibody

iStock, Deagreez The deal comes three months after Pfizer inked a PD-1/VEGF partnership with Summit Therapeutics, leading BMO Capital Markets to express confusion regarding the pharma’s overall strategy. Pfizer is paying $1.25 billion upfront in a licensing pact with 3SBio, gaining access to the Chinese biotech’s PD-1/VEGF bispecific antibody for various solid tumors, the pharma revealed Monday evening. A bispecific antibody, SSGJ-707 is part of a closely watched class of cancer therapies that target the PD-1 and VEGF pathways. The asset is currently being assessed by 3SBio for non-small cell lung cancer, metastatic colorectal cancer and gynecological tumors. Late-stage development of the asset is set to start in China this year, as per Monday’s announcement. BMO Capital Markets, writing to investors shortly after Pfizer’s announcement, said the licensing agreement “shows clear appreciation for the [PD-1/VEGF] mechanism” and “builds on a surge in recent interest” in this pathway. “We appreciate that Pfizer is looking to tap into a market that may have significant revenue potential, but we are left somewhat confused by the broader strategy.” In particular, BMO pointed to Pfizer’s February clinical trials collaboration with Summit Therapeutics, one of the leaders in this emerging therapeutic modality. The companies will test Summit’s bispecific ivonescimab with Pfizer’s antibody-drug conjugates across a variety of solid tumor indications. “We are left wondering how these two separate collaborations are reconciled and whether one of the PD-1/VEGF bispecifics being pursued is differentiated vs. the other and how this may lead to cannibalization of the opportunity initially available for both deals,” the analysts wrote. Aside from the $1.25 billion upfront sum, Monday’s deal also puts Pfizer on the hook for up to $4.8 billion in development, regulatory and commercial milestones. Additionally, 3SBio will be eligible for tiered double-digit royalties on sales of SSGJ-707 if it reaches the market. The total potential investment is higher than other PD-1/VEGF deals coming out of China, BMO noted, adding that the “deal seems to be priced at a premium to others” in the PD-1/VEGF space. “We cannot help but notice Pfizer paying the fee for being late to a new market,” they added. BioNTech, for instance, acquired partner Biotheus and its bispecific PD-1/VEGF antibody in November for up to $950 million. The next day, Merck paid $588 million upfront to LaNova Medicines for its own PD-1/VEGF bispecific. Pfizer and 3SBio expect to close the deal in the third quarter of this year, pending regulatory clearances, shareholder approval and other customary closing conditions. The PD-1/VEGF mechanism first gained widespread attention in September last year, when Summit and its Chinese partner Akeso claimed victory for their ivonescimab over Merck’s blockbuster PD-1 blocker Keytruda in a late-stage NSCLC study. Last month, ivonescimab likewise outperformed BeiGene’s Tevimbra and won approval in China .

License out/inAcquisitionDrug ApprovalADC

14 May 2025

·www.prnewswire.com

Akeso's Penpulimab Approval Intensifies the Competition Among the Other Pharmaceutical Companies Active in the Nasopharyngeal Carcinoma Market | DelveInsight

The FDA has approved Akeso's PD-1 monoclonal antibody, penpulimab-kcqx, for the treatment of recurrent or metastatic non-keratinising nasopharyngeal carcinoma in adults. The approval includes its use as a first-line treatment in combination with platinum-based chemotherapy, as well as a monotherapy option for later-stage metastatic disease. This marks the first FDA approval for a biologic developed in-house by Akeso, signifying the Hong Kong-based company's debut in the US nasopharyngeal carcinoma market. LAS VEGAS, May 14, 2025 /PRNewswire/ -- Nasopharyngeal carcinoma is a rare type of cancer that originates in the nasopharynx, the upper part of the throat behind the nose. It is strongly associated with Epstein-Barr virus (EBV) infection. Unlike many other head and neck cancers, NPC has distinct genetic, viral, and environmental risk factors. As per DelveInsight's analysis, in 2023, there were around 67K incident cases of head and neck cancer and around 2,300 cases of nasopharyngeal cancer in the United States. Due to their location and extent of spread, nasopharyngeal cancers are often not suitable for surgical removal. These cancers are usually managed with a combination of chemotherapy and radiation therapy, often followed by additional chemotherapy. If the cancer recurs, it may be treated with another round of radiation, frequently using brachytherapy. In carefully selected cases, skull base resection may be considered as an alternative to radiation. LOQTORZI (toripalimab-tpzi) is an advanced anti-PD-1 monoclonal antibody that inhibits PD-L1 from binding to the PD-1 receptor at a distinct, high-affinity site, thereby enhancing antitumor immune responses and improving overall survival across multiple cancer types. In October 2023, the FDA approved LOQTORZI in combination with cisplatin and gemcitabine as a first-line treatment for adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. Additionally, the FDA approved toripalimab-tpzi as a monotherapy for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that has progressed following platinum-based chemotherapy. The combination therapy's efficacy was demonstrated in the JUPITER-02 clinical trial. Learn more about the nasopharyngeal carcinoma treatment options @ Nasopharyngeal Carcinoma Treatment Market In April 2025, the FDA approved penpulimab-kcqx, a distinct PD-1 monoclonal antibody, for use alongside cisplatin or carboplatin and gemcitabine as a first-line treatment for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. Additionally, the FDA authorized penpulimab-kcqx as a standalone treatment for adults with metastatic non-keratinizing NPC who have experienced disease progression following platinum-based chemotherapy and at least one other prior therapy. Penpulimab-kcqx was independently developed by Akeso, with further development and commercialization carried out through its joint venture with Chia Tai-Tianqing Pharmaceutical Group. This approval marks the first time an innovative biologic developed internally by Akeso has received FDA clearance, signifying a major milestone. It reflects the strength of the clinical data supporting penpulimab-kcqx and signifies Akeso's successful entry into the US regulatory landscape. The achievement showcases Akeso's innovation in drug development and its dedication to meeting high global standards in pharmaceutical quality. The FDA's decision affirms Akeso's international development and expansion strategy and provides a solid platform for the company to advance its clinical programs in the global therapeutics arena. In China, penpulimab-kcqx is already approved for two uses: as a first-line treatment and as a second-line or later therapy for advanced NPC. The recent US approval introduces a new immunotherapy option for American patients with advanced NPC. This regulatory approval was based on findings from the global Phase III AK105-304 trial and the pivotal AK105-202 study, both of which supported the Biologics License Applications (BLA) for penpulimab-kcqx. These trials confirmed the drug's clinical efficacy and favorable safety profile across different stages of metastatic NPC treatment. AK105-304, a randomized, double-blind international Phase III trial, enrolled patients from various ethnic backgrounds. The results will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. Previously, penpulimab-kcqx had received Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) from the FDA, emphasizing the urgent need for effective NPC treatments. To know more about the new treatment for nasopharyngeal carcinoma, visit @ FDA-approved Drugs for Nasopharyngeal Carcinoma Triggered by promising advances in immunotherapy, there has been growing interest in the use of immune checkpoint inhibitors (ICI), specifically anti-programmed death-1 or programmed death-1 ligand (PD-1/PD-L1) therapies in the treatment of nasopharyngeal carcinoma. Some of the drugs in the pipeline include Nana-val (Viracta Therapeutics), Tislelizumab (BeiGene), PRO1160 (Genmab/ProfoundBio), and others. Discover which therapies are expected to grab major nasopharyngeal carcinoma drug market share @ New Medicine for Nasopharyngeal Carcinoma TEVIMBRA is a humanized IgG4 monoclonal antibody targeting PD-1, engineered to reduce its interaction with Fc-gamma (Fcγ) receptors on macrophages. This design supports the immune system's ability to recognize and combat tumors. Preclinical research has shown that when PD-1 antibodies bind to Fcγ receptors on macrophages, it can reduce their anti-tumor efficacy by triggering macrophage-driven destruction of T-effector cells. Nanatinostat, developed by Viracta, is an orally administered histone deacetylase (HDAC) inhibitor with selectivity for certain Class I HDAC isoforms. These isoforms are crucial for reactivating viral genes that are epigenetically suppressed in cancers associated with Epstein-Barr virus (EBV). Nanatinostat is being evaluated as part of an all-oral regimen called Nana-val, in combination with the antiviral valganciclovir, for the treatment of various EBV-related cancers. Discover more about drugs for nasopharyngeal carcinoma in development @ Nasopharyngeal Carcinoma Clinical Trials Market The anticipated launch of these emerging nasopharyngeal carcinoma treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the nasopharyngeal carcinoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for nasopharyngeal carcinoma in the 7MM is expected to grow at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. DelveInsight's latest published market report titled N asopharyngeal Carcinoma Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the nasopharyngeal carcinoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The nasopharyngeal carcinoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Nasopharyngeal Carcinoma Gender-specific Incident Cases of Nasopharyngeal Carcinoma Age-specific Incident Cases of Nasopharyngeal Carcinoma Stage-specific Incident Cases of Nasopharyngeal Carcinoma Treated Cases of Nasopharyngeal Carcinoma The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM nasopharyngeal carcinoma market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this nasopharyngeal carcinoma market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the nasopharyngeal carcinoma market. Also, stay abreast of the mitigating factors to improve your market position in the nasopharyngeal carcinoma therapeutic space. Related Reports Head and Neck Cancer Market Head and Neck Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key HNC companies, including CEL-SCI, Junshi Biosciences, Coherus, Exelixis, Immutep S.A.S., Merck Sharp & Dohme LLC, Iovance Biotherapeutics, BeiGene, Akeso, Chia Tai-Tianqing, Kura Oncology, Hoffmann-La Roche, Eli Lilly and Company, among others. Head and Neck Cancer Pipeline Head and Neck Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HNC companies, including Debiopharm, Merck, GlaxoSmithKline, QBiotics Group Limited, Memgen, Inc., BioNTech, Alentis Therapeutics AG, Beijing CorreGene Biotechnology, Coordination Pharmaceuticals, Inc., Regeneron Pharmaceuticals, Sichuan Baili Pharmaceutical Co., Ltd., TILT Biotherapeutics Ltd., Coherus Biosciences, Inc., among others. Head and Neck Squamous Cell Carcinoma Market Head and Neck Squamous Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key HNSCC companies, including VCN Biosciences, Moderna Therapeutics, Exelixis, MacroGenics, Nykode Therapeutics, Tizona Therapeutics, Totus Medicines, Turnstone Biologics, Hoffmann-La Roche, Hookipa Pharma, Zenith Epigenetics, HiFiBiO, Nanobiotix, GSK, AstraZeneca, Merus, PureTech Health, Rakuten Medical, Jacobio Pharmaceuticals , among others. Recurrent Head and Neck Squamous Cell Carcinoma Pipeline Recurrent Head and Neck Squamous Cell Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key recurrent HNSCC companies, including AstraZeneca, Astellas, GlaxoSmithKline, Boehringer Ingelheim, Merck, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Drug ApprovalFast TrackOrphan Drug

14 May 2025

·www.businesswire.com

BeiGene Showcases Strength of Hematology Portfolio at EHA 2025 with New Data Highlighting BRUKINSA’s Leadership and Next-Generation Innovation

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that will change its name to BeOne Medicines Ltd., today announced it will share data across a range of hematologic malignancies at the European Hematology Association (EHA) Congress in Milan, Italy, June 12–15. BeiGene has 31 abstracts accepted at EHA 2025, with four selected for oral presentations, featuring data from its best-in-class Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA® (zanubrutinib) and its investigational pipeline assets – a next-generation BCL2 inhibitor, sonrotoclax, and BTK protein degrader, BGB-16673. These data reflect BeiGene’s vision to redefine standards of care in hematology through next-generation science and patient-focused innovation. “With three cornerstone hematology assets – BRUKINSA, sonrotoclax and BGB-16673 – we are advancing a potentially best-in-class portfolio in B-cell malignancies,” said Lai Wang, Ph.D. Global Head of R&D. “At EHA 2025, we’ll share 31 accepted abstracts that highlight the progress of our hematology clinical development program and our commitment to targeted therapies that raise the standard of care. As BRUKINSA continues to expand its impact and our next-generation assets advance, we hope to transform the future of treatment for patients facing B-cell malignancies.” BeiGene’s next-generation pipeline assets, including BGB-16673 and sonrotoclax, continue to demonstrate promising clinical activity and generally well-tolerated safety profiles across multiple B-cell malignancies. Together, these programs have enrolled more than 2,500 patients globally (1,900+ patients for sonrotoclax and 600+ patients for BGB-16673) and are positioned to potentially play a significant role in treatment strategies for chronic lymphocytic leukemia (CLL), Waldenström’s macroglobulinemia (WM) and mantle cell lymphoma (MCL). Additionally, presentations further reinforce BRUKINSA’s durable efficacy and consistent safety profile, as well as its position as a foundational therapeutic option in frontline CLL. Key highlights include: Two oral presentations featuring updated results from the ongoing Phase 1 CaDAnCe-101 study of BGB-16673 in patients with relapsed or refractory (R/R) CLL/SLL and patients with R/R WM, showing continued and promising early efficacy and a tolerable safety profile. Two oral presentations showcasing updated Phase 1 results of sonrotoclax in combination with BRUKINSA in R/R CLL/SLL and R/R MCL, which demonstrate deep and durable responses. This combination is now under evaluation in the ongoing registrational Phase 3 fixed-duration CELESTIAL-TNCLL study ( NCT06073821 ) in patients with treatment-naïve CLL/SLL, which completed enrollment earlier this year, and CELESTIAL-RRMCL study ( NCT06742996 ) in patients with relapsed / refractory MCL, which is currently enrolling. Results from Arm C and D of the SEQUOIA study, which evaluated BRUKINSA in patients with TN CLL/SLL and del(17p) (Arm C) and BRUKINSA plus venetoclax in patients with TN CLL/SLL with del(17p) and/or TP53 mutation or without either mutation (Arm D). Robust analyses across clinical trials and real-world evidence that deepen understanding of treatment patterns, safety, and outcomes in CLL/SLL, MCL and diffuse large B-cell lymphoma (DLBCL). BeiGene Presentations and Publications at EHA2025 Abstract Title Presentation Details (CEST) Lead Author BGB-16673 (BTK CDAC) Updated efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory CLL/SLL: results from the ongoing phase 1 CaDAnCe-101 study Oral Presentation: S158 Session Title: Chronic lymphocytic leukemia and related disorders - Clinical Session Date/Time: Sunday, June 15, 11:00 - 12:15 L. Scarfò Updated efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed/refractory Waldenström macroglobulinemia: ongoing phase 1 CaDAnCe-101 study results Oral Presentation: S231 Session Title: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical Session Date/Time: Saturday, June 14, 17:00 – 18:15 A.M. Frustaci Sonrotoclax (BCL2 Inhibitor) Updated results from the phase 1 study of sonrotoclax (BGB-11417), a novel BCL2 inhibitor, in combination with zanubrutinib for relapsed/refractory CLL/SLL show deep and durable responses Oral Presentation: S159 Session Title: Chronic lymphocytic leukemia and related disorders - Clinical Session Date/Time: Sunday, June 15, 11:00 - 12:15 C.Y. Cheah Combination treatment with novel BCL2 inhibitor sonrotoclax (BGB-11417) and zanubrutinib induces high rate of complete remission for patients with relapsed/refractory mantle cell lymphoma Oral Presentation: S234 Session Title: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical Session Date/Time: Saturday, June 14, 17:00 – 18:15 C.S. Tam Sonrotoclax monotherapy for treatment of patients with relapsed/refractory CLL: data from an ongoing phase 1/1b study (BGB-11417-101) Poster #: PF580 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 S.S. Opat Updated safety and efficacy results of a phase 1 study of the novel BCL2 inhibitor sonrotoclax (BGB-11417) for relapsed/refractory Waldenström's macroglobulinemia Poster #: PF887 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 C.Y. Cheah Primary analysis results of novel BCL2 inhibitor sonrotoclax (BGB-11417) monotherapy in patients with relapsed/refractory b-cell malignancies Poster #: PF574 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 C. Li Updated safety and antileukemic activity data for sonrotoclax (BGB-11417), a potent and selective BCL2 inhibitor, in patients with relapsed/refractory acute myeloid leukemia Poster #: PF491 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 P. Montesinos Updated safety and antileukemic activity data of sonrotoclax (BGB-11417), a potent and selective BCL2 inhibitor, in treatment-naive patients with acute myeloid leukemia unfit for intensive chemotherapy Poster #: PF477 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 J. Shortt Updated interim results of sonrotoclax plus dexamethasone in patients with t(11;14)-positive relapsed/refractory multiple myeloma: an all-oral treatment Poster #: PF721 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 B. Dhakal BGB-11417-302, a phase 3, randomized, double-blind study of sonrotoclax (BGB-11417) plus zanubrutinib versus placebo plus zanubrutinib in patients with relapsed or refractory mantle cell lymphoma Publication Only M. Hughes BRUKINSA SEQUOIA 5-year follow-up in arm C: frontline zanubrutinib monotherapy in patients with del(17p) and treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma Poster #: PS1565 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 C.S. Tam Combination of zanubrutinib plus venetoclax for treatment-naive CLL/SLL: results in SEQUOIA arm D Poster #: PS1566 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 M. Shadman Final analysis of a phase 1 study of zanubrutinib plus lenalidomide in patients with relapsed/refractory diffuse large b-cell lymphoma Poster #: PS1918 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 Z. Song Additional Abstracts Integrative Evidence Generation and Health Economics Related to Zanubrutinib Final independent review data supports sustained benefit of zanubrutinib over ibrutinib in patients with R/R CLL/SLL in ALPINE Publication Only J. Brown Preference Survey and Patient Experience Study Preferences for treatment in first-line chronic lymphocytic leukemia: A multi-criteria decision analysis in Italy Publication Only P. Sportoletti A qualitative study to explore the patient experience of continuous covalent Bruton tyrosine kinase inhibitors in chronic lymphocytic leukemia: study methodology Publication Only L. Scarfò Real-World Evidence Real-world burden of disease, treatment patterns and outcomes in patients with mantle cell lymphoma Poster #: PF899 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 A. Alencar Real-world comparative effectiveness of first-line Bruton tyrosine kinase inhibitors in patients with chronic lymphocytic leukemia Poster #: PS1578 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 R. Jacobs Real-world treatment utilization patterns, discontinuation and healthcare resource utilization of first-line Bruton tyrosine kinase inhibitors in chronic lymphocytic leukemia: age-related disparity Poster #: PF585 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 K. Yang Risk of hypertension in patients newly diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and treated with covalent Bruton tyrosine kinase inhibitors: a real-world study Poster #: PF588 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 A. Ali Real-world Bruton tyrosine kinase inhibitor use and clinical outcomes among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma Publication Only J. Hou Real-world zanubrutinib treatment patterns in chronic lymphocytic leukemia/small lymphocytic lymphoma among US community oncology patients with prior acalabrutinib therapy Publication Only J. Hou Real-world zanubrutinib treatment patterns in mantle cell lymphoma among US community oncology patients with prior Bruton tyrosine kinase inhibitor therapy Poster #: PF914 Poster Presentation Session Title: Poster Session 1 Session Date/Time: Friday, June 13, 18:30 - 19:30 R. Choksi Evaluating uptake of targeted agents by race/ethnicity in patients receiving first-line treatment for chronic lymphocytic leukemia Publication Only A.S. Kittai Serious infections in patients with CLL/SLL treated with combination venetoclax and obinutuzumab compared with those treated with zanubrutinib: a real-world study Poster #: PS1571 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 N. Lamanna Matching-Adjusted Indirect Comparison Comparative efficacy of zanubrutinib versus fixed-duration acalabrutinib plus venetoclax for first-line treatment of chronic lymphocytic leukemia: a matching-adjusted indirect comparison Poster #: PS1581 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 T. Munir Efficacy of continuous zanubrutinib vs fixed-duration venetoclax in combination with obinutuzumab in treatment-naive chronic lymphocytic leukemia: a matching-adjusted indirect comparison Publication only T. Munir Adverse events of interest with zanubrutinib vs fixed-duration combination of venetoclax plus obinutuzumab in treatment-naive chronic lymphocytic leukemia Publication only N. Lamanna Network Meta-Analysis A network meta-analysis of efficacy of zanubrutinib versus fixed-duration acalabrutinib plus venetoclax in treatment-naïve chronic lymphocytic leukemia Publication Only M. Shadman Ociperlimab (BGB-A1217) Advantig-101: a phase 1b/2 study of ociperlimab plus tislelizumab or rituximab in relapsed/refractory diffuse large b-cell lymphoma Poster #: PS1995 Poster Presentation Session Title: Poster Session 2 Session Date/Time: Saturday, June 14, 18:30 - 19:30 Q. Cai About Sonrotoclax (BGB-11417) Sonrotoclax is designed to block the B-cell lymphoma 2 (BCL2) protein, which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a potent and specific inhibitor of BCL2 with a short half-life and no accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and more than 1,900 patients have been enrolled to date across the global development program. The U.S. Food and Drug Administration (FDA) granted sonrotoclax Fast Track Designation for the treatment of adult patients with mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM). About BGB‑16673 BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting protein degrader from BeiGene’s chimeric degradation activation compound (CDAC) platform. BGB-16673 is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease. BGB-16673 is the most advanced BTK protein degrader in the clinic, with an extensive global clinical development program. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). About BRUKINSA® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets, and more than 200,000 patients have been treated globally. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström’s macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA. Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Adverse Reactions The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Drug Interactions CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily. CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. Specific Populations Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily. Please see full U.S. Prescribing Information including U.S. Patient Information. This information is intended for a global audience. Product indications vary by region. About BeiGene BeiGene, which will change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeiGene, please visit www.beigene.com. 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 strength of BeiGene’s hematology portfolio; BeiGene’s commitment to transform treatment for B-cell malignancies; BeiGene’s commitment to targeted therapies that raise the standard of care; the future impact of BRUKINSA; the advancement of BeiGene’s next-generation assets including clinical activities and safety profiles; the role BGB-16673 and sonrotoclax will play in treatment strategies for CLL, WM and MCL; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene'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; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its 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 BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene'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 BeiGene undertakes no duty to update such information unless required by law. To access BeiGene media resources, please visit our News & Media site.

Phase 1Phase 3Clinical ResultDrug ApprovalFast Track

100 Deals associated with Tislelizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11487	Tislelizumab	L01XC	DB14922

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Esophageal Carcinoma	Japan	BeiGene Ltd.	27 Mar 2025
PD-L1 positive Esophageal Squamous Cell Carcinoma	United States	BeiGene Ltd.	03 Mar 2025
HER2 negative Gastric Cancer	United States	BeiGene Ltd.	26 Dec 2024
HER2 negative Gastroesophageal Junction Adenocarcinoma	United States	BeiGene Ltd.	26 Dec 2024
Locally Advanced Gastric Adenocarcinoma	European Union	-	19 Dec 2024
Locally Advanced Gastric Adenocarcinoma	Iceland	-	19 Dec 2024
Locally Advanced Gastric Adenocarcinoma	Liechtenstein	-	19 Dec 2024
Locally Advanced Gastric Adenocarcinoma	Norway	-	19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma	European Union	-	19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Iceland	-	19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Liechtenstein	-	19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Norway	-	19 Dec 2024
Metastatic gastric adenocarcinoma	European Union	-	19 Dec 2024
Metastatic gastric adenocarcinoma	Iceland	-	19 Dec 2024
Metastatic gastric adenocarcinoma	Liechtenstein	-	19 Dec 2024
Metastatic gastric adenocarcinoma	Norway	-	19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma	European Union	-	19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma	Iceland	-	19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma	Liechtenstein	-	19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma	Norway	-	19 Dec 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
stomach adenocarcinoma	NDA/BLA	European Union	BeiGene Ireland Ltd.	17 Oct 2024
Unresectable Lung Non-Small Cell Carcinoma	NDA/BLA	Canada	BeiGene Switzerland GmbH	01 Feb 2024
Squamous Cell Carcinoma	NDA/BLA	China	BeiGene Ltd.	06 Sep 2018
Colorectal Cancer	Phase 3	France	BeiGene Ltd.	16 Apr 2025
Colorectal Cancer	Phase 3	France	Veracyte, Inc.	16 Apr 2025
Lung Cancer	Phase 3	France	Veracyte, Inc.	16 Apr 2025
Lung Cancer	Phase 3	France	BeiGene Ltd.	16 Apr 2025
Non-small cell lung cancer stage III	Phase 3	France	BeiGene Ltd.	16 Apr 2025
Non-small cell lung cancer stage III	Phase 3	France	Veracyte, Inc.	16 Apr 2025
Pancreatic Cancer	Phase 3	France	BeiGene Ltd.	16 Apr 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04579757 (CTgov)	Phase 1/2	Sarcoma \| Malignant Fibrous Histiocytoma \| Rectal Cancer ... View more	87	Tislelizumab+Surufatinib (Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab)	cqunggdsfu = jypkffxzrw gsubvpkqgc (dqiytnypfx, mntbhlqshj - mkltrvljhp) View more	-	08 May 2025
				Tislelizumab+Surufatinib (Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab)	cqunggdsfu = dvcljjbutq gsubvpkqgc (dqiytnypfx, gcsyrmdaks - ywamvnqbcu) View more
NCT04693234 (AdvanTIG-202, CTgov)	Phase 2	Metastatic Carcinoma to the Uterine Cervix	178	tislelizumab+Ociperlimab (Cohort 1: Ociperlimab + Tislelizumab)	nqhbvrjflu = ylvhviflee hrerhprnex (wzwfxhuvev, yomxqqhojl - ouqhdipkza) View more	-	27 Apr 2025
				tislelizumab (Cohort 2: Tislelizumab)	qfllijlkvt = nxajxlqsfc myqtsvbxek (uotcdrzyyf, iwaxcvufvq - xhcbsyfnkt) View more
Pubmed \| Int J Cancer Manual	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	46	tislelizumab + nab-paclitaxel + cisplatin	qsikrkwtmu(wvgjufdacp) = edjlqldarr msvinvqpuo (nxdhthssjv ) View more	Positive	01 Apr 2025
				tislelizumab + paclitaxel + cisplatin	qsikrkwtmu(wvgjufdacp) = anrvgzuqeq msvinvqpuo (nxdhthssjv ) View more
NCT03663205 (RATIONALE-304, ESMO_ELCC2025)	Phase 3	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma First line	110	Tislelizumab + Chemotherapy	mqopadarvp(jgxqbuwdho) = hsjggpuayo kcajdphblb (zztvwowryn, 11.5 - NE) View more	Positive	26 Mar 2025
				Chemotherapy	mqopadarvp(jgxqbuwdho) = bnxefoalpr kcajdphblb (zztvwowryn, 3.5 - 9.7) View more
ESMO_ELCC2025	Not Applicable	Non-Small Cell Lung Cancer First line	452	Camrelizumab	qlledegcnq(wvuqqxxref) = Similar incidences of immune-related adverse events (irAEs) at any grade or ≥3 irAEs were observed in different PD-1 inhibitors (P = 0.21, P = 0.63) zviaishynp (ycnnaghtup )	-	26 Mar 2025
				Pembrolizumab
NCT04716634 (CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	84	Tislelizumab+Fruquintinib (Gastric Cancer (GC): Tislelizumab and Fruquintinib)	jgqmyudlxw = gsewfdcblm pkpkxcuatx (playpzvjja, easfhygooa - pmwkabrtqe) View more	-	25 Mar 2025
				Tislelizumab+Fruquintinib (Colorectal Cancer (CRC): Tislelizumab and Fruquintinib)	jgqmyudlxw = rhairvbizp pkpkxcuatx (playpzvjja, dgcrbvtats - vqxsaiuzvb) View more
NCT04401800 (CTgov)	Phase 2	Unresectable Hepatocellular Carcinoma	64	Tislelizumab+Lenvatinib	umzcpgqxdc = pfmtqmdila yvlmlilnqe (netcpueaua, zyhrmvsaoj - qkrdghxumd) View more	-	10 Mar 2025
NCT03783442 (RATIONALE-306, FDA_CDER) Manual	Phase 3	PD-L1 positive Esophageal Squamous Cell Carcinoma PD-L1 Positive	231	TEVIMBRA + Chemotherapy (PD-L1 TAP ≥1%)	weghjiesem(btrfemjves) = nspczmziei yhintwzlet (dekjfkvuci, 15.3 - 20.8) View more	Positive	03 Mar 2025
				Placebo + Chemotherapy (PD-L1 TAP ≥1%)	weghjiesem(btrfemjves) = hrviljfpch yhintwzlet (dekjfkvuci, 8.9 - 11.8) View more
NCT04005716 (RATIONALE-312, CTgov)	Phase 3	Extensive stage Small Cell Lung Cancer	457	Tislelizumab+Etoposide+Carboplatin+cisplatin (Arm A: Tislelizumab + Chemotherapy)	abiawmykof(zzpoajlaml) = mpbvovbrsz zmoqshspjg (unzhjmjror, vlcqpaxnle - ygihsxacqu) View more	-	28 Feb 2025
				Placebo+Etoposide+Carboplatin+cisplatin (Arm B: Placebo + Chemotherapy)	abiawmykof(zzpoajlaml) = qgtxvxcdzb zmoqshspjg (unzhjmjror, aatxmiihoo - airkwhdhse) View more
NCT04948697 (AdvanTIG-206, CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	94	Tislelizumab+BAT1706+Ociperlimab (Arm A: Ociperlimab + Tislelizumab + BAT1706)	agakdpwnrb = mcllnuydzq phpuhjcqim (olqkljcoxc, hiaullmmbv - bzjyxookuc) View more	-	24 Feb 2025
				Tislelizumab+BAT1706 (Arm B: Tislelizumab + BAT1706)	agakdpwnrb = tkmafndych phpuhjcqim (olqkljcoxc, wermbbebrh - xdtriurqhg) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis