[Translation] A Phase II randomized study to evaluate the safety, efficacy, and optimal dose of ABBV-400 in combination with fluorouracil, leucovorin, and Budigalimab as first-line treatment in subjects with locally advanced, unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (AndroMETa-GEA-977)

‐ 评价ABBV-400联合5-FU、LV和Budigalimab的安全性和耐受性。 ‐ 选择ABBV-400联合5-FU、LV和Budigalimab的推荐III期临床试验剂量（RP3D）。 ‐ 根据无进展生存期（PFS）和客观缓解（OR），评价ABBV-400联合5-FU、LV和Budigalimab的有效性。 ‐ 评估ABBV-400联合氟尿嘧啶（5-FU）、甲酰四氢叶酸（LV）和Budigalimab在剂量递增部分的剂量限制性毒性（DLT）。 ‐ 根据缓解持续时间（DoR）、疾病控制（DC）和总生存期（OS），评价ABBV-400联合5-FU、LV和Budigalimab的有效性。 ‐ 评价ABBV-400联合5-FU、LV和Budigalimab的药代动力学（PK）。

[Translation]

‐ To evaluate the safety and tolerability of ABBV-400 combined with 5-FU, LV, and Budigalimab. ‐ To select the recommended phase III clinical trial dose (RP3D) of ABBV-400 combined with 5-FU, LV, and Budigalimab. ‐ To evaluate the efficacy of ABBV-400 combined with 5-FU, LV, and Budigalimab based on progression-free survival (PFS) and objective response (OR). ‐ To assess the dose-limiting toxicity (DLT) of ABBV-400 combined with fluorouracil (5-FU), leucovorin (LV), and Budigalimab in the dose-escalation part. ‐ To evaluate the efficacy of ABBV-400 combined with 5-FU, LV, and Budigalimab based on duration of response (DoR), disease control (DC), and overall survival (OS). ‐ To evaluate the pharmacokinetics (PK) of ABBV-400 combined with 5-FU, LV, and Budigalimab.

Start Date01 Aug 2025

Sponsor / Collaborator

AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.

[+2]

CTIS2024-514465-18-00

/ RecruitingPhase 1/2

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Budigalimab in Advanced or Metastatic Non-Squamous NSCLC with No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations (AndroMETa-Lung-536) - M24-536

Start Date29 Apr 2025

Sponsor / Collaborator

AbbVie Deutschland GmbH & Co. KG

NCT06772623

/ RecruitingPhase 1/2

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.
Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 132 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Start Date06 Mar 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Budigalimab

100 Translational Medicine associated with Budigalimab

100 Patents (Medical) associated with Budigalimab

Literatures (Medical) associated with Budigalimab

03 Oct 2025·MEDICINE

Global safety profile of PD-1/PD-L1 inhibitors in hepatic autoimmune disorders: A global disproportionality analysis

Article

Author: Kong, Jaehyun ; Hwang, Jiyoung ; Yon, Dong Keon ; Cho, Jaehyeong ; Park, Jaeyu ; Oh, Jeongseon ; Kim, Tae Hyeong ; Kim, Tae Hyeon

The increasing use of programmed cell death protein-1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors in cancer therapy has raised concerns regarding immune-related adverse events. However, global pharmacovigilance studies on autoimmune diseases remain scarce. This study aimed to evaluate the signal detection between PD-1/PD-L1 inhibitors and hepatic autoimmune disorders. A global pharmacovigilance study was conducted using data from individual case safety reports. The analysis centered on PD-1/PD-L1 inhibitors, classified by Anatomical Therapeutic Chemical codes (e.g., atezolizumab, avelumab, budigalimab, cemiplimab, dostarlimab, durvalumab, nivolumab, pembrolizumab, sintilimab, spartalizumab, and tislelizumab). Hepatic autoimmune disorders were defined based on MedDRA Version 26.0 (Maintenance and Support Services Organization, McLean). Disproportionality analyses were performed using reporting odds ratios with 95% confidence intervals and information components (ICs), with IC0.25, to evaluate potential signal detection. A total of 1401 reports of hepatic autoimmune disorders associated with PD-1/PD-L1 inhibitors were identified. Nivolumab (59.89%) and pembrolizumab (27.62%) accounted for the highest reports. Notably, nivolumab (reporting odds ratio, 117.52 [95% confidence interval, 109.52–126.10]; IC, 6.67 [IC0.25, 6.60]) and pembrolizumab (55.69 [50.31–61.64]; 5.65 [5.55]) showed the notable reporting signals, followed by cemiplimab, atezolizumab, durvalumab, avelumab, sintilimab, and tislelizumab. Subgroup analysis showed a stronger signal for hepatic autoimmune disorders in males than in females treated with PD-1/PD-L1 inhibitors. Additionally, the mean time to onset was 22.90 days (standard deviation: 81.66), although some reports presented with substantially delayed onset. Most PD-1/PD-L1 inhibitors showed pharmacovigilance signals for hepatic autoimmune disorders, particularly nivolumab and pembrolizumab. Although our findings do not permit causal inference, these findings underscore the necessity for sustained hepatic monitoring, risk stratification, and appropriate therapeutic management.

01 Oct 2022·Annals of oncology : official journal of the European Society for Medical Oncology

Circulating L-arginine predicts the survival of cancer patients treated with immune checkpoint inhibitors

Article

Author: Chaput, N ; Le Loarer, F ; Tselikas, L ; Fontan, L ; Besse, B ; Roubaud, G ; Peyraud, F ; Cabart, M ; Auzanneau, C ; Italiano, A ; Barlesi, F ; Cousin, S ; Danlos, F-X ; Bodet, D ; Soria, J-C ; Nafia, I ; Bessede, A ; Guégan, J-P ; Planchard, D ; Even, C ; Marabelle, A ; Chomy, F ; Khettab, M

BACKGROUND:

The discovery of immune checkpoint inhibitors (ICIs) has revolutionized the systemic approach to cancer treatment. Most patients receiving ICIs, however, do not derive benefits. Therefore, it is crucial to identify reliable predictive biomarkers of response to ICIs. One important pathway in regulating immune cell reactivity is L-arginine (ARG) metabolism, essential to T-cell activation. We therefore aimed to evaluate the association between baseline plasma ARG levels and the clinical benefit of ICIs.

PATIENTS AND METHODS:

The correlation between ARG levels and clinical ICI activity was assessed by analyzing plasma samples obtained before treatment onset in two independent cohorts of patients with advanced cancer included in two institutional molecular profiling programs (BIP, NCT02534649, n = 77; PREMIS, NCT03984318, n = 296) and from patients in a phase 1 first-in-human study of budigalimab monotherapy (NCT03000257). Additionally, the correlation between ARG levels and ICI efficacy in preclinical settings was evaluated using a syngeneic mouse model of colorectal cancer responsive to ICIs. Using matched peripheral blood mononuclear cell (PBMC) plasma samples, we analyzed the correlation between ARG levels and PBMC features through multiplexed flow cytometry analysis.

RESULTS:

In both discovery and validation cohorts, low ARG levels at baseline (<42 μM) were significantly and independently associated with a worse clinical benefit rate, progression-free survival, and overall survival. Moreover, at the preclinical level, the tumor rejection rate was significantly higher in mice with high baseline ARG levels than in those with low ARG levels (85.7% versus 23.8%; P = 0.004). Finally, PBMC immunophenotyping showed that low ARG levels were significantly associated with increased programmed death-ligand 1 expression in several immune cell subsets from the myeloid lineage.

CONCLUSIONS:

We demonstrate that baseline ARG levels predict ICI response. Plasma ARG quantification may therefore represent an attractive biomarker to tailor novel therapeutic regimens targeting the ARG pathway in combination with ICIs.

01 Apr 2022·Journal of immunotherapy (Hagerstown, Md. : 1997)Q4 · MEDICINE

Association of Baseline and Pharmacodynamic Biomarkers With Outcomes in Patients Treated With the PD-1 Inhibitor Budigalimab

Q4 · MEDICINE

Article

Author: Tribouley, Catherine ; McLaughlin, Robert Tyler ; Masica, David L. ; Sheridan, James ; Vosganian, Greg ; Englert, Stefan ; Turan, Tolga ; Guo, Claire ; Afar, Daniel ; Zhang, Chun ; Lambert, Stacie L. ; Fang, Yuni

Budigalimab, a novel anti–PD-1 monoclonal antibody, demonstrated efficacy and biomarker pharmacodynamics in patients with head and neck squamous cell carcinoma (HNSCC) or non–small cell lung cancer (NSCLC) consistent with those reported by other PD-1 inhibitors. Herein are presented additional outcomes of biomarker analyses from the phase 1 study of budigalimab monotherapy in patients with HNSCC and NSCLC (NCT03000257). PD-1 inhibitor naive patients with advanced HNSCC (n=41) or NSCLC (n=40) received budigalimab intravenously at 250 mg every 2 weeks (Q2W) or 500 mg Q4W until progression. Archival tumor specimens were evaluated by immunohistochemistry for CD8 and tumor PD-1 ligand 1 (PD-L1) expression, RNA, and whole-exome sequencing. Serum and whole blood samples were acquired at baseline and at select on-treatment time points. As of October 2019, best overall response of 15% in HNSCC and 18% in NSCLC was observed in all treated patients; both cohorts reported responses in PD-L1+ and PD-L1– tumors. Treatment with budigalimab was associated with increases in multiple soluble biomarkers including interferon gamma-induced chemokines. Expanded overall T-cell counts, total CD8 T-cell counts, and percentages of CD8+CD45RA–CD62L– effector memory T cells were observed at cycle 1, day 15 in responders. Univariate analysis demonstrated an association between prolonged progression-free survival and higher tumor mutational burden/neoantigen load, smaller tumor size, lower platelet-lymphocyte ratios, lower CCL23, lower colony-stimulating factor 1, and lower interleukin-6 levels at baseline. The biomarker analysis presented herein identified additional early pharmacodynamic biomarkers associated with anti–PD-1 activity and improved clinical responses to budigalimab in patients with advanced HNSCC and NSCLC.

News (Medical) associated with Budigalimab

29 Oct 2025

·www.fiercebiotech.com

AbbVie halts development of Dragonfly cancer asset midflight

Alongside the AbbVie partnership, buzzy Dragonfly has also taken flight with Merck, Gilead and Bristol Myers Squibb.\n AbbVie has scrapped an asset from its ongoing collaboration with Dragonfly Therapeutics, a spokesperson for the Chicago pharma confirmed to Fierce Biotech.“We have terminated clinical activity around ABBV-303,” the spokesperson said, alluding to a phase 1 solid tumor trial of the natural killer (NK) cell engager. “However, our partnership with Dragonfly is still ongoing.”The study was terminated in light of “strategic considerations,\" according to its entry on the federal trial database clinicaltrials.gov. AbbVie and Dragonfly were testing ABBV-303 alone and in combination with AbbVie\'s anti-PD-1 antibody budigalimab (ABBV-181).Dragonfly did not respond to multiple requests for comment from Fierce. ABBV-303 was the first asset from the AbbVie-Dragonfly team-up to hit the clinic, triggering a milestone payment for Dragonfly in March 2024. The duo forged their pact in 2019 and expanded it in 2022 to include additional targets, with a focus on oncology and autoimmune diseases.AbbVie was studying the candidate in solid tumors expressing c-Met, the company spokesperson said, which is a receptor protein commonly found on the surface of tumor cells.“This termination does not impact our commitment to continue advancing c-Met targeted therapies,” the spokesperson added.Dragonfly’s pipeline is packed with Big Pharma collaborations and a clutch of wholly owned assets, the most advanced of which is DF1001, a HER2-targeting NK cell engager currently in a phase 1/2 trial for non-small cell lung cancer and metastatic breast cancer.Alongside the AbbVie partnership, buzzy Dragonfly has also taken flight with Merck, Gilead and Bristol Myers Squibb, with BMS also once dumping an asset back into Dragonfly’s pond.

License out/inPhase 1Clinical Trial TerminationPROTACsADC

27 May 2025

·www.prnewswire.com

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers. "The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs." An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase: Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO. Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC. "The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis." Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123: In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO. This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors. Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4 Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO. PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia. "Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited." Further information on AbbVie clinical trials is available at . Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here. Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp) Please see full Prescribing Information for IMBRUVICA® (ibrutinib) Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138. Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultASCOPhase 1ADCPhase 2

16 Sep 2024

·www.prnewswire.com

Trishula Therapeutics Presents Positive Results from Phase 1 Trial of TTX-030 in First-Line Metastatic Pancreatic Cancer Patients

Results presented at ESMO Congress 2024 SOUTH SAN FRANCISCO, Calif., Sept. 16, 2024 /PRNewswire/ -- Trishula Therapeutics, Inc., a clinical stage, privately held biotechnology company, today reported final results from a Phase 1 trial of TTX-030, a potential first-in-class, anti-CD39 antibody, in patients with first-line metastatic pancreatic cancer. Results were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. "The Phase 1 results demonstrated a strong median overall survival in patients with metastatic pancreatic cancer following treatment with TTX-030 combinations as well as marked benefit in those with high levels of tumor HLA-DQ biomarker expression," said Anil Singhal, Chief Executive Officer of Trishula Therapeutics. "These findings have led to our currently enrolling global, randomized Phase 2 ELTIVATE study with results expected in 2026." The Phase 1 trial evaluated TTX-030 in combination with gemcitabine/nab-paclitaxel, with or without budigalimab (an investigational anti-PD-1 antibody), as first-line treatment for pancreatic adenocarcinoma. In the efficacy-evaluable population (n=57) consisting of 92% first-line metastatic and 8% locally advanced nonresecetable patients, the objective response rate (ORR) was 30%, with 3 complete responses; the median progression free survival (mPFS) was 7.5 months (95%CI 5.2, 9.4); and median overall survival was 19.1 months (9.8, NR). Analysis of pre-treatment tumor biopsies identified a subset of patients with a high expression of an immune-associated biomarker, HLA-DQ (HLA-DQhigh) and favorable clinical outcomes with TTX-030 combinations. Of the 28 HLA-DQhigh patients, the ORR was 46%, mPFS was 9.6 months (95% CI 3.9, 11.8), and mOS of 21.9 months (9.8, NR). Both treatment combinations were well-tolerated, with only five patients (8%) discontinuing treatment due to adverse events (AEs). The most frequent AEs were those expected from the standard of care chemotherapy backbone without an increase in frequency or severity. "Prior evaluation of immune checkpoint treatment has demonstrated limited benefit in this patient population and new approaches are needed. These results are very encouraging, especially in the biomarker high patients and warrant further investigation of TTX-030 for patients with advanced pancreatic cancer," said Zev Wainberg, MD, Professor of Medicine, UCLA. TTX-030 is currently being evaluated as first-line treatment for metastatic pancreatic adenocarcinoma in the global Phase 2 ELTIVATE trial (NCT06119217) that is randomizing approximately 180 patients into three study arms: TTX-030 and chemotherapy (gemcitabine and nab-paclitaxel); TTX-030 plus budigalimab and chemotherapy; or chemotherapy alone. The primary endpoint of the trial is progression-free survival (PFS) in a biomarker-enriched (HLA-DQhigh) population. Secondary endpoints include PFS in the overall population, safety, objective response rate, duration of response and overall survival. Further information on the study can be found at (clinicaltrials.gov link). About TTX-030 TTX-030 is a potential first-in-class, anti-CD39 antibody designed to inhibit the activity of CD39, an enzyme that converts adenosine triphosphate (ATP) to adenosine monophosphate (AMP), the initial step in the generation of adenosine in the tumor microenvironment. TTX-030 prevents the formation of immune-suppressive extracellular adenosine and maintains high levels of immune-activating extracellular ATP, stimulating dendritic and myeloid-derived cells promoting both innate and adaptive anti-tumor immunity. Trishula is continuing to develop TTX-030 in collaboration with AbbVie Inc. About Trishula Trishula is a privately held biotechnology company dedicated to the development of TTX-030. For more information, please visit . Media Contact: Julie Rathbun Rathbun Communications [email protected] 206-769-9219 SOURCE Trishula Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 1Immunotherapy

100 Deals associated with Budigalimab

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D11643	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	United States	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Japan	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Australia	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Belgium	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Chile	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	France	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Israel	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Netherlands	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Spain	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Taiwan Province	AbbVie, Inc.	10 Apr 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05599984 (WCLC2025 \| NEWS) Manual	Phase 1	Extensive stage Small Cell Lung Cancer	80	ABBV-706 1.8 mg/kg Q3WABBV-706 1.8 mg/kg Q3W	evacceamkf(vmhcnqwxdi) = ydxdbqshbl vakncjhxgr (emkoxhmero ) View more	Positive	07 Sep 2025
				ABBV-706 2.5 mg/kg Q3WABBV-706 2.5 mg/kg Q3W	evacceamkf(vmhcnqwxdi) = kmynizenzk vakncjhxgr (emkoxhmero ) View more
NCT03821935 (NCT03821935, Pubmed \| Front Oncol)	Phase 1	Advanced Malignant Solid Neoplasm GARP:TGF-ß1 complex	-	Livmoniplimab	gvjfzqihwu(zptlxgbikd) = iehsuuxlyx qhyxofzojz (yxtzycivda )	Positive	29 Oct 2024
				Budigalimab	dycndyzpdm(hbkssnltdr) = iifquoegks gnmfzlgdjg (isggxjusxv ) View more
NCT03821935 (ASCO2024)	Phase 1	Solid tumor \| Transitional Cell Carcinoma TGF-β1 \| GARP:TGF-β1 complex	200	Livmoniplimab 1500 mg + Budigalimab 500 mg	utmdrmwotg(qocrejqoyb) = nzpkvxhopv ggcfzcajxe (hxxwksyvsp, 12.9 - 39.5) View more	Positive	24 May 2024
NCT03821935 (ASCO_GU2024) Manual	Phase 1	Transitional Cell Carcinoma	48	Livmoniplimab + budigalimab	zghougjhew(romeyhwkrr) = witkmsxfea jdhlnbfzjf (xaplxmvzwa, 12.9 - 39.5) View more	Positive	25 Jan 2024
NCT03000257 (Pubmed \| J Immunother)	Phase 1	Advanced Malignant Solid Neoplasm	182	Budigalimab 250mg Q2W	pgacxtgbpb(cabflvxpty) = pslstbxics ekepnpfhgl (vmdsucebrm )	Positive	17 Jan 2022
				Budigalimab 500mg Q4W	pgacxtgbpb(cabflvxpty) = vapcaqpjqk ekepnpfhgl (vmdsucebrm )
NCT03000257 (Pubmed \| Cancer Immunol Immunother)	Phase 1	Squamous Cell Carcinoma of Head and Neck \| Non-Small Cell Lung Cancer	81	Budigalimab 250 mg	fhhlmjksno(tqmlpwcjuc) = nnpphsjvoi pscqrcjmnx (vykyvzoznk, 5.1 - 24.5)	-	03 Jul 2021
				Budigalimab 500 mg	fhhlmjksno(tqmlpwcjuc) = ctcreufnhy pscqrcjmnx (vykyvzoznk, 9.2 - 32.6)
NCT03000257 (M15-892, Pubmed) Manual	Phase 1	Small Cell Lung Cancer	31	rovalpituzumab tesirine+budigalimab	afsgbxsfya(zvwydxkrvw) = swtmgfcnbx syjnhkaove (ybojmzpvok ) View more	Positive	01 Jan 2021
NCT03000257 (AACR2020)	Phase 1	HR-positive/HER2-low Solid Tumors	81	Budigalimab IV 250 mg every two weeks	iqaebgsnis(hbczegkfre) = afvduhcpil mlefqxnrpm (ozmrbwhkny )	-	15 Aug 2020
				Budigalimab IV 500 mg every four weeks	iqaebgsnis(hbczegkfre) = vneqjdwtse mlefqxnrpm (ozmrbwhkny )
NCT03000257 (M15-891, SITC2018)	Phase 1	Advanced Malignant Solid Neoplasm	62	ABBV-181 1 mg/kg	sylbeamqek(zulqahsvcq) = gldbpulbeg eaqpawynzg (kbymggshyv, 31 - 59) View more	Positive	06 Nov 2018
				ABBV-181 3 mg/kg	sylbeamqek(zulqahsvcq) = vjndiwfydj eaqpawynzg (kbymggshyv, 31 - 59) View more

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