Budigalimab

- 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