On May 27, 2025 AbbVie (NYSE: ABBV) reported 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) (Free ASCO Whitepaper) Annual Meeting (May 30 – June 3, 2025) (Press release, AbbVie, MAY 27, 2025, View Source [SID1234653412]). These new data highlight significant progress in AbbVie’s robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers.
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"The data we’re presenting at this year’s ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper).
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 (Free ASCO Whitepaper).
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 (Free ASCO Whitepaper).
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 View Source
Additional details on key presentations at ASCO (Free ASCO Whitepaper) are available below and the full ASCO (Free ASCO Whitepaper) Annual Meeting 2025 abstracts are available here.
Title
Date/Time
Session
Abstract
Number
Telisotuzumab adizutecan (ABBV-400; Temab-A)
monotherapy vs trifluridine/tipiracil plus bevacizumab in
patients with refractory metastatic colorectal cancer with
increased c-Met protein expression: An open-label,
randomized, phase 3 trial.
Saturday, May 31,
9:00 AM – 12:00
PM CDT
Poster Board: 303a
TPS3635
Telisotuzumab adizutecan (ABBV-400; Temab-A) in
combination with fluorouracil, leucovorin, and budigalimab
in locally advanced/metastatic gastric, gastroesophageal
junction, or esophageal adenocarcinoma (a/m GEA).
Saturday, May 31,
9:00 AM – 12:00
PM CDT
Poster Board: 491b
TPS4202
Efficacy and safety of first-line ibrutinib plus venetoclax in
patients with mantle cell lymphoma (MCL) who were older
or had TP53 mutations in the SYMPATICO study.
Saturday, May 31,
9:12 – 9:18 AM
CDT
Rapid Oral Abstract
Session
Hematologic Malignancies—
Lymphoma and
Chronic
Lymphocytic
Leukemia
7017
LUMINOSITY, a phase 2 study of telisotuzumab vedotin in
patients with c-Met protein–overexpressing non-
squamous EGFR-wildtype advanced NSCLC: Efficacy
outcomes by prior therapy.
Saturday,
May 31,
1:30 – 4:30 PM CDT
Poster Board: 98
8618
Long-term efficacy and safety of etentamig, a B-cell
maturation antigen (BCMA) bispecific antibody in patients
with relapsed/refractory multiple myeloma (RRMM).
Sunday,
June 1,
9:00 AM – 12:00
PM CDT
Poster Board: 95
7527
Novel analysis of 3-y results from the pivotal EPCORE
NHL-1 study: Outcomes in patients (pts) with
relapsed/refractory large B-cell lymphoma (R/R LBCL)
and complete response (CR) at 2 y with epcoritamab
(epcor) monotherapy.
Sunday,
June 1,
9:00 AM – 12:00
PM CDT
Poster Board: 226
7043
Folate receptor alpha (FRα; FOLR1) expression and
persistence in ovarian cancer in clinical trial samples and
real-world patient cohort.
Sunday,
June 1,
9:00 AM – 12:00
PM CDT
Poster Board: 489
5591
Efficacy of third-line and later (3L+) therapies post poly
(ADP-ribose) polymerase inhibitor (PARPi) exposure in
recurrent platinum-sensitive ovarian cancer (PSOC): A
pooled clinical trial database analysis.
Sunday,
June 1,
9:00 AM – 12:00
PM CDT
Poster Board: 477
5579
A phase 1 first-in-human study evaluating safety,
pharmacokinetics, and efficacy of ABBV-291, a CD79b-
targeting antibody-drug conjugate, in patients with
relapsed/refractory B-cell non-Hodgkin lymphoma.
Sunday,
June 1,
9:00 AM – 12:00
PM CDT
Poster Board: 271a
TPS7093
Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met
protein–targeting antibody-drug conjugate (ADC), in
patients (pts) with advanced EGFR-mutated (MT) non-
squamous (NSQ) non-small cell lung cancer (NSCLC):
Results from a phase 1 study.
Monday,
June 2,
8:00 – 8:06 AM
CDT
Rapid Oral Abstract
Session
Lung Cancer—
Non-Small Cell
Metastatic
8512
Phase 1, open-label, first-in-human study of ABBV-969, a
dual variable antibody-drug conjugate, in
patients with metastatic castration-resistant prostate
cancer.
Monday,
June 2,
9:00 AM – 12:00
PM CDT
Poster Board: 309b
TPS5111
A phase 2, open-label, randomized study of livmoniplimab
in combination with budigalimab versus chemotherapy in
patients with metastatic urothelial carcinoma.
Monday,
June 2,
9:00 AM – 12:00
PM CDT
Poster Board: 414b
TPS4618
Safety and efficacy of ABBV-706, a seizure-related
homolog protein (SEZ6)- targeting antibody-drug
conjugate, in high-grade neuroendocrine neoplasms.
Monday,
June 2,
10:09 – 10:21 AM
CDT
Oral Presentation
Clinical Science
Symposium – ADC
2.0: Discovering
the Targets That
Will Change the
Game
105
Efficacy and safety of pivekimab sunirine (PVEK) in
patients (pts) with blastic plasmacytoid dendritic cell
neoplasm (BPDCN) in the CADENZA study.
Monday,
June 2,
3:24 – 3:36 PM
CDT
Oral Presentation
Oral Abstract
Session –
Hematologic
Malignancies—
Leukemia,
Myelodysplastic
Syndromes, and
Allotransplant
6502
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.