AbbVie Highlights Expanding Oncology Pipeline at ASCO 2025 with New Data Across Challenging Solid Tumors and Blood Cancers
AbbVie has announced a significant presence at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for May 30 through June 3. The company will showcase a series of important data readouts from its broad and growing oncology pipeline. The presentations span a range of difficult-to-treat solid tumors and hematologic malignancies, underscoring the company’s continued investment in next-generation targeted cancer therapies, particularly antibody-drug conjugates (ADCs).
“Our presentations at ASCO 2025 reflect the breadth and depth of AbbVie’s oncology portfolio,” said Dr. Roopal Thakkar, executive vice president of research and development and chief scientific officer at AbbVie. “We are committed to advancing research that has the potential to meaningfully improve outcomes for patients facing some of the most challenging cancers. Our progress in ADC innovation exemplifies this mission.”
Temab-A (Telisotuzumab Adizutecan): Advancing Lung and Colorectal Cancer Treatment
One of the centerpieces of AbbVie’s ASCO 2025 showcase is an oral presentation on telisotuzumab adizutecan (Temab-A, also known as ABBV-400). This investigational therapy is a next-generation c-Met-directed ADC featuring a novel topoisomerase I inhibitor (Top1i) payload. Temab-A is being explored in several cancers with significant unmet medical needs, beginning with non-small cell lung cancer (NSCLC).
New data from a Phase 1 dose expansion study (NCT05029882) in 41 patients with advanced, pretreated EGFR-mutated non-squamous NSCLC demonstrate an encouraging objective response rate (ORR) of 63%, even in a heavily pretreated population. Notably, the majority (93%) of participants had previously received anti-EGFR therapies, with a median of three prior lines of treatment. The responses were observed regardless of c-Met protein expression levels, indicating potential utility across a broader NSCLC population. At the time of data cutoff, 54% of responders maintained their response for six months or longer.
Common treatment-emergent adverse events (TEAEs) included anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%). AbbVie plans to present updated results with four additional months of follow-up during the ASCO meeting.
Temab-A is also being evaluated in several ongoing clinical trials:
- A Phase 1/2 study (NCT06772623) in combination with budigalimab, AbbVie’s investigational PD-1 inhibitor, as a first-line therapy for NSCLC patients without actionable genomic mutations.
- A Phase 2 trial (NCT06107413) exploring Temab-A in combination with fluorouracil, folinic acid, and bevacizumab for second-line metastatic colorectal cancer (CRC).
- A pivotal Phase 3 monotherapy study (NCT06614192) in c-Met-overexpressing, refractory metastatic CRC.
“The anti-tumor activity observed with Temab-A in EGFR-mutated NSCLC is highly encouraging,” said Dr. Ross Camidge, professor at the University of Colorado Cancer Center and the study’s principal investigator. “This ADC appears to offer durable responses with a manageable safety profile, which is especially important for patients whose disease has progressed after multiple lines of therapy.”
ABBV-706: A SEZ6-Directed ADC Targeting Rare, Aggressive Solid Tumors
Another investigational ADC gaining attention is ABBV-706, which targets SEZ6 and delivers a Top1i cytotoxic payload. SEZ6 is a novel target expressed in various aggressive tumor types, including high-grade neuroendocrine neoplasms (NENs) and small-cell lung cancer (SCLC).
In a Phase 1 open-label study (NCT05599984), 64 patients with high-grade NENs were treated with ABBV-706 monotherapy at doses ranging from 1.3 to 3.5 mg/kg every three weeks. The objective response rate across the cohort was 31.3%, and the median duration of response reached 5.6 months. Grade 3 or higher treatment-related adverse events included anemia (45%), neutropenia (33%), and thrombocytopenia (21%).
This study remains ongoing, with additional cohorts exploring ABBV-706 both as monotherapy and in combination with budigalimab, carboplatin, or cisplatin in SEZ6-expressing tumors, including CNS malignancies and SCLC.
Pivekimab Sunirine (PVEK): Targeting CD123 in Blastic Plasmacytoid Dendritic Cell Neoplasm
AbbVie is also advancing pivekimab sunirine (PVEK), a novel ADC designed to target CD123, a cell surface antigen commonly overexpressed in blastic plasmacytoid dendritic cell neoplasm (BPDCN). This rare and aggressive blood cancer has limited treatment options and poor overall prognosis.
At ASCO 2025, AbbVie will present data from the Phase 1b/2 CADENZA trial (NCT03386513) evaluating PVEK monotherapy in two patient populations: those with previously untreated BPDCN and those with relapsed/refractory (R/R) disease.
Among 33 treatment-naïve patients, PVEK achieved a composite complete response (CCR) rate of 70%, defined as complete response plus clinical CR (CR with residual skin abnormalities). The median duration of CCR was 9.8 months, and the overall response rate (ORR) was 85%. For the 51 patients with R/R BPDCN, the CCR rate was 14%, with a median duration of response of 9.2 months, and an ORR of 35%.
Across the full cohort of 84 patients, the most common grade ≥3 adverse event was peripheral edema (12%). Discontinuations due to TEAEs occurred in 9% of first-line patients and 7% of those with R/R disease.
PVEK is also under evaluation in an ongoing Phase 1/2 study (NCT04086264) for patients with relapsed/refractory or newly diagnosed acute myeloid leukemia (AML), another challenging hematologic malignancy.
A Strategic Focus on ADCs and Precision Oncology
AbbVie’s portfolio at ASCO 2025 strongly reflects its strategic pivot toward precision oncology, leveraging targeted therapies that disrupt tumor biology while sparing healthy tissues. The focus on ADCs with novel payloads and biomarker-driven development is a cornerstone of the company’s approach to address unmet needs in both solid tumors and hematologic malignancies.
“In just a few years, we’ve expanded our ADC pipeline significantly, targeting cancers that are often aggressive and resistant to conventional therapies,” said Dr. Daejin Abidoye, vice president and therapeutic area head of solid tumors at AbbVie. “These new results demonstrate the potential of our pipeline to offer meaningful clinical benefits where current treatments fall short.”
As AbbVie prepares to present its data at ASCO 2025, the company is clearly positioning itself as a leader in next-generation oncology therapeutics. The consistent focus on difficult-to-treat cancers, the integration of biomarker science, and a growing portfolio of investigational agents across multiple tumor types place the company in a strong position to make a meaningful impact in cancer care.
For patients and clinicians alike, the data AbbVie brings to ASCO this year represent not only progress but also hope—especially for those battling cancers with historically poor outcomes. With multiple late-stage trials underway, including pivotal Phase 3 studies, AbbVie’s oncology pipeline is poised to potentially reshape standard-of-care therapies across a variety of indications in the years to come.
