AbbVie announced it will unveil compelling new data from its antibody-drug conjugate (ADC) platform at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place October 17-21 in Berlin, Germany. The presentations will feature investigational compounds telisotuzumab adizutecan (Temab-A) and ABBV-706, targeting patients with difficult-to-treat solid tumors where urgent unmet medical needs persist.
"Despite recent progress in the treatment of advanced solid tumors, patients still face limited options and pressing unmet needs," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology at AbbVie. "The compelling data we are sharing at ESMO showcases how we are advancing targeted therapies across a range of solid tumors and highlights the potential of our portfolio."
Telisotuzumab Adizutecan Shows Broad Activity Across Tumor Types
AbbVie will present three oral presentations for Temab-A, a next-generation, investigational c-Met directed ADC with a novel topoisomerase 1 inhibitor payload. The Phase 1 results demonstrate activity both as monotherapy and in combination across advanced solid tumors.
Colorectal Cancer Combination Therapy
In biomarker unselected patients with advanced colorectal cancer who had received three or more prior lines of therapy, treatment with 2.4 mg/kg dose of Temab-A plus bevacizumab (n=30) achieved an objective response rate of 26.7% compared to an ORR of 0% with trifluridine/tipiracil with bevacizumab, the current standard of care (n=20). Grade ≥3 treatment emergent adverse events occurred in 67% and 65% of patients, respectively.
MET-Amplified Solid Tumors
Among 100 patients with advanced MET-amplified solid tumors, including non-small cell lung cancer (n=29), colorectal cancer (n=22), gastroesophageal adenocarcinoma (n=14), and 16 other tumor types (n=35) who had progressed after standard of care treatment, Temab-A monotherapy achieved an ORR of 46% across all dose levels and tumor types. Higher responses were observed in patients with NSCLC (69%) and gastroesophageal adenocarcinoma (71%). The most common grade ≥3 treatment emergent adverse events were anemia (40%) and neutropenia (34%).
Pancreatic Ductal Adenocarcinoma
Among 42 biomarker unselected patients with advanced/metastatic pancreatic ductal adenocarcinoma who experienced disease progression while receiving or after completing their first-line therapy, Temab-A demonstrated an ORR of 24% overall and 40% in patients who received first-line gemcitabine-nab-paclitaxel treatment. Grade ≥3 treatment emergent adverse events occurring in ≥10% of all patients were anemia (38%) and neutropenia (21%).
"Temab-A continues to show meaningful clinical activity across an expanding range of solid tumors and patient populations, including patients with MET-amplification and increased c-Met expression as we have seen in previously presented data," said Vivek Subbiah, M.D., Chief, Early-Phase Drug Development, Sarah Cannon Research Institute and Temab-A investigator. "These data reinforce Temab-A's potential in multiple solid tumors and thereby warrant its further clinical investigation."
ABBV-706 Demonstrates Potential in Small Cell Lung Cancer
AbbVie will also present new analysis from a Phase 1 study of ABBV-706, a SEZ6-directed ADC with a topoisomerase 1 inhibitor payload, in relapsed/refractory small cell lung cancer.
A post hoc analysis on data from relapsed/refractory SCLC patients enrolled in the study, whose tumors had progressed after two lines of therapy (n=80), compared the anti-cancer effect of ABBV-706 monotherapy versus platinum-based standard of care. All patients in this group had received the platinum-based standard of care treatment as first-line therapy. Progression-free survival during first-line standard of care and progression-free survival with ABBV-706 monotherapy as a subsequent line of treatment were analyzed in the same patients by paired Kaplan-Meier analysis. The findings suggest that ABBV-706 may have the potential to replace the platinum-based standard of care as a first-line treatment in SCLC.
Biomarker Analysis Shows Promise
In the same trial, ABBV-706 treatment resulted in rapid clearance of circulating tumor DNA (ctDNA) and circulating tumor cells. Patients with 100% ctDNA clearance had significantly higher progression-free survival and overall survival versus patients without ctDNA clearance. These data highlight the potential of ctDNA as an early response marker in SCLC.
A Phase 2 study assessing ABBV-706 in combination with atezolizumab as replacement of platinum-based chemotherapy is currently ongoing in first-line SCLC.
Expanding ADC Portfolio
The data presentations underscore AbbVie's commitment to advancing targeted therapies for difficult-to-treat cancers through its growing ADC portfolio. Both telisotuzumab adizutecan and ABBV-706 are investigational medicines not approved by any health authorities worldwide, with safety and efficacy under evaluation in ongoing clinical studies.
AbbVie's oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors, with more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers.
