Dr Strickler on the Safety and Efficacy of Telisotuzumab Adizutecan in Gastric/GEJ Cancer

John H. Strickler, MD, associate professor, medicine, Division of Medical Oncology, associate director, Clinical Research, Gastrointestinal Oncology, Duke Cancer Institute Molecular Tumor Board, Duke University, discusses the efficacy and safety of telisotuzumab adizutecan(ABBV-400) monotherapy in patients with MET gene–amplified advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. This antibody-drug conjugate (ADC) was evaluated in patients with advanced solid tumors in a first-in-human, phase 1 study (NCT05029882), and data were notably shared at the 2024 ESMO Congress.

In the advanced gastric/GEJ adenocarcinoma cohort of the study (n = 42), investigators evaluated the dose expansion of the agent. Patients, who had progressed after receiving no more than 2 prior cytotoxic chemotherapy regimens, received telisotuzumab adizutecan at a dose of 3.0 mg/kg every 3 weeks. The primary objectives of the study were to assess the safety, tolerability, pharmacokinetics, and efficacy of the agent.

In the patients with advanced gastric/GEJ adenocarcinoma, all of whom were heavily pretreated with at least 1 or 2 prior lines of therapy, the results were promising, Strickler begins. Investigators observed a 28.6% (95% CI, 15.7%-44.6%) objective response rate and a median progression-free survival of 4.0 months (95% CI, 2.76-4.86), findings that compare favorably with data observed with the current standard of care, he explains. From an efficacy standpoint, these findings are compelling and warrant further investigation, Strickler says.

The majority of safety concerns were related to the cytotoxic chemotherapy component of the drug, he continues. Common adverse effects (AEs) included myelosuppression, such as anemia, neutropenia, and thrombocytopenia, as well as nausea and fatigue, which are typically associated with ADCs, Strickler explains. Importantly, interstitial lung disease, also known as pneumonitis, was observed in 9.5% of patients; however, all cases were grade 1 or 2 in severity, with no severe toxicities reported in this patient population, he expands.

Overall, the results indicate that this treatment approach is both effective and generally well tolerated with manageable AEs in patients with gastric/GEJ cancer, Strickler notes. The favorable response rate and safety profile highlight the need for further study to explore thepotential of telisotuzumab adizutecan as a therapeutic option for patients with metastatic gastroesophageal cancer, he concludes.