ABBV-400 Shows Early Promise in Pretreated, Metastatic Colorectal Cancer

Kanwal P.S. Raghav, MBBS, MD, spoke with CancerNetwork® at the 2025 Gastrointestinal Cancer Symposium following his presentation on a phase 2 trial (NCT06107413) evaluating ABBV-400 with fluorouracil, folinic acid, and bevacizumab (Avastin) in patients who were pretreated and had metastatic colorectal cancer.

Raghav, an associate professor in the Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine and clinical medical director in the Division of Ambulatory Treatment Centers at The University of Texas MD Anderson Cancer Center, spoke about how bevacizumab was largely chosen because it elicits VEGF-inhibition in colorectal cancer and that fluorouracil was chosen because of its conduciveness to additive vaccines.

Additionally, when prompted about specific patient populations that this study treatment might have increased benefit for, Raghav noted that it's still early for the phase 2 trial to know, or have data, on specific patient subgroups. There is, however, another phase 1 study (NCT05029882) evaluating ABBV-400 in advanced solid tumors both as a monotherapy and in combination with bevacizumab that offers the possibility that MET expression might be able to signify who may or may not respond to the study treatment.

Transcript:

[For] bevacizumab, VEGF inhibition with bevacizumab continuing in colorectal cancer, has been shown previously to be effective, and therefore it is a very logical partner. There have been additive [vaccines] with [fluorouracil] and irinotecan, and that’s the rationale for combining these drugs.

[Regarding patient subgroups] I don’t think, [so far], from this study, we have any such data, but from our third-line study, with some of the data that was already presented, it does appear like MET expression could be one of the mechanisms wherein you could differentiate between responders and non-responders.

Reference

Raghav K, Hubert A, Fakih M, et al. Phase 2 randomized study evaluating safety, efficacy, and optimal dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab in previously treated patients with metastatic colorectal cancer. J Clin Oncol. 2025;43(4):TPS308. doi:10.1200/JCO.2025.43.4_suppl.TPS308