Dr Raghav on the Safety Profile of ABBV-400 Plus Chemo and Bevacizumab in Previously Treated mCRC

“Safety signals [with ABBV-400 plus fluorouracil, folinic acid, and bevacizumab] are very similar to that of any chemotherapy agent. [We specifically saw] bone marrow suppression with anemia, neutropenia, and thrombocytopenia.”

Kanwal P.S. Raghav, MBBS, MD, associate professor, Department of Gastrointestinal Medical Oncology; associate vice president, Department of Ambulatory Medical Operations, Division of Cancer Medicine; and executive medical director, Department of Ambulatory Treatment Centers, The University of Texas MD Anderson Cancer Center, details the safety profile of ABBV-400 in combination with fluorouracil (5-FU), folinic acid, and bevacizumab (Avastin) in previously treated patients with metastatic colorectal cancer (mCRC) who experienced disease progression after first-line treatment.

A phase 2 study (NCT06107413) is evaluating the safety and efficacy of the combination of ABBV-400, fluorouracil, folinic acid, and bevacizumab in this patient population. Based on earlier findings, the regimen has shown a similar safety profile to chemotherapy agents alone, Raghav begins. He notes that bone marrow suppression was a common adverse effect (AEs), leading to anemia, neutropenia, and thrombocytopenia.

Additionally, there has been some evidence of interstitial lung disease occurring in the patient population, which is a common AE for this class of agents, Raghav says. However, he explains that so far, there have not been major safety signals with the combination.

In the study, 2 stages were included: safety lead-in followed by dose optimization with randomized comparison at different dose levels for ABBV-400. All patients are treated with the combination in 28-day cycles and continue until disease progression, unacceptable toxicity, or treatment discontinuation following other protocol criteria. Of note, the dose escalation includes a target toxicity of 30% and prespecified optimal interval of 23.6% to 33.3%, as guided by the Bayesian optimal interval (BOIN) design. In the stage 2 portion of the study, up to 2 dose cohorts in each of the 2 schedules of ABBV-400 will be evaluated in a randomized fashion, according to the tolerated doses per the BOIN rules.