New Colorectal Cancer Drug Trial: Could Your Patient Benefit?

New colorectal cancer drug trial have been enrolling participants in recent months. Perhaps one of your patients might benefit from participating.

HER2+ colorectal cancer that has spread and/or is incurable. Patients in this situation who have not had anti-HER2 treatment or any systemic medication in the metastatic context may be interested in a randomised, open-label, phase 3 clinical study to see whether a tucatinib (Tukysa)-based combination outperforms standard of care. One set of participants will take tucatinib tablets twice daily for up to three years, or until illness progression or death, whichever comes first. They will also get trastuzumab (Herceptin) intravenous (IV) infusions every three weeks, in addition to conventional chemotherapy every two weeks. In the standard-of-care group, patients will receive IV chemotherapy every two weeks, either alone or in combination with IV bevacizumab (Avastin) every two weeks or IV cetuximab (Erbitux) weekly. In October 2022, study centres in 15 US states and six overseas began enrolling 400 volunteers. The main outcome is progression-free survival (PFS); the secondary endpoints are overall survival (OS) over 6 years and quality of life (QoL). More information is available at

“Combining two drugs that target EGFR and delivering them with chemotherapy in second-line phase 2 studies has shown promise for the subset of colorectal cancers that overexpress EGFR,” said Richard Goldberg, MD, professor emeritus at West Virginia University Cancer Institute, when asked to comment on this study…. This critical first-line phase 3 study in this patient population is a natural next step in evaluating the technique in patients who have previously been untreated for metastatic illness and has the potential to modify the standard of treatment if positive.”

Cachexia due to colorectal cancer. People in this clinical setting who are not receiving tubal or parenteral nourishment are eligible to participate in a randomised, double-blind, phase 2 clinical study for cachexia using the experimental drug ponsegromab (from Pfizer). There are presently no authorised medications to treat cachexia. Although the reasons are unknown, cachexia is associated with an increase in circulating growth-differentiation factor 15 (GDF15). 

Ponsegromab is a humanised anti-GDF15 antibody inhibitor with modest preclinical efficacy. Over a 12-week period, participants will get three subcutaneous injections of either placebo or ponsegromab, four weeks apart. All participants will thereafter be able to get ponsegromab injections in an open-label environment for up to a year. In November 2022, sites in California, Texas, Washington, and Japan began recruiting. The researchers want to enrol 168 people with solid malignancies from three distinct types. Four additional US states and Taiwan are in the works for research facilities. The main outcome is body weight change, while QoL is a secondary target. OS will not be monitored. More information is available at

“Cachexia remains a vexing problem in patients with many types of malignancies,” Goldberg said, “although in colorectal cancer it is commonly associated with peritoneal disease and other mechanical cancer-related issues, which may complicate interpretations of the findings in this study.”

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