Amivantamab + FOLFIRI for Colorectal Cancer

(OrigAMI-3 Trial)

This trial aims to determine if a new treatment, amivantamab (a monoclonal antibody), combined with chemotherapy, can help individuals with certain types of colorectal cancer live longer without disease progression. It compares this combination to a standard treatment using either cetuximab (another monoclonal antibody) or bevacizumab with chemotherapy. The study targets those with a specific type of colorectal cancer that has returned, cannot be removed, or has spread, and who have already undergone at least one round of chemotherapy. Participants must have a type of cancer confirmed by special testing and have experienced cancer progression after initial treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants access to potentially groundbreaking treatment.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Previous studies have shown promise in treating colorectal cancer by combining amivantamab with chemotherapy like FOLFIRI. However, safety remains a crucial consideration. Research indicates that amivantamab with FOLFIRI has a response rate of about 48%, meaning nearly half of the patients responded well to the treatment. Like any treatment, side effects can occur.

Common side effects of amivantamab include skin reactions, which can affect up to 90% of patients, and reactions during or after administration, affecting about 60% of patients. These reactions are usually mild to moderate.

The trial also involves using cetuximab or bevacizumab with FOLFIRI. Both cetuximab and bevacizumab are already used to treat colorectal cancer. Cetuximab can cause skin rashes and low magnesium levels, while bevacizumab might lead to high blood pressure and bleeding risks.

Researchers are excited about these treatments because both options offer novel approaches to tackling colorectal cancer. Unlike traditional treatments that primarily focus on chemotherapy, Amivantamab works by targeting specific receptors involved in tumor growth and survival, potentially offering a more precise attack on cancer cells. Meanwhile, combining Cetuximab or Bevacizumab with FOLFIRI builds on standard regimens by incorporating monoclonal antibodies, which can enhance the immune system's ability to fight cancer. This dual approach of precision targeting and immune enhancement could lead to more effective and personalized treatment strategies for patients.

Research has shown that combining amivantamab with FOLFIRI, which participants in this trial may receive in Arm A, may help treat colorectal cancer. In one study, 39% of patients experienced tumor shrinkage with this combination. Another study found that 48% of patients had a strong initial response. The treatment also continued to work for a promising duration in those who responded. These findings suggest that amivantamab with FOLFIRI can be effective for people with advanced colorectal cancer.¹²³⁵⁶