Longer survival. Slower tumor progression.
ERBITUX plus FOLFIRI (chemotherapy) in a clinical study helped some people with KRAS wild-type, EGFR-expressing
metastatic colorectal cancer (mCRC).
ERBITUX plus a type of chemotherapy called FOLFIRI was studied in a clinical trial of 1217 people with EGFR-expressing colorectal cancer that had spread (metastasized) to other parts of the body. About half of these people (608) were treated with the European Union-approved version of cetuximab (European cetuximab*) plus FOLFIRI, and the other half (609) were treated with FOLFIRI alone.
The main goal of this clinical study was to measure the length of time people lived without their cancer growing or spreading (progression-free survival).
People treated with ERBITUX plus FOLFIRI lived without their cancer growing or spreading for 8.9 months compared to 8.1 months with FOLFIRI alone. Additional goals of the study were to find out how many people had their tumors shrink or disappear (objective response rate), and also to measure how long people survived overall. At the final analysis, 46% of people treated with ERBITUX plus FOLFIRI had their tumors shrink compared to 38% of patients treated with FOLFIRI alone. Overall survival in people treated with ERBITUX plus FOLFIRI was 19.6 months compared to 18.5 months, which was not significantly different.
The original study included patients regardless of whether the patient tested positive for changes (mutations) in a gene called KRAS, or if the results of these tests were unknown. While this study was going on, it became known that ERBITUX may not work for people with KRAS mutations. Because of this new information, the original study results were reexamined to see how well European cetuximab plus FOLFIRI worked in people who did not have KRAS mutations in their tumors. When there is no mutation, it is called KRAS wild-type. In this subgroup of people, 320 were originally treated with ERBITUX plus FOLFIRI and 356 originally received FOLFIRI alone. Based on the results of this subgroup analysis, the FDA approved ERBITUX only in people who do not have KRAS mutations (KRAS wild-type), where the results of this test must be known.
More recently, it has been found that changes in other RAS genes may affect how ERBITUX works. ERBITUX should not be used in people who have RAS-mutant colorectal cancer or when the results of the RAS mutation tests are unknown.
An opportunity for longer survival
Half of the patients with KRAS wild-type, EGFR-expressing tumors who received ERBITUX plus FOLFIRI were still alive at 23.5 months compared to 19.5 months on FOLFIRI alone, which is an improvement of 4 months.
Median overall survival
A chance to slow the progression of your tumor
In the subgroup of people with KRAS wild-type, EGFR-expressing tumors, the length of time half of the people lived without their cancer growing or spreading was longer with ERBITUX plus FOLFIRI (9.5 months) than with FOLFIRI alone (8.1 months).
Median progression-free survival
Shown to shrink tumors in some people
In this subgroup, ERBITUX plus FOLFIRI was also shown to shrink tumors (objective response rate) in some people. 57% of 320 people saw a reduction in combined tumor size (reduction of 50% or more) compared to 39% of 356 people treated with FOLFIRI alone.†
Objective response rate
The safety and effectiveness for ERBITUX are different for everyone. Individual results may vary. Your doctor is the best person to talk to about ERBITUX, what it may offer, and whether it’s the right option for you.
*The version of cetuximab approved in the United States (US ERBITUX) provides approximately 22% more drug in your bloodstream compared to European cetuximab. This study and other studies together demonstrate the effectiveness of US ERBITUX at the recommended dose in combination with FOLFIRI for treatment of KRAS wild-type, EGFR-expressing mCRC.
†Shrinkage of combined tumor size was ≥50%.
What is ERBITUX?
Epidermal growth factor receptor (EGFR) is a receptor found on both normal and tumor cells that is important for cell growth. ERBITUX is a type of drug, called an EGFR inhibitor, used to treat cancer by blocking the activity of EGFR. Blocking EGFR may keep cancer cells from growing.
- EGFR is present on some cancer cells, like colorectal cancer or head and neck cancer
- EGFR is also present on normal cells like skin, nail, or hair follicles
- Laboratory studies have shown that ERBITUX does not have an effect against tumor samples that do not have EGFR
How was ERBITUX shown to work?
In laboratory studies, ERBITUX was shown to:
- Block the signal: ERBITUX can block one of the signals that tells a tumor cell to grow by attaching to a structure on the cell called the EGFR. This structure is found on both normal cells and tumor cells
- Trigger an immune response: ERBITUX can form a bridge between a tumor cell and an immune cell when it is attached to the EGFR on the tumor cell. As a result, the immune cell can begin a response against the tumor cell
Want to know more about your treatment options and ERBITUX?
Your doctor and healthcare team can help answer your questions. Download a discussion guide with a list of questions to share at your next office visit.Questions to ask your doctor