Longer survival. Slower tumor progression.
ERBITUX with FOLFIRI (chemotherapy) in a clinical study helped some people with KRAS wild-type, EGFR-expressing
metastatic colorectal cancer (mCRC).
ERBITUX with a type of chemotherapy called FOLFIRI (irinotecan, fluorouracil, leucovorin) 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) received a cetuximab product (ERBITUX*) with 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 who received ERBITUX with 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 (overall response rate), and also to measure how long people survived overall. At the final analysis, 46% of people who received ERBITUX with FOLFIRI had their tumors shrink compared to 38% of patients treated with FOLFIRI alone. Overall survival in people who received ERBITUX with 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 ERBITUX with 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 originally received ERBITUX with FOLFIRI and 356 were originally treated with 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
People who received ERBITUX with FOLFIRI who had KRAS wild-type, EGFR-expressing tumors were shown to live 4 months longer compared to people treated with FOLFIRI alone (23.5 months compared to 19.5 months, respectively).
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 some people lived without their cancer growing or spreading was longer for those receiving ERBITUX with FOLFIRI (9.5 months) than FOLFIRI alone (8.1 months).
Median progression-free survival
Shown to shrink tumors in some people
In this subgroup, ERBITUX with FOLFIRI was also shown to shrink tumors 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.†
overall 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 US-approved version of cetuximab (US ERBITUX) yields approximately 22% higher blood levels of cetuximab relative to the cetuximab product used in the study. In this study, the side effects and severity of adverse reactions seen with the cetuximab product used were consistent with other studies of US patients receiving ERBITUX for 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