3/14/18 UPDATE: This week, the FDA announced that Opdivo (nivolumab), a PD-1 inhibitor, is able to offer every four week dosing. When Opdivo was approved in 2017 for patients with MSI-H/dMMR biomarkers, the infusion was offered every two weeks in 240mg dosing. Now, patients with a majority of approved indications are able to receive the targeted therapy once every four weeks at 480mg. Optivo was also recently approved for 30-minute less infusion time across all indications.
It is important to talk to your doctor because clinicians may have flexibility to customize treatment options.
You can read Bristol-Myers Squibb’s press release here, as well as the specific indications that are included in the updated dosing.
On August 1, 2017, the FDA approved the use of Opdivo (nivolumab) in microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). This is very exciting for the colorectal cancer community, who has seen a push in research efforts and immunotherapy treatment options.
Nivolumab has been approved for mCRC patients who’s cancer either progressed after being treated with a fluoropyrimidine, oxaliplatin, and irinotecan, or did not respond to those treatments. Nivolumab received accelerated approval due to overall response and duration of response in the CheckMate 142 Trial.
IS IT A NEW DRUG?
Nivolumab was first approved by the FDA in December 2014 to treat advanced melanoma. Since then, it has been approved to treat lung cancer, metastatic renal cell carcinoma, Hodgkin lymphoma, head and neck cancer and metastatic urothelial carcinoma. You may have even seen commercials for it on television for advanced non-small cell lung cancer.
Nivolumab, an immunotherapy treatment, is a treatment for intravenous use, meaning that it is delivered into the vein through an IV. Immunotherapy (also known as immuno-oncology or IO) is a type of treatment that uses certain parts of a person’s own immune system to fight diseases such as cancer.
WHAT WAS THE STUDY THAT LED TO THE APPROVAL?
Nivolumab was approved based on CheckMate 142, which is a Phase II trial hosted at 31 sites across 8 countries. The study is single-arm, meaning everyone enrolled receives the experimental treatment, versus having a group of enrolled patients who receive the standard of care. This type of study is more common in Phase I and II clinical trials.
Patients were eligible for the study if they had cancer progress while on or after, or had been intolerant of at least one previous line of treatment. The previous treatment had to have included a fluoropyrimidine and oxaliplatin or irinotecan. Out of the 74 patients in the study, 72% had been on one or more of the treatments listed previously. In addition, 16% had a BRAF and 35% had a KRAS mutation. (Learn more about BRAF and KRAS mutations.) The patients all received nivolumab at 3 mg/kg intravenously every two weeks until disease progressed, they experienced severe toxicity, or withdrew from the study.
Of those patients who participated in the study and had received previous treatment with a fluoropyrimidine and oxaliplatin or irinotecan, 26% experienced a partial response to the treatment, and almost 2% received complete response.
The data from CheckMate 142 were published in The Lancet Oncology in July, 2017.
There are side effects with nivolumab. The most common include fatigue, rash, musculoskeletal pain, diarrhea, nausea, cough, difficulty breathing, constipation, decreased appetite, back pain, upper respiratory tract infection and fever. In addition, nivolumab is associated with severe embryo-fetal toxicity, therefore pregnant women should avoid the use of this drug.
There are other side effects that could result. Since immunotherapies are fairly new, their long-term side effects have not been fully assessed, though they are currently being tracked and recorded.To learn about how to cope with side effects, download our Side Effects mini mag.
WHAT THIS MEANS FOR PATIENTS
The FDA approval of a new immunotherapy drug for colorectal cancer patients is exciting! This means that there are more treatment options available, and that precision medicine, research, and new studies are forging ahead to find treatments that work for patients.
It is important to note that the CheckMate 142 study and the use of nivolumab currently applies only to MSI-H patients. Therefore, it is imperative for all colorectal cancer patients to know their MSI status. Talk to your doctor to learn if your tumor is MSI-H or MSS.
The National Comprehensive Cancer Network (NCCN) Guidelines in Oncology recommend universal MMR or MSI testing for all patients with a personal history of colorectal cancer to inform their providers if immunotherapy is appropriate to treat metastatic disease. Learn more about MSI-H and MSS status.
If you have an MSS tumor, there are a number of immunotherapy studies going on now to help advance this type of treatment for MSS patients. Talk to your doctor about clinical trials, and visit the Fight CRC Late Stage MSS CRC Trial Finder.
Talk to your doctor about this news and ask if this might be a good treatment for you.
For patient assistance with nivolumab, visit: https://www.patientsupport.bmscustomerconnect.com/opdivo-with-you-registration
NCCN Colon Cancer Guide for Patients: https://www.nccn.org/patients/guidelines/colon/files/assets/common/downloads/files/colon.pdf
Fight CRC Research Efforts: https://fightcolorectalcancer.org/research/
Information about biomarkers: https://fightcolorectalcancer.org/biomarked/
Fight Colorectal Cancer has received funding from Bristol Myers Squibb (producers of Opdivo). Funding has come in the form of unrestricted educational grants. We maintain ultimate authority over website content and the content written in this article. Fight Colorectal Cancer never recommends or endorses any specific physicians, products or treatments for any condition.