FDA UPDATE as of November 3, 2015 - Merck has just announced that the FDA has given pembrolizumab (Keytruda) breakthrough status, which will speed up the development and review for FDA approval. The update was a result of the findings in the ongoing phase II study, which demonstrated high response rates with pembrolizumab in patients with heavily pretreated colorectal cancer with a specific type of tumor. In addition to the phase II study, Merck is planning to launch a phase III trial. We will continue to keep you updated as more details emerge.
Dr. Laura detailed the results of the phase II study that was presented at ASCO this summer back in June.
June 25, 2015 - Last month, we traveled to Chicago to attend the American Society of Clinical Oncology’s (ASCO) Annual Meeting. This is where the top up-and-coming cancer research from the year is presented to more than 25,000 experts, advocates, doctors, researchers and scientists from around the world. Our very own Dr. Laura Porter attended and has been keeping a close eye as studies and information have continued to be released. When it was announced that one of the most exciting experimental drugs would be accepting applicants for a new study, she immediately flagged this as something we needed to get out ASAP.
Here's what you need to know:
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Dr. Laura Porter, MD, stage IV colon cancer survivor and Colon Cancer Alliance Patient Advocate & Medical Advisor.[/caption]
One of the most exciting presentations from ASCO was the results of a clinical trial for a new colorectal cancer drug called pembrolizumab (Keytruda). This drug was hailed as a breakthrough for a subset of patients with metastatic colorectal cancer (mCRC). Pembrolizumab is a monoclonal antibody, which means it works to restore the body’s immune response to tumor cells, enabling a patient’s own body to kill the cancer.
These results are great news if you are in the small percentage of those with MSI-H.
The clinical trial hopes to enroll forty more patients and will start recruiting in August. While study sites have not been announced yet, we wanted to let you know about the trial now. The drug will be given as a single agent. Some of the basic requirements for enrollment are:
- Blood sample and available tumor tissue for confirmation of MSI-H CRC by the Sponsor
- Previously treated with at least two lines of approved standard therapies, which must include fluoropyrimidine (5FU or capecitabine), oxaliplatin, irinotecan, bevacizumab and cetuximab or panitumumab
- Histologically proven, locally advanced unresectable or metastatic CRC
- Life expectancy of greater than three months
- At least one measurable lesion
We will continue to update you as these research sites are announced. You can also visit the website.
Want more information on the latest treatment and research updates? The Colon Cancer Alliance serves as a source of information about colon health. If you have additional questions about colon cancer treatment or are in need of support, please contact our free Helpline at (877) 422-2030. We’re here to help.