Pamela Smith, age 67, had run out of options when her melanoma metastasized and became inoperable. According to a recent article in MedicalXpress, in January 2014, Pamela joined the Checkmate 067 (067) clinical trial.
For four months, Pamela received treatments of ipilimumab (YERVOY) and nivolumab (OBDIVO) every two weeks. Then she began to experience side effects and had to stop treatment. But even without further treatment, Pamela continues to be free of symptoms. Her condition has not changed in five years.
Pamela is feeling well and enjoys spending time with her eight grandchildren.
Immunotherapies Versus Chemotherapies
It is noteworthy that patients who had to withdraw from the 067 trial due to side effects experienced the same outcome as those who remained in the trial for a longer period of time.
One possibility may be that the immune system can be re-educated during immunotherapy, thus enabling it to attack and eliminate errant tumors. This means a shorter time frame than chemotherapy which in order to be rendered effective requires a complete course of treatment.
About Checkmate 067
Patients with advanced melanoma, a total of 945 subjects, were randomly chosen to avoid bias. The groups were divided as follows:
- 314 patients were given a ‘double dose’ of ipilimumab and nivolumab
- 316 patients were treated with nivolumab and a placebo
- 315 patients were treated with ipilimumab and a placebo
The nivolumab groups were compared to ipilimumab as a single agent. The treatments continued until disease progression or until the side-effects could no longer be tolerated.
About the Results
Overall survival at the end of five years for patients given the ipilimumab and nivolumab combination was fifty-two percent. Also at the end of the five years, seventy-four percent of this group no longer required treatment.
As single agents, the nivolumab group showed forty-four percent overall survival while the ipilimumab group registered twenty-six percent.
Reaching a Milestone
Professor James Larkin of The Royal Marsden NHS Foundation Trust led the study. He explains that combining two drugs instead of using one drug (single agent) would be the equivalent of removing two brakes from the immune system. In doing so, the immune system recognizes previously unknown tumors and destroys them.
Professor Larkin remarked that for the first time in ten years, metastatic melanoma patients who were considered untreatable after the disease had metastasized are now given a fifty percent chance of survival.
The study has been published in the New England Journal of Medicine.
What are your thoughts on this exciting study?
