Chris who supervises the clinical trial told us today that there are currently 6 patients on this regiment at Providence Portland. One man who has been on it for over a year, has almost total shrinkage of tumors. The other four have unfortunately not had a positive response. How sad and disappointing! Mark is doing amazingly well!! Not only are tumors shrinking, but the side effects have been minimal. He just started having some skin rashes which are fairly common and can be treated with good creams. Fatigue is the most common side effect and he seems to keep increasing in his energy level as the tumors shrink.
Mark found a report of the clinical trial of Ketruda (pembrolizumab) completed just a year ago. The results are definitely the best yet for metastatic melanoma, but reading through it doesn't sound all that promising. Today we felt the reality of how blessed we are when we realized that only two of six in this new clinical have had positive progression, and he is one of them!
KEYNOTE, a phase Ib trial, enrolled 655 patients treated. Patients were treated with pembrolizumab until disease progression, intolerable toxicity, or investigator decision.
At a median follow-up of 32 months, 358 patients (55%) had died. At 36 months, the overall survival rate was 40%.
A total of 95 patients (15%) achieved a complete response. Among them, 61 (64%) stopped treatment after complete response. Only 2 of the 61 patients who stopped treatment after complete response experienced disease progression. One of the two has been restarted on therapy, but it is too early to evaluate response, Dr. Robert said.
The most common treatment-related adverse events were fatigue (40%), pruritus (28%), and rash (23%). Only 8% of patients stopped pembrolizumab because of side effects.