PI3K Inhibitors in R/R Follicular Lymphoma - Episode 4
Pier Luigi Zinzani, MD, PhD:The concept is that inside the population of follicular lymphoma, we can have low-risk patients and high-risk patients. The most important concept is to apply the PODthe progression of disease—within the first 2 years. These represent the high-risk patients. Besides the CHRONOS-1 study with 170 patients that represented the total population, there were 93 patients with a POD of less than 24 months [POD24]. So, we consider these patients high-risk patients, and when you compare the result in terms of clinical response between these high-risk patients versus patients with a POD of more than 24 months—so, low-risk patients—there is no difference in terms of complete response [CR] rate and in terms of overall response rate. So the concept is that with copanlisib, you can obtain the same clinical response also in high-risk patients. And also, if I check and compare the data in terms of median progression-free survival and median duration of response, there is no statistical significant difference.
The quality of the response in terms of a CR rate and overall response rate and the duration of the response in terms of median progression-free survival, median duration of response, is the same when I compare patients considered at high riskaccording to the POD24, less than 24 months—versus low-risk patients, which I consider patients with a POD of more than 24. This is another important cause of concern regarding the real role of in terms of clinical efficacy of copanlisib as a single agent in the treatment of this setting of patients.
This is a very important message because, as I said before, the specific toxicities of copanlisib are hyperglycemia and hypertension. Hyperglycemia could be a problem if you have to treat the patient with diabetes. But, at the end of the day, with this data, we demonstrated that there is no real problem, and you can follow…the patient very strictly in particular for the first 4, 6 weeks. But you can continue the treatment and, at the end of the day, when I compare the clinical response data between patients with diabetes or hypertension at the beginning of the treatment versus the remaining patients, there are no statistical significant differences, mostly in terms of percentage of discontinuation.
Transcript edited for clarity.