CHRONOS-1: Long-Term Safety and Efficacy Updates

Pier Luigi Zinzani, MD, PhD:This is a very important update at 2 years, concerning the real role in terms of long-term activity of copanlisib as a single agent in relapsed/refractory patients in the third line. So, as I said before, the CHRONOS-1 is a registration study. There was an update, and right now there are 11 patients on treatment after more than 2 years in the CHRONOS-1 [trial]. In the CHRONOS-1 trial, we included 117 patients, and they said that right now there are, after more than 2 years, 11 patients on treatment. But the most important thing is that 7 patients had a conversion rate from PR [partial response] to CR [complete response]. So the concept is, if you continue to use copanlisib, you can have also a late response obtaining a real important conversion from PR, partial response, to complete response. It’s a very important concept.

And at 2-year follow-up of patients treated inside the CHRONOS-1 trial, the median duration of the response is quite good in terms of 14.5 months, and the median progression-free survival is more than 1 year, 12.5 months—very solid data. And, at the same time, I come back to the concept of conversion rate from PR to CR. Right now, according to this 2-year of update of CHRONOS-1, the CR rate is 17% instead of the 14% with CHRONOS-1, and the overall response rate is 61%—very important data when you come back to this study population of patients heavily pretreated with conventional chemoimmunotherapy.

Transcript edited for clarity.