LuPIN is the first trial that has used repeat doses of NOX66. I think the LuPIN results will show what we can expect in the DARRT registration trial.
LuPIN patients receive NOX66 every three weeks, with one dose of the radionuclide LuPSMA added each cycle after the first day of NOX66, for a maximum of 6 cycles or 36 weeks. Interim data showed that the addition of NOX66 provided a major benefit over LuPSMA alone and on Friday we will find out whether this translated into longer survival for the first 36 patients.
Patients in DARRT-1 received a single session of NOX66, with 5 days of low-dose external radiation commencing after the first day of NOX66. Treatment was not repeated because, at the time the protocol was approved, there was insufficient evidence to show that the combination of NOX66 and EBRT would be safe and without side effects. The DARRT registration trial will use repeat doses of NOX66.
At the last AGM, we were told that this will be a randomised, blinded trial in which patients in both the treatment and control arms will receive a single session of low-dose EBRT and will self-administer suppository capsules each month, for six months. Treating physicians will not know who is receiving NOX66 capsules, but you can be sure that they will do everything in their power to keep their patients alive. It is conceivable, in my opinion, that a patient might receive a second session of EBRT should disease progression appear likely.
Physicians will not know whether their patient is in the treatment arm or the placebo arm, but they have the same duty of care in either case. We would expect the placebo arm to have a relatively poor response, even with a second session of EBRT, but the treatment arm is in a much better position to benefit from repeated EBRT. Those patients will have received multiple doses of NOX66.
Interim LuPIN data showed that repeat doses of NOX66 provide a tangible benefit for patients. If Overall Survival data is good, I think we can look forward to the DARRT registration trial with great confidence.
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