What is interesting about the TheraP trial is it aims to directly challenge use of Cabazitaxel as SOC as a third line agent for metastatic prostate cancer, with patients already in a bad state (see below). These patients are potentially in a slightly better condition than those in the LuPIN trial (see below), but it is difficult to say to what extent from the following data. Should LuPSMA outperform Cabazitaxel, then Novartis will take these results to the FDA to apply for approval as the new SOC as a third line agent. Just to quickly clarify, I wasn’t using the TheraP trial as an update on the results shown in the 50 patient LuPSMA study. Instead I was comparing them to a different study that GK has previously referenced (I’ve included the screenshot below).
Novartis are also likely to include the results from the study you cited and results from the VISION study to support FDA approval. Both studies investigated LuPSMA as a fourth line agent, similarly to the use of Veyonda and LuPSMA as a combination therapy in the LuPIN trial. A 13.7-month median overall survival is currently the benchmark for LuPSMA therapy when used alone but results from the VISION study (due to be released soon) is the one to keep an eye out for.
Now lets say that Novartis is successful at making LuPSMA the new SOC as a third line agent. The implications are the Veyonda and LuPSMA combination will need to achieve a statistical/clinical meaningful benefit when tested against LuPSMA alone. The extent to which this is achievable will be dependent on how sizeable the survival benefit is for LuPSMA in the TheraP trial. Use of Veyonda as a fourth line agent with no longer be applicable and there will be a need for a new randomised clinical trial.
Now lets say that the TheraP trial does not show a survival benefit and the VISION study confirms a survival benefit of around 13-14 months. This is the best-case scenario for Veyonda and fits in with the current narrative stated by Noxopharm. In this case, Novartis applies to the FDA to be used as a fourth-line agent who will then look to add Veyonda (or any series of other combinations it is currently testing).
Overall, I agree with most on this thread that the data from the LuPIN trial is impressive. The only questions I have is: 1) how much of this survival benefit is due to Veyonda and not LuPSMA, and 2) will LuPSMA show a 20+ month survival benefit in the TheraP trial. If so, what is the likelihood that any additive benefits of Veyonda will generate a statistical/clinical meaningful benefit in the same patient cohort.
Not advice, DYOR, GLTAHPatient characteristics for TheraP trial:
Patient characteristics for LuPIN trial:
Current strategy for LuPSMA and Veyonda:
