By the way, I did not give my opinion on the use of either PSA or OS. We can discuss it – it’s a lot deeper. What I am doing here is simply reading the paper that Telix supported researchers wrote, where they say the following;
- The secondary objective was to assess the effect ofLu-TLX591 on the rate of disease progression on the basis of serial PSA levelsand follow-up PSMA-PET imaging. Rates of PSA decline, PSA progression and PSAstability within 8 weeks of treatment cessation were attained and the durationof such responses was monitored.
It’s the Telix supported scientists who stated what they believed treatment could achieve, and then measured how close to the target they got. If we ignore the PSA decrease as an outcome, how about the 39% who had a PSA rise?Is this not what is referred to as treatment failure or cancer recurrence (check diagnostic criteria for BCR and its subsets).
If I were to naively accept your point and dispute the PSA: What about the imaging? 41% had disease progression! About the same number as the ones that had a PSA rise (41% and 39%).
As for the study you refer to that had 43months OS: Telix say that this was as single arm study of 17 patients! They did not only have TLX591: they had it as an additional treatment.
Digging a bit deeper (Tagawa et a - link to full paper at the bottoml) - there were more patients overall, but this was a subgroup that received the highest dose o the drug 177Lu-J591. Is a study published in 2019, presumably before Telix put their name to the molecule! Per that study; Of the 23 patients with measurable disease at baseline, 14 (60.8%) had stable disease and 6 (26.1%) had progressive disease according to RECIST criteria.
And guess what: the analysis is quite complex: its not as direct as we may think! ADDITIONAL DRUGS WERE APPROVED and used by the patients! Why use additional drugs if you are cured by the first?
And by the way, being alive with disease is not proof that the drug works. That is why measures such as PSA and imaging are used to judge the treatment itself. Prostate cancer does not always kill the people that are affected.
I will let you guys be!
REFERENCES
Phase1/2 study of fractionated dose lutetium‐177–labeled anti–prostate‐specific membrane antigen monoclonal antibody J591 (177Lu‐J591) for metastatic castration‐resistant prostate cancer - Tagawa - 2019 - Cancer -Wiley Online Library
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