ASCO PRESENTATIONS: 2024 versus 2025: Spot the difference!
I hereby share an update to the views that I shared previously: https://hotcopper.com.au/threads/ann-clarity-receives-u-s-fda-fast-track-designation.8415159/page-71?post_id=77671823. In short (on that post), I was expectantly excited about the upcoming presentations, particularly with the CLARIFY trial, as I saw this as an opportunity for a reveal, of sorts!
From the little we know, here are the titles of the presentations as well as the sessions under which the abstracts were submitted, for the presentations in 2024 and 2025!
COBRA TRIAL (Phase 1/2)
2024: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy. [Session: Genitourinary Cancer - Prostate, Testicular, and Penile]
2025: Assessment of the efficacy of 64Cu-SAR-bisPSMA using histopathology as reference standard in patients with biochemical recurrence of prostate cancer following definitive therapy [Session: Trials in Progress Poster Session A: Prostate Cancer]
CLARIFY TRIAL (Phase 3)
2024: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy (a phase 3 diagnostic study) [Session: Genitourinary Cancer—Prostate, Testicular, and Penile]
2025: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy (a phase 3 diagnostic study)
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CLARIFY TRIAL: This is my main focus! It's meant to lead to the birth of a cash-cow that can fund the development of the much more lucrative therapies, in the unlikely event that no-one loves us! Telix will gross a billion dollars this year from Illuccix alone, so this is not small play!
As a reminder, (ignoring the diagnostics that go hand in had with the therapies to make a perfect paring, the therapy products that will need money include;- 67Cu-Sar-bisPSMA: targeting Prostate Cancer (the SECURE Trial)
- 67Cu-SARTATE: targeting Neuroblastoma, Meningioma, NETS.
- 67Cu-BOMBESIN: Pan cancer target (Prostate, Breast, Ovarian, Lung, Brain, and GI cancers).
- Ac-bisPSMA: for Late stage Prostate cancer
- 67Cu-SAR-bisFAP: Pan cancer target. A new kid on the block whose diagnostic version 64Cu-SAR-bisFAP has already shown superior effects when compared to industry standard 68Ga-FAPI-46!
Back to the CLARITY poster: As is demonstrated above, the authors who are presenting this poster, presented on the same study (same title) at the same meeting last year in 2024. In that meeting, they presented just the study protocol. In my speculative mind, I concluded that this time, they would give us more: perhaps some insights or even some early results! That would have been nice, especially at this time, when positives are proving hard to find!
Although CLARIFY dosed its first patient in December 2023, and on the trials website, still shows an estimated completion month of February 2025 (this month), a number of people have suggested that recruitment is quite behind! Clarity provided no update in its latest 4C!
Anyhow, I have since found ASCO Abstract submission guidelines for this year's chosen session! Here is a mood dampener!
Trials submitted to this (Trials in Progress) session are ongoing and have not reached prespecified endpoints for analysis. As such, inclusion of results would be improper and is strictly forbidden. Ouch!!!
Per ASCO, Clarity can provide "Current enrollment without providing results or endpoints". The following example statements are permitted;
- Phase I studies may say, “Cohorts 1 and 2 have been completed without DLT. Enrollment to cohort 3 began in January 2016”
- Phase II studies may report, “8 of planned 32 patients have been enrolled” or “Prespecified activity goal for the first stage of accrual was met; second stage accrual began in January 2017”
- Phase III trials may report, “The DMC last reviewed the trial in December 2016 and suggested that the trial continue as planned”
Further, ASCO say that: "Enrollment must have already begun or have been completed with
no data analysis available by the submission deadline (there are no exceptions to this criterion). It is acceptable if the trial has not enrolled its first patient yet." The
Clinical trial registry number is required!
The
Abstract Submission Deadline was October 15, 2024! Further searches suggest that, if new results are available post-submission, Clarity might still discuss them at ASCO GU 2025, but they won't be included in the official abstract.
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COBRA TRIAL: 20024 had results! The difference here is that we now have mention of 'histopathology as reference standard'. But even with that, I would have expected them to present results as opposed to taking steps back to the "Trials in Progress"!
I am excited by the stage being mentioned, but I am confused! Perhaps, it will be a case of: the results became available after the deadline - here they are?
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My REVISED feel;
Next week will likely still be a big week!
a) CLARIFY - an update on numbers is the best I am now expecting! That would be good, if the numbers are good! We expect the imaging results to be the same as those from PROPELLER, so all we really need are the numbers. Who knows!
b) COBRA - I am anticipating a statement to the effect that the prespecified goals were met (already stated on the Clarity website), perhaps with references to data that is already known (as per the abstract and poster). On The Clinical Trial registry, the trial is marked as completed and results posted. The histopathology results are not there. So, maybe that qualifies it as a Trial in Progress!
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Here is the COBRA Schedule of Assessments. We are close to the end!
Good Luck to All - Long Term Holders and Traders Alike!
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REFERENCES & LINKSClarity to present at three world leading conferences (3 May 2024);
https://www.claritypharmaceuticals.com/news/conferences24Clarity to present COBRA and CLARIFY abstracts at two world-leading conferences (28 January 2025);
https://www.claritypharmaceuticals.com/news/ascogu_aua/Trials in Progress Submission Guidelines;
https://conferences.asco.org/gu/trials-progress-abstract-submission-guidelinesCOBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy. Eva Lengyelova, Daniel Saltzstein, David Josephson, Gregg E. Franklin, Glynn Morrish, Othon Gervasio, Michelle Parker, Robert M. Miller, Neal D. Shore. Journal of Clinical Oncology 2024 42:16_suppl, 5100-5100
https://ascopubs.org/doi/pdf/10.1200/JCO.2024.42.16_suppl.TPS5129CLARIFY: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy (a phase 3 diagnostic study). Eva Lengyelova, Luke Nordquist, Glynn Morrish, Othon Gervasio, Robert M. Miller, Neal D. Shore. Journal of Clinical Oncology 2024 42:16_suppl, TPS5129-TPS5129 https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5100
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (CLARIFY);
https://clinicaltrials.gov/study/NCT06056830 (Status: Recruiting)
64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA);
https://clinicaltrials.gov/study/NCT05249127 (Status: Completed & Results Posted)
https://clinicaltrials.gov/study/NCT05249127?tab=resultsCOBRA CLINICAL STUDY PROTOCOL: CLP06;
https://cdn.clinicaltrials.gov/large-docs/27/NCT05249127/Prot_000.pdf?
(20min delay)