SABRE's results are exceptional: The Story Just Got Stronger!
This is the third Cu6 product to reach P3 readiness! And, it did so in style, with a 100% Positive Predictive Value!
Its three products in a row that have each produced class leading results from their clinical trials!
For those who need a bit of a primer, see Post #78844780: https://hotcopper.com.au/posts/78844780 from a while back. From that post, I would edit out the statement I made, which says: "SABRE results will sound less impressive than what we are used to." I was wrong: today's results exceeded my expectations!
An important QUOTE FROM TODAY: “Clarity has commenced discussions with key medical experts to determine the most effective pathway for registration of 64Cu-SAR-Bombesin and to explore its development in a range of large oncology indications with high unmet needs.”That’s not just seeking advice - it's mapping a path to FDA registration and broad cancer application.
CONTEXT: PSMA diagnostics (like Illuccix & Pylarify) already have defined roles: staging and treatment selection for Pluvicto. Clarity’s Cu64-SAR-bisPSMA and Cu67-SAR-bisPSMA are navigating a well-trodden road. Just as Cu64-SARTATE is doing in NETS (follows NETSPOT and DetectNET)! GRPR-positive prostate cancer is uncharted, and there is no matching therapy like what Pluvicto is to PSMA tracers for PET/CT. This is a real unmet need - Cu64-SAR-Bombesin is lighting up disease where PSMA fails. But, where and how will it fit? Thats the question!
The BENEFITS are clear: a) 64Cu-SAR-Bombesin will help a group of men where PSMA tests missed node involvement , avoid futile prostatectomy! b) By detecting lesions early, 64Cu-SAR-Bombesin will enable early treatment with External Beam Radiation Therapy!
This is Fast Track and Breakthrough Therapy territory: The criteria are fullfilled; 1) Cancer is a serious condition, and, 2) The data presented do show a great potential to address a need that is clearly unmet, and, 3) The product, 64Cu-SAR-Bombesin, provides substantial improvement on clinically significant endpoints!
Next up: Clarity’s advisors will shape the next trial. Which indication? Prostate? Breast? Which patients? PSMA-negative? HER2-negative? Clarity needs to pick the highest-value niche.
This is when we get reminded of the COMBAT trial (Cu67-Bombesin), which is on ice for now! What a shame! We have a brilliant diagnostic without a matching therapeutic!
But even on its own, 64Cu-SAR-Bombesin will reshape prostate cancer management: Consider this: Patients with PSMA-negative scans get told it’s local disease. Off to surgery they go - what a shame! The prostate gets removed, but the cancer remains!
Now, Cu64-SAR-Bombesin could slot in before surgery, where; a) It can adds a layer of certainty. b) It can catches missed nodes. c) It can help patients avoid pointless ops.
Will it be adopted? That’s the call. It’s an additional scan, but the trade-off is huge!
Learning from others: They call it DUAL TARGETING - From the study: https://jnm.snmjournals.org/content/early/2025/03/19/jnumed.124.269189
68Ga-RM26 (a GRPR targetting product): Sensitivity 43%, Specificity 94%
68Ga-PSMA-617: Sensitivity 52%, Specificity 89%
COMBINED: Sensitivity 76%, Specificity 85%
RM26 picked up 5/10 PSMA-negative nodal metastases - confirmed by pathology.
Could this be the play? We start with Cu64-SAR-bisPSMA. If negative, scan with Cu64-SAR-Bombesin. With Cu64-SAR-bisPSMA already an exceptional performer, this so called dual targeting would push sensitivity even closer to 100%, making biopsy obsolete!
In Closing: I am happy that we are not going straingth to another P3 trial - funding reasons apply! But its important to remain cognisant that, with so many products that are so far advanced, Clarity is in a stronger position today than it was 12 months ago!!
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