RE: Early Efficacy.4 Jul 2025 17:06
Let’s break this down clearly, because your post relies on selective quoting, flawed logic, and theatrical appeals rather than substance.
You cite a pooled analysis of 57 patients across 10 trials and 3 case reports, claiming a 49.5% complete response (CR) rate in r/r AML CAR-T trials. But what you fail to mention is that this is an extremely small, heterogeneous, and outdated dataset. Most of these trials involved early, non-curative CAR-T constructs used primarily as bridging therapies, often combined with other interventions like HSCT. Responses were typically short-lived, toxicities were high, and the failure rate—both biologic and logistical—was substantial. If this dataset were truly indicative of clinical success, we would already have an approved AML CAR-T. We don’t. That alone should tell you something.
Ironically, your point about efficacy being meaningless without durability is precisely why Hemogenyx is drawing attention. Their HEMO-CAR-T appears to have done something no other program has achieved: induce a complete response (very possibly a molecular remission) without HSCT, without further treatment, and with no severe toxicity, now sustained for over 4.5 months in the first patient. That kind of response in r/r AML is rare — and the fact that the FDA approved paediatric expansion after just two adult patients is unprecedented. That’s not hype. That’s regulatory validation.
Your emotional appeals about “pumping false hope” and “mental anguish among retail investors” are not only misplaced but manipulative. Nobody is declaring a cure. What’s being said — and what the FDA’s own decisions suggest — is that this therapy may be the first in class to demonstrate the kind of safety and durability that others have failed to achieve. That’s not “pump”; that’s momentum — and it is grounded in fact.
Finally, your demand that any contradiction must come with a bigger meta-analysis is simply posturing. The right question isn’t how many trials reported a short-term CR — the right question is why none of them translated into an approved, durable, transplant-free therapy. And if Hemogenyx is now showing signs of achieving that — and doing so safely — then it deserves attention, not dismissal.
You’re not defending science — you’re defending precedent. But Hemogenyx may be rewriting it.
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