In the context of cancer therapy, "next generation" refers to advanced, innovative treatment approaches that build on or surpass existing methods, leveraging cutting-edge science and technology to improve effectiveness, precision, and patient outcomes. These therapies often aim to address limitations of traditional treatments like chemotherapy, radiation, or early targeted therapies.
Yes, clearly he is presenting Direct 2.0 as the 1.0 version failed.
The original Direct was used in a P1/2 in 2013-15. This trail was designed with a P1 phase in various cancers after which they would decide what cancers to advance into the P2 phase. The advantage of this type design is that the same trial can serve for both P1 and 2 thus saving time and cash.
Well, the P1 phase completed and they had a 0 ORR. So they never ran the P2 phase. This is despite the fact that it would have been fairly cheap and they had plenty of cash in 2015. Kind of obvious the lack of tumor response (shrinkage) caused them to abandon Direct 1.0. Yet for years they dangled the carrot of Direct and longs lapped it up.
So now with the new motto that ORR matters, they are bringing 2.0 out to address the failure of 1.0 to show any ORR. Expect a P1 for 2.0 to start likely H1 2026.
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