Thanks Lykiri, there is a lot of clinical data (over a decades worth of data) to support the safety and efficacy of the combination of ATL-DC (DCVax-L) + poly-ICLC.
This strongly suggests to me that what the regulators will approve is not just DCVax-L, but DCVax-L 2.0 (DCVax-L + poly-ICLC).
It also suggests to me that every future DCVax-L and DCVax-Direct combination basket trial (for multiple solid tumor cancer types, i.e.: lung, colon, breast, pancreatic, prostate, ovarian, melanoma, bladder, sarcoma, etc.) in the future will include a treatment arm for each if the following:
(1) the current standard of care for each solid tumor cancer type. However, it’s possible or even probable, that they will be able to use the OS from contemporaneous external control arms (ECAs) for this comparator group.
(2) DCVax 2.0 (DCVax + poly-ICLC. Either DCVax-L, if the tumor is operable, or DCVax Direct if the tumor is inoperable).
(3) DCVax 2.0 (DCVax + poly-ICLC. Either DCVax-L, if the tumor is operable, or DCVax Direct if the tumor is inoperable) + PD-1 inhibitor + CSF-1R inhibitor
Bullish