Ganesha--the Disease Control Rate (DCR) is an imperfect statistic. Two points to consider:
The DCR is a composite metric that includes Partial Response (PR), Complete Response (CR), and Stable Disease (SD). Trials can have a similar DCR but the "quality" of the DCR lies in the Overall Response Rate (ORR)--the numbers/percentage of CRs and PRs in patients, compared to SD. In the Sunlight Trial there were no CRs and a small number of PRs, for an ORR of 6%. I am expecting significantly more PRs and CRs in the Clover trial... but of course the data needs to mature.
The Overall Survival rate (OS) is also a crucial part of this. If patients have SD but they are living longer, with a substantial OS compared to the historical averages... well, that is huge. I expect a long "survival tail" in the Clover Trial, in some of the responders. Progression Free Survival is also important here. And if they have a good quality of life with SD, that is also quite meaningful, to oncologists and the FDA, as well as to the patients themselves. And in the Clover Trial patient quality of life is tracked via questionnaires and ECOG status, and early indications are positive.
The following numbers are admittedly optimistic guesses... But in 3rd-line MSS mCRC patients, a DCR in the 70s-80s, an ORR in the 20s-30s, and meaningful longer OS of 15-20 months would be a freaking home run! Extended PFS and patient's feeling better would be the icing and cherry on the top. The final ORR and OS numbers won't be available to us in October, but we will get some initial indications. The early ctDNA numbers and scans make me think the eventual ORR numbers could very well be better...
Consider that the discussion above doesn't even take into account the pairing of an ICI with leronlimab in the rollover extension of the trial... But once again, mature data on prime and pair won't be available to us in October (though I hope we have anecdotal examples to share by then). I think ESMO might very well be dominated by data from the cancer vaccines and the pancreatic drug from Revolution--that would be my expectation, because the Bio Press is beholden to the Big Pharma establishment--but by January we should have the mature, unassailable data to wake up the press and get the attention we deserve. Wouldn't it be nice to wake up one morning and read about a standing ovation for Cytodyn in the headlines come January? If we got a big partnership deal before ESMO... well, that would clearly change the dynamic in our favor, and we could make a splash there, too. Which I would love to see.
I am probably over-optimistic... so do not consider this investment advice. I missed the ORR thread last week, but I did want to put some numbers out there. I am hoping "survival tail" becomes my favorite word in 2027.
The DCR is a composite metric that includes Partial Response (PR), Complete Response (CR), and Stable Disease (SD). Trials can have a similar DCR but the "quality" of the DCR lies in the Overall Response Rate (ORR)--the numbers/percentage of CRs and PRs in patients, compared to SD. In the Sunlight Trial there were no CRs and a small number of PRs, for an ORR of 6%. I am expecting significantly more PRs and CRs in the Clover trial... but of course the data needs to mature.
The Overall Survival rate (OS) is also a crucial part of this. If patients have SD but they are living longer, with a substantial OS compared to the historical averages... well, that is huge. I expect a long "survival tail" in the Clover Trial, in some of the responders. Progression Free Survival is also important here. And if they have a good quality of life with SD, that is also quite meaningful, to oncologists and the FDA, as well as to the patients themselves. And in the Clover Trial patient quality of life is tracked via questionnaires and ECOG status, and early indications are positive.
The following numbers are admittedly optimistic guesses... But in 3rd-line MSS mCRC patients, a DCR in the 70s-80s, an ORR in the 20s-30s, and meaningful longer OS of 15-20 months would be a freaking home run! Extended PFS and patient's feeling better would be the icing and cherry on the top. The final ORR and OS numbers won't be available to us in October, but we will get some initial indications. The early ctDNA numbers and scans make me think the eventual ORR numbers could very well be better...
Consider that the discussion above doesn't even take into account the pairing of an ICI with leronlimab in the rollover extension of the trial... But once again, mature data on prime and pair won't be available to us in October (though I hope we have anecdotal examples to share by then). I think ESMO might very well be dominated by data from the cancer vaccines and the pancreatic drug from Revolution--that would be my expectation, because the Bio Press is beholden to the Big Pharma establishment--but by January we should have the mature, unassailable data to wake up the press and get the attention we deserve. Wouldn't it be nice to wake up one morning and read about a standing ovation for Cytodyn in the headlines come January? If we got a big partnership deal before ESMO... well, that would clearly change the dynamic in our favor, and we could make a splash there, too. Which I would love to see.
I am probably over-optimistic... so do not consider this investment advice. I missed the ORR thread last week, but I did want to put some numbers out there. I am hoping "survival tail" becomes my favorite word in 2027.
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