Ken and Jake--Just to follow up on the topic, Tecentric is not approved for mss/mCRC either. But Exelixis just completed a successful Phase III trial in that indication, combining their next gen tyrosine kinase inhibitor zanzalintinib with Tecentric, with a PDUFA date of December 2026 for FDA approval. For what it's worth, if it is approved that combination will be the new SOC. (Shout out to Lab Monkey on the Livimmune board for the timely reference). Ken's comment that Roche would have to do trials with a Tec/LL combo in mTNBC is likely to be true for the mCRC indication as well.
I would call the increase in OS of 10.9 months, compared to 9.4 months in the comparator arm, as incremental progress. In the pre-defined subset of patients without liver mets the numbers are better at 15.9 months, but the comparator arm (regorafenib) was 12.8 months. So Leronlimab plus an ICI should do much much better, including those with liver mets. In terms of safety, 60% of patients endured grade 3 or higher adverse events, with 18% discontinuing treatment. They call this "acceptable" given the dire prognosis of mCRC...
Excelixis actually got a write-up on this in The Lancet, so it's a big deal in some circles. How are they going to respond to the results from our trial? Conservatively, let's say a 50% ORR in mss/mCRC with LL, TAS-102 and Avastin. And let's say 50% of the patients who progress and get an ICI after LL are still alive at the end of the study. I think even these kind of low-ball numbers will be so good that they will be met with extreme skepticism and even disbelief by some in the medical community. While I've been hoping for some anecdotal news dribbling out of the trial... It's probably best that Cytodyn is keeping things close to the vest.
It strikes me that the video interviews of the Ladies, which we've all been waiting to see, are probably being held back for release after we get what some will consider unbelievable mCRC data. They will provide a compelling human face to the "turning cold tumors hot" paradigm, even if they are in a different cancer. And who knows, perhaps the safety data is being slow-walked to be revealed after mCRC news. Waiting is getting excruciating... but if my speculations are correct, it's part of a larger plan.
Well Jake, perhaps Roche isn't at the top of the list, after all. I think they would make an excellent partner, and have heard that from others, too. I still believe there is a Euro connection here, what with the entourage from Cytodyn that went to Germany last year. But we wait. I think when news breaks, though, we will get a sustained campaign of press releases from Cytodyn, and coverage from OncLive and other oncology-focused media. Wouldn't a cover story on the Lancet be nice? And interest from cancer patients and their advocacy organizations will be off the charts.
Now listen... if Cytodyn doesn't come out with a pr campaign, I'll have questions for management! But I suspect they are on top of this; they have had plenty of time to work out the scenarios and put together a plan... starting but not ending with the "unassailable science." Essentially, they need to introduce leronlimab to a skeptical world that is inclined to say "Must be fake news cause it's too good to be true." It's a good problem to have... but it's a problem nonetheless.
I would call the increase in OS of 10.9 months, compared to 9.4 months in the comparator arm, as incremental progress. In the pre-defined subset of patients without liver mets the numbers are better at 15.9 months, but the comparator arm (regorafenib) was 12.8 months. So Leronlimab plus an ICI should do much much better, including those with liver mets. In terms of safety, 60% of patients endured grade 3 or higher adverse events, with 18% discontinuing treatment. They call this "acceptable" given the dire prognosis of mCRC...
Excelixis actually got a write-up on this in The Lancet, so it's a big deal in some circles. How are they going to respond to the results from our trial? Conservatively, let's say a 50% ORR in mss/mCRC with LL, TAS-102 and Avastin. And let's say 50% of the patients who progress and get an ICI after LL are still alive at the end of the study. I think even these kind of low-ball numbers will be so good that they will be met with extreme skepticism and even disbelief by some in the medical community. While I've been hoping for some anecdotal news dribbling out of the trial... It's probably best that Cytodyn is keeping things close to the vest.
It strikes me that the video interviews of the Ladies, which we've all been waiting to see, are probably being held back for release after we get what some will consider unbelievable mCRC data. They will provide a compelling human face to the "turning cold tumors hot" paradigm, even if they are in a different cancer. And who knows, perhaps the safety data is being slow-walked to be revealed after mCRC news. Waiting is getting excruciating... but if my speculations are correct, it's part of a larger plan.
Well Jake, perhaps Roche isn't at the top of the list, after all. I think they would make an excellent partner, and have heard that from others, too. I still believe there is a Euro connection here, what with the entourage from Cytodyn that went to Germany last year. But we wait. I think when news breaks, though, we will get a sustained campaign of press releases from Cytodyn, and coverage from OncLive and other oncology-focused media. Wouldn't a cover story on the Lancet be nice? And interest from cancer patients and their advocacy organizations will be off the charts.
Now listen... if Cytodyn doesn't come out with a pr campaign, I'll have questions for management! But I suspect they are on top of this; they have had plenty of time to work out the scenarios and put together a plan... starting but not ending with the "unassailable science." Essentially, they need to introduce leronlimab to a skeptical world that is inclined to say "Must be fake news cause it's too good to be true." It's a good problem to have... but it's a problem nonetheless.
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