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Posted On: 10/24/2025 3:19:45 PM
Post# of 158162
Re: USS JOHNSTON #158143
I'll take a quick shot at this.
The endpoint in our mCRC trial is Overall Response Rate (ORR). So that is a useful comparator. The Standard of Care is 6.1%. The ORR for IBI363 in mCRC is 13.6%, according to the Fierce Biotech article. So they can say--with a straight face--that they more than double the ORR of the SOC.
But check out the numbers. There were 22 patients in the trial. 13.6% of 22 is roughly 3 patients with at least a partial response. Another way to look at that is it took 22 patients to achieve 3 responses. In Cytodyn's basket trial it took 5 mCRC patients to get 3 responses. That's a 60% ORR. So, with a very very small sample size, leronlimab looks much better than IBI363. But we won't really know until we get results from our trial, and see if the 60% number holds.
Something else I noticed from the article. Apparently IBI363 works better on the primary tumor. The Overall Survival numbers for the drug in patients with liver metastases was 14 months, while those without metastases lived 17 months. One of leronlimab's strength is controlling metastasis. So I would say we will look pretty good in comparison on that metric.
Those are all monotherapy numbers. The IBI363 numbers are better when paired with bevacizumab--the ORR goes to 15%, and increases to 31% in patients without metastases. Respectable... but our trial is in metastatic patients.
I don't have the OS numbers for leronlimab in mCRC... maybe my69 has them memorized. But once again, its a really small sample size. I don't have the ORR number for the TNBC trial, either; that would be another interesting comparison to make.
None of these mCRC numbers involve an ICI paired with IBI363 or leronlimab. Paired with an ICI the numbers for leronlimab should be quite substantial... based on the MOA and the numbers in the TNBC trial.
In the meantime... we wait on the trial. But I like our chances of becoming
"the backbone immuno-oncology treatment" that IBI363 aspires to be. At least in CCR5-positive cancers.
The endpoint in our mCRC trial is Overall Response Rate (ORR). So that is a useful comparator. The Standard of Care is 6.1%. The ORR for IBI363 in mCRC is 13.6%, according to the Fierce Biotech article. So they can say--with a straight face--that they more than double the ORR of the SOC.
But check out the numbers. There were 22 patients in the trial. 13.6% of 22 is roughly 3 patients with at least a partial response. Another way to look at that is it took 22 patients to achieve 3 responses. In Cytodyn's basket trial it took 5 mCRC patients to get 3 responses. That's a 60% ORR. So, with a very very small sample size, leronlimab looks much better than IBI363. But we won't really know until we get results from our trial, and see if the 60% number holds.
Something else I noticed from the article. Apparently IBI363 works better on the primary tumor. The Overall Survival numbers for the drug in patients with liver metastases was 14 months, while those without metastases lived 17 months. One of leronlimab's strength is controlling metastasis. So I would say we will look pretty good in comparison on that metric.
Those are all monotherapy numbers. The IBI363 numbers are better when paired with bevacizumab--the ORR goes to 15%, and increases to 31% in patients without metastases. Respectable... but our trial is in metastatic patients.
I don't have the OS numbers for leronlimab in mCRC... maybe my69 has them memorized. But once again, its a really small sample size. I don't have the ORR number for the TNBC trial, either; that would be another interesting comparison to make.
None of these mCRC numbers involve an ICI paired with IBI363 or leronlimab. Paired with an ICI the numbers for leronlimab should be quite substantial... based on the MOA and the numbers in the TNBC trial.
In the meantime... we wait on the trial. But I like our chances of becoming
"the backbone immuno-oncology treatment" that IBI363 aspires to be. At least in CCR5-positive cancers.
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