Jake--Yep, chemo was used on 4 of the 5 patients, and the chemo "backbone" was FOLFOX. The other patient received leronlimab as a straight monotherapy, and lasted 4.2 months. [color=var(--text)]Here's the "Results" section of the July 2025 ESMO Annals of Oncology abstract:[/color]
Results
"Five mCRC patients received weekly subcutaneous leronlimab at initial doses of 350mg or 525mg until progression or unacceptable toxicity. Patient’s median age was 51 (34-92 years), and patients had received 1-3 prior systemic therapy lines for mCRC. Adverse events (AEs) were limited, with 7 reported in the trial (5G1 & 2G2), with no serious AEs. Two patients had grade 1 AEs that were deemed treatment related (infusion-related reaction and nausea). Four patients received leronlimab in combination with ongoing or new SOC regimens (n=2 FOLFOX, n=1 FOLFOX + bevacizumab and n=1 FOLFOXIRI + bevacizumab). One patient with a solitary hepatic metastasis underwent liver resection following a reduction (43%) after FOLFOX + leronlimab, and remains alive with no evidence of disease (NED) at ∼57 months. mOS from the first dose of leronlimab was 15.8 months (range 4.2-57), with n=3 achieving partial responses per RECIST 1.1."
FOLFOX chemo is usually pretty tough on patients, so the safety record is notable--7 adverse events, all Grade 1/2, with no Serious Adverse Events. This brings to mind Geoffrey Fourqurean's idea that leronlimab "treats the patient as well as the disease," and helps promote gut health in CRC patients. It's not 5 out of 5 like the Ladies of Leronlimab... but 4 out of 4 responders in MSS mCRC, when paired with chemo--WITHOUT AN ICI--looks pretty good to me. Here's a summary courtesy AI:
Summary Analysis of the 5-Patient Cohort
"The collective outcomes show that when Leronlimab was paired with a functional chemotherapy partner (Patients 1, 2, 3, and 4), it achieved a 100% Disease Control Rate (DCR) consisting of 1 CR, 2 PRs, and 1 SD. The only therapeutic failure occurred when the drug was stripped of a chemotherapy partner (Patient 5). This critical insight directly led to the design of the CLOVER trial, ensuring that no patient receives Leronlimab alone and that all participants are paired with an active, resistance-breaking oral partner (TAS-102)."
https://www.annalsofoncology.org/article/S092...7/fulltext
Results
"Five mCRC patients received weekly subcutaneous leronlimab at initial doses of 350mg or 525mg until progression or unacceptable toxicity. Patient’s median age was 51 (34-92 years), and patients had received 1-3 prior systemic therapy lines for mCRC. Adverse events (AEs) were limited, with 7 reported in the trial (5G1 & 2G2), with no serious AEs. Two patients had grade 1 AEs that were deemed treatment related (infusion-related reaction and nausea). Four patients received leronlimab in combination with ongoing or new SOC regimens (n=2 FOLFOX, n=1 FOLFOX + bevacizumab and n=1 FOLFOXIRI + bevacizumab). One patient with a solitary hepatic metastasis underwent liver resection following a reduction (43%) after FOLFOX + leronlimab, and remains alive with no evidence of disease (NED) at ∼57 months. mOS from the first dose of leronlimab was 15.8 months (range 4.2-57), with n=3 achieving partial responses per RECIST 1.1."
FOLFOX chemo is usually pretty tough on patients, so the safety record is notable--7 adverse events, all Grade 1/2, with no Serious Adverse Events. This brings to mind Geoffrey Fourqurean's idea that leronlimab "treats the patient as well as the disease," and helps promote gut health in CRC patients. It's not 5 out of 5 like the Ladies of Leronlimab... but 4 out of 4 responders in MSS mCRC, when paired with chemo--WITHOUT AN ICI--looks pretty good to me. Here's a summary courtesy AI:
Summary Analysis of the 5-Patient Cohort
"The collective outcomes show that when Leronlimab was paired with a functional chemotherapy partner (Patients 1, 2, 3, and 4), it achieved a 100% Disease Control Rate (DCR) consisting of 1 CR, 2 PRs, and 1 SD. The only therapeutic failure occurred when the drug was stripped of a chemotherapy partner (Patient 5). This critical insight directly led to the design of the CLOVER trial, ensuring that no patient receives Leronlimab alone and that all participants are paired with an active, resistance-breaking oral partner (TAS-102)."
https://www.annalsofoncology.org/article/S092...7/fulltext
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