Abstract is up: 134eP - Observed survival follo
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Posted On: 06/25/2025 6:03:00 PM
Abstract is up:
134eP - Observed survival following treatment with leronlimab in patients with metastatic colorectal cancer
Presentation Topic
Colon cancer
Presentation Number
134eP
Speakers
Benjamin A. Weinberg (Washington, United States of America)
Abstract
Background
CCR5 is a G protein-coupled receptor that plays a role in immune cell trafficking, migration, modulating inflammatory immune responses, and in DNA damage repair. Leronlimab, a humanized monoclonal antibody targeting CCR5, blocks CCR5 mediated signaling and has shown a >60% tumor reduction in murine SW480 colon models. While >10 new therapies for metastatic colorectal cancer (mCRC) have been approved from 2010-2025, improvement in median overall survival (mOS) has only increased from 20 to 27 months and patients with relapsed mCRC currently have a mOS of 15 months, and 7.5 months for 2nd or 3rd therapies, respectively.
Methods
A phase 2 single-arm basket study evaluating leronlimab (PRO 140) in patients with locally advanced or metastatic solid tumors, ineligible for standard-of-care (SOC) treatment, with CCR5-positive tumors by immunohistochemistry (>10% tumor cells or tumor-infiltrating leukocytes) (NCT04504942) was conducted. We report the results of patients enrolled having microsatellite-stable mCRC.
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.
Conclusions
Leronlimab was generally well tolerated, with no related dose limiting toxicities observed and demonstrated potential clinical benefit in patients with relapsed mCRC. Though limited to 5 patients, these findings are encouraging and support further investigation of leronlimab in mCRC-MSS patients.
Clinical trial identification
NCT04504942.
Legal entity responsible for the study
CytoDyn, Inc.
Funding
CytoDyn, Inc.
Disclosure
A. Baron: Financial Interests, Personal, Advisory Board: CytoDyn. C. Arman: Financial Interests, Personal, Full or part-time Employment, CA is an employee of CytoDyn and owns stock in the company. He was the Principal Investigator for the CytoDyn oncology studies previously performed at Quest Clinical Research: CytoDyn. M. Joseph: Financial Interests, Personal, Full or part-time Employment, JM is an employee of CytoDyn and owns stock in the company. He was the Principal Investigator for the CytoDyn oncology studies previously performed at Quest Clinical Research: CytoDyn. D. Adams: Financial Interests, Institutional, Other, Employee: Creatv MicroTech, Inc; Financial Interests, Institutional, Full or part-time Employment: Creatv MicroTech, Inc; Financial Interests, Personal, Stocks/Shares: Creatv MicroTech, Inc. B.A. Weinberg: Financial Interests, Personal, Principal Investigator: CytoDyn; Financial Interests, Personal, Speaker’s Bureau: Bayer, Taiho, Seagen, Daiichi Sankyo / AstraZeneca, Natera, Jazz, Pfizer; Financial Interests, Institutional, Research Grant: Ipsen, Immune System Key, Merck, BioXCel; Financial Interests, Personal, Expert Testimony: AstraZeneca; Financial Interests, Personal, Other, Travel: Merus NV; Financial Interests, Personal, Other, Consulting: Bayer, Daiichi Sankyo / AstraZeneca, DoMore Diagnostics, Foundation Medicine; Financial Interests, Personal, Other, Honoraria: Primimium, Caris Life Sciences. J.P. Lalezari: Financial Interests, Personal, Full or part-time Employment, JL is an employee of CytoDyn and owns stock in the company. He was the Principal Investigator for the CytoDyn oncology studies previously performed at Quest Clinical Research: CytoDyn.
134eP - Observed survival following treatment with leronlimab in patients with metastatic colorectal cancer
Presentation Topic
Colon cancer
Presentation Number
134eP
Speakers
Benjamin A. Weinberg (Washington, United States of America)
Abstract
Background
CCR5 is a G protein-coupled receptor that plays a role in immune cell trafficking, migration, modulating inflammatory immune responses, and in DNA damage repair. Leronlimab, a humanized monoclonal antibody targeting CCR5, blocks CCR5 mediated signaling and has shown a >60% tumor reduction in murine SW480 colon models. While >10 new therapies for metastatic colorectal cancer (mCRC) have been approved from 2010-2025, improvement in median overall survival (mOS) has only increased from 20 to 27 months and patients with relapsed mCRC currently have a mOS of 15 months, and 7.5 months for 2nd or 3rd therapies, respectively.
Methods
A phase 2 single-arm basket study evaluating leronlimab (PRO 140) in patients with locally advanced or metastatic solid tumors, ineligible for standard-of-care (SOC) treatment, with CCR5-positive tumors by immunohistochemistry (>10% tumor cells or tumor-infiltrating leukocytes) (NCT04504942) was conducted. We report the results of patients enrolled having microsatellite-stable mCRC.
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.
Conclusions
Leronlimab was generally well tolerated, with no related dose limiting toxicities observed and demonstrated potential clinical benefit in patients with relapsed mCRC. Though limited to 5 patients, these findings are encouraging and support further investigation of leronlimab in mCRC-MSS patients.
Clinical trial identification
NCT04504942.
Legal entity responsible for the study
CytoDyn, Inc.
Funding
CytoDyn, Inc.
Disclosure
A. Baron: Financial Interests, Personal, Advisory Board: CytoDyn. C. Arman: Financial Interests, Personal, Full or part-time Employment, CA is an employee of CytoDyn and owns stock in the company. He was the Principal Investigator for the CytoDyn oncology studies previously performed at Quest Clinical Research: CytoDyn. M. Joseph: Financial Interests, Personal, Full or part-time Employment, JM is an employee of CytoDyn and owns stock in the company. He was the Principal Investigator for the CytoDyn oncology studies previously performed at Quest Clinical Research: CytoDyn. D. Adams: Financial Interests, Institutional, Other, Employee: Creatv MicroTech, Inc; Financial Interests, Institutional, Full or part-time Employment: Creatv MicroTech, Inc; Financial Interests, Personal, Stocks/Shares: Creatv MicroTech, Inc. B.A. Weinberg: Financial Interests, Personal, Principal Investigator: CytoDyn; Financial Interests, Personal, Speaker’s Bureau: Bayer, Taiho, Seagen, Daiichi Sankyo / AstraZeneca, Natera, Jazz, Pfizer; Financial Interests, Institutional, Research Grant: Ipsen, Immune System Key, Merck, BioXCel; Financial Interests, Personal, Expert Testimony: AstraZeneca; Financial Interests, Personal, Other, Travel: Merus NV; Financial Interests, Personal, Other, Consulting: Bayer, Daiichi Sankyo / AstraZeneca, DoMore Diagnostics, Foundation Medicine; Financial Interests, Personal, Other, Honoraria: Primimium, Caris Life Sciences. J.P. Lalezari: Financial Interests, Personal, Full or part-time Employment, JL is an employee of CytoDyn and owns stock in the company. He was the Principal Investigator for the CytoDyn oncology studies previously performed at Quest Clinical Research: CytoDyn.
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