CX-2051 led to tumor responses and illness management in sufferers with late-line colorectal most cancers, with a positive security profile.
Therapy with the epithelial cell adhesion molecule (EpCAM) PROBODY antibody-drug conjugate CX-2051 demonstrated responses in sufferers with superior, late-line colorectal most cancers, in accordance with interim section 1 knowledge from the continued CTMX-2051-101 examine which had been shared in a information launch from CytomX Therapeutics, Inc.
These interim knowledge demonstrated a confirmed total response price of 28% (5 of 18 sufferers) per RECIST v1.1 standards amongst examine members handled with doses for enlargement, together with 7.2 milligrams per kilogram (mg/kg), 8.6 mg/kg and 10 mg/kg administered each three weeks. These outcomes are vital to notice, in accordance with the information launch, as a result of present total response charges for accredited remedies within the third-or-later-line setting for colorectal most cancers are within the low to mid-single digit percentages.
Notably, on the higher enlargement dose of 10 mg/kg, three of seven evaluable sufferers (43%) achieved confirmed responses. The illness management price was 94% (17 of 18 sufferers) throughout all three dose teams.
As of the info cutoff on April 7, 2025, the median progression-free survival was 5.8 months. Moreover, the protection profile seems favorable, and no dose-limiting toxicities had been noticed on the time of information cutoff.
Glossary:
Antibody-drug conjugate (ADC): a most cancers drug that mixes focused remedy and chemotherapy.
General response price: the proportion of sufferers who’ve a partial or full response to remedy
Illness management price (DCR): the proportion of sufferers that had a whole response, partial response or secure illness.
Development-free survival (PFS): the size of time throughout and after the remedy of a illness, akin to most cancers, {that a} affected person lives with the illness however it doesn’t worsen.
Hypokalemia: a blood stage that’s under regular in potassium
Pancreatitis: irritation of the pancreas.
Interstitial lung illness: a bunch of illnesses that trigger progressive scarring of lung tissue
Febrile neutropenia: the event of fever, usually with different indicators of an infection, in a affected person with neutropenia.
Concerning security, the protection knowledge had been out there for all 25 sufferers and demonstrated a positive security profile, with no dose-limiting toxicities noticed.
Therapy-related unintended effects had been predominantly grade 1 (delicate) or 2 (average). Probably the most regularly reported included diarrhea (18 sufferers; 5 grade 3 [severe]), nausea (11 sufferers; one grade 3), vomiting (eight sufferers; no grade 3), fatigue (eight sufferers; one grade 3), anemia (5 sufferers; three grade 3), hypokalemia (three sufferers; one grade 3), neutrophil rely lower (two sufferers; two grade 3), and neutropenia (two sufferers; one grade 3). Critical treatment-related unintended effects occurred in 5 sufferers — one with a grade 2 facet impact and 4 with grade 3 facet impact. No grade 4 (life-threatening) or 5 (demise) treatment-related unintended effects had been reported.
Importantly, there have been no noticed circumstances of pancreatitis, interstitial lung illness or febrile neutropenia as of the info cutoff.
Based mostly on these outcomes, initiation of a section 2 medical trial is deliberate for the primary half of 2026.
“EpCAM is a excessive potential and broadly expressed most cancers goal that has been difficult to drug traditionally because of expression on regular tissues. We consider we have now damaged vital new floor with our knowledge introduced at this time, which present potential for markedly improved outcomes for sufferers [with] colorectal most cancers,” Dr. Sean McCarthy, CEO and chairman of CytomX, stated within the information launch. “CX-2051 is exhibiting spectacular, sturdy anti-tumor exercise in late line metastatic colorectal most cancers, an space of excessive unmet want and a really tough tumor to deal with. Moreover, CX-2051 has been usually effectively tolerated, highlighting the ability of CytomX PROBODY® masking know-how.”
“Importantly, we consider these outcomes validate EpCAM as an oncology goal and unlock a broad growth alternative for CX-2051 in colorectal most cancers and probably many different most cancers varieties the place EpCAM is expressed. We’re excited to quickly advance CX-2051 for the good thing about sufferers [with] colorectal most cancers and to discover the total potential of this novel antibody-drug conjugate,” Dr. McCarthy added.
Extra Data on the Part 1 Investigation
The section 1a examine is evaluating CX-2051 administration each three weeks, with 25 sufferers handled throughout dose ranges one by means of 5. On the upper dose ranges of seven.2 mg/kg, 8.6 mg/kg and 10 mg/kg, a complete of 23 sufferers obtained remedy. Of those, 18 had been thought-about efficacy-evaluable, having accomplished a minimum of one post-baseline tumor evaluation by the info cutoff.
Affected person traits mirrored a closely pretreated inhabitants, with a median of 4 prior strains of remedy. Among the many 25 handled sufferers, 64% had liver metastases, 64% harbored KRAS mutations and 96% had microsatellite secure tumors. Importantly, sufferers weren’t preselected primarily based on EpCAM expression ranges.
Notably, 10 of the 18 efficacy-evaluable sufferers remained on examine remedy on the time of the info cutoff, in accordance with the information launch.
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