AI Article Synopsis
- Panitumumab is a fully human antibody used to treat metastatic colorectal cancer (mCRC) after chemotherapy fails, and this analysis focused on its immunogenicity and how anti-panitumumab antibodies affect patients' response.
- Three types of assays were employed to detect antibodies in patient samples from clinical trials, and the study assessed how these antibodies influenced pharmacokinetics and safety.
- The results showed that only a small percentage (1.8%) of patients developed binding antibodies, with no significant changes in drug response or safety profiles linked to these antibodies, likely due to panitumumab being fully human.
Article Abstract
Background: Panitumumab is a fully human antibody against the epidermal growth factor receptor that is indicated for the treatment of metastatic colorectal cancer (mCRC) after disease progression on standard chemotherapy. The purpose of this analysis was to examine the immunogenicity of panitumumab and to evaluate the effect of anti-panitumumab antibodies on pharmacokinetic and safety profiles in patients with mCRC receiving panitumumab in combination with oxaliplatin- or irinotecan-based chemotherapies.
Methods: Three validated assays (two screening immunoassays and a neutralizing antibody bioassay) were used to detect the presence of anti-panitumumab antibodies in serum samples collected from patients enrolled in four panitumumab combination chemotherapy clinical trials. The impact of anti-panitumumab antibodies on pharmacokinetic and safety profiles was analyzed using population pharmacokinetic analysis and descriptive statistics, respectively.
Results: Of 1124 patients treated with panitumumab in combination with oxaliplatin- or irinotecan-based chemotherapy with postbaseline samples available for testing, 20 (1.8%) patients developed binding antibodies and 2 (0.2%) developed neutralizing antibodies. The incidence of anti-panitumumab antibodies was similar in patients with tumors expressing wild-type or mutant KRAS and in patients receiving oxaliplatin- or irinotecan-based chemotherapies. No evidence of an altered pharmacokinetic or safety profile was found in patients who tested positive for anti-panitumumab antibodies.
Conclusions: The immunogenicity of panitumumab in the combination chemotherapy setting was infrequent and similar to the immunogenicity observed in the monotherapy setting. Panitumumab immunogenicity did not appear to alter pharmacokinetic or safety profiles. This low rate of immunogenicity may be attributed to the fully human nature of panitumumab.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3231982 | PMC |
| http://dx.doi.org/10.1186/1472-6904-11-17 | DOI Listing |
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