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The administration of ABP 980 plus pertuzumab in a single, 60-minute intravenous infusion was found to be safe and feasible in healthy adult men, according to research presented at the 17th St. Gallen International Breast Cancer Conference 2021.
Vladimir Hanes, MD, from Amgen Inc., and colleagues presented results of the LAVENDER study, which evaluated the safety and tolerability of ABP 980 plus pertuzumab admixture as well as trastuzumab reference product (T-RP) plus pertuzumab admixture. ABP 980 (Kanjinti; Amgen) is a biosimilar to T-RP and has been approved for patients with metastatic breast cancer, early breast cancer, adjuvant breast cancer, and metastatic gastric cancer.
The randomized, double-blind, parallel-group study included 36 healthy adult male volunteers who were randomly assigned 1:1 to receive an intravenous infusion of ABP 980 6 mg/kg plus pertuzumab 420 mg (ABP 980 + P group) or T-RP 6 mg/kg plus pertuzumab 420 mg (T-RP + P group), with both treatments administered as an admixture in a single, 250-mL infusion bag for approximately 60 minutes. The volunteers were followed for 92 days after dosing.
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Among participants in the ABP 980 + P group (n=18), the mean age was 31.0 (7.5) years, and 55.6% were White. In the T-RP + P group (n=18), the mean age was 28.8 (6.3) years, and 61.1% were White. The study’s primary endpoints were safety and immunogenicity, and the secondary endpoint was pharmacokinetics parameters.
The investigators found that the frequency, type, and severity of adverse events were similar between the 2 treatment groups, with no clinically meaningful differences. In addition, no new safety signals were identified
“There were no meaningful differences observed in serum concentration time profiles of ABP 980 and T-RP and their pharmacokinetics parameters between treatment groups,” stated the study authors. “No pre-existing anti-ABP 980/anti-trastuzumab binding/neutralizing antibodies (ADAs) were detected at baseline, and no subject developed binding/neutralizing ADAs at the end of the study.”
Treatment-emergent adverse events were reported in 94.4% of participants in both the ABP 980 + P and the T-RP + P groups. No deaths or treatment-emergent adverse events leading to study discontinuation occurred, and no participants had serious or grade 3 or greater adverse events. Headache was the most frequent adverse event, reported in 55.6% of the ABP 980 + P group and in 77.8% of the T-RP + P group.
“The results of this (LAVENDER) study demonstrate that administration of ABP 980 plus pertuzumab in a single 60-minute IV infusion is safe and feasible,” the researchers concluded. “The pharmacokinetics parameters of ABP 980 and TR-P were not impacted by co-infusion with pertuzumab in a single infusion bag over 60 minutes. The co-infusion may reduce clinic time and increase medical resource utilization.”
Disclosure: This study was sponsored by Amgen Inc. All authors are employees and stockholders of Amgen Inc and/or were investigators for Amgen for this study.
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Reference
Hanes V, Chow V, Stewart T, Puri A. A randomized, double-blind, single-dose study (LAVENDER) to assess the safety and immunogenicity of ABP 980 and pertuzumab combined in a single infusion in healthy subjects. Poster presented at: 17th St Gallen International Breast Cancer Conference 2021; March 17-20, 2021. Abstract P081.
