ABP 980 + paclitaxel

ABP 980 + paclitaxel is a combination therapy used primarily in the treatment of HER2-positive early breast cancer. This combination consists of ABP 980 (a biosimilar of trastuzumab) and paclitaxel, a chemotherapy agent. ## Drug Information ABP 980 is a biosimilar to trastuzumab, developed by Amgen and Allergan. It has the same amino acid sequence as trastuzumab and binds to the extracellular domain of HER2, suppressing receptor activation and subsequent proliferation of HER2-overexpressing cells[2]. The combination with paclitaxel was studied extensively in clinical trials, particularly in the LILAC study, which was a randomized, multicenter, double-blinded, active-controlled Phase 3 trial[3][5]. In the neoadjuvant setting, patients typically receive ABP 980 at a loading dose of 8 mg/kg plus paclitaxel 175 mg/m² in a 90-minute intravenous infusion, followed by three cycles of 6 mg/kg intravenous ABP 980 plus paclitaxel 175 mg/m² every 3 weeks in 30-minute intravenous infusions[1]. Alternatively, paclitaxel may be administered at 80 mg/m² once per week for 12 cycles if that is the local standard of care[1]. ## Clinical Efficacy The LILAC study demonstrated that ABP 980 + paclitaxel achieved pathological complete response (pCR) in 48% of patients compared to 41% for trastuzumab + paclitaxel[1]. This difference actually exceeded the predefined equivalence margins in the local laboratory assessment, though central laboratory assessment showed results within the equivalence margins (48% vs 42%)[1][4]. ## Safety Profile The safety profile of ABP 980 + paclitaxel was comparable to that of trastuzumab + paclitaxel. Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group, with neutropenia being the most frequent serious adverse event, occurring in 6% of patients[1][3]. Immunogenicity was also comparable between the treatments, with anti-drug antibodies developing in 0.6% of patients receiving ABP 980 compared to 1.4% in those receiving reference trastuzumab[4]. ## Regulatory Status ABP 980 (marketed as Kanjinti) has been approved in the European Union, United States, and Japan for the treatment of HER2-positive breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction[2]. The combination with paclitaxel is a standard treatment approach for HER2-positive early breast cancer in the neoadjuvant setting. The development of ABP 980 as a biosimilar to trastuzumab represents an important advancement in providing more accessible treatment options for patients with HER2-positive cancers.