Efficacy and safety of pegfilgrastim biosimilar MD‐110 in patients with breast cancer receiving chemotherapy: Single‐arm phase III

Abstract Introduction Pegfilgrastim is indicated to decrease the incidence of chemotherapy‐induced febrile neutropenia. It is the first granulocyte‐colony stimulating factor approved for prophylactic use regardless of carcinoma type and is marketed in Japan as G‐LASTA (Kyowa Kirin Co., Ltd., Tokyo, Japan). MD‐110 is a biosimilar of pegfilgrastim. This phase III, multicenter, open‐label, single‐arm study investigated the efficacy and safety of MD‐110 in early‐stage breast cancer patients receiving neoadjuvant or adjuvant myelosuppressive chemotherapy. Methods A total of 101 patients received the study drug. Each patient received docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 (TC) for four cycles on day 1 of each cycle. MD‐110 (3.6 mg) was administered subcutaneously on day 2 of each cycle. The primary efficacy endpoint was the duration of severe neutropenia during cycle 1 (days with absolute neutrophil count < 500/mm3). The safety endpoints were adverse events and the presence of antidrug antibodies. Results The mean (SD) duration of severe neutropenia for MD‐110 was 0.2 (0.4) days. The upper limit of the two‐sided 95% confidence interval for the mean duration of severe neutropenia was 0.2 days, below the predefined threshold of 3.0 days. The incidence of febrile neutropenia, the secondary efficacy endpoint, was 6.9% (7/101). Adverse events, occurring in more than 50% of patients, were alopecia, constipation, and malaise, which are common side effects of TC chemotherapy. Antidrug antibodies were negative in all patients. Conclusion MD‐110 was effective against chemotherapy‐induced neutropenia. No additional safety concern, compared with the originator, was observed in patients with breast cancer receiving TC chemotherapy.(JapicCTI‐205230)

Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer

Aim: To evaluate the efficacy and safety of neratinib as extended adjuvant therapy in patients from Asia based on exploratory analyses of the Phase III ExteNET trial. Patients & methods: A total of 2840 women with early stage HER2-positive breast cancer were randomly assigned to neratinib 240 mg/day or placebo for 1 year after trastuzumab-based adjuvant therapy. Results: A total of 341 patients were from Asia (neratinib, n = 165; placebo, n = 176). 2-year invasive disease-free survival rates were 92.8 and 90.8% with neratinib and placebo, respectively (HR: 0.70; 95% CI: 0.31-1.55), and 5-year rates were 91.9 and 87.2%, respectively (HR: 0.57; 95% CI: 0.27-1.13). Diarrhea was the most common adverse event with neratinib. Conclusion: Extended adjuvant therapy with neratinib reduces disease recurrences in Asian women with HER2-positive breast cancer. Trial registration: Clinicaltrials.gov NCT00878709. © 2019 Future Medicine Ltd