Real-World Evidence of Cardiac Safety of Trastuzumab Biosimilar Trastuzumab-anns in Breast Cancer

A retrospective study conducted in Poland confirmed that treatment with trastuzumab-anns was associated with an acceptable cardiac safety profile, even when switching from trastuzumab reference or when combined with pertuzumab.

There is limited real-world evidence of the efficacy and safety of switching from the reference trastuzumab to its biosimilar trastuzumab-anns, as well as in combination with pertuzumab. Therefore, an observational, retrospective study was conducted to confirm the safety profile of trastuzumab-anns in these settings.

The retrospective analysis identified a total of 195 patients with HER2-positive breast cancer who were treated with trastuzumab-anns from July 18, 2018, to January 29, 2020, in Poland. Of these, 99 patients received trastuzumab-anns as monotherapy or with other cytostatic drugs in the neoadjuvant or adjuvant setting. Nearly half the patient population (49%) received trastuzumab-anns in combination with pertuzumab; 34 patients received carboplatin, docetaxel, pertuzumab, and trastuzumab-anns in the neoadjuvant setting, and 62 patients received docetaxel, pertuzumab, and trastuzumab-anns in the metastatic setting. In terms of switching trastuzumab to trastuzumab-anns, 65% of patients with metastatic breast cancer switched and 37% of patients with early breast cancer switched; patients were switched most commonly in the fourth cycle.

During the 12-month follow-up, 6 patients had a decline in left ventricular ejection fraction; there were no other reports of trastuzumab-related adverse events.

These real-world data confirm that treatment with trastuzumab-anns was associated with an acceptable cardiac safety profile, even when switching from trastuzumab reference or when combined with pertuzumab.

Source: Jagiello-Gruszfeld AI, Lemanska I, Brewczynska E, et al. Trastuzumab biosimilar (Kanjinti) in breast cancer patients: one-center retrospective observational study. J Clin Oncol. 2021;39(suppl_15):e13015.