Roche extends add-on evidence in breast cancer

Pharma News: Findings from 6 years median follow-up in the APHINITY study confirm benefit in invasive disease-free survival (IDFS) from adding Roche’s Perjeta (pertuzumab) to standard adjuvant treatment in patients with node-positive, human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

The authors concluded that the second interim analysis of OS in the APHINITY study did not demonstrate a statistically significant OS benefit from adding Perjeta (pertuzumab) to standard chemotherapy plus Herceptin (trastuzumab) in HER2-positive early-stage breast cancer (p = 0.17); the number of OS events still remains relatively low.

The benefits of dual HER2 blockade using Perjeta (pertuzumab) and trastuzumab in the adjuvant setting for patients with node-positive disease observed at the primary analysis are reinforced in the updated analysis of IDFS. There is no evidence to justify the routine use of adjuvant dual anti-HER2 treatment for patients with node-negative early breast cancer.

Cardiac safety was confirmed with primary cardiac events remain <1% in both treatment groups.

The authors underlined that continued follow-up of patients is important to fully assess OS benefit at the time-driven third interim OS analysis planned for 2022.

To directly combat launch of biosimilar Herceptin, Roche in mid-2020 launched Phesgo, a fixed-dose combination of Herceptin and Perjeta, for HER2-positive breast cancer. The single-dose vial can be given in a treatment centre or at home, offering patients significant convenience. Previously, the two drugs had to be given separately. Phesgo is currently approved by the FDA and EMA, and awaiting TGA approval.