Roche recently announced ten-year results from the phase III APHINITY study, revealing a 17% reduction in the risk of death for patients with HER2-positive early-stage breast cancer treated with a Perjeta-based regimen compared to a control group.

Genentech's chief medical officer, Levi Garraway, highlighted the sustained benefits of the Perjeta-based regimen, reinforcing its status as a standard-of-care treatment in curative settings.

Ken Takeshita from Daiichi Sankyo emphasized the potential of new treatment approaches like ENHERTU to improve outcomes for patients who do not achieve a pathological complete response (pCR).

The trial results indicated that trastuzumab deruxtecan-THP demonstrated a better safety profile compared to the standard ddAC-THP treatment, with fewer adverse events.

Participants in the trial were randomly assigned to receive either trastuzumab deruxtecan monotherapy, trastuzumab deruxtecan followed by THP, or standard care, allowing for a comprehensive evaluation of treatment effectiveness.

ENHERTU, jointly developed by Daiichi Sankyo and AstraZeneca, has shown promise in multiple Phase III trials, positioning it as a pivotal option for various stages of HER2-positive breast cancer.

The statistically significant overall survival results from the APHINITY study will be presented as a late-breaking abstract at the 2025 ESMO Breast Cancer Congress.

The safety profiles for both the Perjeta-based regimen and trastuzumab deruxtecan were consistent with previous studies, showing no new safety concerns.

Previously, early data had suggested that Perjeta reduced the risk of death and recurrence by 24% after six years, although it did not outperform the Herceptin-chemo combination on overall survival at that time.

HER2-positive breast cancer accounts for approximately 20% of all breast cancer diagnoses and is characterized by its aggressive nature and poorer prognosis compared to other subtypes.

The APHINITY study maintained its invasive disease-free survival benefit with a hazard ratio of 0.79, although no significant benefits were observed in the node-negative subgroup.

Roche continues to generate substantial revenue from both Herceptin and Perjeta, with projected sales of $4.3 billion for Perjeta and $1.6 billion for Herceptin in 2024.