Roche’s Herceptin and Perjeta duo is already part of a well-established standard of care in early-stage HER2-positive breast cancer. Now, the company can further back up the regimen’s prowess with a decade’s worth of survival data. 

The drugmaker evaluated a post-surgery Herceptin, Perjeta and chemotherapy regimen over ten years in its phase 3 APHINITY study of 4,804 patients. The regimen slashed the risk of death by 17% compared to those who took Herceptin, chemotherapy and placebo without Perjeta. The final overall survival result was statistically significant, according to Roche.

To put it another way, 91.6% of those treated with the Perjeta-based regimen were alive at ten years compared to 89.8% in the control arm, Roche’s Genentech unit reported Tuesday.

For those with early-stage HER2-positive disease, the results “validate the sustained benefits of the Perjeta-based regimen,” Genentech’s chief medical officer and head of global product development, Levi Garraway, M.D., Ph.D., said. “These long-term data reinforce the regimen’s value as a well-established standard-of-care treatment in the curative setting.”

The company also noted a 21% reduction in the risk of death for the group of patients with lymph node-positive disease, supporting Perjeta’s addition to standard post-surgical treatment as “most beneficial for people with HER2-positive breast cancer with lymph node-positive disease who are at high risk of recurrence,” study chair and CEO of research institute German Breast Group Forschungs, Sibylle Loibl, M.D., noted in Genentech’s release.

The full study results will be presented on Thursday at the 2025 European Society for Medical Oncology Breast Cancer Congress. Previously, in 2019, Roche presented an early tease of the long-term study with an analysis showing that the Perjeta addition to Herceptin and chemotherapy cut down the risk of death and recurrence by 24% after six years of treatment. At that time, however, Perjeta didn’t beat the Herceptin-chemo combo on the overall survival measure.

Perjeta was first approved in 2012 as an add-on to Herceptin and chemotherapy in the metastatic setting based on trial data showing the regimen could significantly extend the amount of time patients lived without their disease worsening. 

The Perjeta regimen shortly after became the first breast cancer therapy approved for use before surgery and its label was later extended to cover post-surgical adjuvant treatment of HER2-positive breast cancer with high risk of recurrence.

These days, Herceptin copycats are now prevalent, but Perjeta is yet to face similar competition, although its time is ticking as Shanghai Henlius Biotech’s Perjeta biosimilar candidate was accepted for FDA review in February. 

The 10-year adjuvant data update comes shortly after AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu plus Perjeta beat the standard Perjeta, Herceptin and chemotherapy in delaying tumor progression or death for patients with newly diagnosed HER2-positive metastatic breast cancer.

Herceptin and Perjeta both remain steady earners for Roche, with Perjeta bringing in about $4.3 billion in 2024 sales and Herceptin contributing some $1.6 billion. Roche is projected to take home the crown as the largest drugmaker by sales in 2025, according to Evaluate analysts.