At 10 Years, Pertuzumab Boosts Survival in Early HER2+ Breast Cancer

Ten-year follow-up from the phase 3 APHINITY study (NCT01358877) showed that pertuzumab (Perjeta) had a clinically meaningful survival benefit when added to trastuzumab (Herceptin) and chemotherapy for the treatment of patients with HER2-positive early stage breast cancer.¹

After 10 years, adding pertuzumab to trastuzumab and chemotherapy led to a 17% reduction in risk of death vs trastuzumab, chemotherapy, and placebo as an adjuvant treatment.

“Early treatment of breast cancer can provide substantial patient benefit and also increases the chance for cure. For people with early-stage HER2-positive disease, the APHINITY results validate the sustained benefits of the Perjeta-based regimen,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, in a press release. “These long-term data reinforce the regimen’s value as a well-established standard-of-care treatment in the curative setting.”

Data from the follow-up show that 91.6% of patients treated with the pertuzumab-based regimen were alive at 10 years vs 89.8% in the placebo arm (HR, 0.83; 95% CI, 0.69-1.00; P =.044). In patients with lymph node-positive disease, there was a 21% reduction in the risk of death with the pertuzumab regimen (HR, 0.79; 95% CI, 0.64-0.97). The benefit to invasive disease-free survival (iDFS), the previously reported primary end point of APHINITY, was maintained (HR, 0.79; 95% CI, 0.68-0.92).

Further, the safety profile of the pertuzumab regimen was consistent with previous reports, with no new safety signals identified.

Full data will be presented as a late-breaking abstract on Thursday, May 15, 2025, at the European Society for Medical Oncology (ESMO) Breast Cancer Congress.

“The international collaborations in APHINITY have facilitated important insights about HER2-positive breast cancer and are continuing to yield promising findings,” said Liz Frank, an independent research advocate, in the press release. “Scientists and clinicians are working together with the broader goal of improving our understanding of HER2-positive breast cancer, improving the quality of life for people living with the disease and ultimately, helping them to live longer with no disease occurring.”

About APHINITY

The phase 3, global, randomized, double-blind, placebo-controlled APHINITY study enrolled 4804 patients with early-stage HER2-positive breast cancer to receive adjuvant trastuzumab and chemotherapy with or without pertuzumab. iDFS was the study’s primary end point, and secondary end points included recurrence-free interval (RFI), distant RFI, percentage of patients with primary or secondary cardiac events, change from baseline in quality of life, and pharmacokinetics.²

Patients were eligible for enrollment if they had nonmetastatic, operable, primary invasive HER2-positive breast carcinoma, an ECOG score of 1 or lower, and adequate laboratory functions. Those with a history of any prior invasive breast cancer, node-negative tumors, previous systemic chemotherapy, prior use of anti-HER2 therapy, or serious cardiovascular disease were not eligible for participation in the trial.

REFERENCES:

1. Ten-year APHINITY data show Roche’s Perjeta-based regimen reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer. News release. Roche. May 12, 2025. Accessed May 13, 2025. https://tinyurl.com/5a62pavu

2. A study of pertuzumab in addition to chemotherapy and trastuzumab as adjuvant therapy in participants with human epidermal growth receptor 2 (HER2)-positive primary breast cancer (APHINITY). ClinicalTrials.gov. Updated January 13, 2025. Accessed May 13, 2025. https://clinicaltrials.gov/study/NCT01358877