Ten-Year Data From Roche's Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%

Roche Holdings AG RHHBY on Tuesday released statistically significant final overall survival (OS) results from the phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer.

After ten years, the risk of death was reduced by 17% for people treated with Perjeta (pertuzumab), Herceptin (trastuzumab), and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo.

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After ten years, results show:

• 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, p-value=0.044).
• A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79).
• The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79), strengthening results from earlier APHINITY analyses. No benefit was seen in the node-negative subgroup.
• The safety profile, including cardiac safety, was consistent with previous studies, and no new or unexpected safety signals were identified.

Full results will be presented at the 2025 European Society for Medical Oncology Breast Cancer Congress.

In April, Sarepta Therapeutics, Inc. SRPT and Roche temporarily halted several clinical studies for Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with Duchenne muscular dystrophy.

The company reported a patient death following treatment with Elevidys, having suffered acute liver failure.

In April, Roche’s MUSETTE Phase 3 trial of a high dose of Ocrevus (ocrelizumab) intravenous infusion for relapsing multiple sclerosis did not meet its primary endpoint in showing additional benefit in slowing disability progression compared with the currently approved Ocrevus IV 600 mg dose.

Price Action: RHHBY stock is trading at $38.34 at the last check on Tuesday.

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