Roche's Patritumab Shows 17% Survival Benefit in Early Breast Cancer

Roche has announced the final overall survival (OS) results from its Phase III APHINITY study, which focused on patients with early-stage, HER2-positive breast cancer. The ten-year data showed a statistically significant reduction in the risk of death by 17% for patients who received Patritumab (Perjeta) in combination with Herceptin (trastuzumab) and chemotherapy as adjuvant treatment, compared to those who received Herceptin, chemotherapy, and a placebo.

The APHINITY study (NCT01358877/BO25126/BIG4-11) was a global, Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Patritumab in combination with Herceptin and chemotherapy as adjuvant treatment, compared to Herceptin and chemotherapy alone. The study enrolled 4,804 patients with operable, HER2-positive early breast cancer. The primary endpoint was invasive disease-free survival, with secondary endpoints including cardiac and overall safety, overall survival, and health-related quality of life.

The ten-year results demonstrated that patients treated with the Patritumab regimen had a ten-year survival rate of 91.6%, compared to 89.8% for those who received Herceptin, chemotherapy, and a placebo (hazard ratio [HR]=0.83, 95% CI: 0.69-1.00, p-value=0.044). In the predefined node-positive patient subgroup, the risk of death was reduced by 21% (HR=0.79, 95% CI: 0.64-0.97). The previously reported invasive disease-free survival benefit was maintained (HR=0.79, 95% CI: 0.68-0.92). No benefit was observed in the node-negative subgroup. Safety, including cardiac safety, was consistent with previous findings, with no new or unexpected safety signals identified.

These results are a significant milestone for Roche, demonstrating the long-term benefits of Patritumab in improving survival outcomes for patients with early-stage, HER2-positive breast cancer. The data supports the use of Patritumab as an adjuvant treatment option, potentially changing the standard of care for these patients. The findings also highlight the importance of long-term follow-up in clinical trials to fully assess the benefits of new therapies.

The implications of these results extend to the broader breast cancer community, offering new hope for patients and healthcare providers. The high survival rate achieved with Patritumab suggests that targeted therapies may offer significant advantages over traditional treatments. This could influence future treatment guidelines and protocols, leading to improved patient outcomes. Roche's commitment to advancing cancer treatments is evident in these results, which could pave the way for further research and development in this area.