Roche's Perjeta plus Herceptin and Chemotherapy Demonstrates 16.3-Month Overall Survival Benefit in HER2-Positive Metastatic Breast Cancer: 8-Year Follow-Up Data from Phase III CLEOPATRA Study

June 06, 2019 /BioValleyBIOON/ -- Swiss pharmaceutical giant Roche recently held the 2019 American Clinical in ChicagoTumorpresented at the American Society of Clinical Oncology (ASCO) Annual MeetingBreast CancerLatest Data from the Phase III CLEOPATRA Clinical Study.

This international, randomized, double-blind, placebo-controlled study enrolled a total of 808 patients with HER2-positive metastatic breast cancer (mBC) who had not received prior treatment for metastatic disease or who had relapsed after previous adjuvant or neoadjuvant therapy. The study evaluated the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel chemotherapy (the Perjeta regimen), compared with placebo plus Herceptin and chemotherapy (the control regimen).

Results presented at this year’s ASCO Annual Meeting showed that, after 8 years of follow-up, the Perjeta group achieved a statistically significant 16.3-month improvement in overall survival (OS) compared with the control group (median OS: 57.1 months vs. 40.8 months), with a 31% significant reduction in the risk of death (HR=0.69, 95% CI: 0.58–0.82; p<0.0001).

These new data are consistent with previously reported results and confirm that the Perjeta regimen maintained an unprecedented overall survival (OS) benefit after an additional 4 years of follow-up. Notably, more than one-third (37%) of patients with HER2-positive metastatic breast cancer (mBC) in the Perjeta regimen group were still alive at 8 years, compared with 23% in the control group. The safety data from the long-term follow-up study were consistent, indicating that the Perjeta regimen maintained a favorable cardiac and overall safety profile.

Furthermore, data from the Chinese Phase III PUFFIN study were also presented at the ASCO Annual Meeting. The results were consistent with those of the CLEOPATRA study, further confirming the superior efficacy and safety of the Perjeta regimen in patients with HER2-positive metastatic breast cancer (mBC).

Breast cancer is the most common type of cancer in women, with over 2 million new cases diagnosed globally each year. HER2-positive breast cancer is a particularly aggressive subtype, accounting for approximately 15–20% of all breast cancer cases. Among patients with HER2-positive early breast cancer (eBC) treated with Herceptin plus chemotherapy, approximately one-quarter experience disease recurrence or death within 10–11 years, with even higher rates of recurrence or death observed in those with high-risk eBC.

Perjeta is a novel anti-HER2 agent that exerts its anti-HER2 effects by inhibiting both heterodimerization and homodimerization of HER2. Perjeta and Herceptin share the same mechanism of action, as both target and bind to the HER2 receptor, albeit at different epitopes. The combination of these two agents provides more comprehensive blockade of the HER2 signaling pathway, thereby inhibiting cancer cell growth and survival.

In the United States and the European Union, the Perjeta + Herceptin + chemotherapy regimen has been approved for: (1) neoadjuvant treatment of HER2-positive early breast cancer (eBC); (2) adjuvant treatment of HER2-positive eBC at high risk of recurrence; and (3) treatment of HER2-positive advanced breast cancer (aBC), where it significantly prolongs patient survival compared with Herceptin plus chemotherapy.

In China, the Perjeta + Herceptin + chemotherapy regimen was approved in December 2018 for the adjuvant treatment of patients with HER2-positive early breast cancer (eBC) at high risk of recurrence. This approval marks the advent of a new era in breast cancer treatment in China! Data from the global pivotal Phase III adjuvant therapy study demonstrated that, compared with the current standard of care (Herceptin + chemotherapy), adjuvant therapy with the Perjeta + Herceptin + chemotherapy regimen significantly prolonged invasive disease-free survival in patients with HER2-positive eBC at high risk of recurrence.Adverse ReactionsControllable, with a clear clinical benefit/risk advantage. (Bioon.com)

Original Source:Roche Official Website