• New data from Phase II NeoSphere study provide additional evidence on the role of Perjeta in the neoadjuvant (pre-surgery) treatment of HER2-positive early breast cancer (eBC)
• These data suggest that the benefit observed with the Perjeta regimen over Herceptin and chemotherapy in the primary analysis of the trial may translate into longer-term improvements in patient outcomes
• The results also add to the body of evidence suggesting an association between pathological complete response (pCR) and longer-term outcomes in patients with HER2-positive eBC
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new results from the Phase II NeoSphere study. The results suggest that Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy given prior to surgery reduced the risk of disease getting worse and increased the time people lived without their cancer returning compared to Herceptin and chemotherapy in people with HER2-positive early breast cancer (eBC). The safety profile of the Perjeta regimen was consistent with that seen in previous studies, and no new safety signals were identified. These data will be presented today at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago by Dr Luca Gianni, Medical Oncology, San Raffaele Hospital, Scientific Institute (Abstract #505).
In the NeoSphere study, both progression-free survival (PFS) and disease-free survival (DFS) were evaluated at three years. The results suggest that people who received the Perjeta regimen prior to surgery were 31 percent less likely to experience disease worsening, recurrence or death (PFS HR=0.69; 95% CI, 0.34–1.40) compared to those who received Herceptin and chemotherapy.1 People treated with the Perjeta regimen were also 40 percent less likely to experience disease recurrence or death (DFS HR=0.60; 95% CI, 0.28–1.27).1 People in the NeoSphere study who were treated in the neoadjuvant setting also received a year of adjuvant treatment with Herceptin plus chemotherapy after their surgery. The results of this analysis are descriptive, as the study was not designed to show statistical significance for three-year PFS and DFS.
“Treating breast cancer early, before it has spread, may help prevent the disease from returning or reaching an advanced stage,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. “These new results add to the body of data for Perjeta in the neoadjuvant setting, and we look forward to the Phase III APHINITY study results to better understand the broader impact of Perjeta in the adjuvant treatment of HER2-positive early breast cancer.”
The results also suggest that people who achieved pCR, i.e. had no tumour tissue detectable at the time of surgery in the affected breast and local lymph nodes, were more likely across all arms of the study to be alive and disease-free at three years (PFS HR=0.54; 95% CI, 0.29–1.00; DFS HR=0.68; 95% CI, 0.36–1.26), supporting the association between pCR and improvements in longer-term outcomes.1
It was previously reported that the Perjeta regimen significantly increased the number of people who achieved pCR compared to Herceptin and docetaxel chemotherapy (39.3 vs. 21.5 percent).2 These new data presented at ASCO suggest that this pCR benefit seen with the combination of Perjeta, Herceptin and chemotherapy may translate into longer-term improvements in patient outcomes.
In 2013, the U.S. Food and Drug Administration (FDA) granted accelerated (or ‘conditional’) approval of the Perjeta regimen for neoadjuvant treatment in people with high-risk, HER2-positive eBC. A full review of data from the ongoing Phase III APHINITY study will be required for the accelerated approval to be converted to a full approval. APHINITY compares Perjeta, Herceptin and chemotherapy with Herceptin and chemotherapy for adjuvant (post-surgery) treatment in people with HER2-positive eBC. Data from APHINITY are expected in 2016.
Roche recently submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for the Perjeta regimen as a neoadjuvant treatment for people with HER2-positive eBC. This submission was based primarily on results from the NeoSphere study, with additional data from the Phase II TRYPHAENA study, as well as longer-term safety data from the Phase III CLEOPATRA study of Perjeta in HER2-positive advanced breast cancer.
About the NeoSphere trial3
The NeoSphere trial (Neoadjuvant Study of Pertuzumab and Herceptin in an Early Regimen Evaluation) is a randomised, multicentre, international Phase II study in 417 people with newly diagnosed HER2-positive, operable, locally advanced, or inflammatory eBC. Participants were randomised to one of four study arms and received four cycles (12 weeks) of neoadjuvant treatment followed by surgery and a year of adjuvant treatment with Herceptin plus chemotherapy. The primary endpoint was pCR. Secondary endpoints included clinical response, time to clinical response, safety profile, PFS, DFS, breast-conserving surgery rate and biomarker assessment.
These new data suggest:1
• PFS rate at three years was 90 percent in the Perjeta-based arm compared to 86 percent in the Herceptin and docetaxel chemotherapy arm (HR=0.69).
• DFS rate was 92 percent in people who received the Perjeta regimen compared to 85 percent in people who received Herceptin and chemotherapy (HR=0.60).
• The safety profile was consistent with the previous studies of Perjeta, and no new safety signals were identified.
Previously reported data from the primary analysis showed:2
•Treatment with Perjeta, Herceptin and docetaxel chemotherapy significantly improved the rate of pCR in the affected breast and local lymph nodes by 17.8 percent compared to Herceptin and chemotherapy alone (39.3 vs. 21.5 percent, p=0.0063).
- pCR of 21.5 percent for Herceptin and chemotherapy
- pCR of 39.3 percent for Perjeta, Herceptin and chemotherapy
- pCR of 11.2 percent for Perjeta and Herceptin
- pCR of 17.7 percent for Perjeta and chemotherapy
• The Perjeta regimen was not associated with a significant increase in adverse events (AEs), compared to Herceptin and chemotherapy alone.
• The most common severe (Grade 3 or higher) AEs for the Perjeta regimen were neutropenia (decrease in a certain type of white blood cell, 44.9 percent), febrile neutropenia (fever associated with decrease in a certain type of white blood cell, 8.4 percent), leukopenia (decrease in overall white blood cells, 4.7 percent) and diarrhoea (5.6 percent).
About Perjeta
Perjeta is a medicine that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Perjeta is designed specifically to prevent the HER2 receptor from pairing (or ‘dimerising’) with other HER receptors (EGFR/HER1, HER3 and HER4) on the surface of cells, a process that is believed to play a role in tumour growth and survival. Binding of Perjeta to HER2 may also signal the body’s immune system to destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive blockade of HER signalling pathways, thus preventing tumour cell growth and survival.
About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival for people with both early and advanced HER2-positive disease.
Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 20 percent of patients.4 Over the past 15 years, the outlook for people with HER2-positive disease has improved to the extent that those with this form of the disease treated with these innovative medicines now typically experience better outcomes than people with less aggressive HER2- negative disease.5
Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, saving time from the outset by identifying patients who will likely benefit from these medicines at the onset of their disease.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit roche.com.
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