On June 3, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from a number of abstracts highlighting studies including the treatment of both PD-L1-positive triple-negative and HER2-positive breast cancer at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, 31 May – 4 June, in Chicago, United States (Press release, Hoffmann-La Roche, JUN 3, 2019, View Source [SID1234536789]). Data include results from the second overall survival (OS) interim analysis from the phase III IMpassion130 study evaluating Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the initial (first-line) treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).1 In HER2-positive breast cancer, results of an end-of-study analysis of the phase III CLEOPATRA study will also be presented, evaluating the long-term efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and docetaxel chemotherapy (the Perjeta-based regimen) in patients with previously untreated HER2-positive metastatic breast cancer (mBC).2

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"Our science-driven approach has been transforming standards of care in breast cancer for more than 20 years, and we are excited to present data from a Perjeta study, that showed an unprecedented survival benefit for patients living with advanced HER2-positive disease," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are continuing our transformative work in breast cancer, presenting updated interim overall survival results from our phase III Tecentriq combination, the first positive immunotherapy study in PD-L1-positive metastatic triple-negative breast cancer, a disease with high unmet need."

TNBC is a form of breast cancer representing approximately 15% of all cases.3,4 Metastatic TNBC is one of the most aggressive and difficult-to-treat forms of breast cancer.3,4 HER2-positive disease is another particularly aggressive form of breast cancer accounting for approximately 15-20% of all cases of breast cancer.5

IMpassion130 study results
Results presented at ASCO (Free ASCO Whitepaper) were consistent with the first interim analysis reported at the European Society for Medical Oncology congress in October 2018.1,6 At the second interim analysis, statistical significance was not met for overall survival (OS) in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72-1.02, p=0.078).1 However, Tecentriq and nab-paclitaxel showed a clinically meaningful OS improvement of seven months vs placebo and nab-paclitaxel in patients who were tested positively for PD-L1 expression on tumour-infiltrating immune cells (median OS=25.0 vs 18.0 months; HR=0.71, 95% CI: 0.54-0.93) with more mature data.1 OS results in the PD-L1-positive population were not formally tested due to the prespecified hierarchical analysis plan of the study. Over half (51% (43-59%)) of PD-L1-positive metastatic TNBC patients in the Tecentriq arm were alive at two years, compared with 37% (29-45%) in the control arm. Follow-up will continue until the next planned analysis.1

Additional analyses of patient-reported outcomes from IMpassion130 showed that the combination was well-tolerated, similarly to nab-paclitaxel alone.7 Tecentriq plus nab-paclitaxel showed gains in clinical benefit without compromising patients health-related quality of life (HRQoL), day-to-day functioning and without increasing patients toxicity burden compared to nab-paclitaxel alone.7 HRQoL evaluates the overall impact of disease and treatment on patient’s quality of life in terms of disease related symptoms, treatment side effects and function/well-being. An expanded safety analysis showed that the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles from the primary data with no new safety signals observed.8

CLEOPATRA study results
After a follow-up of eight years, results from the phase III CLEOPATRA study, investigating patients with previously untreated HER2-positive mBC, showed a median OS benefit of 57.1 months in the Perjeta arm compared with 40.8 months in the control arm (placebo, Herceptin and chemotherapy), an absolute improvement of 16.3 months, with a 31% overall reduction in the risk of death (HR=0.69, 95% CI 0.58-0.82, p<0.0001).2

These new data are consistent with previously published results and confirm that the unprecedented OS benefit of the Perjeta-based regimen was maintained after an additional four years of follow-up.2 Significantly, over a third (37%) of HER2-positive mBC patients in the Perjeta arm were alive at eight years, compared with 23% in the control arm.2 Safety data from the long-term follow-up study were consistent, and showed that the cardiac and overall safety profiles of the Perjeta-based regimen were maintained.2

Additionally, data from the Chinese phase III PUFFIN study were presented at this year’s meeting further confirming the use of the Perjeta-based regimen in HER2-positive mBC, as results were consistent with those seen in the CLEOPATRA study.9

Roche’s breadth of expertise continues to advance breast cancer research with the goal of expanding treatment options to improve the lives of patients living with the disease worldwide.

About the IMpassion130 study
The IMpassion130 study is a phase III, multicentre, randomised, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for mBC. The study enrolled 902 people who were randomised equally (1:1). The co-primary endpoints are progression-free survival (PFS) per investigator assessment (RECIST 1.1) in the ITT population and in the PD-L1-positive population and OS in the ITT population. Secondary endpoints include objective response rate and duration of response.

About the CLEOPATRA Study
CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) was an international, phase III, randomised, double-blind, placebo-controlled study. The study compared the combination of Perjeta, Herceptin and docetaxel chemotherapy with placebo, Herceptin and chemotherapy in 808 people with previously untreated HER2-positive mBC, or with HER2-positive mBC that had come back after prior therapy in the adjuvant or neoadjuvant setting. The primary endpoint of the study was PFS as assessed by an independent review committee. Secondary endpoints included OS and safety profile.

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

Our targeted medicines Herceptin, Perjeta and Kadcyla are continuing to transform the treatment of early and advanced HER2-positive breast cancer and, through our Tecentriq and ipatasertib clinical programmes, we are committed to bring new treatment combinations to people with triple-negative breast cancer, ultimately improving outcomes.