Roche to present data from across its breast cancer portfolio at ASCO Meeting.

Pharmaceutical

Roche presents new and updated 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 Annual Meeting, 31 May – 4 June, in Chicago, United States. 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]

“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.”

“Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting“

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 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

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