On October 20, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported positive results from the Phase III IMpassion130 study of Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line) treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) (Press release, Hoffmann-La Roche, OCT 20, 2018, View Source [SID1234530313]). The Tecentriq and chemotherapy combination significantly reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in all randomised patients (intention-to-treat [ITT]) (median PFS=7.2 vs. 5.5 months; hazard ratio [HR]=0.80, 95% CI: 0.69-0.92, p=0.0025) and the PD-L1-positive population (median PFS=7.5 vs. 5.0 months; HR=0.62, 95% CI: 0.49-0.78, p<0.0001), a subgroup determined by PD-L1 biomarker testing. At this interim analysis, statistical significance was not met for overall survival (OS) in the ITT population (median OS=21.3 vs 17.6 months; HR=0.84, 95% CI: 0.69-1.02, p=0.0840), but showed a clinically meaningful 9.5-month OS improvement in the PD-L1-positive population (median OS=25.0 vs 15.5 months; HR=0.62, 95% CI: 0.45-0.86). Due to the hierarchical statistical design, results in the PD-L1-positive population were not formally tested. Follow-up will continue until the next planned analysis. Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.
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"These important results in people with metastatic triple-negative breast cancer whose disease expresses the PD-L1 protein are highly encouraging and represent a significant step forward in the treatment of this challenging disease," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We have shared the IMpassion130 results with global health authorities with the hope of bringing this Tecentriq combination to people with PD-L1-positive, metastatic triple-negative breast cancer as soon as possible."
These data are being presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress Presidential Symposium at 16:30 – 16.45 pm CEST (abstract LBA1_PR) and will also be featured in the official ESMO (Free ESMO Whitepaper) press programme at 08:15 –09:00 am CEST. These results will simultaneously be published in the New England Journal of Medicine.
Currently, Roche has seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease.
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 metastatic breast cancer (mBC). The study enrolled 902 people who were randomised equally (1:1).
The co-primary endpoints are PFS per investigator assessment (RECIST 1.1) and OS. PFS and OS were assessed in all randomised patients (ITT) and in the PD-L1-positive population. Secondary endpoints include objective response rate (ORR), duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.
A summary of the key study results is included below:
About triple-negative breast cancer
Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.[1] TNBC represents approximately 15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.[2;3] It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification.[4;5] Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer.[6]
About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.
Tecentriq is already approved in the European Union, United States and more than 80 countries for people with previously treated metastatic non-small cell lung cancer (NSCLC) and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).
Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
