Roche's ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative br...
01 Abril 2019 - 2:00AM
F. Hoffmann-La Roche Ltd / Roche's ipatasertib in combination
with Tecentriq and chemotherapy shows promising anti-tumour
activity in triple-negative breast cancer in early phase trial .
Processed and transmitted by West Corporation. The issuer is solely
responsible for the content of this announcement.
-
Data from Phase Ib study to be
presented at American Association for Cancer Research (AACR) 2019
annual congress
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73% overall response rate (ORR)
irrespective of PD-L1 status or PI3KCA/AKT1/PTEN alteration
status
Basel, 01 April 2019 - Roche (SIX: RO, ROG; OTCQX:
RHHBY) will today present the initial results from a Phase Ib study
evaluating the efficacy and safety for the combination of
ipatasertib, Tecentriq® (atezolizumab) and chemotherapy (paclitaxel
or nab-paclitaxel (Abraxane® [paclitaxel
albumin-bound particles for injectable suspension]) as a first-line
treatment option for people with advanced triple-negative breast
cancer (TNBC). Combination treatment demonstrated a confirmed
objective response rate (ORR) of 73% (95% CI 53-88%), irrespective
of tumour biomarker status. The median duration of follow-up was
6.1 months (range 3.1-10.6). Grade >=3 adverse events occurred
in 14 people (54%); the most common all-grade adverse events were
diarrhea (88%; grade >=3 19%) and rash (69%; grade >=3
27%).
"We are enthusiastic about the potential of this combination in
triple-negative breast cancer, an aggressive type of breast
cancer," said Sandra Horning, MD, Roche's Chief Medical
Officer and Head of Global Product Development. "These early
results support the contribution of ipatasertib to our combination
treatment approach in TNBC and reinforce our vision to develop
medicines that may benefit patients with this challenging
disease."
Preliminary efficacy data for the first 26 patients (18 paclitaxel,
8 nab-paclitaxel) show confirmed responses in
19/26 patients, giving a confirmed ORR of 73%. Responses were seen
irrespective of PD-L1 status (9/11 [82%] PD-L1+; 6/8 [75%] PD-L1-;
4/7 [57%] PD-L1 unknown) or PIK3CA/AKT1/PTEN
alteration status (5/7 [71%] Dx+, 9/11 [82%] Dx-; 5/8 [63%] Dx
unknown).
Activation of the PI3K/AKT pathway has been implicated in
resistance to chemotherapies and hormonal therapies in multiple
tumour types and loss of PTEN, a negative regulator of AKT, has
emerged as a potential mechanism for resistance to checkpoint
inhibitor therapy. By inhibiting the PI3K/AKT pathway, ipatasertib
may contribute to reversal of T-cell-mediated immunotherapy
resistance. These results and the potential benefit that
ipatasertib plus the Tecentriq/taxane combination may bring to
patients are encouraging and add to the Roche development program
in triple-negative breast cancer following the approval of the
Tecentriq combination.
Trial enrolment for the Phase 1b study is ongoing. Later this year,
Roche will initiate a pivotal multi-center, randomised,
double-blind Phase III study investigating the combination of
ipatasertib, atezolizumab and paclitaxel as first-line
therapy for locally advanced/metastatic triple-negative breast
cancer.
About the study
The Phase Ib study is an open-label, multicentre study evaluating
the safety and efficacy of ipatasertib in combination with
atezolizumab and paclitaxel or nab-paclitaxel
for patients with locally advanced or metastatic triple-negative
breast cancer who have not previously received chemotherapy in the
advanced setting. Two triplets: ipatasertib in combination with
atezolizumab and paclitaxel (Paclitaxel arm) and ipatasertib in
combination with atezolizumab and nab-paclitaxel (nab-Paclitaxel
arm) are being evaluated for first-line treatment for advanced
TNBC. A second cohort, which is enrolling now, will allow
collection of tumour biopsies to assess treatment-related biomarker
changes in TNBC patients who have progressed after at least one
line of chemotherapy in the advanced setting.
About ipatasertib
Ipatasertib is an oral, highly specific, investigational medicine
designed to target and bind to all three isoforms of AKT, which
blocks the PI3K/AKT signaling pathway and may prevent cancer cell
growth and survival.
Ipatasertib is being studied in tumours that are frequently found
to have activation of the PI3K/AKT pathway, including breast and
prostate cancers. Pivotal studies are ongoing to evaluate the
efficacy and safety of ipatasertib and the opportunity it may
provide to address significant unmet needs for patients with these
diseases. Ipatasertib has demonstrated clinically meaningful
activity in both breast and prostate cancers, with a manageable
safety profile.
Ipatasertib was discovered at Genentech in partnership with Array
BioPharma Inc.
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 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;4] It is
defined by the lack of expression and/or amplification of the
targetable receptors for oestrogen, progesterone and HER2
amplification.[5] Patients
with metastatic TNBC generally experience rapid progression and
shorter overall survival (OS) compared to other subtypes of breast
cancer.[3]
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 the 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-postive breast cancer and, through our Tecentriq and
ipatasertib clinical programmes, we hope to bring new treatment
combinations to people with breast cancer, ultimately improving
outcomes.
In the United States Tecentriq in combination with nab-paclitaxel
is approved for treatment of PD-L1-positive metastatic
triple-negative breast cancer. Roche currently has seven phase III
studies in TNBC.
About Roche
Roche is a
global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths
of pharmaceuticals and diagnostics under one roof have made Roche
the leader in personalised healthcare - a strategy that aims to fit
the right treatment to each patient in the best way
possible.
Roche is the world's largest biotech company, with truly
differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and diseases of the central nervous system.
Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management.
Founded in 1896, Roche continues to search for better ways to
prevent, diagnose and treat diseases and make a sustainable
contribution to society. The company also aims to
improve patient access to medical innovations by working with
all relevant stakeholders. Thirty medicines developed by Roche are
included in the World Health Organization Model Lists of Essential
Medicines, among them life-saving antibiotics, antimalarials and
cancer medicines. Moreover, for the tenth consecutive year, Roche
has been recognised as the most sustainable company in the
Pharmaceuticals Industry by the Dow Jones Sustainability Indices
(DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in
over 100 countries and in 2018 employed about 94,000 people
worldwide. In 2018, Roche invested CHF 11 billion in R&D and
posted sales of CHF 56.8 billion. 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 www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
References
[1] Breast Cancer
Factsheet. World Health Organization. Available from:
http://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf
Accessed February 2019.
[2] Yao H et al. Triple-negative breast cancer: is there a
treatment on the horizon? Oncotarget.
2017;8(1):1913-1924.
[3] What is Triple-Negative Breast Cancer? BreastCancer.org.
Available from:
https://www.breastcancer.org/symptoms/diagnosis/trip_neg?what
Accessed February 2019.
[4] Triple negative breast cancer risk factors. Cancer Treatment
Centers of America. Available from:
https://www.cancercenter.com/breast-cancer/risk-factors/tab/triple-negative-breast-cancer-risk-factors/
Accessed February 2019.
[5] Pal SK et al. Triple negative breast cancer: unmet medical
needs. Breast Cancer Res Treat. 2011;125(3):627-636.
Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail:
media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
20190401_Ipatasertib_EN
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Source: F. Hoffmann-La Roche Ltd via Globenewswire
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