F. Hoffmann-La Roche Ltd / Roche's Tecentriq in combination with
Abraxane improves outcomes as an initial treatment for people with
PD-L1-positive metastatic triple-negative breast cancer . Processed and
transmitted by West Corporation. The issuer is solely responsible for
the content of this announcement.
-- Tecentriq combination first immunotherapy regimen to demonstrate positive
Phase III results in breast cancer
-- Tecentriq and nab-paclitaxel significantly reduced the risk of disease
worsening or death in both the intention-to-treat and PD-L1-positive
populations
-- Clinically meaningful overall survival improvement in the PD-L1-positive
population at this interim analysis
-- Data are being presented at the European Society for Medical Oncology
(ESMO) 2018 Congress, featured in the press programme and simultaneously
published in the New England Journal of Medicine on 20 October 2018
Basel, 20 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today
announced positive results from the Phase III IMpassion130 study of
Tecentriq(R) (atezolizumab) plus chemotherapy (Abraxane(R)
[albumin-bound paclitaxel; nab-paclitaxel]) for the initial (first-line)
treatment of unresectable locally advanced or metastatic triple-negative
breast cancer (TNBC). 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.
"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) 2018 Congress Presidential Symposium at 16:30 - 16.45 pm
CEST (abstract LBA1_PR) and will also be featured in the official ESMO
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:
PD-L1-positive population ITT population
(programmed death-ligand 1 expression >=1% on IC) (intention-to-treat)
Placebo + Placebo +
Tecentriq + nab-paclitaxel nab-paclitaxel Tecentriq + nab-paclitaxel nab-paclitaxel
n=185 n=184 n=451 n=451
Number of
patients 369 (40.9%) 902
PFS (co-primary endpoint)
Median (months) 7.5 5.0 7.2 5.5
(95% CI) (6.7, 9.2) (3.8, 5.6) (5.6, 7.5) (5.3, 5.6)
Stratified HR
(95% CI) 0.62 (0.49,0.78) 0.80 (0.69,0.92)
Stratified
p-value<0.0001 0.0025
OS (co-primary endpoint)
Median (months) 25.0 15.5 21.3 17.6
(95% CI) (22.6, NE) (13.1, 19.4) (17.3, 23.4) (15.9, 20.0)
Stratified HR
(95% CI) 0.62 (0.45,0.86) 0.84 (0.69,1.02)
Stratified
p-value Results were not formally tested 0.0840
ORR (secondary endpoint)
Responders 59% 43% 56% 46%
95% CI 51%, 66% 35%, 50% 51%, 61% 41%, 51%
Stratified 0.0016 0.0021
p-value Not significant (alpha=0.001) Not significant (alpha=0.001)
Adverse events
The nature and incidence of severe adverse events
(SAEs) and Grade 3-4 adverse events (AEs) were consistent
with the known safety profile of the individual study
drugs or the underlying disease.
-- SAEs were reported in 23% of people receiving
Tecentriq plus nab-paclitaxel compared to 18% of
people receiving chemotherapy alone. SAEs occurring
in 1% or more of people receiving Tecentriq plus
nab-paclitaxel were pneumonia (2%), urinary tract
infection (1%), difficulty breathing (dyspnea, 1%)
and fever (pyrexia, 1%).
-- Grade 3-4 AEs were reported in 49% of people
receiving Tecentriq plus nab-paclitaxel compared to
42% of people receiving chemotherapy alone. The most
common Grade 3-4 AEs in people receiving Tecentriq
plus nab-paclitaxel were an abnormal low count of a
certain type of white blood cell (neutropenia, 8%);
decreased neutrophil count (5%); numbness, tingling
or pain in the hands or feet (peripheral neuropathy,
6%); fatigue (4%); and decrease in red blood cells
(anaemia, 3%). Peripheral neuropathy was the only
Grade 3-4 AE reported with a 2% or higher incidence
in people receiving Tecentriq plus nab-paclitaxel
compared to people receiving chemotherapy alone (6%
vs. 3%).
Multimedia assets
: https://www.roche.com/dam/jcr:83655b86-48ca-4a3c-93e4-ebcb28568307/en/breast-cancer-tnbc.pdf https://www.roche.com/dam/jcr:d42b5b04-64b1-4b26-a4a8-29d85d06c20f/en/the-unmet-need.mp4
Learn more about triple-negative breast cancer, which Professor Peter Schmid discusses the unmet need in
affects 15% of all breast cancer cases: https://www.roche.com/dam/jcr:83655b86-48ca-4a3c-93e4-ebcb28568307/en/breast-cancer-tnbc.pdf triple-negative breast cancer https://www.roche.com/dam/jcr:d42b5b04-64b1-4b26-a4a8-29d85d06c20f/en/the-unmet-need.mp4
https://www.roche.com/dam/jcr:8762997f-5579-40f9-b7cc-e680cd81cec6/en/overview-IMpassion130.mp4 https://www.roche.com/dam/jcr:fae35beb-9d14-437e-8f67-3535697e59a6/en/the-IMpassion130-design.mp4
Professor Peter Schmid provides an overview of the Professor Peter Schmid describes the IMpassion130
IMpassion130 study results https://www.roche.com/dam/jcr:8762997f-5579-40f9-b7cc-e680cd81cec6/en/overview-IMpassion130.mp4 study design https://www.roche.com/dam/jcr:fae35beb-9d14-437e-8f67-3535697e59a6/en/the-IMpassion130-design.mp4
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
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