Genentech’s Investigational Immunotherapy MPDL3280A Doubled the Likelihood of Survival Compared with Chemotherapy in People...
May 13 2015 - 5:00PM
Business Wire
-- Results indicated PD-L1 expression
correlated with how well people with previously treated, advanced
non-small cell lung cancer did on MPDL3280A --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced interim results from a global, randomized
Phase II study (POPLAR) in people with previously treated non-small
cell lung cancer (NSCLC). The study showed the investigational
cancer immunotherapy MPDL3280A (anti-PDL1) doubled the likelihood
of survival (overall survival [OS]; hazard ratio [HR]=0.47) in
people whose cancer expressed the highest levels of PD-L1
(programmed death ligand-1) compared with docetaxel chemotherapy.
An improvement in survival was also observed in people who had
medium and high (HR=0.56) or any level of PD-L1 expression
(HR=0.63), as characterized by a test being developed by Roche.
MPDL3280A was generally well tolerated and adverse events were
consistent with what has been previously reported for MPDL3280A in
NSCLC. Updated results will be presented in an oral session at the
51st Annual Meeting of the American Society of Clinical Oncology
(ASCO).
“In our study of MPDL3280A in previously treated lung cancer,
the amount of PD-L1 expressed by a person’s cancer correlated with
improvement in survival,” said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. “The goal of PD-L1
as a biomarker is to identify people most likely to experience
improved overall survival with MPDL3280A alone, and which people
may be appropriate candidates for a combination of medicines.”
In February 2015, MPDL3280A received Breakthrough Therapy
Designation from the U.S. Food and Drug Administration (FDA) for
the treatment of people whose NSCLC expresses PD-L1 and who
progressed during or after standard treatments (e.g.,
platinum-based chemotherapy and appropriate targeted therapy for
EGFR mutation-positive or ALK-positive disease). Genentech is
discussing the interim data from POPLAR with the FDA as part of
Breakthrough Therapy Designation in lung cancer. Genentech
currently has three Phase II and six Phase III studies of MPDL3280A
ongoing in various kinds of lung cancer.
About the POPLAR Study
Interim results of the POPLAR study will be presented by Dr.
Alexander I. Spira, Virginia Cancer Specialists Research Institute,
U.S. Oncology Research (Abstract #8010, Sunday, May 31, 4:42-4:54
P.M. CDT): Efficacy, safety and predictive biomarker results from a
randomized Phase II study comparing MPDL3280A vs docetaxel in 2L/3L
NSCLC (POPLAR).
The Phase II study enrolled 287 people with previously treated,
advanced NSCLC. The primary endpoint was OS; secondary endpoints
included progression-free survival (PFS), overall response rate
(ORR) and safety. People were stratified by PD-L1 expression on
tumor-infiltrating immune cells (IC), histology and prior lines of
therapy. PD-L1 expression was assessed on both tumor cells (TC) and
IC; and people were scored as TC 0, 1, 2 or 3 and IC 0, 1, 2 or 3
with an immunohistochemistry (IHC) test.
Overall Survival Results (Primary Endpoint) Study
Group
TC3 or IC3
(High)
TC2/3 or IC2/3
(Medium and
High)
TC1/2/3 or
IC1/2/3 (Any
Expression)
TC0 and IC0
ITT
(All Patients)
n= MPDL
24
Doc
23
MPDL
50
Doc
55
MPDL
93
Doc
102
MPDL
51
Doc
41
MPDL
144
Doc
143
Median OS (months) NR 11.1 13
7.4 NR 9.1 9.7 9.7 11.4
9.5
HR*(95% CI)
0.47
(0.20, 1.11)
0.56
(0.33, 0.95)
0.63
(0.42, 0.95)
1.22
(0.69, 2.14)
0.78
(0.59, 1.03)
CI: confidence interval; Doc: docetaxel; HR: hazard ratio; IC:
tumor-infiltrating immune cell; ITT: intention to treat; MPDL:
MPDL3280A; NR: not reached; OS: overall survival; TC: tumor cell.
*Stratified HR for ITT and unstratified HR for subgroups.
Progression-Free Survival (Secondary Endpoint)
Study Group
TC3 or IC3
(High)
TC2/3 or IC2/3
(Medium and
High)
TC1/2/3 or
IC1/2/3
(Any
Expression)
TC0 and IC0
ITT
(All Patients)
n= MPDL
24
Doc
23
MPDL
50
Doc
55
MPDL
93
Doc
102
MPDL
51
Doc
41
MPDL
144
Doc
143
Median PFS
(months)
9.7 3.9 4.0 2.8 3.3 3.0
1.9 4.1 2.8 3.4
HR* (95% CI)
0.56
(0.28, 1.11)
0.70
(0.45, 1.08)
0.87
(0.63, 1.20)
1.15
(0.72, 1.82)
0.96
(0.76, 1.20)
Overall Response Rate (Secondary Endpoint) ORR (%)
38 13 22 15 18 18 8
10 15 15
HR: hazard ratio; ITT: intention to treat; NR: not reached.
*Stratified HR for ITT and unstratified HR for subgroups.
Fewer people receiving MPDL3280A experienced Grade 3 to 5
adverse events compared to docetaxel (44% vs. 56%). More
respiratory events were reported for MPDL3280A. The median length
of treatment with MPDL3280A was 3.7 months compared to 2.1 months
for chemotherapy. Other immune-related adverse events in the
MPDL3280A arm included increase of enzyme levels in the blood
(aspartate and alanine aminotransferase; 4% each), inflammation in
the lining of the colon (colitis; 1%), inflammation of the liver
(hepatitis; 1%) and lung tissue (pneumonitis; 2%).
About MPDL3280A
MPDL3280A (also known as anti-PDL1 and RG7446) is an
investigational monoclonal antibody designed to interfere with a
protein called PD-L1. MPDL3280A is designed to target PD-L1
expressed on tumor cells and tumor-infiltrating immune cells,
preventing it from binding to PD-1 and B7.1 on the surface of T
cells. By inhibiting PD-L1, MPDL3280A may enable the activation of
T cells.
About Lung Cancer
According to the American Cancer Society, it is estimated that
more than 221,000 Americans will be diagnosed with lung cancer in
2015, and NSCLC accounts for 85 percent of all lung cancers. It is
estimated that approximately 60 percent of lung cancer diagnoses in
the United States are made when the disease is in the advanced
stages.
About Genentech in Lung Cancer
Lung cancer is a major area of focus and investment for
Genentech, and we are committed to developing new approaches,
medicines and tests that can help people with this deadly disease.
Our goal is to provide an effective treatment option for every
person diagnosed with lung cancer. We currently have two approved
medicines to treat certain kinds of lung cancer and more than 10
medicines being developed to target the most common genetic drivers
of lung cancer or to boost the immune system to combat the
disease.
About Genentech in Cancer Immunotherapy
For more than 30 years, Genentech has been developing medicines
with the goal to redefine treatment in oncology. Today, we’re
investing more than ever in our effort to bring innovative
treatment options that help a person’s own immune system fight
cancer. Our Personalized Cancer Immunotherapy research and
development program comprises more than 20 investigational
candidates, seven of which are in clinical trials. All studies
include the evaluation of biomarkers to determine which people may
be appropriate candidates for our medicines. For more information
visit http://www.gene.com/immunotherapy.
About Genentech
Founded more than 35 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious or
life-threatening medical conditions. The company, a member of the
Roche Group, has headquarters in South San Francisco, California.
For additional information about the company, please visit
http://www.gene.com.
GenentechMedia Contact:Holli Dickson, 650-467-6800Advocacy
Contact:Sonali Padhi, 650-467-0842Investor Contacts:Stefan Foser,
650-467-2016Karl Mahler, 011 41 61 687 8503
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