Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced results from a Phase I open-label study that showed the
investigational cancer immunotherapy MPDL3280A (anti-PDL1) shrank tumors
(overall response rate) in 43 percent (13/30) of people previously
treated for metastatic urothelial bladder cancer (UBC) whose tumors were
characterized as PD-L1 (Programmed Death Ligand-1) positive by a test
being developed by Roche. Adverse events (AEs) were consistent with what
has been previously reported for MPDL3280A. There were no severe (Grade
4-5) treatment-related AEs.
The FDA has granted MPDL3280A Breakthrough Therapy Designation. This
designation is designed to expedite the development and review of
medicines intended to treat serious diseases and to help ensure patients
have access to them through FDA approval as soon as possible.
“Bladder cancer is the ninth most common cancer worldwide, for which
there have been no new treatment advances in nearly 30 years, so we are
pleased the FDA has granted breakthrough designation for MPDL3280A in
metastatic bladder cancer,” said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. “We are evaluating
MPDL3280A in a broad range of tumors, and have begun pivotal studies
that include a companion diagnostic test in lung and bladder cancers.”
Full results of the study will be presented today at the 50th Annual
Meeting of the American Society of Clinical Oncology (ASCO) by Thomas
Powles, M.D., clinical professor of Genitourinary Oncology, Barts Cancer
Institute at the Queen Mary University of London, United Kingdom
(Abstract #5011, Saturday, May 31, 3:36–3:48 p.m. CDT).
About the Phase I MPDL3280A Study
-
The Phase I study is a single-arm, multi-center, open-label trial with
a cohort of 68 people with previously treated, metastatic bladder
cancer.
-
The study included 30 patients who were identified as PD-L1 positive
(immunohistochemistry [IHC] 2/3) using an investigational PD-L1
diagnostic test being developed by Roche.
-
After six weeks of follow-up, the objective response rate (ORR) as
measured by RECIST criteria was 43 percent (13/30), and after 12
weeks, ORR was 52 percent (13/25) in people with PD-L1-positive tumors.
-
A complete response (no radiographic evidence of tumor) was
observed in 7 percent of PD-L1-positive people (2/30).
-
The ORR was 11 percent (4/35) in people whose tumors were
identified as PD-L1-negative (IHC 0/1) by our investigational test.
-
People in the study experienced a median time to response of 42
days.
-
Treatment-related Grade 3 AEs occurred in 4 percent (3/68) of people
in the study and included weakness (asthenia; 2 percent), low platelet
count (thrombocytopenia; 2 percent) and low phosphate levels (blood
phosphorus decrease; 2 percent).
-
The most common AEs observed to date occurring in more than 5 percent
of people in the study were decreased appetite (12 percent), fatigue
(12 percent), nausea (12 percent), fever (pyrexia; 9 percent) and
weakness (asthenia; 7 percent).
About MPDL3280A (anti-PDL1)
MPDL3280A (also known as anti-PDL1) 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, restoring their ability to effectively detect and attack tumor
cells.
About Bladder Cancer
Metastatic urothelial bladder cancer is associated with a poor prognosis
and limited treatment options. According to the American Cancer Society
(ACS), it is estimated that more than 74,000 Americans will be diagnosed
with bladder cancer in 2014, and approximately 15,000 of new diagnoses
are made when bladder cancer is in advanced stages. There is a dramatic
difference in survival rates between early and advanced bladder cancer.
The ACS estimates that approximately 15 percent of people with advanced
bladder cancer (stage IV) will live for five years, compared to 88
percent when diagnosed during stage I. Men are about three to four times
more likely to get bladder cancer during their lifetime than women.
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, which include the evaluation of biomarkers
to determine which people may be appropriate candidates for our
medicines.
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.
Copyright Business Wire 2014