Galera Announces Results of Phase 3 ROMAN Trial of Avasopasem for Radiotherapy-Induced Severe Oral Mucositis
October 19 2021 - 7:00AM
Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage
biopharmaceutical company focused on developing and commercializing
a pipeline of novel, proprietary therapeutics that have the
potential to transform radiotherapy in cancer, today announced
results from the Phase 3 ROMAN trial of avasopasem manganese
(avasopasem) for severe oral mucositis (SOM) in patients with
locally advanced head and neck cancer (HNC) undergoing
standard-of-care radiotherapy. The trial did not meet its primary
endpoint of reduction in the incidence of SOM. The Company is
continuing to analyze the results.
“While the data, as in previous trials, showed reductions in the
incidence, duration and severity of SOM, we are surprised and
disappointed that the trial did not achieve statistical
significance in its primary endpoint,” said Mel Sorensen, M.D.,
Galera’s President and CEO. “We would like to extend our heartfelt
thanks to the patients who participated in this trial while they
underwent radiotherapy for head and neck cancer. As we evaluate
next steps for this program, we remain committed to our goal of
transforming radiotherapy in cancer treatment with our selective
dismutase mimetics.”
Key findings include:
- 16% relative reduction in the
incidence of SOM in the avasopasem treatment group (54%) vs.
placebo group (64%) (p=0.113) (primary endpoint)
- 56% relative reduction in the number
of days of SOM in the avasopasem treatment group (8 days) vs.
placebo group (18 days) (p=0.011) (secondary endpoint)
- 27% relative reduction in the
severity (incidence of Grade 4 OM) of SOM in the avasopasem
treatment group (24%) vs. placebo group (33%) (p=0.167) (secondary
endpoint)
- Avasopasem was generally well
tolerated with similar rates of adverse events in the active and
placebo arms
Dr. Sorensen continued, “We continue to be excited about the
potential of our second dismutase mimetic product candidate,
GC4711, in clinical-stage development to augment the anti-cancer
efficacy of stereotactic body radiation therapy (SBRT) in patients
with non-small cell lung cancer (NSCLC) and locally advanced
pancreatic cancer (LAPC). We recently initiated a Phase 2b trial of
GC4711 in combination with SBRT in LAPC based on promising tumor
and survival outcome benefits observed in a Phase 1/2 pilot trial.
In addition, enrollment is ongoing in a Phase 1/2 trial of GC4711
in combination with SBRT in patients with NSCLC. We look forward to
providing updates as these trials progress.”
The ROMAN trial is a randomized, double-blind,
placebo-controlled trial in 455 patients with locally advanced HNC
receiving seven weeks of standard-of-care radiotherapy plus
cisplatin. Patients were randomized to one of the two treatment
groups (3:2) to receive 90 mg of avasopasem or placebo by infusion
on the days they receive their radiation treatment.
About Oral MucositisOral mucositis is a side
effect of radiation therapy characterized by severe pain,
inflammation, ulceration and bleeding of the mouth. In patients
with head and neck cancer, radiotherapy is a mainstay of treatment.
Approximately 70 percent of patients receiving radiotherapy for
head and neck cancer develop severe oral mucositis (SOM), defined
by the inability to eat solid food (Grade 3) or drink liquids
(Grade 4). The impact on patients who develop SOM is substantial,
particularly when hospitalization and/or surgical placement of PEG
tubes to maintain nutrition and hydration are required. SOM can
adversely affect cancer treatment outcomes by causing interruptions
in radiotherapy, which may compromise the otherwise good prognosis
for tumor control in many of these patients. There is currently no
drug approved to prevent or treat SOM.
About AvasopasemAvasopasem manganese
(avasopasem, or GC4419) is a selective small molecule dismutase
mimetic in development for the reduction of radiation-induced
severe oral mucositis (SOM) in patients with locally advanced head
and neck cancer (HNC) and for the reduction of radiation-induced
esophagitis in patients with lung cancer. The FDA has granted Fast
Track and Breakthrough Therapy designations to avasopasem for the
reduction of SOM induced by radiotherapy, with or without systemic
therapy.
About the Phase 3 ROMAN TrialThe ROMAN trial is
a randomized, double-blind, placebo-controlled trial designed to
evaluate the ability of avasopasem to reduce the incidence and
severity of radiation-induced SOM in patients with locally advanced
head and neck cancer, receiving seven weeks of radiotherapy plus
cisplatin. For more information, please visit
https://clinicaltrials.gov/ct2/show/NCT03689712.
About Galera TherapeuticsGalera Therapeutics,
Inc. is a clinical-stage biopharmaceutical company focused on
developing and commercializing a pipeline of novel, proprietary
therapeutic candidates that have the potential to transform
radiotherapy in cancer. Galera’s technology consists of selective
small molecule dismutase mimetics that are in late-stage
development in patients with cancer. Avasopasem is in development
for radiotherapy-induced toxicities, including SOM in patients with
head and neck cancer and esophagitis in patients with lung cancer.
Avasopasem has been granted FDA Fast Track and Breakthrough Therapy
designations for the reduction of SOM induced by radiotherapy, with
or without systemic therapy. Galera’s second dismutase mimetic
product candidate, GC4711, is in clinical-stage development to
augment the anti-cancer efficacy of stereotactic body radiation
therapy in patients with non-small cell lung cancer and locally
advanced pancreatic cancer. Galera is headquartered in Malvern, PA.
For more information, please visit www.galeratx.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including without limitation statements regarding: expectations
surrounding the continued advancement of our product pipeline; the
potential safety and efficacy of Galera’s product candidates and
their regulatory and clinical development, including the
interpretation of the safety and efficacy results from the Phase 3
ROMAN trial and expectations surrounding the progress of the Phase
2b trial of GC4711 in patients with LAPC and the Phase 1/2 trial of
GC4711 in patients with NSCLC; the Company’s ability to achieve its
goal of transforming radiotherapy in cancer treatment with its
selective dismutase mimetics; and the potential of GC4711 to
augment the anti-cancer efficacy of SBRT in patients with NSCLC and
LAPC. These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause Galera’s actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: Galera’s limited operating history; anticipating
continued losses for the foreseeable future; needing substantial
funding and the ability to raise capital; Galera’s dependence on
avasopasem manganese (GC4419); uncertainties inherent in the
conduct of clinical trials; difficulties or delays enrolling
patients in clinical trials; the FDA’s acceptance of data from
clinical trials outside the United States; undesirable side effects
from Galera’s product candidates; risks relating to the regulatory
approval process; failure to capitalize on more profitable product
candidates or indications; ability to receive or maintain
Breakthrough Therapy Designation or Fast Track Designation for
product candidates; failure to obtain regulatory approval of
product candidates in the United States or other jurisdictions;
ongoing regulatory obligations and continued regulatory review;
risks related to commercialization; risks related to competition;
ability to retain key employees and manage growth; risks related to
intellectual property; inability to maintain collaborations or the
failure of these collaborations; Galera’s reliance on third
parties; the possibility of system failures or security breaches;
liability related to the privacy of health information obtained
from clinical trials and product liability lawsuits; unfavorable
pricing regulations, third-party reimbursement practices or
healthcare reform initiatives; environmental, health and safety
laws and regulations; the impact of the COVID-19 pandemic on
Galera’s business and operations, including preclinical studies and
clinical trials, and general economic conditions; risks related to
ownership of Galera’s common stock; and significant costs as a
result of operating as a public company. These and other important
factors discussed under the caption “Risk Factors” in Galera’s
Annual Report on Form 10-K for the year ended December 31, 2020
filed with the U.S. Securities and Exchange Commission (SEC) and
Galera’s other filings with the SEC could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any forward-looking
statements speak only as of the date of this press release and are
based on information available to Galera as of the date of this
release, and Galera assumes no obligation to, and does not intend
to, update any forward-looking statements, whether as a result of
new information, future events or otherwise.
Investor Contacts:Christopher DegnanGalera
Therapeutics, Inc.610-725-1500cdegnan@galeratx.com
William WindhamSolebury
Trout646-378-2946wwindham@soleburytrout.com
Media Contact:Zara LockshinSolebury
Trout646-378-2960zlockshin@soleburytrout.com
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