Enrollment completed ahead of schedule. The Company plans to
announce topline data in Q1 2018 and file a Biologics License
Application (BLA) next year.
To strengthen the regulatory package for U.S. and EU, the Company
is enrolling patients in an additional international Phase 3 study
(RECOVER), which is expected to complete enrollment in Q1 2018.
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company
with fully integrated commercial and drug development operations with a
primary focus in Hematology and Oncology, announced today the Company
has completed enrollment with 405 patients randomized in the ROLONTIS
Phase 3 ADVANCE pivotal study under a Special Protocol Assessment (SPA)
with the Food and Drug Administration. The study is evaluating the
safety and efficacy of ROLONTIS in the management of
chemotherapy-induced neutropenia in patients with breast cancer.
"I am pleased to report that we have been able to complete enrollment in
the ADVANCE study ahead of schedule," said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We
plan to announce topline data early next year and expect to file a BLA
in 2018. RECOVER, the second Phase 3 study for ROLONTIS, is a smaller
study that will include sites in the U.S. and Europe, and is currently
enrolling patients. RECOVER will leverage established relationships with
U.S. sites from the ADVANCE study to help expedite enrollment. We
believe ROLONTIS, if approved by the FDA, has the opportunity to change
the growth trajectory of our Company because it targets a multi-billion
dollar market and our team has a deep knowledge and understanding of the
space. We are excited to be in the final stages of what could be a
transformational development for the Company."
Spectrum is conducting a second Phase 3 study, RECOVER, which is a
multicenter, randomized, active-controlled study similar in design to
the ADVANCE study that is currently enrolling in the U.S. and Europe.
This study will enroll approximately 218 early-stage breast cancer
patients, who will receive adjuvant or neoadjuvant TC (docetaxel and
cyclophosphamide) chemotherapy every 21 days for up to 4 cycles.
Adjuvant chemotherapy is treatment given after primary surgical therapy
to kill any remaining cancer cells and increase the chance of long-term,
disease-free survival; neoadjuvant chemotherapy is the administration of
cytotoxic agents before surgical resection in early-stage breast cancer
to help shrink the tumor and potentially allow for breast-conserving
surgery. The primary study endpoint is the Duration of Severe
Neutropenia (Absolute Neutrophil Counts [ANC] < 0.5×109/L)
in Cycle 1 of chemotherapy, based on central laboratory assessment of
ANC over the 21 day cycle. Secondary endpoints include the incidence of
neutropenic complications, incidence of febrile neutropenia, relative
dose intensity, and safety.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in Hematology and Oncology. Spectrum currently markets six
hematology/oncology drugs, and has an advanced stage pipeline that has
the potential to transform the Company. Spectrum's strong track record
for in-licensing and acquiring differentiated drugs, and expertise in
clinical development have generated a robust, diversified, and growing
pipeline of product candidates in advanced-stage Phase 2 and Phase 3
studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially. These
statements are based on management's current beliefs and expectations.
These statements include, but are not limited to, statements that
relate to Spectrum's business and its future, including certain company
milestones, Spectrum's ability to identify, acquire, develop and
commercialize a broad and diverse pipeline of late-stage clinical and
commercial products, the timing and results of FDA decisions, and any
statements that relate to the intent, belief, plans or expectations of
Spectrum or its management, or that are not a statement of historical
fact. Risks that could cause actual results to differ include the
possibility that Spectrum's existing and new drug candidates may not
prove safe or effective, the possibility that our existing and new
applications to the FDA and other regulatory agencies may not receive
approval in a timely manner or at all, the possibility that our existing
and new drug candidates, if approved, may not be more effective, safer
or more cost efficient than competing drugs, the possibility that our
efforts to acquire or in-license and develop additional drug candidates
may fail, our dependence on third parties for clinical trials,
manufacturing, distribution and quality control and other risks that are
described in further detail in the Company's reports filed with the
Securities and Exchange Commission. The Company does not plan to
update any such forward-looking statements and expressly disclaims any
duty to update the information contained in this press release except as
required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a
registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate.
REDEFINING CANCER CARE™, ROLONTIS™ and the Spectrum Pharmaceuticals
logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any
other trademarks are the property of their respective owners.
© 2017 Spectrum Pharmaceuticals, Inc. All Rights Reserved
View source version on businesswire.com: http://www.businesswire.com/news/home/20170801005708/en/
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
President, Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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