Spectrum Pharmaceuticals Announces Completion of Enrollment in the Phase 3 Pivotal Study (ADVANCE) of ROLONTIS™ (eflapegras...
August 01 2017 - 7:00AM
Business Wire
- 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.
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
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Spectrum Pharmaceuticals, Inc.Shiv Kapoor, 702-835-6300Vice
President, Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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