Patients currently receiving palbociclib in the study will be advised about next steps by their physicians and long-term follow up of all patients will proceed as planned. No unexpected new safety signals were observed in patients receiving palbociclib.
The PALLAS trial compares palbociclib plus standard adjuvant endocrine therapy to standard adjuvant endocrine therapy alone in women and men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early (stage 2 and 3) breast cancer and is an academically-led global collaboration, involving more than 400 centers in 21 countries around the globe.
'We are disappointed in this outcome. Breast cancer is a leading cause of death around the world and delaying or preventing the development of metastatic disease is a significant unmet need. PALLAS is a large study with many subgroups and we are actively collaborating to determine if there are patients who may benefit from adjuvant treatment with the palbociclib combination,' said
'This result is not what we hoped for, but we are steadfast in our commitment to advancing the science and care for people living with breast cancer,' said
Health authorities and trial investigators have been notified of this decision. When available, the full results from the PALLAS study will be shared with the scientific community at a later date.
Palbociclib is also being studied in patients with high-risk early breast cancer and results from the collaborative PENELOPE-B trial are expected later this year.
In the
About the PALLAS Trial
PALLAS is a randomized (1:1), prospective, international, multicenter, open-label Phase 3 study comparing the combination of palbociclib and standard adjuvant endocrine therapy for two years followed by continuing standard adjuvant therapy to complete five years versus at least five years of standard adjuvant endocrine therapy for pre- and postmenopausal women or men with HR+, HER2- early invasive (Stage 2 and Stage 3) breast cancer, including those at moderate to high risk of recurrence. The trial is co-sponsored by the
About IBRANCE (palbociclib) 125 mg tablets and capsules
IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are key regulators of the cell cycle that trigger cellular progression.2,3 In the
IBRANCE currently is approved in more than 95 countries and has been prescribed to more than 300,000 patients globally.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 22 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, prostate, kidney and lung cancers, as well as leukemia and melanoma.
At
DISCLOSURE NOTICE
The information contained in this release is as of
This release contains forward-looking information about IBRANCE (palbociclib), including its potential benefits and the anticipated timing of results from the Phase 3 PENELOPE-B study, and the Company's projected compound annual growth rate for revenuesthat involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of IBRANCE; uncertainties regarding the commercial impact of the results of the PALLAS trial; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for IBRANCE for the treatment of high-risk early breast cancer or in any jurisdictions for any other potential indications for IBRANCE; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether such product candidate will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of IBRANCE; the uncertainties inherent in business and financial planning, including, without limitation, risks related to
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