- Results show a positive trend in the secondary endpoint of overall survival, though not reaching statistical significance
- IBRANCE is approved worldwide in combination with fulvestrant based on compelling results from the primary endpoint of progression-free survival
June 25, 2018 I Pfizer today announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine therapy. The results demonstrated a positive trend in the hazard ratio favoring the IBRANCE combination, although this trend did not reach statistical significance. Overall survival is a secondary endpoint of the PALOMA-3 trial and, as such, the trial design was not optimized to detect a statistically significant difference in OS.
“While the difference in overall survival narrowly missed the threshold for statistical significance – a high bar for any trial in this patient population – it is similar, in absolute terms, to the improvement in median progression-free survival previously demonstrated in this trial.1 We are encouraged by these results, which build on the compelling clinical benefit delivered by IBRANCE,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “IBRANCE in combination with endocrine therapy has transformed the treatment landscape for patients with HR+, HER2- metastatic breast cancer.”
PALOMA-3 met its primary endpoint of progression-free survival (PFS) at interim analysis and results were published in The New England Journal of Medicine in June 2015; updated PFS data were later presented at the 2016 San Antonio Breast Cancer Symposium. The trial demonstrated a statistically significant and clinically meaningful improvement in PFS for IBRANCE plus fulvestrant compared to placebo plus fulvestrant. PFS is a well-established measure of clinical benefit in metastatic breast cancer trials.2 IBRANCE in combination with fulvestrant has been approved in more than 80 countries around the world based on the PFS demonstrated in PALOMA-3.
“The duration of the survival in hormone receptor-positive metastatic breast cancer patients, and the potential for subsequent therapies to confound overall survival outcomes, make demonstrating statistically significant improvement in overall survival extremely difficult,” said Nicholas Turner, M.D., Ph.D., professor of molecular oncology at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, as well as principal investigator of the PALOMA-3 trial. “The results from this overall survival analysis support the strong progression-free survival results from PALOMA-3 and, while not statistically significant, are encouraging for physicians and patients. We look forward to presenting the detailed data at an upcoming medical meeting.”
The most common adverse reactions in PALOMA-3 included neutropenia, leukopenia, infections, fatigue and nausea; no new safety signals were identified as part of this final OS analysis.
IBRANCE in combination with endocrine therapy is a standard of care for HR+, HER2- metastatic breast cancer. IBRANCE has been prescribed to more than 120,000 patients globally to date.
The full prescribing information for IBRANCE can be found at www.pfizer.com.
About IBRANCE® (palbociclib) 125 mg capsules
IBRANCE is an oral inhibitor of CDKs 4 and 6,3 which are key regulators of the cell cycle that trigger cellular progression.4,5 In the U.S., IBRANCE is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on people living with cancer. Our growing pipeline of biologics, small molecules and immunotherapies is focused on identifying and translating the best scientific breakthroughs into clinical application for patients across a diverse array of solid tumors and hematologic cancers. Today, we have 10 approved oncology medicines and 14 assets currently in clinical development. By maximizing our internal scientific resources and collaborating with other companies, government and academic institutions, as well as patients and non-profit and professional organizations, we are bringing together the brightest and most enterprising minds to take on the toughest cancers. Together we can accelerate breakthrough treatments to patients around the world and work to redefine life with cancer.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 10
- Results show a positive trend in the secondary endpoint of overall survival, though not reaching statistical significance
- IBRANCE is approved worldwide in combination with fulvestrant based on compelling results from the primary endpoint of progression-free survival
June 25, 2018 I Pfizer today announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine therapy. The results demonstrated a positive trend in the hazard ratio favoring the IBRANCE combination, although this trend did not reach statistical significance. Overall survival is a secondary endpoint of the PALOMA-3 trial and, as such, the trial design was not optimized to detect a statistically significant difference in OS.
“While the difference in overall survival narrowly missed the threshold for statistical significance – a high bar for any trial in this patient population – it is similar, in absolute terms, to the improvement in median progression-free survival previously demonstrated in this trial.1 We are encouraged by these results, which build on the compelling clinical benefit delivered by IBRANCE,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “IBRANCE in combination with endocrine therapy has transformed the treatment landscape for patients with HR+, HER2- metastatic breast cancer.”
PALOMA-3 met its primary endpoint of progression-free survival (PFS) at interim analysis and results were published in The New England Journal of Medicine in June 2015; updated PFS data were later presented at the 2016 San Antonio Breast Cancer Symposium. The trial demonstrated a statistically significant and clinically meaningful improvement in PFS for IBRANCE plus fulvestrant compared to placebo plus fulvestrant. PFS is a well-established measure of clinical benefit in metastatic breast cancer trials.2 IBRANCE in combination with fulvestrant has been approved in more than 80 countries around the world based on the PFS demonstrated in PALOMA-3.
“The duration of the survival in hormone receptor-positive metastatic breast cancer patients, and the potential for subsequent therapies to confound overall survival outcomes, make demonstrating statistically significant improvement in overall survival extremely difficult,” said Nicholas Turner, M.D., Ph.D., professor of molecular oncology at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, as well as principal investigator of the PALOMA-3 trial. “The results from this overall survival analysis support the strong progression-free survival results from PALOMA-3 and, while not statistically significant, are encouraging for physicians and patients. We look forward to presenting the detailed data at an upcoming medical meeting.”
The most common adverse reactions in PALOMA-3 included neutropenia, leukopenia, infections, fatigue and nausea; no new safety signals were identified as part of this final OS analysis.
IBRANCE in combination with endocrine therapy is a standard of care for HR+, HER2- metastatic breast cancer. IBRANCE has been prescribed to more than 120,000 patients globally to date.
The full prescribing information for IBRANCE can be found at www.pfizer.com.
About IBRANCE® (palbociclib) 125 mg capsules
IBRANCE is an oral inhibitor of CDKs 4 and 6,3 which are key regulators of the cell cycle that trigger cellular progression.4,5 In the U.S., IBRANCE is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on people living with cancer. Our growing pipeline of biologics, small molecules and immunotherapies is focused on identifying and translating the best scientific breakthroughs into clinical application for patients across a diverse array of solid tumors and hematologic cancers. Today, we have 10 approved oncology medicines and 14 assets currently in clinical development. By maximizing our internal scientific resources and collaborating with other companies, government and academic institutions, as well as patients and non-profit and professional organizations, we are bringing together the brightest and most enterprising minds to take on the toughest cancers. Together we can accelerate breakthrough treatments to patients around the world and work to redefine life with cancer.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 10
