NEU-ISENBURG, Germany & FRANKFURT, Germany & NEW YORK, NY, USA I October 9, 2020 I The German Breast Group (GBG) and Pfizer Inc. (NYSE: PFE) today announced that the collaborative Phase 3 PENELOPE-B trial did not meet the primary endpoint of improved invasive disease-free survival (iDFS) in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer (eBC) who have residual invasive disease after completing neoadjuvant chemotherapy. No unexpected safety signals were observed.
PENELOPE-B is a randomized, double-blind, placebo-controlled Phase 3 study comparing one year of palbociclib plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy. The trial is sponsored by the GBG as part of a clinical research collaboration with Pfizer and other study groups.
“Reducing the risk of disease recurrence in patients who have residual disease after neoadjuvant chemotherapy is a complex clinical challenge,” said Professor Sibylle Loibl, Chair of GBG. “This unique trial was made possible through the collaboration and support from all the research partners involved. Despite this outcome, we believe that key learnings will emerge from the large number of biomarkers being analyzed from collected tumor tissue, which will help inform future breast cancer research.”
“This is the first randomized Phase 3 study to establish mature iDFS results for a CDK4/6 inhibitor as part of the adjuvant treatment for early breast cancer. While we are disappointed with this result, we look forward to continuing to work with our research partners to understand subgroup data and how these could inform the development of our next-generation CDK inhibitors in early breast cancer,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We are proud of the transformative impact IBRANCE has had on the treatment of HR+, HER2- metastatic breast cancer – a vastly different treatment setting than early breast cancer. Our commitment to the metastatic patient community is as strong as ever as we continue to generate new data, including the most extensive body of real-world evidence for a CDK 4/6 inhibitor.”
Detailed findings from PENELOPE-B will be presented at an upcoming medical congress.
About the PENELOPE-B Study
PENELOPE-B is a randomized, double-blind, placebo-controlled Phase 3 study comparing one year of palbociclib plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy in 1,250 women with HR+, HER2- eBC at high risk of recurrence who have residual invasive disease after completing neoadjuvant chemotherapy. Patients in the trial scored 3 or higher (or 2 if there were lymph node metastases at the time of surgery) on the clinical-pathologic stage – estrogen/grade (CPS-EG). The CPS-EG is a validated risk assessment tool combining: clinical stage before neoadjuvant treatment, pathological stage after neoadjuvant treatment, grading and estrogen-receptor status. The trial is sponsored by the GBG as part of a clinical research collaboration with other study groups, including ABCSG, AGO-B, ANZBCTG, BIG, CCTG, GEICAM, LACOG, IBCSG, ICORG, ISPy-2, JBCRG, KCSG, NSABP, Unicancer and Pfizer.
More than 190 clinical sites in 12 countries around the globe participated in PENELOPE-B. The study opened in November 2013 and closed recruitment on December 31, 2017.
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 U.S., IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.
IBRANCE currently is approved in more than 95 countries and has been prescribed to nearly 340,000 patients globally. IBRANCE is not indicated for early breast cancer.
The full U.S. Prescribing Information for the IBRANCE tablets and the IBRANCE capsules can be found here and here.
About the German Breast Group
The German Breast Group (GBG) is the largest academic research organization devoted to breast cancer in Germany and one of the largest worldwide with, over 50,000 patients recruited in their trials. GBG is active in all parts of breast cancer research, including surgery and niche indications such breast cancer during pregnancy. The main research activities are devoted to neoadjuvant therapy and postneoadjuvant concepts. Please visit us on www.gbg.de
or follow us on twitter, https://twitter.com/GBG_Forschung
.
About NSABP Foundation
The NSABP Foundation, Inc., an academic research organization, conducts industry-supported cancer research in new chemotherapeutic and targeted biologic agents for evaluation in adjuvant and neoadjuvant clinical trials in breast and colorectal cancers. The NSABP Foundation has research sites in North America and an international network made up of oncology and research professionals.
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 people living with cancer. Today, we have an industry-leading portfolio of 23 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.
Pfizer Inc.: Breakthroughs that change patients’ lives
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, including innovative medicines and vaccines. 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.
IBRANCE® (palbociclib) Prescribing Information. New York. NY: Pfizer Inc: 2019.
2 Weinberg, RA. pRb and Control of the Cell Cycle Clock. In: Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY: Garland Science; 2014:275-329.
3 Sotillo E, Grana X. Escape from Cellular Quiescence. In: Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY: Humana Press; 2010:3-22.
SOURCE: Pfizer
Post Views: 25
NEU-ISENBURG, Germany & FRANKFURT, Germany & NEW YORK, NY, USA I October 9, 2020 I The German Breast Group (GBG) and Pfizer Inc. (NYSE: PFE) today announced that the collaborative Phase 3 PENELOPE-B trial did not meet the primary endpoint of improved invasive disease-free survival (iDFS) in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer (eBC) who have residual invasive disease after completing neoadjuvant chemotherapy. No unexpected safety signals were observed.
PENELOPE-B is a randomized, double-blind, placebo-controlled Phase 3 study comparing one year of palbociclib plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy. The trial is sponsored by the GBG as part of a clinical research collaboration with Pfizer and other study groups.
“Reducing the risk of disease recurrence in patients who have residual disease after neoadjuvant chemotherapy is a complex clinical challenge,” said Professor Sibylle Loibl, Chair of GBG. “This unique trial was made possible through the collaboration and support from all the research partners involved. Despite this outcome, we believe that key learnings will emerge from the large number of biomarkers being analyzed from collected tumor tissue, which will help inform future breast cancer research.”
“This is the first randomized Phase 3 study to establish mature iDFS results for a CDK4/6 inhibitor as part of the adjuvant treatment for early breast cancer. While we are disappointed with this result, we look forward to continuing to work with our research partners to understand subgroup data and how these could inform the development of our next-generation CDK inhibitors in early breast cancer,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We are proud of the transformative impact IBRANCE has had on the treatment of HR+, HER2- metastatic breast cancer – a vastly different treatment setting than early breast cancer. Our commitment to the metastatic patient community is as strong as ever as we continue to generate new data, including the most extensive body of real-world evidence for a CDK 4/6 inhibitor.”
Detailed findings from PENELOPE-B will be presented at an upcoming medical congress.
About the PENELOPE-B Study
PENELOPE-B is a randomized, double-blind, placebo-controlled Phase 3 study comparing one year of palbociclib plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy in 1,250 women with HR+, HER2- eBC at high risk of recurrence who have residual invasive disease after completing neoadjuvant chemotherapy. Patients in the trial scored 3 or higher (or 2 if there were lymph node metastases at the time of surgery) on the clinical-pathologic stage – estrogen/grade (CPS-EG). The CPS-EG is a validated risk assessment tool combining: clinical stage before neoadjuvant treatment, pathological stage after neoadjuvant treatment, grading and estrogen-receptor status. The trial is sponsored by the GBG as part of a clinical research collaboration with other study groups, including ABCSG, AGO-B, ANZBCTG, BIG, CCTG, GEICAM, LACOG, IBCSG, ICORG, ISPy-2, JBCRG, KCSG, NSABP, Unicancer and Pfizer.
More than 190 clinical sites in 12 countries around the globe participated in PENELOPE-B. The study opened in November 2013 and closed recruitment on December 31, 2017.
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 U.S., IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.
IBRANCE currently is approved in more than 95 countries and has been prescribed to nearly 340,000 patients globally. IBRANCE is not indicated for early breast cancer.
The full U.S. Prescribing Information for the IBRANCE tablets and the IBRANCE capsules can be found here and here.
About the German Breast Group
The German Breast Group (GBG) is the largest academic research organization devoted to breast cancer in Germany and one of the largest worldwide with, over 50,000 patients recruited in their trials. GBG is active in all parts of breast cancer research, including surgery and niche indications such breast cancer during pregnancy. The main research activities are devoted to neoadjuvant therapy and postneoadjuvant concepts. Please visit us on www.gbg.de
or follow us on twitter, https://twitter.com/GBG_Forschung
.
About NSABP Foundation
The NSABP Foundation, Inc., an academic research organization, conducts industry-supported cancer research in new chemotherapeutic and targeted biologic agents for evaluation in adjuvant and neoadjuvant clinical trials in breast and colorectal cancers. The NSABP Foundation has research sites in North America and an international network made up of oncology and research professionals.
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 people living with cancer. Today, we have an industry-leading portfolio of 23 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.
Pfizer Inc.: Breakthroughs that change patients’ lives
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, including innovative medicines and vaccines. 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.
IBRANCE® (palbociclib) Prescribing Information. New York. NY: Pfizer Inc: 2019.
2 Weinberg, RA. pRb and Control of the Cell Cycle Clock. In: Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY: Garland Science; 2014:275-329.
3 Sotillo E, Grana X. Escape from Cellular Quiescence. In: Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY: Humana Press; 2010:3-22.
SOURCE: Pfizer
Post Views: 25
