Pfizer and the German Breast Group (GBG) recently announced that the Phase 3 PENELOPE-B trial of Ibrance (trade name: palbociclib) for the treatment of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early-stage breast cancer (eBC) who still have invasive disease after neoadjuvant chemotherapy failed to meet the primary endpoint of improved iDFS. No unexpected safety signals were observed in the study.
PENELOPE-B is a randomized, double-blind, placebo-controlled phase 3 study that enrolled 1250 HR+/HER2- eBC patients with invasive disease and a high risk of recurrence after completing neoadjuvant chemotherapy. The study is evaluating the efficacy and safety of 1 year of Ibrance treatment plus at least 5 years of standard adjuvant endocrine therapy, and placebo plus at least 5 years of standard adjuvant endocrine therapy. This trial is sponsored by GBG as part of a clinical study conducted in collaboration with Pfizer and other research groups. Detailed results from this study will be presented at an upcoming medical conference.
In late May of this year, Pfizer updated its Phase 3 PALLAS trial evaluating Ibrance in combination with endocrine therapy for HR+/HER2- eBC. This trial was conducted in female and male patients with HR+/HER2- eBC, including those at intermediate to high risk of recurrence, evaluating the efficacy and safety of Ibrance in combination with standard adjuvant endocrine therapy (2 years of combination therapy followed by endocrine therapy to complete 5 years) and standard adjuvant endocrine therapy (at least 5 years of treatment). Following a pre-planned efficacy and futility analysis, the independent data monitoring committee (DMC) determined that the trial was unlikely to demonstrate a statistically significant improvement in the primary endpoint of iDFS.
Ibrance, the first CDK4/6 inhibitor to be marketed globally, was first approved in February 2015 and has since been approved in over 90 countries worldwide for first-line and second-line treatment of HR+/HER2- breast cancer. In April 2019, Ibrance was approved by the US FDA, becoming the world's first CDK4/6 inhibitor to be used in combination with an aromatase inhibitor as first-line treatment for male patients with HR+/HER2- metastatic breast cancer. In the United States, Ibrance is used to treat adult patients with HR+/HER2- advanced or metastatic breast cancer: (1) in combination with an aromatase inhibitor as initial endocrine therapy for postmenopausal women or men; and (2) in combination with fulvestrant for patients whose disease has progressed after receiving endocrine therapy. In China, Ibrance was approved in August 2018 for use in combination with an aromatase inhibitor as an initial endocrine therapy for the treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer.
Original source: PENELOPE-B TRIAL OF IBRANCE® (PALBOCICLIB) IN EARLY BREAST CANCER DID NOT MEET PRIMARY ENDPOINT
The above is the latest information regarding the failure of the Phase 3 trial of Ibrance (a targeted breast cancer drug) for the treatment of HR+/HER2- early breast cancer (eBC)! For more information about Ibrance, please contact our pharmacist customer service.
