The German Breast Group (GBG) and Pfizer announced that the Ibrance (palbociclib) has failed to meet the primary endpoint in phase 3 early breast cancer trial.
The phase 3 PENELOPE-B trial has failed to achieve 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 the residual invasive disease after completing neoadjuvant chemotherapy.
PENELOPE-B is a randomised, double-blind, and placebo-controlled phase 3 study that compared 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.
GBG sponsored the trial as part of clinical research collaboration with Pfizer and other study groups.
The trial recruited 1,250 women with HR+ and HER2- eBC at high risk of recurrence who have the residual invasive disease after completing neoadjuvant chemotherapy. It was carried at over 190 clinical sites in 12 countries across the globe.
Pfizer oncology global product development chief development officer Dr Chris Boshoff said: “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.”
Ibrance is an oral inhibitor of CDKs 4 and 6, which are major regulators of the cell cycle that activates cellular progression.
Ibrance is designated to treat adult patients with HR+ and HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men, as well as with fulvestrant in patients with disease progression following endocrine therapy.
At present, Ibrance secured approval in over countries and was prescribed to treat around 340,000 patients across the globe.
In July this year, Pfizer, along with BioNTech, commenced the phase 2/3 safety and efficacy clinical study to assess a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine programme against SARS-CoV-2.