PrECOG, LLC has announced the final results from the phase 3 PATINA study, published in the New England Journal of Medicine. The study investigated whether adding palbociclib to anti-HER2 and endocrine therapy after induction chemotherapy could extend progression-free survival for patients with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–positive (HER2+) metastatic breast cancer.
The findings revealed that patients who received palbociclib had a median progression-free survival of 44.3 months, compared to 29.1 months in those who received only anti-HER2 and endocrine therapy.
"These results show that adding palbociclib, a well-tolerated, oral agent, to our standard treatment regimen provides a substantial and meaningful prolongation of response time and disease control for these patients who suffer from a currently incurable disease," said Angela M. DeMichele, MD, MSCE, PrECOG co-principal Investigator for PATINA and the Mariann T. and Robert J. MacDonald Professor in Breast Cancer Care Excellence at the University of Pennsylvania Perelman School of Medicine.
The publication marks PATINA as the first large randomized phase 3 trial to show clinical benefit from CDK4/6 inhibition in HR+, HER2+ metastatic breast cancer. This may introduce a new approach for maintenance therapy in this group of patients.
About 10% of all breast cancers are classified as HR+, HER2+. Standard first-line treatment involves dual anti-HER2 therapy combined with chemotherapy, followed by maintenance HER2-targeted and endocrine therapies. Despite improvements in care, resistance to both endocrine and anti-HER2 therapies remains an issue for clinicians treating this population. Previous laboratory studies indicated that CDK4/6 inhibitors might help address this resistance.
The PATINA trial enrolled 518 participants between June 2017 and July 2021 at 109 sites across the United States, Europe, New Zealand, and Australia. Patients were randomly assigned to receive either palbociclib alongside anti-HER2 and endocrine therapy or just anti-HER2 and endocrine therapy alone.
Funding for the study was provided by Pfizer Inc., with support from Alliance Foundation Trials LLC as global sponsor along with other international academic research organizations including Breast Cancer Trials (Australia and New Zealand), Fondazione Michelangelo, GBG Forschungs GmbH, PrECOG, SOLTI, and Unicancer.
"The PATINA study exemplifies the power of global academic collaboration to answer clinically important questions that directly impact patient care," said Peter J. O'Dwyer, MD, chief executive officer and chair of PrECOG. "We are proud to have partnered with international research groups to help advance a potential new standard for frontline maintenance therapy in this distinct subset of metastatic breast cancer."
