Combination Treatment Misses Overall Survival Endpoint in Breast Cancer Trial

In the phase 3 PALOMA-3 trial, Pfizer’s palbociclib (Ibrance) narrowly missed reaching its secondary endpoint of overall survival (OS), according to a press release.

The PALOMA-3 trial evaluated palbociclib in combination with 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.

Palbociclib in combination with endocrine therapy is a standard of care for HR+, HER2- metastatic breast cancer. Palbociclib is approved for use in combination with fulvestrant based on results from the primary endpoint of progression-free survival (PFS). In the trial, palbociclib plus fulvestrant demonstrated a statistically significant and clinically meaningful improvement in PFS compared with placebo plus fulvestrant.

“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,” Mace Rothenberg, MD, chief development officer of Oncology at Pfizer Global Product Development, said in the press release. “We are encouraged by these results, which build on the compelling clinical benefit delivered by Ibrance.”

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