Positive Late-Stage Trial Not Enough to Move the Needle for Pfizer

Health and Healthcare

Published: June 25, 2018 9:00 am

Last Updated: January 11, 2020 9:58 pm

Pfizer Inc. (NYSE: PFE) shares slipped slightly on Monday morning after the firm announced results from its late-stage trial of breast cancer. Ultimately the results were positive, but not exactly what the study was looking for.

The firm announced that its overall survival (OS) results from the Phase 3 PALOMA-3 trial demonstrated a positive trend in the hazard ratio favoring the Ibrance (palbociclib) combination with fulvestrant, although this trend did not reach statistical significance. Overall survival is a secondary endpoint of the PALOMA-3 trial and, as such, the trial design was not optimized to detect a statistically significant difference in OS.

The study met its primary endpoint of progression-free survival (PFS) at interim analysis and results. The trial demonstrated a statistically significant and clinically meaningful improvement in PFS for Ibrance plus fulvestrant. Ibrance in combination with fulvestrant has been approved in more than 80 countries around the world based on the PFS demonstrated in PALOMA-3.

In a nutshell, the results from this overall survival analysis support the strong progression-free survival results from PALOMA-3 and, while not statistically significant, are encouraging for physicians and patients.

Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development, commented:

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.1 We are encouraged by these results, which build on the compelling clinical benefit delivered by IBRANCE. IBRANCE in combination with endocrine therapy has transformed the treatment landscape for patients with HR+, HER2- metastatic breast cancer.

Shares of Pfizer closed Friday at $36.51, with a consensus analyst price target of $39.86 and a 52-week range of $32.32 to $39.43. Following the announcement, the stock was down 0.3% at $36.40 in early trading indications Monday.

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