Pfizer (PFE - Free Report) announced disappointing overall survival (OS) results from the phase III PALOMA-3 study. The study showed that the combination of Ibranceand AstraZeneca’s (AZN - Free Report) Faslodex (fulvestrant) failed to improve OS compared with Faslodex and placebo 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. The study is being conducted to assess the efficacy and safety of Ibranceplus Faslodex in women with endocrine therapy-resistant metastatic breast cancer.
OS was a secondary endpoint for the PALOMA-3 trial. The company stated that, as a secondary endpoint, the study was not "optimized" to detect a statistically significant difference in OS.
The primary endpoint of progression-free survival (PFS) was previously reported and led to the FDA approval for Ibrance plus Faslodex for pretreated women with HR+/HER2- metastatic breast cancer. In findings published in The Lancet Oncology, the median PFS was 9.5 months with Ibrance and Faslodex compared with 4.6 months for Faslodex alone.
The most common adverse reactions in PALOMA-3 included neutropenia, leukopenia, infections, fatigue and nausea; No new safety signals were identified as part of this final OS analysis.
Year to date, shares of Pfizer have increased 0.4% against the industry’s decline of 4.9%.
We remind investors that Ibrance had received accelerated approval from the FDA in February 2015. to be used in combination with Novartis’ (NVS - Free Report) Femara (letrozole) for the first-line treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as an initial endocrine-based therapy for their metastatic disease.Pfizer is working on expanding Ibrance’s label further by targeting different segments of breast cancer patients. The company will present the detailed data at an upcoming medical meeting.
Zacks Rank & Stock to Consider
Pfizer carries a Zacks Rank #3 (Hold).
A better-ranked stock from the same space is ANI Pharmaceuticals, Inc. (ANIP - Free Report) carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
ANI Pharmaceuticals’earnings per share estimates have moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 5.4% so far this year.
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