Pfizer Inc. (PFE - Free Report) announced that detailed results of phase III PALOMA-2 study evaluating the combination of its breast cancer drug Ibrance (palbociclib) and Novartis AG’s (NVS - Free Report) Femara (letrozole) for the treatment of first-line ER+, HER2- metastatic breast cancer were published in The New England Journal of Medicine.
In the study, it was seen that a combination of Ibrance and Femara led to an improvement in progression-free survival (PFS), or the time before tumor growth, by more than 10 months compared with Femara plus placebo. In other words, the study demonstrated median PFS for women treated with Ibrance plus Femara of 24.8 months, compared with 14.5 months on the Femara -placebo combination arm, indicating a 42% reduction in the risk of disease progression. PALOMA-2 had enrolled a total of 666 women from 186 global sites in 17 countries. We remind investors that this data was presented at the 52nd American Society of Clinical Oncology (ASCO) Annual Meeting in June.
On the basis of the phase II PALOMA-1 study, Ibrance was approved under accelerated approval in Feb 2015 for use in combination with Femara for the treatment of post-menopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced or metastatic breast cancer who did not received previous systemic treatment for their disease. Pfizer believes that the PALOMA-2 confirmatory trial has proven the clinical benefit of the combination therapy and should help the company obtain continued approval in the U.S in this indication.
A supplemental New Drug Application to support the conversion of the accelerated approval into a regular approval based on the PALOMA-2 results has been submitted to the FDA.
Earlier this year, the FDA approved a label expansion for Ibrance to include the treatment of hormone receptor-positive (HR+), HER2-advanced or metastatic breast cancer in combination with AstraZeneca plc’s (AZN - Free Report) Faslodex in patients whose disease has progressed following endocrine therapy.
Meanwhile, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on the approval of Pfizer’s marketing authorization for Ibrance for the treatment of women with HR+/HER2- locally advanced or metastatic breast cancer. Presently, Ibrance is approved in over 50 countries.
Ibrance has been off to a strong start, having registered sales of $1.5 billion in the second half of 2016 compared with $0.4 million in the year-ago period. The drug’s label and geographical expansion would boost its commercial potential significantly. Going forward, we expect investor focus to remain on the commercialization and sales ramp-up of Ibrance.
Zacks Rank & Key Picks
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Cambrex Corp. (CBM - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 9.7% year to date.
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