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Pfizer’s Ibrance misses the mark in early breast cancer

Drug was unable to demonstrate statistical significance in primary endpoint

Pfizer HQ

Pfizer’s breast cancer drug Ibrance has failed to demonstrate statistical significance in a pivotal phase 3 trial in early breast cancer.

The phase 3 PALLAS study is “unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival”, according to a statement from Pfizer.

The study had compared CDK4/6 inhibitor Ibrance (palbociclib) plus standard adjuvant endocrine therapy to standard adjuvant endocrine therapy alone in women and men with hormone receptor-positive epidermal growth factor receptor 2-negative early (stage 2 and 3) breast cancer.

“We are disappointed in this outcome. Breast cancer is a leading cause of death around the world and delaying or preventing the development of metastatic disease is a significant unmet need,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.

“PALLAS is a large study with many subgroups and we are actively collaborating to determine if there are patients who may benefit from adjuvant treatment with the palbociclib combination," he added.

Ibrance was first approved in 2015 by the US Food and Drug Administration (FDA) as a first-line treatment for postmenopausal women with oestrogen receptor positive (ER+), HER2-negative advanced breast cancer who have not received previous systemic treatment.

Although Pfizer’s drug is the leader in this indication, it is facing increasing competition from the likes of Novartis’ Kisqali (ribociclib) and others for a share in the market.

Pfizer’s drug brought in $3.35bn in US sales last year despite the competition, with its overall sales reaching an impressive $4.96bn.

While the PALLAS study missed the mark, Pfizer is still holding out hope for another study of Ibrance, PENELOPE-B, which is due to produce results later this year.

The PENELOPE-B study is evaluating Ibrance in patients with early breast cancer at high risk of recurrence who have residual disease after neoadjuvant chemotherapy.

“This result is not what we hoped for, but we are steadfast in our commitment to advancing the science and care for people living with breast cancer,” said Albert Bourla, Pfizer Chairman and CEO.

“Given the continued breadth of our marketed portfolio and strength of our pipeline, our growth projections are not reliant upon any individual marketed medicine or pipeline opportunity,” he added.

Article by
PMGroup

2nd June 2020

From: Research, Regulatory, Healthcare

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