Date: 2017-12-08
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 2017 San Antonio Breast Cancer Symposium (SABCS)
Company: Pfizer (USA - NY)
Product: Ibrance® (palbociclib)
Action
mechanism:
- CDK inhibitor. Palbociclib is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation.
- Palbociclib was the first CDK 4/6 inhibitor approved by any regulatory authority, and now is approved in more than 75 countries. These global approvals are based on data from the PALOMA program, including PALOMA-2 as well as the Phase 3 PALOMA-3 trial, which evaluated Ibrance® in combination with fulvestrant in pre-, peri- and postmenopausal women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy. Pre- and peri-menopausal women enrolled in PALOMA-3 received the LHRH agonist goserelin.
Disease: postmenopausal women with ER+, HER2- metastatic breast cancer
Therapeutic
area: Cancer - Oncology
Country: Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Ireland, Italy, Japan, Republic of Korea, Poland, Russian Federation, Spain, Taiwan, Ukraine, UK, USA
Trial
details:
- PALOMA-2 is a randomized (2:1), multicenter, multinational, double-blind Phase 3 study designed to assess the PFS of Ibrance® (125 mg orally once daily for three out of four weeks in repeated cycles) in combination with letrozole (2.5 mg once daily continuously) versus letrozole plus placebo as a first-line treatment for postmenopausal women with ER+, HER2- metastatic breast cancer. PALOMA-2 evaluated a total of 666 women from 186 global sites in 17 countries.
- Results from PALOMA-2 after a median 23-month follow-up were previously published in The New England Journal of Medicine in November 2016. (NCT01740427)
Latest
news:
- • On December 8, 2017, Pfizer presented updated progression-free survival (PFS) results from the Phase 3 PALOMA-2 trial at the 2017 San Antonio Breast Cancer Symposium (SABCS). The study is evaluating the clinical benefit of Ibrance® (palbociclib) combined with letrozole. The data demonstrate that the combination of Ibrance® plus letrozole reduced the risk of disease progression by 44 percent and improved median PFS by more than one year compared to letrozole plus placebo (27.6 months [95% CI: 22.4, 30.3] vs 14.5 months [95% CI: 12.3, 17.1]) when used as the initial treatment for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer (HR=0.56 [95% CI: 0.46, 0.69]). This updated, post-hoc analysis included a median follow-up of more than three years, which is the longest to date of any Phase 3 study of a CDK 4/6 inhibitor.
- The updated data are consistent with results from the primary analysis for PALOMA-2, which showed a median PFS for women treated with Ibrance® plus letrozole of 24.8 months (95% CI: 22.1, NE) compared with 14.5 months (95% CI: 12.9, 17.1) for women treated with letrozole plus placebo (HR=0.58 [95% CI: 0.46,0.72], p<0.0001). Consistent with findings from the primary analysis, the updated data demonstrate that clinical benefit was observed across all patient subgroups receiving the combination of Ibrance® and letrozole. Overall survival data were not yet mature at the time of this updated PFS analysis.
Is
general: Yes
