Abstract 1423
Background
In the PALOMA-3 trial, palbociclib plus fulvestrant demonstrated a clinically meaningful improvement in overall survival compared with fulvestrant plus placebo in patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer who had relapsed or progressed on prior endocrine therapy (Turner NC et al., NEJM 2018). Detailed analyses for first-line (1L) and second- or later- line (2L+) therapy are still limited.
Methods
The prospective, multicenter phase 2 INGE-B trial was designed to generate efficacy and safety data on the combination of palbociclib with letrozole (1L) or fulvestrant (1L, 2L+) in accordance with the PALOMA trials and to generate so far lacking trial data on the combination of palbociclib with anastrozole (1L), exemestane (1L) or letrozole (2L+). This pre-planned interim analysis was conducted to evaluate data on pts receiving palbociclib plus fulvestrant as 1L or 2L+ therapy. The primary endpoint was the clinical benefit rate (CBR) in pts with measurable disease according to RECIST v1.1. Key secondary endpoints included the overall response rate (ORR), the CBR for all pts, and safety. Data were analyzed with descriptive statistics.
Results
At the cut-off date of the interim analysis (Dec 17, 2018), 124 pts have been recruited from 03/2017 through 06/2018 at 47 sites across Germany to receive palbociclib plus fulvestrant (1L: 57 pts; 2L+: 67 pts). 57 of 67 pts treated in 2L+ were evaluable. Median age was 68.0 years, 91.2% (n = 52) of pts had an ECOG performance score of 0 or 1. 28.1% (n = 16) of pts presented with non-measurable bone-only disease. The CBR was 35% (n = 14) for the 40 pts with measurable disease (RECIST v1.1) and 51% (n = 29) for all pts (investigator assessment). The ORRs were 25% (n = 10) and 21% (n = 12), respectively. Grade 3/4 adverse events experienced by at least 10% of pts were neutropenia (n = 21, 36.8%) and leukopenia (n = 7, 12.3%).
Conclusions
This INGE-B interim analysis showed a remarkable clinical benefit for palbociclib plus fulvestrant as second- or later-line therapy for pts with HR+/HER2- advanced breast cancer. No new safety signals were detected.
Clinical trial identification
2015-001603-32.
Editorial acknowledgement
Legal entity responsible for the study
iOMEDICO AG.
Funding
Pfizer Pharma GmbH.
Disclosure
D. Lüftner: Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Celgene; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Teva; Advisory / Consultancy: Tesaro; Advisory / Consultancy: L’Oréal; Advisory / Consultancy: MSD; Advisory / Consultancy: AstraZeneca. M.K. Welslau: Honoraria (self), Advisory / Consultancy: Amgen; Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: GILEAD; Honoraria (self), Advisory / Consultancy: HEXAL; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Medac; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self): Astellas; Honoraria (self): AstraZeneca. A. Welt: Advisory / Consultancy: Roche; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Eisai; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Amgen. M. Zaiss: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Janssen; Advisory / Consultancy: Novartis. N.W. Marschner: Leadership role, Shareholder / Stockholder / Stock options: iOMEDICO AG; Research grant / Funding (institution): Pfizer. All other authors have declared no conflicts of interest.
Resources from the same session
4581 - Timing to achieve complete response (CR) after definitive chemoradiotherapy (ChRT) in patients with squamous cell carcinoma of the anal (SCCAC) with and without HIV infection: a multicenter retrospective study
Presenter: Marcos Camandaroba
Session: Poster Display session 2
Resources:
Abstract
1712 - Planned organ preservation for T2 T3 M0 rectal adenocarcinoma. A possible option using chemoradiotherapy (CRT) and Contact X-ray Brachytherapy (CXB). A French multicenter study.
Presenter: Jean-Pierre Gérard
Session: Poster Display session 2
Resources:
Abstract
4639 - A Phase 1b Study of E7046 (AN0025) in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Rectal Cancer
Presenter: Lucjan Wyrwicz
Session: Poster Display session 2
Resources:
Abstract
2310 - Upfront radical surgery with total mesorectal excision (TME) versus preoperative chemoradiotherapy followed by TME in clinical stage II/III patients with rectal cancer: a propensity score analysis
Presenter: Ahrong Ham
Session: Poster Display session 2
Resources:
Abstract
2747 - Neoadjuvant chemoradiotherapy with/without lateral lymph node dissection for low rectal cancer: Which patients can benefit?
Presenter: Daisuke Nishizaki
Session: Poster Display session 2
Resources:
Abstract
2877 - The impact of completeness of chemotherapy on the efficacy of irinotecan in the preoperative chemoradiotherapy of locally advanced rectal cancer.
Presenter: Jingwen Wang
Session: Poster Display session 2
Resources:
Abstract
3050 - Feasibility of robot-assisted surgery in elderly patients with rectal cancer
Presenter: Wei-Chih Su
Session: Poster Display session 2
Resources:
Abstract
4109 - Feasibility of chemoradiotherapy in rectal cancer patients with peritumoral abscesses and fistulas: a case-control non-inferiority trial
Presenter: Valerii Ivanov
Session: Poster Display session 2
Resources:
Abstract
4813 - Differential of the nutritional index before and after neoadjuvant chemoradiotherapy as a prognostic factor of recurrence in patients with locally advanced adenocarcinoma of the rectum
Presenter: Leslie Navia-Ortuño
Session: Poster Display session 2
Resources:
Abstract
5345 - Short-term Clinical Outcomes of Robotic-Assisted Total Mesorectal Excision in Rectal Cancer after concurrent chemoradiotherapy
Presenter: Pojung Chen
Session: Poster Display session 2
Resources:
Abstract