Real World Evidence
At the time of our RWD piece, __ years had passed with _________prescribers and ______patients being treated.
What is 4 years, 13,000 and 100,000
The most frequently reported adverse reaction in Study 1 & 2 is_____________________ and was reported in what percentage of patients?
What is Neutropenia, 80% and 83%
The PALOMA-2 is a___, ______, _________, ______ Trial
What are 2:1, Randomized, Double-Blind, Phase 3?
The following were secondary endpoints in PALOMA-3 study.
What is Clinical Benefit Rate, Duration of Response, and Overall Survival
IBRANCE is covered by ____of commercial plans and ____% of Medicare Part D plans
What is 98% and 100%
The IRIS study contained how many chart reviews by how many physicians
What is 652 and 65
In Study 1 and Study 2 the median time to the first episode of any grade neutropenia was ____ and the median duration of _____.
What is 15 days and 7 days?
The PALOMA -2 Secondary Endpoints are _________
What are Overall Survival, Overall Response Rate, Safety, and Tolerability
What __ % Patients in the IBRANCE=fulvestrant had previous chemotherapy for treatment of metastatic disease (with or without adjuvant or neoadjuvant)
What is 33%?
The new NCCN recommendations for Palbociclib we can share with our customers are_________.
What is nothing (We currently can't share any recommendations).
_____ patients received IBR/AI and ____patients received IBR/Fulvestrant
What is 360 and 292
Permanent discontinuation in Study 1 was ___% in the IBR/LET arm and ____% in the LET only arm
What is 9.7% and 5.9%
The % of patients with bone only disease
What is 23.2%
In both treatment groups of PAL 3, 79% of patients were _______ and 21% of patients were ________; the majority of patients had received _____ previous line(s) of endocrine treatment.
What is postmenopausal and peri/premenopausal, and 1?
Permanently discontinue IBRANCE for severe ______and _________.
What are ILD and Pneumonitis?
The progression free rate with IBR/AI as initial therapy was ____% at 24 months
What is 64.3%
Human bone marrow cells treated with Palbo in the presence or absence of anti-estrogen in vitro di not become _______ and resumed _________following Palbo withdrawal.
What is Senescent and Proliferation
In the PAL 2 the median PFS was __ in the IBR+Let arm, __ in the Let only arm and had __ events in the IBR arm
What are 24.8 Months and 14.5 Months and 194 events
In PAL 3, the median PFS as assessed by the investigators in the ITT population was __ months in the IBR+fulvestrant group and __ months in the placebo+fulvestrant group, and ORR was ____
What is 9.5 and 4.6 and 24.6%
From Study 1 (PAL-2) and Study 2 (PAL-3) what are two highest % lab abnormalities.
What are decreased WBCs and Neutrophils
The percentage of patients that started at the 125 mg dose was ____
What is 78%
In study 2 there were ____patients in the IBR/Fulvestrant arm, with a median age of __ and ___% postmenopausal.
What is 347, 57 and 80%
In the updated non-prespecified PFS analysis, the PFS for patients with bone only disease was____mos
What is 36.2 months?
In the PAL 3 the median OS was __ in the IBRANCE + fulvestrant group and __ in the Pacebo+fulvestrant group with a p-value of ___
What is 34.9 months and 28 months and 0.09
The key pillars (boxes) of the Winning Formula are?
What are Experience, Efficacy, Safety/Monitoring, and Access/Support?