THE COMPETITION
TITAN, ARCHES and ENZAMET - which trial's Primary Endpoint includes OS data, yet is not included in their approved product labeling?
What is: ENZAMET (Xtandi)
Patients often present with metastases at the time of initial diagnosis this is known as __________.
What is: De Novo Metastatic Disease
What does the SPARTAN patient look like clinically?
What is: On ADT, rapidly rising PSA, no distant metastasis detected by conventional imaging
Number 1 adverse reaction for patients on ERLEADA + ADT, effecting what percent of patients?
What is: Rash at 28%
Two terms that physicians use interchangeably with the De Novo.
What is: Metastatic Castrate Sensitive Prostate Cancer or Metastatic Hormone Sensitive Prostate Cancer.
What are the dosing requirements for Darolutimide?
What is: Two tablets b.i.d. with food
OS for ERLEADA + ADT
What is: 33%
SPARTAN Trial - Primary endpoint is ____? Endpoint details include ____?
What is: Metastasis-free survival ERLEADA + ADT improved median MFS by 2 YEARS (24.3 months) vs placebo + ADT. (40.5 months vs. 16.2 months)
SPARTAN Trial: patients with nmCRPC. What was the occurrence (%) of ischemic cardiovascular events for those treated with ERLEADA? Placebo?
What is: 4 percent of patients on ERLEADA and 3 percent of patients on placebo.
Other terms used to describe metastatic castration-sensitive prostate cancer (mCSPC) in medical literature include?
What is:
In the ARCHES trial, what type of prostate patient is being studied?
What is: Patients with mCSPC, of whom 1146 patients received either a (GnRH) analogue concurrently or had bilateral orchiectomy. Patients received either 160 mg q.d. or placebo.
ERLEADA + ADT reduces risk of initiation of Cytotoxic chemotherapy by what percent vs Placebo + ADT?
What is: 61%
What percent of SPARTAN study evaluated patients presented with baseline characteristics that included local or regional nodal disease?
What is: 16%
*1 in 6 patients in SPARTAN had local or regional lymph node metastases at baseline.
The most common adverse reactions that occurred more frequently in the ERLEADA treated patients over placebo from the randomized placebo-controlled clinical trials (TITAN and SPARTAN)?
What are: fatigue, arthralgia, rash, decreased appetite, fall, weight decrease, hypertension, hot flush, diarrhea, and fracture.
TITAN Trial - Serious adverse reactions occurred in what percent of patients treated with ERLEADA + ADT arm vs. placebo + ADT arm?
What is: 20% of patients in ERLEADA + ADT arm and 20% of patients in placebo + ADT arm.
In the ENZAMET trial investigators looked at enzalutimide + ADT and outcomes for patients that also received concurrent ___________.
What is: Docetaxel
Median OS of men with mCSPC who were treated with ADT alone?
What is: ≤4 years
In the SPARTAN endpoint of MFS, what was the percent reduction in the risk of distant metastasis or death?
What is: 72%
How is ERLEADA initially dosed for patients with Renal or Hepatic impairment?
What is: No initial dose adjustments are necessary
What is MFS and why does it matter?
What is: The time from randomization to the time of first evidence of distant metastasis.
Percentage of the patients from the ENZAMET trial were from the U.S.?
What is: 4%
In the TITAN trial consistent improvement was observed with ERLEADA + ADT vs. placebo + ADT across which two patient subgroups?
What is: Disease volume (high vs. low) and Gleason Score at diagnosis (≤7 vs >7).
What is:
Spartan Trial: falls occurred in what percent of patients treated with ERLEADA compared to Placebo?
What is: 16% of patients treated with ERLEADA compared to 9% of patients treated with placebo.
Start early with ERLEADA
to _________.
What is: give your patients with nmCRPC a chance to live longer without metastasis.