ECHELON-1
True or False - Patients in both treatment arms were treated on days 1 and 14 of each 28-day cycle?
False
days 1 and 15 of each 28-day cycle
Q: In the AETHERA trial patients had received a median of how many prior therapies excluding autologous hematopoietic stem cell transplantation?
2
True or False: Study 2 for relapse sALCL was multi-center, Double blind, placebo controlled trial.
False
Single arm, open label, multi-centered
N=_______
Median Age=________
sALCL ALK - ______%
ALK + _______%
452, 58, 48, 22
Q: Adcetris is individually boxed single dose vials of ______mg?
50
At the median follow up time of 24.6 months, what was the difference in PFS between the 2 treatment arms?
4.9% (18% of patients experienced events with A+AVD versus 22% receiving ABVD)
What was the median PFS follow up time from randomization in the AETHERA trial?
22 months
What was the median age of patients in the Clinical Trial in Relapsed CHL (Study 1)
31 years
True or False Q: Number of cycles received, either 6 or 8 was similar between A+CHP and CHOP?
True
(70% vs 18%/6 or 8), (62% vs 19%)
Q: A fever over what temp should a pt call their doctor?
100.5 degrees
Q: The modified progression-free survival (PFS) endpoint in the E1 trial is considered a more rigorous endpoint than standard PFS due to the inclusion of which components?
Additional anticancer therapy for patients not in complete remission after FL therapy.
In AETHERA patients were randomized 1:1 to receive placebo or ADECETRIS 1.8mg/kg every 3 weeks for up to _________ cycles?
16
In Study 2 for relapse sALCL, 58 pts mostly male and white had received a median of _____ prior therapies, ______% of pt had received a Auto-HSCT and _____% of pts had relapsed and _____% of pts were refractory. 72% were ALK -
2, 26, 50, 50
PFS in months A+CHP vs CHOP _____ vs _____.
A: 48.2 vs 20.8
Fill in the blanks - For females of reproductive potential, ADCETRIS can cause _______ harm. Advise women to _________ pregnancy during ADCETRIS treatments and for _____ months after the final dose.
fetal, avoid, 6
Out of the patients enrolled in the E1 trial__had Stage III disease and__had Stage IV disease. Of these patients__had extrnodal envolvement.
36%,64% and 62%
ALCANZA was a randomized, open label, muticenter, clinical trial in patients with primary cutaneous anaplastic large cell lymphoma and mycosis fungoides. Although 131 patients were randomzied, efficacy were based on 128 patients. Patients had received a median of 4 prior therapies including a median of 1 prior skin directed therapy and 2 systemic therapies. Additionally, both pcALCL and MF patients were required to at least 1 skin biopsies resulting in a CD30 expression of > 10%. Patients were randomized on a 1:1 to receive Adcetris 1.8 mg/kg intravenously every 3 weeks for up to a maximum of 16 weeks or physician's choice of what two therapies?
Methotrexate or Bexarotene
In the Clinical Trial in Relapsed CHL (Study 1) What was the median duration of response for the patients who had a CR?
20.5 months
OS was statistically significant and showed ______% reduction in risk of death.
34
True or False - Q: Vials should be stored at 8-12 degrees C?
A: False
??
Due to the results of the E1 study, Adcetris received FDA approval for what indication? State the indication.
Adcetris is indicated for the treatment of adult patients with previously untreated Stage III/IV cHL in combination with doxorubicin, vinblastine and dacarbazine
Efficacy was estrablished based on the proportion of patients achieving an objective response (CR+PR) that lasted at least 4 months (ORR4). What percentage of patient achieved an ORR4 in the 2 treatment arms?
56.3% Adcetris vs. 12.5% Physician's Choice
In study 2 for relapse sALCL Match efficacy results: 1)CR, 2)PR, 3)ORR
A)29%, B)86%, C)57%
1=C 2=A 3=B
Q: What other 2 endpoints showed statistical significance?
CR and ORR
Q: Which of the following does NOT fall under Patient counseling : Progressive Multifocal Leukoencephalopathy, Hepatotoxicity, Tumor Lysis Syndrome, Neutropenia, Pulmonary Toxicity
Tumor Lysis Syndrome