ASH News Daily 2016 - Issue 2 - A-21

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Her remission means the world to her.

PROTECT IT.

In the post auto-HSCT consolidation treatment of patients with classical
Hodgkin lymphoma (HL) at high risk of relapse or progression, ADCETRIS®
(brentuximab vedotin) significantly increased PFS compared to placebo1

18.8

month median PFS benefit1

ADCETRIS: 42.9 months (95% CI: 30.4, 42.9†)
Placebo: 24.1 months (95% CI: 11.5, NE)
HR=0.57 (95% CI: 0.40, 0.81) P=0.001
NE=Not estimable. †Estimates are unreliable.

STUDY DESIGN: ADCETRIS was evaluated as post auto-HSCT consolidation treatment in a multicenter, randomized,
double-blind, placebo-controlled trial of 329 patients aged ≥18 years with classical Hodgkin lymphoma (histologically
confirmed) at high risk of relapse or disease progression within 30-45 days post auto-HSCT. Patients were randomized
to receive ADCETRIS 1.8 mg/kg (n=165) or placebo (n=164) q3w for up to 16 cycles. High risk of relapse/progression
was defined by ≥1 of the following risk factors: refractory disease, relapse <12 months after frontline therapy, relapse
≥12 months with extranodal disease. Primary endpoint was PFS per independent review facility.1,2
The most common adverse reactions (≥20%) in the ADCETRIS-treatment arm (167 patients), regardless of causality,
were: neutropenia, peripheral sensory neuropathy, thrombocytopenia, anemia, upper respiratory tract infection, fatigue,
peripheral motor neuropathy, nausea, cough, and diarrhea1

Visit ADCETRISpro.com to learn more.
Visit ADCETRISpro.com to learn more.

other possible contributory factors include prior
* Gastrointestinal (GI) complications: Fatal and
therapies and underlying disease that may cause
serious GI complications, including perforation,
immunosuppression. Consider the diagnosis of
hemorrhage, erosion, ulcer, intestinal obstruction,
PML in any patient presenting with new-onset
enterocolitis, neutropenic colitis, and ileus, have
signs and symptoms of central nervous system
been reported in ADCETRIS-treated patients.
abnormalities. Hold ADCETRIS if PML is suspected
Lymphoma with preexisting GI involvement may
and discontinue ADCETRIS if PML is confirmed.
increase the risk of perforation. In the event of
new or worsening GI symptoms, perform a prompt
* Pulmonary toxicity: Events of noninfectious
pulmonary toxicity including pneumonitis, interstitial diagnostic evaluation and treat appropriately.
lung disease, and acute respiratory distress
* Embryo-fetal toxicity: Based on the mechanism of
syndrome, some with fatal outcomes, have been
action and findings in animals, ADCETRIS can cause
reported. Monitor patients for signs and symptoms
fetal harm when administered to a pregnant woman.
of pulmonary toxicity, including cough and dyspnea.
Females of reproductive potential should avoid
In the event of new or worsening pulmonary
pregnancy during ADCETRIS treatment and for at
symptoms, hold ADCETRIS dosing during evaluation least 6 months after the final dose of ADCETRIS.
and until symptomatic improvement.
* Serious dermatologic reactions: Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis
(TEN), including fatal outcomes, have been
reported with ADCETRIS. If SJS or TEN occurs,
discontinue ADCETRIS and administer appropriate
medical therapy.

Adverse Reactions:

The most common serious adverse reactions in the
ADCETRIS-treated arm, regardless of causality, were
pneumonia, pyrexia, vomiting, nausea, hepatotoxicity,
and peripheral sensory neuropathy.

References: 1. ADCETRIS [Prescribing Information]. Bothell, WA: Seattle Genetics, Inc.; March
2016. 2. Moskowitz CH, Nademanee A, Masszi T, et al; for the AETHERA Study Group. Brentuximab
vedotin as consolidation therapy after autologous stem-cell transplantation in patients with
Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind,
placebo-controlled, phase 3 trial. Lancet. 2015;385:1853-1862.

Drug Interactions:

Concomitant use of strong CYP3A4 inhibitors
or inducers, or P-gp inhibitors, has the potential
to affect the exposure to monomethyl auristatin E
(MMAE).

Use in Specific Populations:

MMAE exposure and adverse reactions are increased
in patients with moderate or severe hepatic
impairment or severe renal impairment. Avoid use.
Advise females of reproductive potential to avoid
pregnancy during ADCETRIS treatment and for at
least 6 months after the final dose of ADCETRIS.
Advise males with female sexual partners of
reproductive potential to use effective contraception
during ADCETRIS treatment and for at least 6 months
after the final dose of ADCETRIS.
Advise patients to report pregnancy immediately and
avoid breastfeeding while receiving ADCETRIS.
Please see brief summary of Prescribing
Information on following page and full Prescribing
Information at ADCETRIS.com.

ADCETRIS, Seattle Genetics, and their logos are US registered trademarks of Seattle Genetics, Inc.
© 2016 Seattle Genetics, Inc., Bothell, WA 98021 All rights reserved. Printed in USA USP-BVP-2015-0161(2)

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Table of Contents for the Digital Edition of ASH News Daily 2016 - Issue 2