Hero

In the post auto-HSCT consolidation treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or disease progression1

Her remission
means the world to her.
Protect it.

AETHERA demonstrated the benefit of ~1 year (up to 16 cycles) of ADCETRIS® (brentuximab vedotin) as post auto-HSCT consolidation1

ADCETRIS as consolidation treatment significantly improved PFS vs placebo1

Post auto-HSCT consolidation with ADCETRIS was evaluated in a multicenter, randomized, double-blind, placebo-controlled trial in which 329 patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression were randomized to receive either ADCETRIS (n=165) or placebo (n=164). Patients received best supportive care regardless of treatment arm.1,2

Kaplan-Meier curve of Independent Review Facility (IRF)–assessed PFS1,2

A line chart, depicting percentage of patients free of PD or death against time in months. 18.8-month median PFS benefit; 42.9 months vs 24.1 months with placebo; HR=0.57, P=0.001.

PD=progressive disease; HR=hazard ratio. Progression-free survival (PFS) as measured per IRF. NE=Not estimable.

95% CI: 0.40, 0.81. Estimates are unreliable.
  • In the AETHERA trial, overall survival (OS) was a secondary endpoint and the interim analysis showed no significant difference in OS between treatment arms1,2
  • Patients in the placebo arm with progressive disease per investigator could receive ADCETRIS as part of a separate trial 1
  • Primary endpoint was progession-free survival (PFS) by independent review, defined as the time from randomization to the first documentation of tumor progression or death (due to any cause).

ADCETRIS achieved a median 18.8-month PFS benefit over placebo1

Median IRF-assessed PFS1

A bar chart, depicting PFS in months. ADCETRIS is 42.9 months (95% CI: 30.4, 42.9), placebo is 24.1 months (95% CI: 11.5, NE). Median 18.8 months’ difference; HR=0.57, P=0.001 (95% CI: 0.40, 0.81).

NE=not estimable. Estimates are unreliable. Progression-free survival (PFS) as measured per IRF.

Adverse reactions in the AETHERA trial1

Most common adverse reactions (≥20%) in the ADCETRIS-treatment arm (167 patients)
  • Neutropenia (78%)
  • Peripheral sensory neuropathy (56%)
  • Thrombocytopenia (41%)
  • Anemia (27%)
  • Upper respiratory tract infection (26%)
  • Fatigue (24%)
  • Peripheral motor neuropathy (23%)
  • Nausea (22%)
  • Cough (21%)
  • Diarrhea (20%)
The most common serious adverse reactions reported in the ADCETRIS-treatment arm (167 patients)
  • Pneumonia (4%)
  • Pyrexia (4%)
  • Vomiting (3%)
  • Nausea (2%)
  • Hepatotoxicity (2%)
  • Peripheral sensory neuropathy (2%)
  • 32% of patients in the ADCETRIS arm discontinued treatment due to adverse events compared with 6% of patients in the placebo arm1,5
    • Adverse reactions that led to treatment discontinuation in 2 or more patients were peripheral sensory neuropathy (14%), peripheral motor neuropathy (7%), acute respiratory distress syndrome (1%), paresthesia (1%), and vomiting (1%)1

Brentuximab vedotin (ADCETRIS®) as post auto-HSCT consolidation treatment for patients with classical HL at high risk of relapse or progression is recommended by consensus groups3,4

The NCCN Guidelines recommend brentuximab vedotin as a consideration for consolidation therapy (category 2A) following autologous hematopoietic stem cell transplantation3.

American Society for Blood and Marrow Transplantation (ASBMT™) evidence-based review gives ADCETRIS as post auto-HSCT consolidation therapy a Grade A recommendation (1+ level of evidence).4


ASBMT recommends post auto-HSCT consolidation therapy for high-risk patients (refractory disease, relapse <12 months after frontline therapy, or relapse ≥12 months with extranodal disease).4

National Comprehensive Cancer Network® (NCCN)3

The NCCN Guidelines recommend brentuximab vedotin as a consideration for consolidation therapy (category 2A) following autologous hematopoietic stem cell transplantation3.

American Society for Blood and Marrow Transplantation (ASBMT™)4

American Society for Blood and Marrow Transplantation (ASBMT™) evidence-based review gives ADCETRIS as post auto-HSCT consolidation therapy a Grade A recommendation (1+ level of evidence)4

ASBMT recommends post auto-HSCT consolidation therapy for high-risk patients (refractory disease, relapse <12 months after frontline therapy, or relapse ≥12 months with extranodal disease)4

*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way

View the safety profile in the classical HL consolidation trial »

Please see Important Safety Information, including BOXED WARNING, and read full Prescribing Information.

Seattle Genetics does not guarantee that enrollment will result in coverage and/or reimbursement.

ADCETRIS and its logo, SeaGen Secure and its logo, Seattle Genetics and Seattle Genetics Mark are US registered trademarks of Seattle Genetics, Inc.
© 2017 Seattle Genetics, Inc., Bothell, WA 98021. All rights reserved. USP-BVP-2016-0167(1)

Request a visit from a Seattle Genetics representative

Please fill out the form below to request a visit from a Seattle Genetics sales representative. A representative will contact you via email or telephone to schedule a convenient time for a visit.

Required fields.
Your Name:
Your Contact Details:
Preferred Contact Method
By checking this box, I understand that the information I have provided will be used only by Seattle Genetics to contact me by email with information on ADCETRIS® (brentuximab vedotin) and other Seattle Genetics drugs, new resources, and/or new data. Seattle Genetics will not sell or transfer my name or contact information to any third-party vendor.

This site is intended for US audience only

This site is intended for US healthcare professionals (HCP) only. If you are not a US HCP, please choose one of the following options:


Important Safety Information

Indications

ADCETRIS® (brentuximab vedotin) is indicated for treatment of patients with:

Classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.

Classical HL at high risk of relapse or progression as post auto-HSCT consolidation treatment.

Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.

The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information

Boxed Warning

Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS® (brentuximab vedotin).

Contraindication:

ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions:

  • Peripheral neuropathy (PN): ADCETRIS treatment causes a PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness and institute dose modifications accordingly.
  • Anaphylaxis and infusion reactions: Infusion-related reactions, including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an infusion-related reaction occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Patients who experienced a prior infusion-related reaction should be premedicated for subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.
  • Hematologic toxicities: Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS. Febrile neutropenia has been reported with ADCETRIS. Monitor complete blood counts prior to each dose of ADCETRIS and consider more frequent monitoring for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.
  • Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in patients treated with ADCETRIS. Closely monitor patients during treatment for the emergence of possible bacterial, fungal or viral infections.
  • Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor and high tumor burden.
  • Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment compared to patients with normal renal function. Avoid the use of ADCETRIS in patients with severe renal impairment.
  • Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment compared to patients with normal hepatic function. Avoid the use of ADCETRIS in patients with moderate or severe hepatic impairment.
  • Hepatotoxicity: Serious cases of hepatotoxicity, including fatal outcomes, have occurred with ADCETRIS. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first dose of ADCETRIS or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may also increase the risk. Monitor liver enzymes and bilirubin. Patients experiencing new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.
  • Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death has been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS therapy, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider the diagnosis of PML in any patient presenting with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.
  • Pulmonary toxicity: Events of noninfectious pulmonary toxicity including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, some with fatal outcomes, have been reported. Monitor patients for signs and symptoms of pulmonary toxicity, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation 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.
  • Gastrointestinal (GI) complications: Fatal and serious GI complications, including perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus, have been reported in ADCETRIS-treated patients. Lymphoma with preexisting GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, perform a prompt diagnostic evaluation and treat appropriately.
  • Embryo-fetal toxicity: Based on the mechanism of action and findings in animals, ADCETRIS can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should avoid pregnancy during ADCETRIS treatment and for at least 6 months after final dose of ADCETRIS.

Adverse Reactions:

In two uncontrolled single-arm trials of ADCETRIS as monotherapy in 160 patients with relapsed classical HL and sALCL, the most common adverse reactions (≥20%), regardless of causality, were: neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.

In a placebo-controlled trial of ADCETRIS in 329 patients with classical HL at high risk of relapse or progression post auto-HSCT, 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 diarrhea.

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.

You are now leaving ADCETRISpro.com

Do you wish to continue?

Reference
1.
ADCETRIS [Prescribing Information]. Bothell, WA: Seattle Genetics, Inc.; September 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.
3.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hodgkin lymphoma (V.1.2017). © National Comprehensive Cancer Network, Inc. 2017. All rights reserved. Accessed June 2017. To view the most recent and complete version of the guidelines, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.
4.
Perales M-A, Ceberio I, Armand P, et al. Role of cytotoxic therapy with hematopoietic cell transplantation in the treatment of Hodgkin lymphoma: Guidelines from the American Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2015;21:971-983.
5.
Data on file. Seattle Genetics, Inc.