On December 1, 2022 Seagen Inc. (Nasdaq: SGEN) reported that new data for ADCETRIS (brentuximab vedotin) will be featured at the upcoming 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 10-13, 2022 (Press release, Seagen, DEC 1, 2022, View Source [SID1234624702]). The abstracts, including five oral presentations, highlight updated and interim efficacy and safety clinical trial results for ADCETRIS in both early- and advanced stage settings of classical Hodgkin lymphoma (cHL), and in patients with other CD30-expressing lymphomas and other rare cancers.

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"The investigation of ADCETRIS as a single agent or in novel combinations with other agents demonstrates its continued potential to help people impacted by early- and advanced stage Hodgkin lymphoma," said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development at Seagen. "Additional data from real-world settings further support the efficacy, safety and impact of ADCETRIS treatment in its approved indications for multiple types of lymphoma."

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of cHL that is expressed on the surface of several types of lymphomas. It is approved in seven indications in the U.S.

Updated results will also be presented from a phase 1 study of the investigational agent SEA-BCMA in patients with relapsed/refractory multiple myeloma.

Presentations of Company-Sponsored ADCETRIS Clinical Development Trials

Abstract Title

Abstract #

Presentation Time

Lead Author

Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine (AN+AD) for Advanced Stage Classic Hodgkin Lymphoma: Updated Efficacy and Safety Results from the Single-Arm Phase 2 Study (SGN35-027 Part B)

314

Oral Presentation

Saturday, Dec. 10

4–5:30 p.m. CT

H. Lee

Population Pharmacokinetics (PPK) and Exposure-Response to Support Body Surface Area (BSA)-Based Dosing of Brentuximab Vedotin in Pediatric Patients with Advanced-Stage Newly Diagnosed Hodgkin Lymphoma (HL)

1616

Poster Session I
Saturday, Dec. 10

5:30–7:30 p.m. CT

X. Zhou

Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine (AN+AD) for Early-Stage Classic Hodgkin Lymphoma: Interim Efficacy and Safety Results from the Single-Arm Phase 2 Study (SGN35-027 Part C)

4230

Poster Session III
Monday, Dec. 12

6–8:00 p.m. CT

H. Lee

Brentuximab Vedotin in Frontline Therapy of Hodgkin Lymphoma in Patients with Significant Comorbidities Ineligible for Standard Chemotherapy (SGN35-015 Part E)

1598

Online Abstract

C. Yasenchak

Efficacy and Safety of Retreatment with Brentuximab Vedotin in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma or CD30-Expressing Peripheral T-Cell Lymphoma

5469

Online Abstract

D. Sano

A Phase 4 Multicenter Study of Brentuximab Vedotin Treatment in Chinese Patients with CD30-Positive Cutaneous T-Cell Lymphoma

5491

Online Abstract

Q. Wang

A Spanish Medical Record Review of Adults with Relapsed or Refractory CD30+ Malignancies When Re-Treated with Brentuximab Vedotin (BV): Preliminary Analysis of the BELIEVE Study (NCT04998331)

5528

Online Abstract

A. Sureda

Presentations of Company-Sponsored Health Economic Outcomes Research

Abstract Title

Abstract #

Presentation Type

Lead Author

Real-World Treatment Patterns and Clinical Outcomes with Brentuximab Vedotin or Other Standard Therapies in Patients with Previously Treated Cutaneous T-Cell Lymphoma (CTCL): A Retrospective Chart Review Study in the United States

2265

Poster Session I
Saturday, Dec. 10

5:30–7:30 p.m. CT

S. Barta

Real-World Patient Characteristics, Treatment Patterns, and Outcomes in Patients with Stage III/IV Classic Hodgkin Lymphoma Treated with Frontline ABVD: A Retrospective Analysis Using a Real-World Database

3596

Poster Session II
Sunday, Dec. 11

6–8 p.m. CT

A. Winter

10-Year Impact on Productivity Costs Associated with Mortality in Stage III or IV Classical Hodgkin Lymphoma Based on the Overall Survival Update of the ECHELON-1 Trial: Application of an Oncology Simulation Model in the United States

4846

Poster Session III
Monday, Dec. 12

6–8 p.m. CT

T. Phillips

Economic Burden of Hematopoietic Cell Transplantation (HCT) Among Commercially Insured Patients with Hematological Malignancies in the United States

4850

Poster Session III
Monday, Dec. 12

6–8 p.m. CT

M. Narkhede

Presentation of Company-Sponsored Trials of Pipeline Agents

Abstract Title

Abstract #

Presentation Type

Lead Author

SEA-BCMA Mono- and Combination Therapy in Patients with Relapsed/Refractory Multiple Myeloma: Updated Results of a Phase 1 Study (SGN-BCMA001)

4562

Poster Session III
Monday, Dec. 12

6–8 p.m. CT

J. Hoffman

Presentations of Investigator- and Cooperative-Group Sponsored ADCETRIS Trials

Abstract Title

Abstract #

Presentation Type

Lead Author

Treatment Related Morbidity in Patients with Classical Hodgkin Lymphoma: Results of the Ongoing, Randomized Phase III HD21 Trial by the German Hodgkin Study Group

317

Oral Presentation

Saturday, Dec. 10

4–5:30 p.m. CT

P. Borchmann

Frontline PET-Directed Therapy with Brentuximab Vedotin Plus AVD Followed by Nivolumab Consolidation in Patients with Limited Stage Hodgkin Lymphoma

728

Oral Presentation

Monday, Dec. 12

10:30 a.m.–12 p.m. CT

S. Park

Brentuximab Vedotin Combined with Chemotherapy in Newly Diagnosed, Early-Stage, Unfavorable-Risk Hodgkin Lymphoma: Extended Follow-Up with Evaluation of Baseline Metabolic Tumor Volume and PET2

730

Oral Presentation
Monday, Dec. 12
10:30 a.m.–12 p.m. CT

R. Stuver

Addition of Brentuximab Vedotin to Gemcitabine in Relapsed or Refractory T-Cell Lymphoma: Final Analysis of a LYSA Multicenter, Phase II Study "The TOTAL Trial"

956

Oral Presentation
Monday, Dec. 12
4:30–6 p.m. CT

O. Tournilhac

A Phase I Trial Assessing the Feasibility of Romidepsin Combined with Brentuximab Vedotin for Patients Requiring Systemic Therapy for Cutaneous T-Cell Lymphoma

2911

Poster Session II
Sunday, Dec. 11

6–8 p.m. CT

S. Barta

Peripheral Neuropathy in Children with High-Risk Hodgkin Lymphoma (HL): The Role of Protocol-Stipulated Dose Modification in the Children’s Oncology Group (COG) AHOD1331 Study

2914

Poster Session II
Sunday, Dec. 11

6–8 p.m. CT

S. Parsons,

F. Keller

Evaluating CHIPS in Pediatric High Risk Hodgkin Lymphoma Treated on AHOD1331

2921

Poster Session II

Sunday, Dec. 11

6–8 p.m. CT

C. Schwartz

Phase I Trial of Brentuximab Vedotin Plus Cyclosporine in Relapsed/Refractory Hodgkin Lymphoma

4239

Poster Session III
Monday, Dec. 12

6–8 p.m. CT

S. Kambhampati, M. Mei

About ADCETRIS

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seagen’s proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.

ADCETRIS is indicated for the treatment of:

Adult patients with previously untreated Stage III/IV cHL in combination with doxorubicin, vinblastine, and dacarbazine.
Pediatric patients 2 years and older with previously untreated high risk cHL in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide.
Adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
Adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.
Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Seagen and Takeda jointly develop ADCETRIS. Under the terms of the collaboration agreement, Seagen has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seagen recognizes royalty revenues from Takeda based on a percentage of Takeda’s net sales of ADCETRIS in its licensed territories based on annual net sales tiers. Seagen and Takeda jointly fund development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) for injection U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

CONTRAINDICATION

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

WARNINGS AND PRECAUTIONS

Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay, change in dose, or discontinuation of ADCETRIS.

Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.

Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS.

Administer G-CSF primary prophylaxis beginning with Cycle 1 for adult patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL, and pediatric patients who receive ADCETRIS in combination with chemotherapy for previously untreated high risk cHL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently 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 ADCETRIS-treated patients. Closely monitor patients during treatment for infections.

Tumor lysis syndrome: Patients with rapidly proliferating tumor and high tumor burden may be at increased risk. Monitor closely and take appropriate measures.

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. Avoid use 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. Avoid use in patients with moderate or severe hepatic impairment.

Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.

PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, 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 PML diagnosis in patients 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: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, 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: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.

Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with pre-existing GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately.

Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated.

Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of this potential risk, and to avoid pregnancy during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.

ADVERSE REACTIONS

The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia.

DRUG INTERACTIONS

Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions.

USE IN SPECIAL POPULATIONS

Lactation: Breastfeeding is not recommended during ADCETRIS treatment.

Females and Males of Reproductive Potential: Advise females to report pregnancy immediately and advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.

Please see full Prescribing information, including BOXED WARNING, for ADCETRIS here.