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Seattle Genetics Highlights Multiple Data Sets Evaluating the Combination of ADCETRIS® (Brentuximab Vedotin) and Opdivo® (Nivolumab) at ASH Annual Meeting
December 1, 2018 at 12:00 PM EST
-Initial Data Reported from Phase 2 Clinical Trial in Relapsed Primary Mediastinal Large B-Cell Lymphoma-
-Results from Phase 1/2 Trial in Relapsed Hodgkin Lymphoma Continue to Support Combination Strategy-
-Phase 2 Trial Evaluating Novel Combination Strategies in Children, Adolescents and Young Adults in Relapsed Hodgkin Lymphoma to be Featured in Oral Presentation-
“Our goal with ADCETRIS is to identify the most effective treatment
strategies to improve the outcome of patients, and the combination of
ADCETRIS and Opdivo has demonstrated enhanced activity with a
tolerable safety profile in Hodgkin lymphoma and now a type of
non-Hodgkin lymphoma called primary mediastinal large B-cell lymphoma,
or PMBL,” said
Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory
Primary Mediastinal Large B-Cell Lymphoma: Preliminary Results from the
Phase 2 Checkmate 436 Trial (Abstract #1691, poster presentation on
Data from the Checkmate 436 phase 2 trial of 30 patients with relapsed
or refractory PMBL who received a combination of ADCETRIS plus Opdivo
treatment after failure of frontline therapy or autologous stem cell
transplant (ASCT) will be presented for the first time. Patients were
treated once every three weeks until disease progression or unacceptable
toxicity. The median age of patients was 35.5 years. Key findings will
be presented in a poster presentation by
Phase 1/2 Study of Brentuximab Vedotin in Combination with Nivolumab
in Patients with Relapsed or Refractory Classic Hodgkin Lymphoma: Part 3
(Concurrent Dosing) Results and Updated Progression-Free Survival
Results from Parts 1 and 2 (Staggered Dosing) (Abstract #1635, poster
Data will be reported from 30 patients with relapsed or refractory HL who received concurrent combination of ADCETRIS plus Opdivo treatment after failure of frontline therapy, representing Part 3 of the study. Patients were treated once every three weeks, with up to four cycles of combination therapy in the outpatient setting. After completion of the fourth cycle of treatment, patients were eligible to undergo an ASCT. The median age of patients was 31.5 years. Data from Parts 1 and 2 of the study were recently reported at the 11th International Symposium on Hodgkin Lymphoma (ISHL) and can be found here. Key findings will be presented in a poster presentation and include:
An additional poster will be presented on
Additional ADCETRIS and Opdivo ASH Data Presentation
The first data will be reported in an oral presentation from the phase 2 CheckMate-744 study, the first risk-stratified, response-adapted study of ADCETRIS and Opdivo, followed by ADCETRIS and bendamustine for suboptimal response, in children, adolescents and young adults with relapsed/refractory classical HL, prior to ASCT. At time of analysis, all evaluable patients achieved complete metabolic remission after completing induction and, as needed, intensification therapy. The most common AEs were nausea (53 percent), diarrhea (31 percent) and pyrexia (28 percent). No AEs led to discontinuation and there were no deaths. Presentation information includes:
About ADCETRIS (brentuximab vedotin)
ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three recently completed phase 3 trials: ECHELON-2 in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma. The phase 3 CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma is ongoing.
ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ 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 tumor cells.
ADCETRIS injection for intravenous infusion has received
ADCETRIS received conditional marketing authorization from the
ADCETRIS has received marketing authorization by regulatory authorities in 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.
ADCETRIS (brentuximab vedotin) Important Safety Information
BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML):
JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.
ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
Most Common (≥20% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis.
Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).
Use in Specific Populations
Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.
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.
Seattle Genetics Forward-Looking Statements
Certain of the statements made in this press release are
forward-looking, such as those, among others, relating to the potential
utilization of ADCETRIS (brentuximab vedotin) in treatment settings and
in combination with Opdivo and other agents which have not received
regulatory approval. Actual results or developments may differ
materially from those projected or implied in these forward-looking
statements due to factors such as that ADCETRIS may not receive
regulatory approval for use in the treatment settings and in combination
with Opdivo and other agents as referenced, competitive conditions
including the availability of alternative treatment regimens, the
availability and extent of reimbursement, the risk of adverse events,
and adverse regulatory action. More information about the risks and
uncertainties faced by