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Seattle Genetics Highlights Long-Term Follow-Up Data from ADCETRIS® (Brentuximab Vedotin) in T-Cell Lymphomas at ASH Annual Meeting
December 5, 2016 at 1:00 PM EST
-Long-Term ADCETRIS Data Support Development Strategy to Establish
-ADCETRIS Pivotal Trial in Systemic Anaplastic Large Cell Lymphoma Shows Estimated Five-Year Survival Rate of 60 Percent with Majority of Patients Achieving Durable Remissions-
-Phase 1 Trial of ADCETRIS in Combination with CHP Chemotherapy in Frontline Mature T-Cell Lymphoma Shows Four-Year Survival Rate of 80 Percent-
“The long-term ADCETRIS data presented at ASH demonstrate durable
remissions in these historically difficult-to-treat disease settings. We
believe these clinical trials in addition to the many ongoing clinical
trials support the potential to establish ADCETRIS as the foundation of
care in CD30-expressing lymphomas,” said
Five-Year Survival Data from a Pivotal Phase 2 Study of Brentuximab
Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic
Large Cell Lymphoma (Abstract #4144, poster presentation on
A pivotal, single-arm clinical trial was conducted in 58 relapsed or refractory sALCL patients to assess the efficacy and safety of single-agent ADCETRIS. In addition, the trial was designed to determine duration of response, progression-free survival and overall survival. Patients received 1.8 milligrams per kilogram (mg/kg) of ADCETRIS administered every three weeks for up to 16 cycles. As previously reported, 86 percent of patients on the trial achieved an objective response, including 59 percent with a complete remission.
Data from long-term patient follow-up in this pivotal trial after a median observation time of 71.4 months from the first dose of ADCETRIS include:
Four-Year Survival and Durability Results of Brentuximab Vedotin in
Combination with CHP in the Frontline Treatment of Patients with
CD30-Expressing Peripheral T-Cell Lymphomas (Abstract #2993, poster
Data were reported from 26 frontline MTCL patients who received the combination regimen of ADCETRIS plus cyclophosphamide, doxorubicin and prednisone (CHP). Patients who achieved at least a partial remission with combination therapy following six cycles of ADCETRIS plus CHP were eligible to receive up to ten additional cycles of single-agent ADCETRIS treatment. The median age of patients was 56 years. Nineteen patients (73 percent) had a subtype of MTCL called sALCL, including 16 patients (62 percent) with anaplastic lymphoma kinase (ALK)-negative disease, which is typically associated with a poor prognosis. Seven patients had a diagnosis of other types of MTCL. The majority of patients had advanced stage disease and were considered high risk. As previously reported, 100 percent of patients on the trial achieved an objective response, including 88 percent with a complete response and 12 percent with a partial response.
Updated key findings based on a median observation time of 53 months from first dose of therapy include:
A global phase 3 study called ECHELON-2 completed enrollment in
About T-Cell Lymphomas
Lymphoma is a general term for a group of cancers that originate in the
lymphatic system. There are two major categories of lymphoma: Hodgkin
lymphoma and non-Hodgkin lymphoma. Non-Hodgkin lymphomas are broadly
divided into two major groups: B-cell lymphomas, which develop from
abnormal B-lymphocytes, and T-cell lymphomas, which develop from
ADCETRIS is being evaluated broadly in more than 70 ongoing clinical trials, including three phase 3 studies, the ongoing ECHELON-1 trial in frontline classical Hodgkin lymphoma and the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, as well as the completed ALCANZA trial in cutaneous T-cell lymphoma for which a supplemental BLA is planned in the first half of 2017.
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 for intravenous injection has received approval from the
ADCETRIS was granted conditional marketing authorization by the
ADCETRIS has received marketing authorization by regulatory authorities in 65 countries. See important safety information below.
ADCETRIS (brentuximab vedotin) U.S. Important Safety Information
Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.
ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
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.
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.
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic and
commercial potential of ADCETRIS, including ADCETRIS’ potential as a
treatment for MTCL, the anticipated timing of data from the ECHELON-2
trial, the anticipated benefits of Seattle Genetics’ ADCETRIS clinical
development program, and the potential submission of applications (e.g.,
a supplemental Biologics License Application in the U.S.) seeking label
expansion for ADCETRIS use in the ALCANZA and ECHELON-2 settings. Actual
results or developments may differ materially from those projected or
implied in these forward-looking statements. Factors that may cause such
a difference include the risks of adverse events associated with
ADCETRIS use, negative or unexpected results from the ECHELON-2 trial
even after promising results in earlier company- and
investigator-sponsored trials, and adverse regulatory actions affecting
ADCETRIS, all of which could result in