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|Seattle Genetics and Takeda Highlight Long-term Follow-up Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Clinical Trials in Relapsed or Refractory Hodgkin Lymphoma and Systemic Anaplastic Large Cell Lymphoma at ASH 2013|
- Median Overall Survival of 40.5 Months in Relapsed/Refractory Hodgkin Lymphoma Patients -
- Estimated Three Year Survival Rate of 63 Percent with Median Overall Survival Not Yet Reached in Relapsed/Refractory Systemic Anaplastic Large Cell Lymphoma -
New Orleans, LA – December 9, 2013 – Seattle Genetics, Inc. (Nasdaq: SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502) today announced updated overall survival data from two ADCETRIS (brentuximab vedotin) pivotal Phase 2 clinical trials in relapsed/refractory Hodgkin lymphoma (R/R HL) and relapsed/refractory systemic anaplastic large cell lymphoma (R/R sALCL) were presented at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans, LA, December 7-10, 2013. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. Median overall survival (OS) of 40.5 months was reported in R/R HL, and was not yet reached in R/R sALCL.
“The updated data from the pivotal ADCETRIS clinical trials demonstrate extended survival among this heavily pretreated patient population. Median overall survival in the relapsed/refractory Hodgkin lymphoma trial was 3.4 years, which includes 18 patients who remained in remission and were still being followed. In relapsed/refractory systemic ALCL, median overall survival had not yet been reached and the estimated three-year survival rate was 63 percent,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “These data strengthen the already demonstrated patient benefit associated with ADCETRIS in relapsed Hodgkin lymphoma and systemic ALCL disease settings and further support our three ongoing Phase 3 clinical trials in earlier lines of therapy: AETHERA in high risk post-transplant patients with Hodgkin lymphoma, ECHELON-1 in frontline Hodgkin lymphoma and ECHELON-2 in frontline mature T-cell lymphoma.”
“In this heavily pre-treated HL and sALCL patient population, exceeding three year median survival with single-agent ADCETRIS is substantial,” said Michael Vasconcelles, M.D., Senior Vice President, Head, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company. “We continue to work with regulatory agencies in our territories to expand the availability of ADCETRIS and plan to seek the inclusion of these important survival updates into our label.”
Three-year Follow-up Data and Characterization of Long-term Remissions from an Ongoing Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #4382)
A pivotal, single-arm trial was conducted in 102 R/R HL patients after autologous stem cell transplant (ASCT) to assess the efficacy and safety of single-agent ADCETRIS. In addition, the trial was designed to determine duration of response, progression-free survival (PFS) and OS. Enrolled patients had received a median of more than three prior chemotherapy regimens. Patients received 1.8 milligrams per kilogram (mg/kg) of ADCETRIS administered through a 30-minute intravenous (IV) infusion every three weeks for up to 16 cycles for patients who achieved stable disease or better.
Data highlights from the long-term survival analysis in this pivotal trial were:
Three-year Survival Results from an Ongoing Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (Abstract #1809)
Data highlights from long-term patient follow up in this pivotal trial were:
ADCETRIS (brentuximab vedotin) 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 received accelerated approval from the U.S. Food and Drug Administration (FDA) and approval with conditions from Health Canada for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.
ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive HL following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in more than 35 countries. See important safety information below.
Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda will be solely responsible for development costs.
ADCETRIS (brentuximab vedotin) U.S. Important Safety Information
Warnings and Precautions:
ADCETRIS was studied as monotherapy in 160 patients in two Phase 2 trials. Across both trials, 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.
Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to MMAE.
Use in Specific Populations:
MMAE exposure is increased in patients with hepatic impairment and severe renal impairment.For additional important safety information, including Boxed WARNING, please see the full U.S. prescribing information for ADCETRIS at www.seattlegenetics.com or www.ADCETRIS.com.
ADCETRIS Global Important Safety Information
ADCETRIS® is indicated for the treatment of adult patients with relapsed or refractory (r/r) CD30+ Hodgkin lymphoma (HL):
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
ADCETRIS is contraindicated for patients who are hypersensitive to ADCETRIS. In addition, combined use of bleomycin and ADCETRIS causes pulmonary toxicity, and is contraindicated.
ADCETRIS can cause serious side effects, including:
Serious adverse drug reactions were: neutropenia, thrombocytopenia, constipation, diarrhea, vomiting, pyrexia, peripheral motor neuropathy and peripheral sensory neuropathy, hyperglycemia, demyelinating polyneuropathy, tumor lysis syndrome, and Stevens-Johnson syndrome.
ADCETRIS was studied as monotherapy in 160 patients in two Phase 2 studies. Across both studies, adverse reactions defined as very common (≥1/10) were: infections, neutropenia, peripheral sensory neuropathy, diarrhea, nausea, vomiting, alopecia, pruritis, myalgia, fatigue, pyrexia, and infusion-related reactions. Adverse reactions defined as common (≥1/100 to <1/10) were: upper respiratory tract infection, herpes zoster, pneumonia, anemia, thrombocytopenia, hyperglycemia, peripheral motor neuropathy, dizziness, demyelinating polyneuropathy, cough, dyspnea, constipation, rash, arthralgia, back pain, and chills.
These are not all of the possible side effects with ADCETRIS. Please refer to Summary of Product Characteristics (SmPC) before prescribing.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development and commercialization of innovative antibody-based therapies for the treatment of cancer. Seattle Genetics is leading the field in developing antibody-drug conjugates (ADCs), a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. The company’s lead product, ADCETRIS® (brentuximab vedotin) is an ADC that, in collaboration with Takeda Pharmaceutical Company Limited, has been approved for two indications in more than 35 countries, including the U.S., European Union and Canada. Additionally, ADCETRIS is being evaluated broadly in more than 20 ongoing clinical trials. Seattle Genetics is also advancing a robust pipeline of clinical-stage ADC programs, including SGN-CD19A, SGN-CD33A, SGN-LIV1A, ASG-22ME and ASG-15ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including AbbVie, Agensys (an affiliate of Astellas), Bayer, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
For Seattle Genetics:
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the estimated overall survival rates in HL and ALCL resulting from treatment with ADCETRIS. 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 potential that events occur more quickly than estimated thereby reducing the overall survival rate. In addition, historical results in clinical trials for ADCETRIS may not predict results in ongoing or future clinical trials of ADCETRIS and the data resulting from additional trials with ADCETRIS may not support approvals in the studied indications. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company’s 10-Q for the quarter ended September 30, 2013 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.