On November 5, 2015 Pfizer Inc., working collaboratively with the European School of Oncology (ESO), within the scope of the Advanced Breast Cancer Third International Consensus Conference (ABC3), reported the Global Status of Metastatic Breast Cancer (MBC): A 2005 – 2015 Decade Report, which revealed both areas of improvement and substantial gaps in care, access to resources and support, and treatment outcomes for women with MBC (Press release, Pfizer, NOV 5, 2015, View Source [SID:1234507973]).

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MBC is the most advanced stage of breast cancer for which there is no cure.1 Further, public health experts estimate there will be a 43 percent increase in breast cancer related deaths globally from 2015 to 2030, the majority of which are a result of metastatic disease.2,3 Previous research has shown that women with MBC have distinct needs that are not often addressed and there are fewer patient and community resources available for these women compared with those for women with early-stage disease.4

Over the past decade – due to the collective efforts of the broader breast cancer community – some progress has been made to address the unique needs of women with MBC.5,6 However, there is still a great deal of improvement that needs to be made in this area. The findings from theGlobal Status of MBC: A Decade Report reinforce the urgent need for change in MBC care, patient support, research and the important role increased disease awareness can play.

This report is the most comprehensive analysis to date of the global advanced and metastatic breast cancer landscape over the past decade, and was developed with guidance from a global steering committee (link is external) of multidisciplinary leaders in the MBC community. Results from the preliminary report were presented today at ABC3 in Lisbon, Portugal.7

As a result of these findings, ESO and members of the breast cancer community are calling for policymakers, advocates and the medical community to unite to develop a global charter as a call-to-action toward changing and improving MBC outcomes by the year 2025.

"As members of the global breast cancer community, we need to change the way we comprehend, research and prioritize metastatic breast cancer, a disease that is highly complex clinically and emotionally, yet has received far less attention than other forms of breast cancer," said Fatima Cardoso, MD, director, Breast Cancer Unit at Champalimaud Clinical Center in Lisbon. "The Global Status of MBC: A Decade Report underscores the great challenges that continue to exist in the metastatic breast cancer landscape, and the need for worldwide unity in support of the hundreds of thousands of women living with the disease today."8,9,10,11

The report includes three newly commissioned primary surveys examining current perceptions of the state of breast cancer in 34 countries around the world, including the first survey of global public perceptions of MBC. Secondary analyses were also conducted, and included an analysis of existing breast cancer resources and more than 3,000 previously published articles and abstracts, to determine the global landscape of MBC over the past decade. This analysis examined several key areas of MBC patient care and contains the first comprehensive analysis of the MBC scientific landscape.

"While significant progress has been made in the past few decades in our understanding of breast cancer, there is an unquestionable need for more research surrounding metastatic breast cancer worldwide," said Liz Barrett, global president and general manager, Pfizer Oncology. "Through our work, we hope to leverage our scientific expertise and partnerships with the global breast cancer community to ultimately make metastatic breast cancer a chronic disease where patients can live with their condition and thrive as active contributors to their families and society."

Beyond the results highlighted in the preliminary report, there is ongoing analysis of the policy and socioeconomic aspects of MBC, and additional findings will be presented in 2016.

For more information on the Global Status of MBC: A Decade Report, including methodology, please visit:www.BreastCancerVision.com (link is external).

Primary Survey Highlights

Three new studies evaluating the current state of breast cancer from the perspective of breast cancer care centers, patient support organizations and the general population found:

More than half of 582 surveyed oncologists and other healthcare practitioners in the U.S., Europe, Latin America and Australia, report that they have not been trained on how to effectively deliver difficult information to their patients and have a desire for more training.12

The majority of the 50 interviewed patient support organizations in North America, Europe, Asia Pacific, Latin America, Africa and the Middle East, recognize women with MBC require more support than those with early-stage disease, but report a range of barriers that can impact efforts to meet patient needs, including limited resources, cultural views and logistics.13

There is a global lack of familiarity with metastatic or advanced breast cancer among the general public leading to widespread misperceptions about the disease, according to a survey of more than 14,000 people in 14 countries throughout Europe, Latin America, the Middle East, Africa and the Asia Pacific.14

The survey also found that among the general public, approximately 1 out of 5 people believe that those with metastatic breast cancer should keep their diagnosis a secret and not discuss their disease with anyone other than their physician, potentially contributing to the stigma that is associated with MBC and leading to feelings of isolation by the patient.13,15

These findings reinforce results from a 2014 survey conducted by Pfizer and breast cancer leaders in the United States that found the majority of Americans (60%) know little to nothing about MBC.16

Secondary Analysis Highlights

An analysis of more than 3,000 previously published articles and abstracts identified key limitations to progress for women with MBC over the past decade relating to patient care, the environmental landscape and scientific research, including:

Despite the benefits of supportive and palliative care to the quality of life for patients, implementation of supportive care has been variable across certain countries and significant gaps remain.17,18,19,20,21
Better psychological support for women with MBC is needed to ease the end-of-life care experience, particularly when it comes to anxieties about what they may experience.22,23
There has not been a significant improvement in the quality of life for women with MBC in more than a decade, and there has even been a slight decrease since 2004.24,25,26,27,28,29
The pace of innovation in MBC appears to have slowed in recent years with treatment advances, clinical research, publications and guideline development, particularly when compared with other tumor types, such as melanoma and lung cancer.30,31,32

About Metastatic Breast Cancer

MBC occurs when cancer spreads beyond the breast to other parts of the body, including the bones, lungs, liver and brain.1 An estimated 1.7 million new cases of breast cancer are diagnosed globally each year.7 Globally, five to 10 percent of newly diagnosed breast cancer patients will present with metastatic disease, however, in low- and middle-income countries 50-80 percent are initially diagnosed with advanced disease.8 In developed countries, approximately 20-30 percent of women diagnosed with early breast cancer progress to MBC, and this number may be higher in less developed countries.9,10

On November 5, 2015 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of cancers, reported that Phase 1 data for CUDC-907, Curis’ proprietary dual histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) inhibitor will be presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held from Dec. 5-8, 2015 in Orlando, FL (Press release, Curis, NOV 5, 2015, View Source [SID:1234507991]).

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The Principal Investigator of the study, Dr. Anas Younes, Chief of the Lymphoma Service of the Memorial Sloan Kettering Cancer Center in New York City, will present the data in an oral presentation at the meeting.

Additional information on the presentation can be found below and abstracts can be accessed at www.hematology.org.

Oral Presentation

Date/Session Time: Sunday, Dec. 6, 2015, 12:00 PM – 1:30 PM
Session Name: Lymphoma: Chemotherapy, excluding Pre-Clinical Models: NHL – New Drugs
Presentation Title: Phase 1 Trial Testing Single Agent CUDC-907, a Novel, Oral Dual Inhibitor of Histone Deacetylase (HDAC) and PI3K: Initial Assessment of Patients with Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL), Including Double Expressor (DE) Lymphoma
Presentation Time: 1:00 PM
Location: Orange County Convention Center, W311

On November 5, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that more than 45 abstracts featuring eight of its approved or investigational medicines will be presented during the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 5-8 in Orlando (Press release, Hoffmann-La Roche , NOV 5, 2015, View Source [SID:1234508007]). The abstracts include more than 15 oral presentations across a broad range of molecular targets and combinations, as well as different clinical endpoints that Roche is exploring in various blood diseases and lines of treatment.

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"Our data at ASH (Free ASH Whitepaper) this year showcase the evolution of our haematology portfolio and represent potential future approaches to helping people with blood cancers and blood disorders," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "We’re particularly excited about studies evaluating new combinations with Gazyva/Gazyvaro and venetoclax, as well as studies examining the potential clinical significance of minimal residual disease negativity."

Data for Gazyva/Gazyvaro include results from combination studies such as the Phase IIIb GREEN study and the pivotal CLL11 and GADOLIN studies. GREEN results will include data for Gazyva/Gazyvaro in combination with bendamustine in previously untreated chronic lymphocytic leukemia (CLL). Roche will also share updated results from the Phase III CLL11 study, which formed the basis of the Gazyva/Gazyvaro approval in previously untreated CLL in combination with chlorambucil, and further data from the pivotal Phase III GADOLIN study for the investigational use of Gazyva/Gazyvaro in patients with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to MabThera/Rituxan (rituximab)-based treatment, that add to the positive results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June this year.

Roche will also present findings from multiple studies that suggest a potential role for minimal residual disease (MRD)-negativity in the treatment of certain blood cancers. In collaboration with AbbVie, Roche will share new data for investigational medicine venetoclax as a monotherapy or in combinations across a number of blood cancers, including CLL, non-Hodgkin’s lymphoma (NHL), multiple myeloma (MM) and acute myeloid leukemia (AML). Data will also be shown for investigational medicine ACE910, which was recently granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for the prophylactic treatment of people who are 12 years or older with haemophilia A with factor VIII inhibitors.

The table below contains key abstracts featuring Roche medicines that will be presented. Follow Roche on Twitter via @Roche and keep up to date with ASH (Free ASH Whitepaper) Annual Meeting news and updates by using the hashtag #ASH2015.

Separately, the FDA has accepted for priority review the company’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro in the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to a rituximab-containing regimen, based on GADOLIN study results. Marketing applications for Gazyva/Gazyvaro have also been submitted to other health authorities, including the European Medicines Agency, for approval consideration in the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. In addition, AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under breakthrough therapy designation, based in part on results of the pivotal Phase II M13-982 study evaluating venetoclax in people with relapsed/refractory CLL harboring the 17p deletion. Roche and AbbVie announced positive top-line results from this study earlier this year.

On November 5, 2015 CTI BioPharma Corp. (NASDAQ and MTA: CTIC) reported financial results for the third quarter ended September 30, 2015 (Press release, CTI BioPharma, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107565 [SID:1234508027]).

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"We are focused on preparing our NDA submission for pacritinib and are on track to submit our application to the FDA this quarter," said James A. Bianco, M.D., CTI BioPharma’s President and CEO. "We also remain committed to completing the second Phase 3 trial of pacritinib, PERSIST-2, which we believe could serve as a post-approval confirmatory trial in the event our NDA application is accepted and approved under accelerated approval. Additionally, we look forward to upcoming data presentations of pacritinib and tosedostat studies at the ASH (Free ASH Whitepaper) Annual Meeting in December."

Third Quarter 2015 and Recent Highlights

In September 2015, announced plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) with partner Baxalta Inc. for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R for the treatment of patients with myelofibrosis, in the fourth quarter of 2015 and to request accelerated approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (< 50,000/uL) for whom there are no approved drugs. Priority review of the application will be requested at the time of NDA submission.
In September 2015, completed registered direct offering resulting in net proceeds of approximately $15.1 million and in October 2015, completed underwritten public offering resulting in net proceeds of approximately $46.5 million.
In November 2015, announced the upcoming presentations of data highlighting pacritinib and tosedostat at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) to be held December 5-8, 2015, in Orlando, FL.

Third Quarter 2015 Financial Results

Total revenues for the third quarter and the nine months ended September 30, 2015 were $1.0 million and $4.8 million, respectively, compared to $39.5 million and $42.3 million for the same periods in 2014. The decrease in total revenue is primarily due to recognition of milestone payments in 2014, specifically a $20.0 million development milestone payment received from Baxalta for completion of enrollment in the PERSIST-1 Phase 3 clinical trial of pacritinib and $17.3 million from an upfront payment under the PIXUVRI collaboration agreement with Servier. Net product revenues of PIXUVRI for the third quarter and the nine months ended September 30, 2015 were $0.7 million and $2.4 million, respectively, compared to $2.0 million and $4.4 million for the same periods in 2014. The decrease in net product sales was primarily related to the pricing and volume variances between the periods presented as well as the decline in average exchange rate of the euro for our euro-denominated sales.

The non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the third quarter and nine months ended September 30, 2015 was $26.1 million and $77.5 million, respectively, compared to non-GAAP operating income of $11.3 million and a non-GAAP operating loss of $29.8 million for the same periods in 2014. The GAAP operating loss for the third quarter and nine months ended September 30, 2015 was $32.0 million and $90.5 million, respectively, compared to a GAAP operating income of $7.5 million and operating loss of $46.9 million for the same period in 2014. The increase in operating loss for the nine-month period is predominantly associated with the Phase 3 development program for pacritinib and the PIX306 post-authorization Phase 3 trial for PIXUVRI as well as the milestone and the upfront payments received in the 2014 periods as mentioned above. Non-cash share-based compensation expense for the third quarter and nine months ended September 30, 2015 was $5.9 million and $13.0 million, respectively, compared to $3.8 million and $17.0 million for the same periods in 2014. For information on CTI BioPharma’s use of the aforementioned non-GAAP measure and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures."

Net loss for the third quarter of 2015 was $32.6 million, or $(0.19) per share, compared to a net income of $4.6 million, or $0.03 per share, for the same period in 2014. Net loss for the first nine months of 2015 was $93.8 million, or $(0.54) per share, compared to a net loss of $51.8 million, or $(0.36) per share, for the same period in 2014.

As of September 30, 2015, cash and cash equivalents totaled $46.4 million, compared to $70.9 million as of December 31, 2014. Subsequent to September 30, 2015, we received approximately $46.5 million in net proceeds from an underwritten public offering in October 2015.

2015 Financial Outlook

CTI BioPharma now expects total revenues for 2015 will be approximately $30 million to $45 million, which are primarily based upon updated current expectations regarding license and contract revenues under the agreements with Baxalta and Teva and net product sales from PIXUVRI commercial operations. Non-GAAP operating loss for 2015 will be approximately $75 million to $85 million, which excludes non-cash share-based compensation expense. These financial projections are primarily based on our current expectations regarding patient enrollment, NDA submission timing and other factors previously outlined in the Company’s fourth quarter and full year 2014 financial results press release.

On November 5, 2015 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that a record number of abstracts were accepted for presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place in Orlando, Florida, December 5-8, 2015, including the following:

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Several oral and poster data presentations on ADCETRIS (brentuximab vedotin) as both monotherapy and combination therapy in multiple Hodgkin lymphoma (HL) disease settings, supporting the company’s goal to establish ADCETRIS as the foundation of care for HL;

Data presentations on ADCETRIS in frontline non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphomas (PTCL), to be presented in oral and poster sessions;

Phase 1 clinical data for SGN-CD33A (vadastuximab talirine) in acute myeloid leukemia (AML) as monotherapy and in combination with hypomethylating agents (HMAs) to be presented in two oral sessions; preclinical data supporting HMA combination strategy to be presented in poster session;

Updated phase 1 clinical data to be presented for SGN-CD19A (denintuzumab mafodotin) in acute lymphoblastic leukemia (ALL) and NHL in oral and poster sessions; and

Preclinical data from two new ADCs for hematologic malignancies, SGN-CD19B and SGN-CD123A, using the company’s proprietary pyrrolobenzodiazepine (PBD) technology to be presented in oral sessions (Press release, Seattle Genetics, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107576 [SID:1234508059]).

"There will be more than 20 data presentations, including 13 orals, from corporate and investigator studies, representing the largest presence Seattle Genetics has ever had at ASH (Free ASH Whitepaper)," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "Our broad ADCETRIS development program continues to generate data that support its potential as the foundation of care for Hodgkin lymphoma and other CD30-expressing lymphomas. We are also excited to share updates from our ongoing SGN-CD33A and SGN-CD19A programs and to present preclinical data from two new programs, SGN-CD19B and SGN-CD123A, which will advance into the clinic in 2016."

With more than 15 years of experience and innovation, Seattle Genetics is the leader in developing ADCs, a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. More than 25 ADCs in clinical development utilize Seattle Genetics’ proprietary ADC technology. ADCETRIS is the first drug approved utilizing this technology.

ADCETRIS is currently not approved for the treatment of frontline HL, frontline NHL, salvage HL in patients eligible for autologous transplant, GVHD or as a combination therapy for HL or NHL.

Multiple corporate and investigator presentations will be featured at ASH (Free ASH Whitepaper). Abstracts can be found at www.hematology.org and include the following:

Saturday, December 5, 2015

Frontline Treatment of CD30+ Peripheral T-Cell Lymphomas with Brentuximab Vedotin in Combination with CHP: 3-Year Durability and Survival Follow-up (Abstract #1537, poster presentation)

A Phase 1 Study of Denintuzumab Mafodotin (SGN-CD19A) in Adults with Relapsed or Refractory B-Lineage Acute Leukemia (B-ALL) and Highly Aggressive Lymphoma (Abstract #1328, poster presentation)

AMC-085: A Pilot Trial of AVD and Brentuximab Vedotin in the Upfront Treatment of Stage II-IV HIV-Associated Hodgkin Lymphoma. A Trial of the AIDS Malignancy Consortium (Abstract #1526, poster presentation)

Risk Factors and a Prognostic Score in Patients with Relapsed or Refractory Hodgkin Lymphoma (rrHL) after Treatment with Autologous Stem Cell Transplantation (ASCT) (Abstract #1978, poster presentation)

Multicenter Phase I Trial of Brentuximab Vedotin for Steroid Refractory Acute Graft-vs.-Host Disease (GVHD) (Abstract #1930, poster presentation)

Sunday, December 6, 2015

A Phase 1 Study of Denintuzumab Mafodotin (SGN-CD19A) in Relapsed/Refractory B-Lineage Non-Hodgkin Lymphoma (Abstract #182, oral presentation at 7:45 a.m. ET)

TARC Predicts PET-Normalization and Event Free Survival in Relapsed/Refractory Hodgkin Lymphoma Patients Treated with Brentuximab Vedotin (Abstract #180, oral presentation at 8:45 a.m. ET)

A Phase 1 Trial of SGN-CD33A as Monotherapy in Patients with CD33-Positive Acute Myeloid Leukemia (AML) (Abstract #324, oral presentation at 5:45 p.m. ET)

SGN-CD123A, a Pyrrolobenzodiazepine Dimer Linked Anti-CD123 Antibody Drug Conjugate, Demonstrates Effective Anti-Leukemic Activity in Multiple Preclinical Models of AML (Abstract #330, oral presentation at 5:45 p.m. ET)

Five-Year Survival Data Demonstrating Durable Responses from a Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #2736, poster presentation)

Updated Efficacy and Safety Data from the AETHERA Trial of Consolidation with Brentuximab Vedotin after Autologous Stem Cell Transplant (ASCT) in Hodgkin Lymphoma Patients at High Risk of Relapse (Abstract #3172, poster presentation)

Brentuximab Vedotin in Combination with Multi-Agent Chemotherapy is Well Tolerated and Effective as Frontline Treatment for Primary Mediastinal B-Cell Lymphoma (Abstract #2694, poster presentation)

Monday, December 7, 2015

Post Transplant Outcome of a Multicenter Phase II Study of Brentuximab Vedotin As First Line Salvage in Relapsed/Refractory HL Prior to AHCT (Abstract #519, oral presentation at 7:30 a.m. ET)

SGN-CD33A Plus Hypomethylating Agents: A Novel, Well-Tolerated Regimen with High Remission Rate in Frontline Unfit AML (Abstract #454, oral presentation at 7:45 a.m. ET)

Preliminary Safety and Efficacy of the Combination of Brentuximab Vedotin and Ipilimumab in Relapsed/Refractory Hodgkin Lymphoma: A Trial of the ECOG-ACRIN Cancer Research Group (E4412) (Abstract #585, oral presentation at 11:00 a.m. ET)
Targeted BEACOPP Variants in Patients with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma: Final Analysis of a Randomized Phase II Study (Abstract #580, oral presentation at 11:15 a.m. ET)

The Combination of Brentuximab Vedotin (Bv) and Bendamustine (B) Demonstrates Marked Activity in Heavily Treated Patients with Relapsed or Refractory Hodgkin Lymphoma (HL) and Anaplastic Large T-Cell Lymphoma (ALCL): Results of an International Multicenter Phase I/II Experience (Abstract #586, oral presentation at 11:15 a.m. ET)

Brentuximab Vedotin in Combination with Dacarbazine or Bendamustine for Frontline Treatment of Hodgkin Lymphoma in Patients Aged 60 Years and Above: Interim Results of a Multi-Cohort Phase 2 Study (Abstract #587, oral presentation at 11:30 a.m. ET)
Evaluation of the Regimen Brentuximab Vedotin Plus ESHAP (BRESHAP) in Refractory or Relapsed Hodgkin Lymphoma Patients: Preliminary Results of a Phase I-II Trial from the Spanish Group of Lymphoma and Bone Marrow Transplantation (GELTAMO) (Abstract #582, oral presentation at 11:45 a.m. ET)

SGN-CD19B, a Pyrrolobenzodiazepine (PBD)-Based Anti-CD19 Drug Conjugate, Demonstrates Potent Preclinical Activity Against B-Cell Malignancies (Abstract #594, oral presentation at 11:45 a.m. ET)

Brentuximab Vedotin with RCHOP As Frontline Therapy in Patients with High-Intermediate/High-Risk Diffuse Large B-cell Lymphoma (DLBCL): Results from an Ongoing Phase 2 Study (Abstract #814, oral presentation at 5:15 p.m. ET)

SGN-CD33A in Combination with Hypomethylating Agents Is Highly Efficacious in Preclinical Models of AML (Abstract #3785, poster presentation)

Brentuximab Vedotin Plus Bendamustine: A Highly Active Salvage Treatment Regimen for Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #3982, poster presentation)

A Phase I Trial of Brentuximab Vedotin in Combination with Lenalidomide in Relapsed or Refractory Diffuse Large B-cell Lymphoma (Abstract #3988, poster presentation)

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 30 ongoing clinical trials, including the phase 3 ALCANZA trial and two additional phase 3 studies, ECHELON-1 in frontline classical HL and ECHELON-2 in frontline mature T-cell lymphomas, as well as trials in many additional types of CD30-expressing malignancies, including B-cell lymphomas.

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 FDA for three indications: (1) regular approval for the treatment of patients with classical 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, (2) regular approval for the treatment of classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with 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 the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory HL and sALCL.

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 55 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 is solely responsible for development costs.

About SGN-CD33A (Vadastuximab Talirine)

SGN-CD33A (vadastuximab talirine) is a novel ADC targeted to CD33 utilizing Seattle Genetics’ newest ADC technology. CD33 is expressed on most AML cells. The CD33 antibody is attached to a highly potent DNA binding agent, a pyrrolobenzodiazepine (PBD) dimer, via a proprietary site-specific conjugation technology to a monoclonal antibody with engineered cysteines (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the site-specific conjugation technology (EC-mAb) allows uniform drug-loading of the cell-killing PBD agent to the anti-CD33 antibody. The ADC is designed to be stable in the bloodstream and to release its potent DNA binding agent upon internalization into CD33-expressing cells. SGN-CD33A is being evaluated in ongoing phase 1 clinical trials for patients with AML.

About SGN-CD19A (Denintuzumab Mafodotin)

SGN-CD19A (denintuzumab mafodotin) is an ADC targeting CD19, a protein expressed broadly on B-cell malignancies. Denintuzumab mafodotin is comprised of an anti-CD19 monoclonal antibody linked to a synthetic cytotoxic cell-killing agent, monomethyl auristatin F (MMAF). The ADC is designed to be stable in the bloodstream, and to release its cytotoxic agent upon internalization into CD19-expressing tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity. SGN-CD19A is being evaluated in two ongoing phase 1 clinical trials for patients with B-cell ALL and aggressive NHL as well as a phase 2 clinical trial in relapsed or refractory DLBCL.