On November 1, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on developing gene and cell-based immunotherapies for cancer, reported that five abstracts highlighting data from the Company’s adoptive cell-based therapeutic programs have been accepted for presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, December 9-12, in Atlanta (Press release, Ziopharm, NOV 1, 2017, View Source [SID1234521408]).

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Data from ongoing clinical and preclinical studies will be highlighted at ASH (Free ASH Whitepaper) including research, conducted with collaborators at The University of Texas MD Anderson Cancer Center and Intrexon Corporation (NYSE:XON), that further validates the Company’s Sleeping Beauty (SB) platform in chimeric antigen receptor (CAR) modified T cell therapy and demonstrates the potential for very rapid T-cell production (<2 days) with point-of-care (P-O-C) technology.

Presentations include long-term follow-up data from the initial clinical trial infusing first-generation SB-modified CD19-specific CAR+ T cells and interim data from the Company’s ongoing clinical trial of second-generation SB-modified CD19-specific CAR+ T cells that serves as a gateway to the trial infusing T cells manufactured under the P-O-C platform.

Additional abstracts include an update on the Company’s lentiviral approach to express CD33-specific CAR with a kill switch in patients with relapsed of refractory acute myeloid leukemia, as well as preclinical data supporting the use of genetically engineered regulatory T cells to treat graft versus host disease.

Details for ASH (Free ASH Whitepaper) presentations are as follows:

Title: Long Term Follow up after Adoptive Transfer of CD19-Specific CAR+T Cells Genetically Modified Via Non-Viral Sleeping Beauty System Following Hematopoietic Stem Cell Transplantation (HSCT)
Presenter: Partow Kebriaei, M.D.
Session Title: 801. Gene Therapy and Transfer: Poster I
Date and Time: Saturday, December 9, 2017, 5:30 — 7:30 p.m. ET
Publication ID: 2059
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Title: Shortening the Time to Manufacture CAR+ T Cells with Sleeping Beauty System Supports T-Cell Engraftment and Anti-Tumor Effects in Patients with Refractory CD19+ Tumors
Presenter: Partow Kebriaei, M.D.
Session Title: 801. Gene Therapy and Transfer: Poster I
Date and Time: Saturday, December 9, 2017, 5:30 — 7:30 p.m. ET
Publication ID: 2060
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Title: Genetically Engineered Regulatory T Cells for Treatment of Graft-Versus-Host-Disease
Presenter: Hanspeter Waldner, Ph.D.
Session Title: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster II
Date and Time: Sunday, December 10, 2017, 6:00 — 8:00 p.m. ET
Publication ID: 3176
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Title: CD19-Specific Chimeric Antigen Receptor-Modified T Cells with Safety Switch Produced Under “Point-Of-Care” Using the Sleeping Beauty System for the Very Rapid Manufacture and Treatment of B-Cell Malignancies
Presenter: Tim Chan, Ph.D.
Session Title: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster
Date and Time: Saturday, December 9, 2017, 5:30 — 7:30 p.m. ET
Publication ID: 1324
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

Title: Autologous T Cells Modified to Co-express CD33-Specific Chimeric Antigen Receptor and a Kill Switch for Treatment of CD33+ Acute Myeloid Leukemia
Presenter: Tim Chan, Ph.D.
Session Title: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster
Date and Time: Saturday, December 9, 2017, 5:30 — 7:30 p.m. ET
Publication ID: 1376
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2

On November 1, 2017 Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, reported that four abstracts have been selected for presentation, including two oral presentations, at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 Annual Meeting being held December 9-12, 2017 in Atlanta (Press release, Verastem, NOV 1, 2017, View Source [SID1234521407]). Included among the oral presentations are the detailed results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). As previously announced, the DUO study achieved its primary endpoint with oral duvelisib monotherapy demonstrating superiority over ofatumumab for progression free survival (PFS) in patients with CLL/SLL.

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“Previously reported top-line data from the pivotal Phase 3 DUO study significantly favored duvelisib monotherapy over ofatumumab, an approved standard of care treatment for patients with relapsed or refractory CLL/SLL, achieving a statistically significant improvement in median PFS and a hazard ratio (HR) of 0.52 (p<0.0001), with a consistent and manageable safety profile," said Robert Forrester, President and Chief Executive Officer of Verastem. "We look forward to sharing the detailed results from the DUO study with the medical community at ASH (Free ASH Whitepaper) this year."

Verastem recently announced that a meeting was held with the U.S. Food and Drug Administration (FDA) regarding the regulatory path for duvelisib. Based on the meeting with, and written feedback from the FDA, Verastem intends to submit a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). Along with the clinical data from the DUO study, the duvelisib NDA submission will also contain the favorable results from the Phase 2 DYNAMO study in double-refractory indolent non-Hodgkin’s lymphoma (iNHL), which also achieved its primary endpoint with an ORR of 46% (p<0.0001). In the subset of patients enrolled in the DYNAMO study with double-refractory FL (n=83), duvelisib demonstrated an ORR of 41%. The Company expects to submit the duvelisib NDA during the first quarter of 2018.

Details for the ASH (Free ASH Whitepaper) 2017 presentations are as follows:

Oral Presentations

Title: Results from the Phase 3 DUOTM Trial: A Randomized Comparison of Duvelisib Vs Ofatumumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Presenter: Ian Flinn, M.D., Ph.D., Sarah Cannon Research Institute
Abstract Number/Publication ID: 493
Session: 642. CLL: Therapy, excluding Transplantation: Targeting MRD Negative CLL with Combinations of Novel Agents and Chemoimmunotherapy Regimens, New Treatments; Sunday, December 10, 2017 from 4:30-6:00 PM ET
Date and Time: Sunday, December 10, 2017 at 4:30 PM ET
Location: Georgia World Congress Center, Building B, Level 5, Murphy BR 3-4

Title: In Vitro, In Vivo, and Parallel Phase I Evidence Support the Safety and Activity of Duvelisib, a PI3K-δ,γ Inhibitor, in Combination with Romidepsin or Bortezomib in Relapsed/Refractory T-Cell Lymphoma
Presenter: Steven Horwitz, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number/Publication ID: 819
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: T-Cell Lymphoma Clinical Studies; Monday, December 11, 2017 from 4:30-6:00 PM ET
Date and Time: Monday, December 11, 2017 at 5:00 PM ET
Location: Georgia World Congress Center, Building A, Level 4, Marcus Auditorium

Poster Presentations

Title: The Dual PI3K-δ,γ Inhibitor Duvelisib Stimulates Anti-Tumor Immunity and Enhances Efficacy of Immune Checkpoint and Co-Stimulatory Antibodies in a B Cell Lymphoma Model
Presenter: Jonathan Pachter, Ph.D., Verastem
Abstract Number/Publication ID: 1541
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster I
Date and Time: Saturday, December 9, 2017 from 5:30-7:30 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: Combinatorial Inhibition of Focal Adhesion Kinase and BCL-2 in AML
Presenter: Xiangmeng Wang, Ph.D., MD Anderson Cancer Center
Abstract Number/Publication ID: 2653
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017 from 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

About Duvelisib
Duvelisib is a first-in-class investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib is currently being evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints and Verastem intends to submit a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). Duvelisib is also being developed by Verastem for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On November 1, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that updated data for TGR-1202 (umbralisib), the Company’s once-daily PI3K delta inhibitor, and TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, have been selected for presentation at the upcoming 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, to be held December 9-12, 2017, at the Georgia World Congress Center in Atlanta, Georgia (Press release, TG Therapeutics, NOV 1, 2017, View Source [SID1234521406]). Abstracts are now available online and can be accessed on the ASH (Free ASH Whitepaper) meeting website at www.hematology.org . Clinical abstract highlights as well as the details of clinical and preclinical posters to be presented at ASH (Free ASH Whitepaper) are outlined below.

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Clinical Abstract Highlights:

TGR-1202 Integrated Analysis: 336 patients with relapsed/refractory Lymphoid Malignancies exposed to a TGR-1202 based regimen for upwards of 4+ years, demonstrated a favorable safety profile with infrequent Grade 3/4 adverse events prevalent amongst prior generation PI3K delta inhibitors: transaminitis ( < 3%), colitis ( < 1%), and pneumonitis ( < 0.5%)
Kinase Inhibitor Intolerance Study: In patients with Chronic Lymphocytic Leukemia (CLL) who are intolerant to prior BTK or PI3K delta inhibitor therapy, no patients (n=22) discontinued due to TGR-1202 intolerance with a median follow-up of 6 months
TG-1101 + TGR-1202 + PD-1 Triplet: 60% ORR (3 of 5) observed in BTK refractory CLL patients treated with the triple combination of TGR-1202 plus TG-1101 plus pembrolizumab
Poster presentations at the ASH (Free ASH Whitepaper) 2017 meeting include the following:

Sunday December 10, 2017:

Title: Phase I/II Study of Pembrolizumab in Combination with Ublituximab (TG-1101) and Umbralisib (TGR-1202) in Patients with Relapsed/Refractory CLL
Abstract Number: 3010
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Anthony R. Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: Umbralisib/TGR-1202 as a Novel Dual PI3K/CK1 Inhibitor Has a Unique Therapeutic Role in Silencing Oncogenes in Aggressive Lymphomas
Abstract Number: 2809
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
Date and Time: Sunday, December 10, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Ipsita Pal, PhD, Columbia University Medical Center, New York, NY

Title: Differential Regulation of T Cells By PI3K Delta Inhibitors in a CLL Murine Model
Abstract Number: 3009
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Kamira K. Maharaj, BS, Moffit Cancer Center, Tampa, FL
Monday, December 11, 2017:

Title: An Integrated Safety Analysis of the Next Generation PI3Kδ Inhibitor Umbralisib (TGR-1202) in Patients with Relapsed/Refractory Lymphoid Malignancies
Abstract Number: 4037
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
Date and Time: Monday, December 11, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Matthew S. Davids, MD, Dana Farber Cancer Institute, Boston, MA

Title: KI Intolerance Study: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib (TGR-1202) in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-δ Inhibitor Therapy
Abstract Number: 4314
Session: 642. CLL: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 11, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Anthony R. Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: PI3K-Delta Inhibitors Induce Primary Monocyte Cytotoxicity but Do Not Alter Monocyte Differentiation
Abstract Number: 4284
Session: 641. CLL: Biology and Pathophysiology, excluding Therapy: Poster III
Date and Time: Monday, December 11, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Daphne Friedman, MD, Durham VA-Duke University Medical Center, Durham, NC
The above referenced abstracts can be viewed online through the ASH (Free ASH Whitepaper) meeting website at www.hematology.org. Following each presentation, the data presented will be available on the Publications page of the Company’s website at www.tgtherapeutics.com.

TG THERAPEUTICS INVESTOR & ANALYST EVENT

TG Therapeutics will also host a reception on Sunday, December 10, 2017 beginning at 8:00pm ET with featured presentations beginning promptly at 8:15pm ET. The event will take place at the Ritz Carlton Atlanta (Downtown) in the Congress Room. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics December 2017 Investor & Analyst Event.

On November 1, 2017 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, reported that the pivotal Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has met its primary endpoint (Press release, Stemline Therapeutics, NOV 1, 2017, View Source [SID1234521405]). Based on feedback from the U.S. Food and Drug Administration (FDA), Stemline remains on track to begin submission of its Biologics License Application (BLA) in the 4Q17-1Q18 timeframe.

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SL-401 has been granted Breakthrough Therapy Designation (BTD) by the FDA for the treatment of BPDCN, and Orphan Drug Designation (ODD) by the FDA and EU for the treatment of patients with BPDCN and acute myeloid leukemia (AML).

Pivotal Trial

The pivotal Phase 2 trial of SL-401 is the largest multicenter prospective study ever conducted in BPDCN. The trial enrolled 45 BPDCN (32 first-line, 13 relapsed/refractory) patients at 7 sites in the U.S. The trial consisted of 3 Stages: Stage 1 (lead-in, dose escalation), Stage 2 (expansion), and Stage 3 (pivotal, confirmatory).

Stage 3: Design

Stage 3 of the Phase 2 trial was designed with input from the FDA to provide the pivotal, confirmatory evidence of efficacy of SL-401 in BPDCN. First-line-only BPDCN patients received SL-401 intravenously at 12 mcg/kg/day on days 1-5 of a 21-day cycle. The primary endpoint of Stage 3 was the rate of CR, defined per protocol as CR + CRc + CRi (CR = complete response; CRc = clinical complete response: absence of gross disease with minimal residual skin abnormality; CRi = CR with incomplete hematologic recovery) by investigator assessment. Statistical significance is achieved if the lower bound of the 95% confidence interval (CI) of the primary endpoint exceeds 10%.

Stage 3: Top-Line Results

In Stage 3 of the trial, 13 first-line BPDCN patients were enrolled. Stage 3 met its primary endpoint, with a CR rate of 54% (7/13) (95% CI: 25.1, 80.8). Overall response rate (ORR) was 77% (10/13). 46% (6/13) of patients were bridged to stem cell transplant (SCT) following remission on SL-401. 86% (6/7) of complete responders remain relapse-free at 5+ to 8+ months, ongoing.

All Stages (1, 2, and 3): Top-Line Results

Across all stages, lines, and doses in the trial (n=45 BPDCN patients; 32 first-line, 13 relapsed/refractory), the CR rate was 60% (27/45) and the ORR was 82% (37/45). In first-line patients who received SL-401 at all tested doses (n=32 patients), the CR rate was 69% (22/32) and the ORR was 88% (28/32). 41% (13/32) of first-line patients who received SL-401 at all tested doses have been bridged to SCT following remission on SL-401.



All SL-401 Trials: Top-Line Safety Results

The most common treatment-related adverse events (TRAEs) with SL-401 across BPDCN and other clinical trials (acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), and multiple myeloma) (n=148 patients) were hypoalbuminemia (47%), aspartate aminotransferase increase (46%), alanine aminotransferase increase (45%), nausea (28%), and thrombocytopenia (28%). Capillary leak syndrome (CLS), a well-documented side effect, occurred in 19% of patients, of which 2% (3/148) were grade 5, as previously reported.

Andrew A. Lane, M.D., Ph.D., Director of the BPDCN Center at the Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School in Boston, and a co-investigator on the study, commented, “BPDCN is a devastating malignancy for which there are no approved therapies. Due to the increasing awareness around BPDCN and the promise of novel targeted agents such as SL-401, we have built a new BPDCN center at Dana-Farber to focus on this historically poorly understood, yet increasingly appreciated, patient population with unmet need. SL-401 has demonstrated efficacy with meaningful clinical benefit in BPDCN while maintaining a manageable safety profile, particularly notable in this predominantly older population, representing a major advance in the management of BPDCN. Also, given the presence of CD123 on additional aggressive hematologic cancers, we are also exploring SL-401 in combination with other agents in clinical trials of high risk MDS and AML.”

Ivan Bergstein, MD, CEO of Stemline, commented, “The successful completion of the largest prospective clinical trial ever conducted in BPDCN, is a major milestone for Stemline, our investigators, and most importantly, patients and their families. We would like to thank and congratulate all those involved in this groundbreaking trial. We look forward to working closely with regulatory authorities in an effort to provide SL-401 to patients as quickly as possible. In parallel, our commercial team continues to ramp-up activities setting the stage, if SL-401 is approved, for a successful launch.”

Conference Call and Webcast

Stemline Therapeutics will host a conference call and audio webcast this morning, Tuesday, October 31, 2017 at 8:30 AM ET. Interested participants and investors may access the conference call by dialing 844-389-8660 (U.S./Canada) or 478-219-0408 (International) and referencing conference ID: 1686609. An audio webcast can also be accessed via the Investor Relations tab of the Stemline Therapeutics website at View Source

About BPDCN

Please visit www.bpdcninfo.com and the BPDCN awareness booth (#3143) at ASH (Free ASH Whitepaper) 2017

On November 1, 2017 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that 18 abstracts featuring data from the broad ADCETRIS (brentuximab vedotin) development program have been accepted for presentation, including a plenary presentation, at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place from December 9-12, 2017 in Atlanta, Georgia (Press release, Seattle Genetics, NOV 1, 2017, View Source [SID1234521404]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non-Hodgkin lymphoma. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.

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Data accepted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting include the following:

Data from the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS in combination with chemotherapy in frontline advanced classical Hodgkin lymphoma patients will be featured in the Plenary Scientific Session on Sunday, December 10, 2017 from 2:00 – 4:00 p.m. ET. Based on the positive results from the ECHELON-1 trial, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. Seattle Genetics expects to submit in the fourth quarter of 2017 a supplemental Biologics License Application (BLA) to the FDA for approval of ADCETRIS in frontline advanced classical Hodgkin lymphoma.
Numerous oral and poster presentations highlighting additional progress within the ADCETRIS development program including:
Updated durability results from the phase 3 ALCANZA clinical trial in patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma, the most common subtypes of cutaneous T-cell lymphoma (CTCL). Based on the positive results from the ALCANZA trial, a supplemental BLA for ADCETRIS in CTCL was accepted for filing by the FDA. The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is December 16, 2017. ADCETRIS previously received FDA Breakthrough Therapy Designation in this setting.
Updated results from a phase 1/2 study of ADCETRIS in combination with Opdivo (nivolumab) among patients with relapsed or refractory Hodgkin lymphoma
Final five-year survival and durability results in patients with CD30-expressing peripheral T-cell lymphomas who received ADCETRIS with cyclophosphamide, hydroxydaunorubicin, and prednisone (CHP) as frontline therapy
“At this year’s ASH (Free ASH Whitepaper) Annual Meeting, we will present data from 18 abstracts, highlighting several ADCETRIS clinical program advancements that support our plans to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Importantly, the results of the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS combination therapy in frontline advanced Hodgkin lymphoma patients was selected from over 6,000 abstracts submitted to be featured in the Plenary Scientific Session. These data are the basis for our planned supplemental biologics license application to the FDA requesting approval of ADCETRIS in this setting. The breadth of data being presented with ADCETRIS in CD30-expressing lymphomas demonstrates the power of antibody-drug conjugates with a goal of improving patient outcomes.”

ADCETRIS is currently not approved for the treatment of frontline Hodgkin lymphoma, CTCL, or as combination therapy for Hodgkin lymphoma or non-Hodgkin lymphoma.

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 9, 2017

Updated analyses of the international, open-label, randomized, phase 3 ALCANZA study: longer-term evidence for superiority of brentuximab vedotin versus methotrexate or bexarotene for CD30-positive cutaneous T-cell lymphoma (Abstract #1509, poster presentation)
A pilot study of weekly brentuximab vedotin in patients with CD30+ malignancies resistant to every 3 week brentuximab vedotin (Abstract #1528, poster presentation)
Brentuximab vedotin with R-CHP chemotherapy as frontline treatment for patients with CD30 positive primary mediastinal large B-cell, diffuse large B-cell, and grey zone lymphomas: results of a phase I/II multisite trial (Abstract #191, oral presentation at 3:00 p.m. ET)
Patient-reported distress in Hodgkin lymphoma patients on active therapy vs. long-term survivors (Abstract #2173, poster presentation)
Real world clinical and economic burden of patients with Hodgkin lymphoma who fail frontline therapy in the US (Abstract #2128, poster presentation)
Sunday, December 10, 2017

Brentuximab vedotin plus doxorubicin, vinblastine, dacarbazine (A+AVD) as frontline therapy demonstrates superior modified progression-free survival versus ABVD in patients with previously untreated stage III or IV Hodgkin lymphoma (HL): the phase 3 ECHELON-1 study (Plenary Scientific Session presentation from 2:00 – 4:00 p.m. ET)
Five-year survival results: frontline brentuximab vedotin in combination with CHP in patients with CD30-expressing peripheral T-cell lymphomas (Abstract #2790, poster presentation)
Radiographic and high-throughput sequencing (HTS)-based response assessment after brentuximab vedotin plus ifosfamide, carboplatin, and etoposide (ICE) for relapsed/refractory classical Hodgkin lymphoma: updated results of a phase I/II trial (Abstract #2806, poster presentation)
Patient and physician preferences for front-line treatment of advanced stage Hodgkin lymphoma (Abstract #4082, poster presentation)
Changes in serum TARC predict PET response among pediatric patients with relapsed or refractory Hodgkin lymphoma treated with brentuximab vedotin and gemcitabine: a report from the Children’s Oncology Group (Abstract #2798, poster presentation)
Phase 2 Study of Brentuximab Vedotin in Patients with Advanced Systemic Mastocytosis (Abstract #2909, poster presentation)
Monday, December 11, 2017

Results from a phase 1/2 study of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (Abstract #649, oral presentation at 10:30 a.m. ET)
Sequential brentuximab vedotin before and after adriamycin, vinblastine, and dacarbazine (A-VAD-A) for older patients with untreated Hodgkin lymphoma: final results from a multicenter phase II study (Abstract #733, oral presentation at 2:45 p.m. ET)
About ADCETRIS

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30 and is being evaluated broadly in more than 70 clinical trials, including four phase 3 studies: the ECHELON-1 trial in frontline classical Hodgkin lymphoma from which positive top-line results were recently reported and the FDA granted Breakthrough Therapy Designation in this setting, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, the completed ALCANZA trial in cutaneous T-cell lymphoma that supported the supplemental BLA with a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2017, and the recently initiated CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

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 FDA approval for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma 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 Hodgkin lymphoma 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 Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-ASCT consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

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 Hodgkin lymphoma 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. The European Commission extended the current conditional marketing authorization of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.

ADCETRIS has received marketing authorization by regulatory authorities in 68 countries for relapsed or refractory Hodgkin lymphoma and sALCL. 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.