1stOncology™: Cancer Intelligence Service – Page 14772 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Seattle Genetics to Present Data from Broad ADCETRIS® (Brentuximab Vedotin) Development Program at ASH 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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.

Regeneron to Share Clinical Progress of REGN1979 and Cemiplimab (REGN2810) in B-Cell Lymphomas at the 2017 ASH Annual Meeting

On November 1, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that data from two Phase 1 clinical trials of REGN1979 and cemiplimab (REGN2810) in patients with different forms of B-cell lymphoma will be presented at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 9-12, 2017, in Atlanta, GA(Press release, Regeneron, NOV 1, 2017, View Source [SID1234521403]).

Regeneron’s clinical presentations will include new safety and activity results from a Phase 1 study of cemiplimab alone or in combination with REGN1979, as well as updated results from a Phase 1 study of REGN1979 monotherapy. Collectively, the two studies enrolled patients with B-cell non-Hodgkin lymphoma (B-NHL) or Hodgkin lymphoma (HL) previously treated with at least one prior therapy and for whom no standard-of-care options exist.

REGN1979 is an investigational bispecific monoclonal antibody that binds to CD3 on immune system T-cells and to CD20 on B-cell malignancies to help trigger tumor killing. Cemiplimab is an investigational human, monoclonal antibody targeting PD-1 (programmed cell death protein 1).

The studies will be presented as posters during the 2017 ASH (Free ASH Whitepaper) Annual Meeting as follows:

Safety and Preliminary Antitumor Activity of the Anti-PD-1 Monoclonal Antibody REGN2810 Alone or in Combination with REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients with B-Lymphoid Malignancies
Abstract # 1495
Saturday, December 9, 5:30 – 7:30 p.m. ET

Safety and Preliminary Clinical Activity of REGN1979, an Anti-CD20 x Anti- CD3 Bispecific Antibody, in Patients with B-NHL Previously Treated with CD20-Directed Antibody Therapy
Abstract # 1550
Saturday, December 9, 5:30 – 7:30 p.m. ET

The FDA granted orphan drug designation to REGN1979 for diffuse large B-cell lymphoma (DLBCL) and breakthrough therapy designation status to cemiplimab for metastatic or locally advanced and unresectable cutaneous squamous cell carcinoma (CSCC) earlier in 2017. Cemiplimab is being developed jointly with Sanofi under a global collaboration agreement.

REGN1979 and cemiplimab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

Kitov Pharmaceuticals Announces Receipt of FDA’s Favorable Response to NT219’s pre-IND Meeting Package

On November 1, 2017 Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported that it has received the U.S. Food and Drug Administration’s (FDA) response to the NT219’s pre-IND meeting package (Press release, Kitov Pharmaceuticals , NOV 1, 2017, View Source [SID1234521402]). FDA has agreed to the proposed Chemistry Manufacturing and Controls (CMC), preclinical, and clinical development plans for NT219. For the clinical development plan, the FDA agreed with TyrNovo’s proposed development plan to test NT219 in combination with gemcitabine for the treatment of advanced pancreatic cancer. The FDA further agreed that the initial clinical trial with NT219 will be a Phase I/II clinical trial, and that "the overall design of proposed first-in-human trial appears reasonable". The FDA further agreed that one-month animal toxicology studies for NT219 would be sufficient to support the IND and that no toxicology studies of NT219 together with gemcitabine would be necessary.

"We are very pleased that FDA’s Division of Oncology Products has accepted our chemistry, non-clinical, and clinical development plans for TyrNovo’s cancer drug, NT219, and we are moving forward with these development plans. We appreciate FDA’s helpful guidance and look forward to continuing to work with the FDA toward an IND submission, which based on our current development plans, we now expect to submit during the first half of 2019," said Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.

Dr. Hadas Reuveni, TyrNovo’s Founder and CTO added: "According to the National Cancer Institute, pancreatic cancer is the fourth leading cause of cancer death in the US and is known to be one of the most aggressive and difficult-to-treat cancer types. NT219 works by overcoming drug resistance and can be combined with various oncology drugs. Our drug’s efficacy was demonstrated in preclinical patient-derived xenograft (PDX) models with various oncology therapies such as chemotherapy agents, EGFR Antibodies, MEK and mTOR inhibitors, and also in combination with immuno-oncology agents such as Keytruda. We will initially be clinically testing NT219 in combination with gemcitabine on advanced pancreatic cancer patients, based on our consistent encouraging results in preclinical PDX models. Our long-term strategy is to develop NT219 in combination with other oncology drugs and for additional oncology indications in collaboration with potential strategic partners, who have expressed solid preliminary interest in NT219."

Karyopharm to Present Phase 1b/2 STOMP Clinical Data at the American Society of Hematology 2017 Annual Meeting

On November 1, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that 14 abstracts have been selected for presentation, including three 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, Karyopharm, NOV 1, 2017, View Source [SID1234521401]). Four key abstracts being presented at the meeting will feature clinical data from Karyopharm’s ongoing Phase 1b/2 STOMP study evaluating selinexor, the Company’s lead, novel, oral SINE compound, in combination with backbone therapies for the treatment of patients with heavily pretreated multiple myeloma (MM). The four STOMP presentations will include updated data from the arms evaluating selinexor in combination with Velcade (bortezomib) and low-dose dexamethasone (SVd), selinexor in combination with Pomalyst (pomalidomide) and low-dose dexamethasone (SPd), and selinexor in combination with Revlimid (lenalidomide) and low-dose dexamethasone (SRd), and preliminary data from the arm evaluating selinexor in combination with Darzalex (daratumumab) and low-dose dexamethasone (SDd).

“Despite several treatment advances for myeloma patients, there is a need for treatments with novel mechanisms, and many patients favor orally administered medicines,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “Previously reported data from the ongoing Phase 1b/2 STOMP study showed promising response rates in patients with heavily pretreated myeloma when oral selinexor is combined with Velcade (“SVd”) or Pomalyst (“SPd”). We are very pleased to provide updated data for selinexor in combination with these agents, new data for selinexor in combination with Revlimid (“SRd”), and early results from the new Darzalex (“SDd”) combination arm at ASH (Free ASH Whitepaper) this year. We believe these data support the potential of selinexor as a backbone therapy with commonly used agents for multiple myeloma. Moreover, we believe the new data continue to support our ongoing Phase 3 BOSTON study of SVd in myeloma.”

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

Phase 1b/2 STOMP Study Data Presentations

Title: Selinexor in combination with weekly low dose bortezomib and dexamethasone (SVd) induces a high response rate with durable responses in patients with refractory multiple myeloma (MM)
Presenter: Nizar Bahlis, Southern Alberta Cancer Research Institute, Calgary, Alberta
Abstract Number/Publication ID: 3135
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: Selinexor in Combination with Pomalidomide and Low Dose Dexamethasone in a Relapsed / Refractory Multiple Myeloma Patient Population with Prior Proteasome Inhibitor and Lenalidomide Exposure
Presenter: Christine Chen, Princess Margaret Cancer Center, Toronto, Ontario
Abstract Number/Publication ID: 3136
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: A Phase Ib/II Trial of Selinexor Combined with Lenalidomide and Low Dose Dexamethasone in Patients with Relapsed / Refractory Multiple Myeloma
Presenter: Darrell White, Dalhousie University and QEII Health Sciences Center, Halifax; Nova Scotia
Abstract Number/Publication ID: 1861
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date and Time: Saturday, December 9, 2017; 5:30-7:30 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: A Phase 1b Study to Assess the Combination of Selinexor and Daratumumab in Patients with Relapsed/Refractory Multiple Myeloma Previously Exposed to Proteasome Inhibitors (PI) and Immunomodulatory Drugs (IMiDs)
Presenter: Cristina Gasparetto, Duke University Cancer Center, Durham, North Carolina
Abstract Number/Publication ID: 3100
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Investigator-sponsored Study Oral Presentations

Title: Selinexor in Combination with Cladribine, Cytarabine and G-CSF for Relapsed or Refractory AML
Presenter: Geoffrey Uy, Washington University School of Medicine in St. Louis
Abstract Number/Publication ID: 816
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targeted and Immune-based Approaches in the Treatment of AML; Monday, December 11, 2017 from 4:30-6:00 PM ET
Date and Time: Monday, December 11, 2017 at 5:45 PM ET
Location: Georgia World Congress Center, Building B, Level 5, Murphy BR 1-2

Investigator-sponsored Study Poster Presentations

Title: Selinexor maintenance is feasible and tolerable after allogeneic stem cell transplant (allo-SCT) for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
Presenter: Hongtao Liu, University of Chicago Medical Center
Abstract Number/Publication ID: 3312
Session: 732. Clinical Allogeneic Transplantation: Results: 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

Title: A Phase I/II study of Selinexor (SEL) with Sorafenib in Patients (pts) with Relapsed and/or Refractory (R/R) FLT3 mutated Acute Myeloid Leukemia (AML)
Presenter: Naval Daver, University of Texas MD Anderson Cancer Center
Abstract Number/Publication ID: 1344
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: 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: Phase I/II Study of Liposomal Doxorubicin (DOX) in Combination with Selinexor (SEL) and Dexamethasone (Dex) for Relapsed and Refractory Multiple Myeloma (RRMM)
Presenter: Rachid Baz, H. Lee Moffitt Cancer Center and Research Institute
Abstract Number/Publication ID: 3095
Session: 653. Myeloma: 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

Preclinical Oral Presentations

Title: Non-cytotoxic Low Doses of Selinexor Promote the Differentiation of AML Cells Harboring Mutant-NPM1 into Monocytes
Presenter: Saunthararajah Yogen, Cleveland Clinic
Abstract Number/Publication ID: 105742
Session: 603. Oncogenes and Tumor Suppressors: Nuclear Export and Metabolic Regulation; Monday, December 11, 2017, 6:15-7:45 PM ET
Date and Time: Monday, December 11, 2017 at 6:30 PM ET
Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium

Title: PAK4 Inhibition Impacts Growth and Survival, and Increases Sensitivity to DNA-Damaging Agents in Waldenstrom Macroglobulinemia
Presenter: Li Na, Dana Farber Cancer Institute
Abstract Number/Publication ID: 102879
Session: 622. Lymphoma Biology—Non-Genetic Studies: Novel Mechanisms Implicated in Lymphoma Biology; Monday, December 11, 2017, 10:30AM — 12:00 PM ET
Date and Time: Monday, December 11, 2017 at 11:45 AM ET
Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium

Preclinical Poster Presentations

Title: XPO1 Inhibitor Selinexor Overcomes Ibrutinib Resistance in Mantle Cell Lymphoma (MCL) via Nuclear Retention of IκB
Presenter: Mei Ming, University of Chicago
Abstract Number/Publication ID: 104320
Session: 605. Molecular Pharmacology, Drug Resistance-Lymphoid and Other Diseases
Date and Time: Monday, December 11, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: XPO1 Inhibition Synergizes with BCR Inhibition, Blocks Tumor Growth and Prolongs Survival in a Bioluminescent Animal Model of Primary Central Nervous System Lymphoma
Presenter: Marta Crespo, Hall d’Hebron, Barcelona
Abstract Number/Publication ID: 107008
Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

Title: Eltanexor (KPT-8602), a Second-Generation Selective Inhibitor of Nuclear Export (SINE) Compound, in Patients with Refractory Multiple Myeloma
Presenter: Robert Frank Cornell, Vanderbilt University Medical Center
Abstract Number/Publication ID: 107422
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,200 patients have been treated with selinexor, and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

Roche to present new data across a range of blood diseases at the American Society of Hematology (ASH) 2017 Annual Meeting

On November 1, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data on its approved and investigational medicines for blood diseases will be presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from 9 – 12 December, in Atlanta (Press release, Hoffmann-La Roche, NOV 1, 2017, View Source [SID1234521400]). Ten Roche medicines will be featured in over 75 abstracts, including 26 oral presentations, across eight blood diseases.

“At ASH (Free ASH Whitepaper) this year, we look forward to presenting a wealth of data highlighting potential advances across the spectrum of blood diseases, from rare conditions like haemophilia A to common blood cancers like lymphoma,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Our ongoing development programme in haematology is one of the largest in this area, underscoring our commitment to developing practice-changing medicines and improving outcomes for people with diseases of the blood.”

Among Roche’s clinical data to be featured at ASH (Free ASH Whitepaper) are results from the ongoing trials for the investigational medicine emicizumab. Updated data with an additional six months of follow-up from the phase III HAVEN 1 and HAVEN 2 studies evaluating the safety and efficacy of emicizumab in adults, adolescents and children with haemophilia A with inhibitors will be presented. The HAVEN 2 study will be highlighted as part of ASH (Free ASH Whitepaper)’s official press program on 9 December at 07:30am EST. Additional results from the emicizumab clinical development programme will be presented during the meeting, including preliminary data from the phase III HAVEN 4 study exploring emicizumab prophylaxis administered every four weeks in people with haemophilia A with and without inhibitors, as well as real-world data from a non-interventional study in children under 12 years of age with haemophilia A with inhibitors.

Roche will also be sharing data for medicines in late-stage development for a range of blood cancers. Highlights include results from a randomised phase II study evaluating polatuzumab vedotin, an investigational anti-CD79b antibody drug conjugate, in combination with MabThera/Rituxan (rituximab) and bendamustine versus MabThera/Rituxan and bendamustine for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Based on data from this study, polatuzumab vedotin was recently granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) and had previously received the PRIME (PRIority MEdicines) designation in Europe.

Additionally, results from studies of Gazyva/Gazyvaro (obinutuzumab), including new data from the
phase III GALLIUM study in previously untreated follicular lymphoma, and data from the phase III PrefMab study evaluating patient preference for the subcutaneous (SC) formulation of MabThera/Rituxan Hycela (rituximab/rituximab and hyaluronidase human) as a treatment for DLBCL and follicular lymphoma will also be shared. Finally, results from multiple studies assessing the safety and efficacy of Venclexta/Venclyxto (venetoclax) across chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) and acute myeloid leukaemia (AML) will be presented. Venclexta/Venclyxto is being developed by AbbVie and Roche.

Key abstracts featuring Roche medicines that will be presented at ASH (Free ASH Whitepaper) can be found in the table below.

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 #ASH17.