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Saturday, December 1, 2018

Genmab to Hold R&D Update and 2018 ASH Data Review Meeting


  • Event to be held live in San Diego, California
  • Independent experts to discuss data presented at the 2018 ASH Annual Meeting
  • Meeting to be webcast live and archived on http://www.genmab.com

Genmab A/S (Nasdaq Copenhagen: GEN) will hold a R&D Update and 2018 ASH Data Review Meeting on December 3, 2016 at 8:00 PM Pacific Time (5:00 AM CET / 4:00 AM GMT on 4 December).  The event will take place in San Diego, California, and will also be webcast live and archived on the company’s website. The meeting will include presentations by independent experts on data from daratumumab studies presented at the 60th Annual Meeting of the American Society of Hematology (ASH), including some key aspects of the Phase III MAIA study. Genmab speakers will also discuss the pre-clinical data from Genmab’s DuoBody-CD3xCD20 and DuoHexaBody-CD37 programs presented at ASH, as well as the company’s progress and key goals for 2019.
The following cancer experts and senior Genmab staff will be at the event:
Independent experts:
  • Dr. Meletios A. Dimopoulos, National and Kapodistrian University of Athens, School of Medicine
  • Professor Philippe Moreau, University Hospital of Nantes
  • Dr. Saad Usmani, University of North Carolina at Chapel Hill, Levine Cancer Institute
Genmab:
  • Dr. Jan van de Winkel, President and CEO, Genmab
  • Dr. Judith Klimovsky, Executive Vice President and CDO, Genmab
  • Dr. Kate Sasser, Corporate Vice President, Translational Research, Genmab
The event will take place at the Manchester Grand Hyatt in San Diego, California, Harbor Ballroom A & B. Those wishing to attend in person should email cmh@genmab.com.
The event can also be attended via webcast. To view this webcast visit: https://edge.media-server.com/m6/p/8gdmxojt.  Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player. An archive of the webcast will be available on Genmab’s website. The webcast will be conducted in English.
This meeting is not an official program of the ASH Annual Meeting.
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Good news on the way for blood cancer patients, Barron’s says


Biotech investors will get an infusion of good news beginning this weekend when researchers gather in San Diego to hear about new blood cancer drugs, Bill Alpert writes in this week’s edition of Barron’s. The annual meeting of the American Society of Hematology, or ASH, will feature developments from big companies like Celgene (CELG) and Amgen (AMGN), as well as up-and-comers like Bluebird Bio (BLUE) and Genmab (GNMSF), the report notes, adding that there will be early results of gene therapies and news on the fight against a hard-to-beat cancer called multiple myeloma.
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J&J DARZALEX Combos Show Positive Results for Multiple Myeloma: ASH


Updated Phase 3 ALCYONE results, featured as oral presentation at ASH 2018, showimproved progression-free survival in newly diagnosed patients
· Data from Phase 2 LYRA and GRIFFIN studies support the safety and efficacy of DARZALEX combination treatments in newly diagnosed and relapsed patients, including the feasibility of a split first dose
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today long-term results from the Phase 3 ALCYONE study showing that the addition of DARZALEX® (daratumumab) to bortezomib, melphalan and prednisone (VMP) continued to demonstrate significant improvement in progression-free survival (PFS) in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).1 These data (Abstract #156), as well as updates from the Phase 2 LYRA (Abstract #152) and GRIFFIN (Abstract #151) studies in patients with multiple myeloma, were featured during an oral abstract session at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, CA.
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AbbVie Presents New Data from Phase 3 Leukemia Trial at ASH


AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company today presented updated data from the pivotal Phase 3 MURANO trial of venetoclax (VENCLEXTA® or VENCLYXTO®) in combination with rituximab (VenR). The results at median follow-up of 36 months demonstrated that the majority of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), treated with VenR, did not experience disease progression or death (PFS; the time on treatment without disease progression or death2) after all patients completed the fixed duration of therapy and stopped treatment, compared to patients treated with a standard of care regimen of bendamustine plus rituximab (BR).1The estimated PFS rate at 36 months was 71.4 percent (95% confidence interval [CI]: 0.64, 0.78) for patients treated with VenR compared with 15.2 percent (95% CI: 0.09, 0.21) for patients who completed treatment with a standard of care combination of BR (hazard ratio [HR]: 0.16; 95% CI: 0.12, 0.23).1 The data were presented today during the 60th American Society of Hematology (ASH) Annual Meeting & Exposition.
Of the 130 patients who completed the two-year treatment course of venetoclax and remained off therapy for a median of 9.9 months (range: 1.4 to 22.5), six- and 12-month PFS estimates were 92 percent (95% CI: 0.87, 0.96) and 87 percent (95% CI: 0.81, 0.93), respectively.1 At the time of analysis, the overall survival (OS) benefit estimated at three years was approximately 10 percent higher in the VenR arm (87.9 percent) than in the BR arm (79.5 percent) (HR: 0.50; 95% CI: 0.30, 0.85).1
‘There is a need for a chemo-free option with a fixed treatment duration that can potentially provide prolonged progression-free survival, along with minimal residual disease negativity, in patients with relapsed or refractory chronic lymphocytic leukemia,’ said Prof. John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and Director of the Department of Hematology at the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia. ‘The results of this analysis showed that a high proportion of patients with relapsed or refractory chronic lymphocytic leukemia who were treated with venetoclax in combination with rituximab maintained minimal residual disease negativity and progression-free survival well after completing the fixed treatment duration.’
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MorphoSys Updates Data on Study of MOR208 combo at ASH


MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) today presented data from the ongoing single-arm phase 2 clinical trial known as L-MIND in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting 2018 in San Diego, USA. L-MIND is designed to investigate the antibody MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). MOR208 is an investigational humanized Fc-enhanced monoclonal antibody directed against CD19 and is currently in clinical development in blood cancer indications.
The L-MIND study enrolled patients with r/r DLBCL, who are ineligible for HDC and ASCT, after up to three prior lines of therapy, with at least one prior therapy including an anti-CD20 targeting therapy, such as rituximab. The updated interim data reported today (cut-off date June 5, 2018) included all 81 patients enrolled in the L-MIND trial, with a median observation time of 12 months. Efficacy results in this update are based on assessment by the investigators for all 81 patients. Patients enrolled had a median age of 72 years and had received a median of two prior treatment lines.
The data showed a response in 47 out of 81 patients (overall response rate, or ORR, 58%), with complete responses (CR) in 27 (33%) and partial responses (PR) in 20 (25%) patients. The median progression-free survival (mPFS) was 16.2 months (95% confidence interval (CI) 6.3 months – not reached). Responses were durable with the median duration of response (DoR) not reached (95% CI: NR – NR) and 70% of responding patients were without progression at 12 months (12-month DoR rate: 70%, Kaplan-Meier estimate). A significant proportion of patients (37/81; 46%) were still on study treatment, with 19 having been treated for over 12 months. Median overall survival (OS) was not reached (95% CI: 18.6 months – NR); the 12-month OS rate was 73% (95% CI: 63% – 85%).
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ImmunoGen New Data on Novel Antibody Drug Conjugates Presented at ASH


Initial Data for CD123-Targeting IMGN632 Demonstrate Encouraging Anti-Leukemia Activity and Tolerable Safety Profile in Both AML and BPDCN; Dose Exploration Continues
Maturing Data for CD33-Targeting IMGN779 Reflect Consistent Activity and Tolerability Profile in AML; Dose Exploration Continues
Preclinical Data on IMGN632 from Collaborators Further Support the Potential in AML and BPDCN
ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that new data from the ongoing Phase 1 studies of IMGN632 and IMGN779, next-generation CD123- and CD33-targeting ADCs, respectively, in patients with relapsed or refractory adult acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) will be presented during an oral session at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego. Preclinical data for IMGN632 as a monotherapy in BPDCN patient-derived xenografts, as well as in combination with a PARP inhibitor in AML models, will also be presented at the conference.
The data presented at ASH demonstrate the potential of ADCs generated from the company’s IGN platform to overcome the narrow therapeutic window seen with previous generations of DNA-targeted agents and offer new treatment options for AML and other hematological malignancies.
“We designed our IGN payloads to alkylate one strand of DNA to produce potent anti-leukemia activity, while reducing toxicity to normal cells caused by the double-stranded damage associated with earlier DNA-acting approaches,” said Anna Berkenblit, MD, Vice President and Chief Medical Officer of ImmunoGen. “IMGN779 and IMGN632 each incorporate an IGN payload and we are pleased to share Phase I clinical results for both programs today at ASH.”
“With IMGN632, we are encouraged by both the tolerability and responses seen thus far, including repeat dosing and complete remissions in AML and BPDCN,” said Naval Daver, MD, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center. “We look forward to continuing to enroll patients at several dose levels to establish a recommended Phase 2 dose and schedule for both indications.”
“With IMGN779, I am encouraged to see a significant decrease in blasts in many patients with some achieving CRi,” said Jorge Cortes, MD, Deputy Chair and Professor of Medicine in the Department of Leukemia at MD Anderson Cancer Center. “The anti-leukemia activity and tolerability seen with both the weekly and the every two week schedule support continued enrollment to identify a dose and schedule to enable further development of IMGN779 as combination therapy in AML.”
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Seattle Genetics: Data Sets on CETRIS- Opdivo Lymphoma Combo at ASH


-Initial Data Reported from Phase 2 Clinical Trial in Relapsed Primary Mediastinal Large B-Cell Lymphoma-
-Results from Phase 1/2 Trial in Relapsed Hodgkin Lymphoma Continue to Support Combination Strategy-
-Phase 2 Trial Evaluating Novel Combination Strategies in Children, Adolescents and Young Adults in Relapsed Hodgkin Lymphoma to be Featured in Oral Presentation-
Seattle Genetics, Inc. (Nasdaq:SGEN) today highlighted data from three ongoing clinical trials evaluating the combination of ADCETRIS (brentuximab vedotin) and Opdivo(nivolumab) at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Diego, Calif., December 1-4, 2018. Initial data were presented from a phase 2 clinical trial evaluating the combination in relapsed or refractory primary mediastinal large B-cell lymphoma (PMBL). In addition, data were presented from the ongoing phase 1/2 clinical trial evaluating the combination in relapsed or refractory classical Hodgkin lymphoma (HL). Lastly, an oral presentation on Monday, December 3, 2018 will highlight initial data from a phase 2 study evaluating combination approaches with ADCETRIS, Opdivo and bendamustine in children, adolescents and young adults with relapsed or refractory classical HL. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor growth and survival. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumor immune response. ADCETRIS and Opdivo are not approved in combination for the treatment of relapsed or refractory PMBL, HL or for other indications.
“Our goal with ADCETRIS is to identify the most effective treatment strategies to improve the outcome of patients, and the combination of ADCETRIS and Opdivo has demonstrated enhanced activity with a tolerable safety profile in Hodgkin lymphoma and now a type of non-Hodgkin lymphoma called primary mediastinal large B-cell lymphoma, or PMBL,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “In the Hodgkin lymphoma setting, ADCETRIS plus Opdivo data continue to support investigation of this combination regimen in multiple ongoing studies. The initial data reported from the phase 2 PMBL clinical trial demonstrate a high level of activity of the combination, with an objective response rate of 70 percent and a complete response rate of 27 percent. We and BMS are exploring specific settings where the combination of ADCETRIS and Opdivo has the potential to improve patient outcomes.”
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