On May 15, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that clinical and non-clinical data on BTK inhibitor BRUKINSA (zanubrutinib) and clinical data on anti-PD-1 antibody tislelizumab will be presented in an oral presentation and eight posters at the 25thEuropean Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress, taking place on June 11-14, 2020 (Press release, BeiGene, MAY 14, 2020, View Source [SID1234558062]).

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Oral Presentation:

Title: ASPEN: Results of a Phase 3 Randomized Trial Of Zanubrutinib Versus Ibrutinib for Patients with Waldenström Macroglobulinemia (WM)
Abstract #: S225
Session Title: Indolent and Mantle-Cell Non-Hodgkin Lymphoma – Clinical
Presenter: Meletios Dimopoulos, M.D., National and Kapodistrian University of Athens, Greece
Poster Presentations:

Title: Updated Results of the ASPEN Trial from a Cohort of Patients with MYD88 Wild-Type Waldenström Macroglobulinemia
Abstract #: EP1180
Session Title: Indolent and Mantle-Cell Non-Hodgkin Lymphoma – Clinical
Lead Author: Meletios Dimopoulos, M.D., National and Kapodistrian University of Athens, Greece

Title: Three-Year Follow-Up of Treatment-Naïve and Previously Treated Patients with Waldenström Macroglobulinemia (WM) Receiving Single Agent Zanubrutinib
Abstract #: EP1168
Session Title: Indolent and Mantle-Cell Non-Hodgkin Lymphoma – Clinical
Lead Author: Stephen Opat, MBBS, Monash University, Australia

Title: Phase 1/2 Study of Single-Agent Zanubrutinib in Patients with Relapsed/Refractory Marginal Zone Lymphoma
Abstract #: EP1165
Session Title: Indolent and Mantle-Cell Non-Hodgkin Lymphoma – Clinical
Lead Author: Alessandra Tedeschi, M.D., Niguarda Cancer Center, Italy

Title: Tislelizumab (BGB-A317) for Relapsed/Refractory Extranodal NK/T-Cell Lymphoma: Preliminary Efficacy and Safety Results from a Phase 2 Study
Abstract #: EP1268
Session Title: Aggressive Non-Hodgkin Lymphoma – Clinical
Lead Author: Huiqiang Huang, M.D., Ph.D., Sun Yat-sen University Cancer Center, China

Title: Tislelizumab (BGB-A317) for Relapsed/Refractory Peripheral T-Cell Lymphomas: Safety and Efficacy Results from a Phase 2 Study
Abstract #: EP1235
Session Title: Aggressive Non-Hodgkin Lymphoma – Clinical
Lead Author: Pier Luigi Zinzani, M.D., Ph.D., University of Bologna, Italy

Title: Biomarker Identification in Relapsed/Refractory Non-Germinal Center B-Cell–Like Diffuse Large B-Cell Lymphoma Treated with Zanubrutinib
Abstract #: EP1246
Session Title: Aggressive Non-Hodgkin Lymphoma – Clinical
Lead Author: Haiyan Yang, M.D., Zhejiang Cancer Hospital, China

Title: Zanubrutinib (BGB-3111) in Combination with Rituximab in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma
Abstract #: EP1271
Session Title: Aggressive Non-Hodgkin Lymphoma – Clinical
Lead Author: Jianfeng Zhou, M.D., Tongji Medical College, China

Title: Outcomes of Relapsed/Refractory MCL Patients Treated with Zanubrutinib Monotherapy in the Second Line and in Later Lines: A Pooled Analysis from 2 Studies
Abstract #: EP1169
Session Title: Indolent and Mantle-Cell Non-Hodgkin Lymphoma – Clinical
Lead Author: Keshu Zhou, M.D., Henan Cancer Hospital, China

On May 14, 2020 Omeros Corporation (Nasdaq: OMER) reported that the results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy will be presented at the 25th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held June 11-14, 2020 (Press release, Omeros, MAY 14, 2020, View Source [SID1234558061]). This year the congress will be held virtually .

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The presentation, entitled Narsoplimab (OMS721) for the Treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy, will be delivered by Alessandro Rambaldi, M.D., Professor of Hematology at the University of Milan and Head of the Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni XXIII in Bergamo, Italy. Selected by EHA (Free EHA Whitepaper) for a podium presentation, it will include efficacy data not previously presented.

About HSCT-TMA

Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplants. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, GvHD, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 25,000 to 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an HSCT-TMA incidence of approximately 40 percent, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae are common. There is no approved therapy or standard of care for HSCT-TMA.

About Narsoplimab

Narsoplimab, also known as "OMS721," is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

Phase 3 clinical programs are in progress for narsoplimab in HSCT-TMA, in immunoglobulin A (IgA) nephropathy, and in atypical hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.

On May 14, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported plans to present updated clinical data for pralsetinib in RET-altered cancers and avapritinib in systemic mastocytosis (Press release, Blueprint Medicines, MAY 14, 2020, View Source [SID1234558060]).

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"The upcoming presentations reflect our commitment to bring transformative therapies to patients by selectively targeting genomic drivers of disease," said Andy Boral, M.D., Ph.D., Chief Medical Officer of Blueprint Medicines. "The data support the rapid clinical advancement of pralsetinib and avapritinib, with multiple global regulatory submissions under review or planned in 2020. These abstracts reinforce the consistent clinical activity shown by our drug candidates across broad patient populations with RET-altered cancers and systemic mastocytosis."

Updated clinical data will be presented in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program, at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress and at the Virtual Edition of the 25th European Hematology Association (EHA) (Free EHA Whitepaper) (EHA25) Annual Congress. Accepted abstracts are listed below. Abstracts are expected to be available on the EAACI conference website (View Source) at the start of the congress, and are now available on the following conference websites: View Source and View Source The following presentations will be available to registered participants of each virtual meeting at its conference website.

ASCO20 Virtual Scientific Program
May 29-31, 2020

Oral Presentation

Presentation Title: Clinical activity of the RET inhibitor pralsetinib (BLU-667) in patients with RET fusion+ solid tumors
Session Title: Drug Development for Rare Mutations: The Opportunity to Unite and Conquer
Session Date & Time (Scheduled Broadcast): Sunday, May 31, 2020 from 10:30 a.m. – 12:00 p.m. ET
Abstract Number: 109

Poster Discussion Presentation

Presentation Title: Registrational dataset from the Phase I/II ARROW trial of pralsetinib (BLU-667) in patients (pts) with advanced RET fusion+ non-small cell lung cancer (NSCLC)
Presentation Date & Time (On-Demand): Friday, May 29, 2020 beginning at 8:00 a.m. ET
Session Title: Lung Cancer—Non-Small Cell Metastatic
Abstract Number: 9515

Poster Presentation

Presentation Title: AcceleRET Lung: A Phase III study of first-line pralsetinib in patients (pts) with RET-fusion+ advanced/metastatic non-small cell lung cancer (NSCLC)
Presentation Date & Time (On-Demand): Friday, May 29, 2020 beginning at 8:00 a.m. ET
Session Title: Lung Cancer—Non-Small Cell Metastatic
Abstract Number: TPS9633

EAACI Digital Congress
June 6-8, 2020

Late Breaking Oral Presentation

Presentation Title: Avapritinib reduced cutaneous symptoms and mast cell (MC) burden in patients (pts) with indolent systemic mastocytosis (ISM) in the PIONEER study
Presentation Date & Time (On-Demand): Saturday, June 6, 2020 beginning at 9:00 a.m. CEST (3:00 a.m. ET)
Session Title: Skin Diseases: What Is New?
Abstract Number: 1832

EHA25 Virtual Congress
June 11-14, 2020

Poster Presentations

Presentation Title: Avapritinib induces responses in patients (pts) with advanced systemic mastocytosis (AdvSM), regardless of prior midostaurin therapy
Presentation Date & Time (On-Demand): Friday, June 12, 2020 beginning at 8:30 a.m. CEST (2:30 a.m. ET)
Session Title: Myeloproliferative Neoplasms – Clinical
Abstract Number: EP1079

Presentation Title: Results from PIONEER: a randomized, double-blind, placebo-controlled, Phase 2 study of avapritinib in patients with indolent systemic mastocytosis
Presentation Date & Time (On-Demand): Friday, June 12, 2020 beginning at 8:30 a.m. CEST (2:30 a.m. ET)
Session Title: Myeloproliferative Neoplasms – Clinical
Abstract Number: EP1082

On May 14, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that positive data from envafolimab in a pivotal trial in China for the treatment of MSI-H/dMMR cancer will be presented by the Company’s corporate partners, 3D Medicines and Alphamab, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Press release, Tracon Pharmaceuticals, MAY 14, 2020, View Source [SID1234558059]).

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ASCO abstract #3021 entitled "Envafolimab (KN035) in Advanced Tumors with Mismatch-Repair Deficiency" reviewed data available on December 17, 2019 from the ongoing pivotal Phase 2 trial of envafolimab given by subcutaneous injection without an adjuvant in MSI-H/dMMR cancer. The trial enrolled 103 patients with MSI-H colorectal (CRC) or gastric cancer (GC) or with dMMR in other advanced solid tumors, in an open label format with efficacy endpoints, including the primary endpoint of confirmed objective response rate (ORR) determined by independent central review. MSI-H/dMMR status was assessed centrally for CRC and GC and locally for other tumors.

Key highlights included:

The confirmed ORR in 50 patients with CRC who failed a fluoropyrimidine, oxaliplatin and irinotecan (n=39) plus those with advanced GC who failed at least one prior systemic treatment (n=11), with at least two on-study tumor assessments, was 30% (95% CI: 18%, 45%), of whom 80% were responding with median follow-up of 7.5 months at the time of the data cutoff.
The confirmed ORR in the overall population (n=103) was 34% (95% CI: 25%, 44%), of whom 86% were responding with median follow-up of 6.7 months at the time of the data cutoff.
The confirmed ORR in 24 patients with CRC who failed a fluoropyrimidine and oxaliplatin or irinotecan (n=24) was 54% (95% CI: 33%, 74%) of whom 85% were responding at the time of the data cutoff.
Envafolimab was well tolerated with a safety profile similar to that of approved PD-(L)1 checkpoint inhibitors but without infusion related reactions.
"We are impressed by the confirmed ORR of envafolimab from its pivotal trial in Chinese patients with MSI-H/dMMR cancer, which is a genetically defined tumor type," said Charles Theuer, M.D., Ph.D., President and CEO. "We believe these data are important in assessing the potential of this novel subcutaneously administered product candidate in TRACON’s initial indications in the U.S. of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS), two soft tissue sarcoma subtypes which have responded to treatment with other checkpoint inhibitors. Moreover, these data indicate that envafolimab’s activity in MSI-H cancer is similar to other checkpoint inhibitors, such as Keytruda or Opdivo but without infusion related reactions. We look forward to initiating our pivotal ENVASARC trial for envafolimab in UPS and MFS in the second half of 2020, for which we recently reached agreement on the key elements with the U.S. FDA."

The complete abstract is available at: View Source

About Envafolimab

Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in Phase 1 trials in the U.S. and Japan and is being studied in China in a Phase 2 registration trial as a single agent in MSI-H/dMMR tumor patients, and in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer. 3D Medicines plans to file a BLA in China for envafolimab in 2020 based on overall response rate and duration of response in MSI-H/dMMR patients. The filing would be based on the the ongoing pivotal phase 2 trial data of envafolimab in MSI-H/dMMR cancer.

On May 14, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported that it will present new efficacy and cardiovascular safety data from the Phase 3 HERO study of once-daily, oral relugolix (120 mg) in men with advanced prostate cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s upcoming ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, to be held May 29-31, 2020 (Press release, Myovant Sciences, MAY 14, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-present-new-data-relugolix-prostate-cancer [SID1234558058]).

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The new data will be presented by Neal Shore, M.D., medical director of the Carolina Urologic Research Center and HERO program steering committee member. Dr. Shore’s presentation (#5602), titled "HERO phase III trial: Results comparing relugolix, an oral GnRH receptor antagonist, versus leuprolide acetate for advanced prostate cancer" will be included in the oral abstract session, "Genitourinary Cancer—Prostate, Testicular, and Penile," which will be available for on-demand viewing starting at 8:00 a.m. Eastern Time / 5:00 a.m. Pacific Time on Friday, May 29, 2020.

In April 2020, Myovant submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for relugolix as a potential treatment for men with advanced prostate cancer. The NDA is supported by positive results from the Phase 3 HERO study, a randomized pivotal study comparing relugolix versus leuprolide acetate.