On June 12, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from its ADCETRIS (brentuximab vedotin) clinical development program at the 24th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 13-16 in Amsterdam; and the International Conference on Malignant Lymphoma (ICML) from June 18-22 in Lugano (Press release, Seattle Genetics, JUN 12, 2019, View Source [SID1234537045]). Updated analyses from clinical trials evaluating ADCETRIS in combination with Opdivo (nivolumab), as well as encore analyses from the phase 3 ECHELON-1, ECHELON-2 and ALCANZA clinical trials, will be highlighted in 12 presentations at EHA (Free EHA Whitepaper) and ICML. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma (HL) and expressed on the surface of several types of peripheral T-cell lymphomas. 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 primary mediastinal large B-cell lymphoma (PMBL), HL, pediatric HL or for other indications. ADCETRIS in combination with bendamustine is not approved for HL.

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"This year at the EHA (Free EHA Whitepaper) and ICML meetings, key ADCETRIS data will be featured that continue to support our goal of further expanding our clinical development program beyond the six ADCETRIS approved indications," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are excited about several ADCETRIS-related presentations including encore oral presentations from the ECHELON-1 and ECHELON-2 phase 3 trials, as well as clinical research updates on ADCETRIS combination treatment strategies."

Details of oral and poster presentations featured at EHA (Free EHA Whitepaper) include:

Abstract Title: Frontline Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin Lymphoma: 3-Year Update of the ECHELON-1 Study (Abstract #S820)
Oral Presentation Date and Time: Saturday, June 15, 12:00-12:15 p.m. CEST
Location: Hall 5

Abstract Title: Nivolumab and Brentuximab Vedotin-based, Response-adapted Treatment in Primary Refractory and in Pediatric Patients with Relapsed/Refractory Classical Hodgkin Lymphoma in Checkmate 744 (Abstract #S822)
Oral Presentation Date and Time: Saturday, June 15, 12:30-12:45 p.m. CEST
Location: Hall 5

Abstract Title: The ECHELON-2 Trial: Results of a Randomized, Double-blind Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) versus CHOP in Frontline Treatment of Patients with CD30+ Peripheral T-cell Lymphomas (Abstract #PS1070)
Poster Presentation Date and Time: Saturday, June 15, 5:30-7:00 p.m. CEST
Location: Poster Area

Abstract Title: Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma: Efficacy and Safety Results from the Phase 2 Checkmate 436 Study (Abstract #S1601)
Oral Presentation Date and Time: Sunday, June 16, 9:00-9:15 a.m. CEST
Location: Hall 5

Details of oral and poster presentations featured at ICML include:

Abstract Title: Safety and Response after 2 Cycles of Brentuximab Vedotin Substituting Vincristine in the OEPA/COPDAC Regimen for High Risk Pediatric Hodgkin Lymphoma (HL) (Abstract #025)
Oral Presentation Date and Time: Wednesday, June 19, 5:25 p.m. CEST
Location: Cinema Corso

Abstract Title: Response-Adapted Treatment with Nivolumab and Brentuximab Vedotin in Young Patients with Relapsed/Refractory Classical Hodgkin Lymphoma: Checkmate 744 Subgroup Analyses (Abstract #026)
Oral Presentation Date and Time: Wednesday, June 19, 5:35 p.m. CEST
Location: Cinema Corso

Abstract Title: Extended Follow-up a Phase 1 Study of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma: A Trial of the ECOG-ACRIN Research Group (E4412: Arms A-I) (Abstract #077)
Oral Presentation Date and Time: Thursday, June 20, 5:45 p.m. CEST
Location: Cinema Corso

Abstract Title: Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma: Efficacy and Safety Results from the Phase 2 Checkmate 436 Study (Abstract #108)
Oral Presentation Date and Time: Friday, June 21, 2:15 p.m. CEST
Location: Room B, Palazzo dei Congressi

Abstract Title: Response to A+CHP by CD30 Expression in the ECHELON-2 Trial (Abstract #228)
Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CEST
Location: Marquee Parco Ciani

Abstract Title: Exploratory Biomarker Analysis in the Phase 3 ECHELON-1 Study: Worse Outcome with ABVD in Patients with Elevated Baseline Levels of sCD30 and TARC (Abstract #235)
Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CEST
Location: Marquee Parco Ciani

Abstract Title: Brentuximab Vedotin and Bendamustine is a Feasible and Effective Drug Combination as First-line Treatment of Hodgkin Lymphoma in the Elderly (HALO trial) (Abstract #237)
Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CEST
Location: Marquee Parco Ciani

Abstract Title: Final Data from the Phase 3 ALCANZA Study: Brentuximab Vedotin (BV) vs Physician’s Choice (PC) in Patients (pts) with CD30-positive (CD30+) Cutaneous T-cell Lymphoma (CTCL) (Abstract #232)
Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CEST
Location: Marquee Parco Ciani

On June 12, 2019 BioInvent International AB (BINV) reported the publication of the first data from two parallel Phase l/lla clinical trials of its lead product candidate BI-1206 as single agent and/or in combination with rituximab, currently being conducting in the UK and the US/EU respectively (Press release, BioInvent, JUN 12, 2019, View Source [SID1234537044]).

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In the UK trial, 10 patients have received single agent therapy with up to 100 mg BI-1206 once weekly for a period of 4 weeks. In the US/EU study, five patients have received up to 100 mg BI-1206 in combination with rituximab. The data are published in the Abstract Book from the 15-ICML International Conference on Malignant Lymphoma, available online as of today (View Source).

Receptor occupancy is dose proportionate and anticipated to yield high levels of receptor blockade at clinically relevant doses of BI-1206. While target-mediated drug disposition has not yet been overcome, as the optimal dose has still not been reached, pharmacodynamic analysis at the current doses showed depletion of peripheral B cells, including circulating mantle cell lymphoma cells during the first week of induction therapy.

"These are exciting results that further support the development of BI-1206 as a potential first-in-class therapeutic with a unique mechanism of action. Circumventing rituximab internalization by FcγRIIB blocking means it will potentially enhance rituximab’s efficacy," says BioInvent’s CEO Martin Welschof.

On June 12, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that two abstracts from the Company’s lead innate cell engager AFM13 have been accepted for oral and poster presentation at the 15th International Conference on Malignant Lymphoma (ICML) being held June 18 to 22, 2019 in Lugano, Switzerland (Press release, Affimed, JUN 12, 2019, View Source [SID1234537043]).

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Presentations related to AFM13, Affimed’s lead CD30/CD16A bispecific ROCK antibody, include a data update of the completed clinical study of AFM13 in combination with Merck’s Keytruda (pembrolizumab) in patients with relapsed or refractory Hodgkin lymphoma and updated clinical and immunological data from Columbia University on AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation. Details for the ICML presentations are as follows:

Oral Presentation:

Abstract: Investigating safety and preliminary efficacy of AFM13 plus Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure
Session: 11 – New Drugs Combination
Date and Time: Saturday, June 22, 8:30 – 10:00 am (CET)
Location: Room A (main hall of Palazzo dei Congressi)

Poster Presentation:

Abstract: Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma with Cutaneous Presentation: A Biomarker Phase Ib/IIa Study (NCT03192202)
Section: Immunotherapy
Poster sessions: Wednesday, June 19, 12:00 – 17:00 (CET), Thursday, June 20, 9:00 – 17:00 (CET) and Friday, June 21, 9:00 – 18:30 (CET)
Location: Marquee Parco Ciani

Full abstracts of the presentations are published in the supplement to "Hematological Oncology" (John Wiley and Sons, Inc.), available on the Wiley Online Library website.

On June 12, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported upcoming data in three oral presentations and one poster presentation on its investigational BTK inhibitor zanubrutinib at the 15thInternational Conference on Malignant Lymphoma (ICML), taking place June 18-22, 2019 in Lugano, Switzerland (Press release, BeiGene, JUN 12, 2019, View Sourcenews-releases/news-release-details/beigene-announces-clinical-data-zanubrutinib-be-presented-15th" target="_blank" title="View Sourcenews-releases/news-release-details/beigene-announces-clinical-data-zanubrutinib-be-presented-15th" rel="nofollow">View Source [SID1234537042]). The company will also host an investor conference call and webcast of mid-2019 clinical data updates on Thursday, June 20 at 8:00 a.m. EDT.

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Oral Presentations:

Title: Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma
Session: Focus on Mantle Cell Lymphoma
Date: Wednesday, June 19
Time: 17:45 CEST
Lead Author: Yuqin Song, M.D., Ph.D.

Title: Zanubrutinib for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
Session: Session 3 – CLL
Date: Thursday, June 20
Time: 14:45 CEST
Lead Author: Wei Xu, M.D.

Title: Zanubrutinib Plus Obinutuzumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Relapsed/Refractory (R/R) Follicular Lymphoma (FL)
Session: Focus on Non-Clinical and Early Clinical Data with New Combinations
Date: Thursday, June 20
Time: 17:25 CEST
Lead Author: Constantine S. Tam, M.D.
Poster Presentation:

Title: Updated Safety and Efficacy Data in the Phase 1 Trial of Patients with Mantle Cell Lymphoma (MCL) Treated with Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib (BGB-3111)
Abstract Code: 191
Session: Mantle Cell Lymphomas section
Dates and Times: Wednesday, June 19 (12:00-17:00), Thursday, June 20 (9:00-17:00) and Friday, June 21 (9:00-18:30) CEST
Lead Author: Constantine S. Tam, M.D.

Mid-2019 Clinical Data Update Conference Call and Webcast Information:

BeiGene will host a conference call and webcast on Thursday, June 20 at 8:00 a.m. EDT. Investors and analysts are invited to join the conference call using the following dial-in information:

U.S. Toll-Free: +1 (844) 461-9930
U.S. Toll: +1 (478) 219-0535
Hong Kong Toll-Free: +852 800 279 19250
China Toll-Free: +86 800 914 686
Conference ID: 1790069

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available two hours after the event for 90 days.

About Zanubrutinib

Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated in a broad pivotal clinical program globally as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Clinical trials of zanubrutinib include a fully-enrolled, global Phase 3 clinical trial in patients with Waldenström macroglobulinemia (WM) comparing zanubrutinib to ibrutinib, currently the only approved BTK inhibitor for WM; a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); a pivotal Phase 2 trial in patients with relapsed/refractory (R/R) follicular lymphoma in combination with GAZYVA (obinutuzumab); a pivotal Phase 2 trial in patients with R/R marginal zone lymphoma (MZL); a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with R/R CLL/SLL; and a global Phase 1 trial. In China, BeiGene has completed two pivotal Phase 2 clinical trials of zanubrutinib in patients with MCL and CLL/SLL and the enrollment in the pivotal Phase 2 clinical trials in patients with WM.

Zanubrutinib has been granted by the U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of patients with WM, and Breakthrough Therapy designation for the treatment of adult patients with MCL who have received at least one prior therapy. The NDAs in China for R/R MCL and R/R CLL/SLL have been accepted by the China National Medical Products Administration (NMPA) and granted priority review.

On June 12, 2019 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that its Chief Executive Officer, Nancy Simonian, M.D., will participate in a fireside chat at the JMP Securities Life Sciences Conference. Details are as follows (Press release, Syros Pharmaceuticals, JUN 12, 2019, View Source [SID1234537041]):

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JMP Securities Life Sciences Conference:
Date: Wednesday, June 19
Time: 1:00 p.m. ET
Location: The St. Regis New York, 2 East 55th Street, New York, NY

A live webcast of the fireside chat will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay will be available for approximately 30 days following the fireside chat.