Curis Announces Abstracts Accepted for Presentation at the European Hematology Association 2022 Congress (EHA)

On May 12, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that multiple abstracts have been accepted for presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (EHA) (Free EHA Whitepaper), which will be held virtually and in-person in Vienna on June 9-12, 2022 (Press release, Curis, MAY 12, 2022, View Source [SID1234614322]). The abstracts include data from both the TakeAim Leukemia and TakeAim Lymphoma studies as well as other studies by Curis and independent collaborators. These planned presentations are in addition to the previously announced presentations scheduled for the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago and online June 3-7, 2022.

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!

"We are pleased that research from our lead programs will be shared with the oncology community at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) this year," said James Dentzer, Chief Executive Officer of Curis. "We are excited to share the initial data from the TakeAim Lymphoma study investigating the use of emavusertib in combination with ibrutinib in patients with several types of Non-Hodgkin’s Lymphoma. Data in the abstract indicates that the combination has shown signs of early anti-cancer activity, including in patients with prior BTK inhibitor use, and the regimen appears to be well tolerated. The data from the TakeAim Leukemia study are consistent with our findings reported in January of this year, demonstrating emavusertib’s encouraging monotherapy activity in patients with R/R AML and MDS including importantly those with spliceosome and FLT3 mutations. Currently the prognosis for patients with R/R AML or MDS is grim, there are no effective therapies and new options are very much needed. In addition to data from Curis, there will be several interesting data sets from Curis’s collaborators. We look forward to providing further updates at EHA (Free EHA Whitepaper) and ASCO (Free ASCO Whitepaper) next month."

Both of the TakeAim studies are to be presented at both the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings. In addition, at EHA (Free EHA Whitepaper) Curis will present data on the development of potential biomarkers for emavusertib in AML. Finally, Curis’s collaborators will present data at EHA (Free EHA Whitepaper) on the use of emavusertib in primary CNS lymphoma.

Details of the EHA (Free EHA Whitepaper) presentations are as follows:

Abstract Title: TakeAim Lymphoma- An Open-Label, Dose Escalation And Expansion Trial Of Emavusertib (CA-4948) In Combination With Ibrutinib In Patients With Relapsed Or Refractory Hematologic Malignancies
Presenting Author: Grzegorz Nowakowski, MD, Mayo Clinic Rochester
Abstract Code: P1121
Session Type/Title: Poster Session
Date and Time: June 10, 2022, 4:30 – 5:45 pm CEST

Abstract Title: TakeAim Leukemia A Phase 1/2a Study Of The IRAK4 Inhibitor Emavusertib (CA-4948) As Monotherapy Or In Combination With Azacitidine Or Venetoclax In Relapsed/Refractory AML Or MDS
Presenting Author: Guillermo Garcia-Manero, MD, MD Anderson Cancer Center
Abstract Code: S129
Session Type/Title: Novel insights into AML treatment
Session Room: Hall A7
Date and Time: June 11, 2022, 4:30 – 5:45 pm CEST

Abstract Title: Development of Potential Biomarkers for IRAK4 Inhibitor Emavusertib in Human Acute Myeloid Leukemia
Presenting Author: Andrey Ugolkov, PhD
Abstract Code: P473
Session Title: Poster session
Date and Time: Friday, June 10, 2022 – 4:30 – 5:45 pm CEST

Collaborator Presentations

Abstract Title: The IRAK-4 Inhibitor Emavusertib (CA-4948) For The Treatment Of Primary CNS Lymphoma
Presenting Author: Christina Von Roemeling, PhD The University of Florida
Abstract Code: P1298
Session Type/Title: Poster Session
Date and Time: June 10, 2022, 4:30 – 5:45 pm CEST

The abstracts are available online at ehaweb.org/.

Caribou Biosciences Announces Positive Initial Data for CB-010 Anti-CD19 Allogeneic CAR-T Cell Therapy

On May 12, 2022 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported initial results demonstrating a 100% overall response rate (ORR) and 80% complete response rate (CR) in cohort 1 (n=5 evaluable) from its ANTLER Phase 1 trial for CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) (Press release, Caribou Biosciences, MAY 12, 2022, View Source [SID1234614321]). These initial data are scheduled to be shared at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress, being held in Vienna, Austria, June 9-17, 2022.

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!

"Our initial CB-010 data are exciting, and we believe these results show the potential to set a new therapeutic bar in treating patients with aggressive r/r B-NHL. These excellent initial outcomes represent important steps toward validating our chRDNA genome-editing platform as well as our plans for future development of CB-010 and our broader pipeline," said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. "CB-010 is the first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knock-out, a genome-editing strategy designed to limit premature CAR-T cell exhaustion, potentially leading to better tumor debulking and an improved therapeutic index through sustained antitumor activity. We are slated to present additional ANTLER interim data at EHA (Free EHA Whitepaper) next month and expect more data by year end as we continue to advance our lead program. Our overarching goal is to develop CB-010 such that it will meaningfully rival autologous cell therapies to reach broader groups of patients globally who are in need of off-the-shelf treatments."

"We are excited to see a 100% overall response rate with CB-010 at dose level 1 for these patients who have limited treatment options," said Syed Rizvi, M.D., Caribou’s chief medical officer. "We believe this initial level of activity is unparalleled for a single, starting dose of cell therapy. CB-010 was generally well-tolerated with adverse events routinely observed in autologous or allogeneic anti-CD19 CAR-T cell therapies. At EHA (Free EHA Whitepaper) next month, we are scheduled to share longer follow up data from the patients in Cohort 1 who received a single administration of CB-010 at the first dose level. We look forward to continuing the development of our pipeline of allogeneic CAR-T cell therapies for patients with hematologic malignancies."

The EHA (Free EHA Whitepaper) abstract includes safety, tolerability, and initial antitumor activity of CB-010 administered at dose level 1 (40×106 CAR-T cells) to 6 patients with r/r B-NHL who had relapsed after previous treatment with a median of 3 prior therapies (range 2-8). Prior to a single dose of CB-010, patients received a lymphodepletion regimen consisting of cyclophosphamide at 60 mg/kg/d for 2 days followed by fludarabine at 25 mg/m2/d for 5 days.

As of the February 23, 2022 data cutoff date, 6 patients had been treated with CB-010 and 5 had completed the 28-day dose-limiting toxicity (DLT) evaluation period. 100% (n=5) achieved a response; 80% (n=4) achieved a CR, and 20% (n=1) achieved a partial response (PR). All 4 patients who achieved a CR at 28 days had an ongoing CR at 3 months. The longest measured CR as of the data cutoff date was 6 months.

Footnote: data cutoff date of February 23, 2022, data collection ongoing, efficacy based on Lugano criteria

Following treatment with CB-010, there were no cases of graft versus host disease. 3 of 6 patients developed Grade 3 or 4 adverse events (AEs) within the first 28 days: neutropenia (50%), thrombocytopenia (33%), anemia (17%), and hypogammaglobulinemia (17%). One patient experienced Grade 1 CRS (17%) and Grade 3 ICANS (17%), which was characterized as a DLT, for which the patient received tocilizumab and steroids and recovered from the DLT within 39 hours. This patient went on to achieve a CR.

Based on promising initial safety and efficacy data from cohort 1 at dose level 1 (40×106 CAR-T cells), the ANTLER trial is now enrolling patients in cohort 2 at dose level 2 (80×106 CAR-T cells). Additional data are expected by year end.

Details of the poster presentation at EHA (Free EHA Whitepaper) are as follows:

Title: First-in-human trial of CB-010, a CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knock out, in patients with relapsed or refractory B cell non-Hodgkin lymphoma (ANTLER study)

Abstract: P1455

Presenter: Loretta J. Nastoupil, M.D., section chief, new drug development; associate professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center

Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST (10:30 – 11:45 am ET)

Session Title: Gene therapy, cellular immunotherapy and vaccination – Clinical

Location: Messe Wien Exhibition & Congress Center, Vienna, Austria

Presentations and posters will be available for registered attendees of EHA (Free EHA Whitepaper) for on-demand viewing on the EHA (Free EHA Whitepaper) website on June 10, 2022 at 9:00 am CEST (3:00 am ET). Caribou plans to issue a press release on the data at 9:00 am CEST (3:00 am ET) on Friday June 10, 2022 and the poster will be available on the Presentations page of the Investors section of Caribou’s website.

Webcast Conference Call Today at 10:15 am ET

Caribou will host a webcast conference call today to discuss the initial ANTLER data for CB-010 in the accepted EHA (Free EHA Whitepaper) abstract. The webcast presenters will include:

Rachel Haurwitz, Ph.D., president and chief executive officer of Caribou

Syed Rizvi, M.D., chief medical officer of Caribou

Steven Kanner, Ph.D., chief scientific officer of Caribou

Jason O’Byrne, chief financial officer of Caribou

The live webcast and conference call, with an accompanying presentation, will be accessible under Events in the Investors section of the company’s website. To participate in the conference call, dial 844-862-9351 (domestic) or 929-517-0932 (international) and reference conference ID #7589468. The archived audio webcast will be available on Caribou’s website following the call and will be available for 30 days.

img25401123_0.jpg

About CB-010

CB-010 is the lead product candidate from Caribou’s allogeneic CAR-T cell therapy platform and is being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 trial. CB-010 is an allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9 CRISPR hybrid RNA-DNA (chRDNA) technology to insert a CD19-specific CAR into the TRAC gene and knock out PD-1 to boost the persistence of antitumor activity. CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knock out. Additional information on the ANTLER trial can be found at View Source using identifier NCT04637763.

About Caribou’s Novel Next-Generation CRISPR Platform

CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Class 2 CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems are capable of editing unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced "chardonnays") that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA technology to carry out high efficiency multiple edits, including multiplex gene insertions, to develop CRISPR-edited therapies.

Cogent Biosciences Announces Presentation at European Hematology Association (EHA) Annual Congress

On May 12, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported a poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress being held June 9-12, 2022 (Press release, Cogent Biosciences, MAY 12, 2022, View Source [SID1234614320]). The poster will review initial clinical data from the Company’s ongoing Phase 2 APEX trial with bezuclastinib. The abstract is available on the EHA (Free EHA Whitepaper) website at www.ehaweb.org and the poster will be published on the EHA (Free EHA Whitepaper) Congress platform on June 10, 2022.

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!

Presentation Title: A Phase 2 Study of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent KIT D816V inhibitor, in Adults with Advanced Systemic Mastocytosis (Apex): Methods, Baseline Data, and Early Insights
Session Type: Poster Session
Session Date and Time: Friday, June 10, 2022 – 16:30 – 17:45 CEST (10:30am-11:45am ET)
Abstract Number: P1049

Genmab Announces Multiple Abstracts to be Presented at the European Hematology Association (EHA) Annual Congress

On May 12, 2022 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, being held in Vienna, Austria, and virtually, June 9-12 (Press release, Genmab, MAY 12, 2022, View Source [SID1234614319]). The presentations will include data from various clinical trials, including multiple arms of the phase 1b/2 EPCORE NHL-2 trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of B-cell non-Hodgkin lymphoma (NHL), including first-line, high-risk diffuse large B-cell lymphoma (DLBCL), relapsed or refractory DLBCL, and relapsed or refractory follicular lymphoma (FL). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).

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!

Additionally, results from several clinical trials evaluating Janssen Biotech, Inc. (Janssen’s)’s subcutaneous formulation of daratumumab, and Janssen’s bispecific programs leveraging Genmab’s DuoBody technology platform will be presented. Daratumumab is being developed by Janssen under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab, and the companies have a research and license agreement to create and develop bispecific antibodies using Genmab’s DuoBody technology platform.

All abstracts accepted for presentation have been published on the EHA (Free EHA Whitepaper) website.

"We are looking forward to presenting the results from a variety of clinical trials evaluating the safety and efficacy of epcoritamab at this year’s EHA (Free EHA Whitepaper), which shows the significant progress we have made developing epcoritamab," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Together with AbbVie, we continue to evaluate epcoritamab in a variety of clinical settings and patient populations, with the shared commitment of potentially delivering a new treatment option to patients in need."

Abstracts accepted for presentation at EHA (Free EHA Whitepaper) include:

Epcoritamab (DuoBody-CD3xCD20):

Abstract #: P1214. Subcutaneous epcoritamab + R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma: phase 1/2 data update; Clausen et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1135. Subcutaneous epcoritamab in combination with rituximab + lenalidomide in relapsed or refractory follicular lymphoma: phase 1/2 trial update; Belada et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1215 Preliminary phase 1/2 results of subcutaneous epcoritamab + R-DHAX/C in patients with relapsed or refractory diffuse large B-cell lymphoma eligible for autologous stem cell transplant; Cordoba et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1213. Subcutaneous epcoritamab with GemOx induced high response rates in patients with relapsed/refractory diffuse large B-cell lymphoma ineligible for autologous stem cell transplant; Wahlin et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Publication: Assessing safety, tolerability, and efficacy of subcutaneous epcoritamab in novel combinations with anti-neoplastic agents in patients with non-Hodgkin lymphoma in a phase 1b/2, open-label study; Sehn et al

Daratumumab:

Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) Alone in Chinese Patients With Relapsed or Refractory Multiple Myeloma (RRMM): Updated Analysis of LEPUS; Fu et al
Efficacy and safety of daratumumab (DARA) in pediatric and young adult patients (pts) with relapsed/refractory T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL): results from the phase 2 DELPHINUS study; Hogan et al
Daratumumab (DARA) in combination with bortezomib plus dexamethasone (D-Vd) or lenalidomide plus dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): subgroup analysis of the phase 3 CASTOR and POLLUX studies in patients (pts) with early or late relapse after initial therapy; Spencer et al
Time to response, duration of response, and patient-reported outcomes (PROs) with daratumumab (DARA) plus lenalidomide and dexamethasone (D-Rd) vs lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of the phase 3 MAIA study; Facon et al
Daratumumab (DARA) + lenalidomide, bortezomib, and dexamethasone (RVd) in transplant-eligible newly diagnosed multiple myeloma (NDMM): a post hoc analysis of sustained minimal residual disease (MRD) negativity from GRIFFIN; Rodriguez et al

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.i Epcoritamab was developed with selective, silencing mutations that may limit systemic, non-specific activity.ii CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.iii,iv Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat certain multiple myeloma indications. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of certain multiple myeloma indications and the first and only approved treatment for certain patients with light-chain (AL) amyloidosis.v,vi,vii

Please see local country prescribing information for all labeled indication and safety information.

Astellas Highlights Data on Advanced and Rare Cancers during 2022 ASCO Annual Meeting and EHA 2022 Hybrid Congress

On May 12, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that will share new research during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress from June 9-12 (Press release, Astellas, MAY 12, 2022, View Source [SID1234614318]). A total of 13 abstracts from the company’s expanding portfolio of approved and investigational therapies will be presented across both meetings, underscoring the company’s commitment to advancing treatment options for advanced and rare cancers, including prostate, pancreatic and urothelial cancer, as well as acute myeloid leukemia (AML).

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!

"While a robust Phase 3 clinical trial program in gastric/gastroesophageal junction cancer for our investigational therapy zolbetuximab is well underway, the ASCO (Free ASCO Whitepaper) Annual Meeting will include the first trial-in-progress presentation from our expanded Phase 2 clinical trial in Claudin 18.2-positive pancreatic cancer," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "The progress of these clinical studies reflects our enthusiasm to continue investigating the potential to benefit patients by targeting the emerging Claudin 18.2 biomarker."

"At Astellas, our mission is to not only advance innovative science, but to create value for patients and the oncology community," said Erhan Berrak, M.D., Vice President of Global Medical Affairs, Oncology, Astellas. "Our advanced prostate cancer data at ASCO (Free ASCO Whitepaper), which range from new analyses of our ARCHES pivotal trial in metastatic hormone-sensitive prostate cancer to data on patient preferences and prescriber treatment decisions, will help inform discussions between patients and providers about novel hormone therapies."

Highlights at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting include:

An overview of the expanded Phase 2 open-label, randomized study of zolbetuximab in combination with nab-paclitaxel and gemcitabine as an investigational first-line treatment for patients with Claudin 18.2-positive metastatic pancreatic cancer
Long-term (24-month) data from the Phase 3 EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor
Four post-hoc analyses from the Phase 3 ARCHES study, which compared enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC)
Highlights at the EHA (Free EHA Whitepaper) 2022 Hybrid Congress include:

Encore data from the COMMODORE Phase 3 confirmatory study of gilteritinib versus salvage chemotherapy in FLT3 mutation-positive relapsed or refractory AML in China and other countries
An overview of the CLEVO non-interventional investigational study of FLT3 mutation frequency in patients with AML in Europe and the U.S.
Astellas Presentations at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

Long-term outcomes in EV-301: 24-month findings from the Phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma

J. Rosenberg

Type: Poster Discussion

Abstract Number: 4516

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Poster Discussion Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 4:30 – 6 p.m. CDT

Benchmarking maintenance therapy survival in first-line advanced urothelial carcinoma using disease modeling

M. Galsky

Type: Poster Presentation

Abstract Number: 4575

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Real-world treatment patterns and clinical outcomes with first-line therapy in cisplatin-eligible and ineligible patients with advanced urothelial carcinoma

G. Sonpavde

Type: Poster Presentation

Abstract Number: 4565

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible

D. Petrylak

Type: Poster Presentation

Abstract Number: 4582

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Enzalutamide

Presentation Title

Lead Author

Presentation Details

Radiographic progression in the absence of prostate-specific antigen (PSA) progression in patients with metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analysis of ARCHES

A. Armstrong

Type: Poster Presentation

Abstract Number: 5072

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Prevalence of DNA damage repair (DDR) alterations in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving enzalutamide (ENZA) or placebo (PBO) plus androgen deprivation therapy (ADT): ARCHES post hoc analysis

A. Azad

Type: Poster Presentation

Abstract Number: 5074

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

The association of germline HSD3B1 genotype with outcomes in metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation therapy (ADT) with or without enzalutamide (ENZA) [ARCHES]

N. Sharifi

Type: Poster Presentation

Abstract Number: 5022

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Clinical outcomes and safety of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) in patients aged <75 and ≥75 years: ARCHES post hoc analysis

R. Szmulewitz

Type: Poster Presentation

Abstract Number: 5069

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Reasons for oncologist and urologist treatment choice in metastatic castration-sensitive prostate cancer (mCSPC): A physician survey linked to patient chart reviews in the United States

S. Freedland

Type: Poster presentation

Abstract Number: 5065

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Patient preferences for treatment and outcomes in hormone-sensitive prostate cancer (HSPC)

D. George

Type: Abstract publication

Abstract Number: e18757

Zolbetuximab

Presentation Title

Lead Author

Presentation Details

Zolbetuximab plus gemcitabine and nab-paclitaxel (GN) in first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer (mPC): Phase 2, open-label, randomized study

W. Park

Type: Poster Presentation

Abstract Number: TPS4186

Date: Saturday, June 4, 2022

Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Presentation: 8 – 11 a.m. CDT

Astellas Presentations at EHA (Free EHA Whitepaper) 2022 Hybrid Congress

Gilteritinib

Presentation Title

Lead Author

Presentation Details

CLEVO: a non-interventional study to investigate clonal evolution of FMS-like tyrosine kinase 3 (FLT3) gene mutations during disease progression in patients with acute myeloid leukemia

P. Vyas

Type: Abstract publication

Abstract Number: PB1834

Gilteritinib versus salvage chemotherapy for relapsed/refractory FLT3-mutated acute myeloid leukemia: a Phase 3, randomized, multicenter, open-label trial in Asia

J. Wang

Type: Poster session

Abstract Number: P554

Enfortumab Vedotin and the Astellas and Seagen Collaboration
Astellas and Seagen are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. In the United States, Astellas and Seagen co-promote enfortumab vedotin. In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

Enzalutamide and the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States.