On May 25, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported the presentation of new data showcasing the range of BeiGene’s research expertise and the productivity of one of the industry’s largest research and development teams at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, BeiGene, MAY 25, 2023, View Source [SID1234632046]). These results include data for BeiGene’s cornerstone therapies, BRUKINSA (zanubrutinib) and tislelizumab, as well as early results for BeiGene’s OX40 agonist and BCL-2 inhibitor.

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"The data presented at ASCO (Free ASCO Whitepaper) demonstrate the strength of BeiGene’s oncology portfolio, from early data supporting the differentiated biological hypotheses for our BCL-2 inhibitor and OX40 agonist and continuing results from the global development programs for our innovative medicines, BRUKINSA and tislelizumab, as monotherapies and in combination regimens," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "At BeiGene, we believe the patients we serve come first, and we will continue to partner with patients to advance innovative potential best- and first-in-class medicines."

For more information on BeiGene’s clinical program and company updates, please visit BeiGene’s virtual ASCO (Free ASCO Whitepaper) booth: www.BeiGeneVirtualExperience.com.

Cornerstone Medicines Continue to Demonstrate Consistent Safety and Efficacy Profile

In a risk factor analysis of RATIONALE-301, a Phase 3 study of tislelizumab vs sorafenib as first-line treatment of unresectable hepatocellular carcinoma, tislelizumab demonstrated numerically longer median overall survival (OS) versus sorafenib in the biomarker subgroups of ALBI grade 1 (19.9 months vs. 16.9 months), PLR ≤141 (19.4 months vs. 14.5 months), and NLR ≤3 (20.9 months vs. 15.2 months), suggesting the potential for prognostic value.

In a European/North American (EU/NA) subgroup analysis of RATIONALE-301, numerically longer median OS, median duration of response, and a higher objective response rate (ORR) were seen with tislelizumab versus sorafenib. Notably, the EU/NA subgroup had a higher rate of patients with non-viral etiology and a slightly lower number of patients with advanced-stage disease (BCLC Stage C) compared with the overall population from RATIONALE-301.

Additionally, incidence of grade ≥3 treatment-emergent adverse events (TEAEs; 46% vs 66%), grade ≥3 treatment-related TEAEs (TRAEs; 17% vs 50%), and TRAEs leading to discontinuation (9% vs 15%) were lower with tislelizumab versus sorafenib in the EU/NA subgroup respectively and similar to incidences observed in the overall study population.

These results will be presented on Monday, June 5, as poster presentations from 8:00-11:00 a.m. CT. (Abstracts #4082 and #4083).
In an updated analysis of the ROSEWOOD study, BRUKINSA in combination with obinutuzumab demonstrated clinically meaningful activity and manageable safety profile in patients with heavily pretreated relapsed/refractory (R/R) follicular lymphoma (FL). The combination of BRUKINSA and obinutuzumab represents a potentially new therapy for patients with R/R FL.

Demonstrating a commitment to developing rigorous evidence for potential new treatments for rare hematologic malignancies, BeiGene will detail the trial design of its ongoing Phase 3 MAHOGANY study of BRUKINSA plus obinutuzumab versus lenalidomide plus rituximab in R/R FL or marginal zone lymphoma during the Trials in Progress session.

These posters will be presented on Monday, June 5 from 8:00-11:00 a.m. CT (Abstracts #7545 and #TPS7590).
First-in-Human Results Show Promise for Key Pipeline Assets

BeiGene’s investigational BGB-A445 is a novel monoclonal antibody OX40 agonist that does not compete with endogenous OX40 ligand binding. The molecule is being studied as a single agent or in combination with tislelizumab in patients with advanced solid tumors in an ongoing, Phase 1 dose escalation and expansion study.

In first-in-human results presented at ASCO (Free ASCO Whitepaper), BGB-A445 monotherapy or in combination with tislelizumab was generally well-tolerated across all doses with no dose-limiting toxicities and demonstrated preliminary antitumor activity in patients with advanced solid tumors.

As further evaluation, the dose expansion phase is currently enrolling patients into non-small cell lung cancer and head and neck squamous cell carcinoma cohorts.

These results will be presented on Saturday, June 3, as a poster presentation from 8:00 – 11:00 a.m. CT (Abstract #2574).
BGB-11417 is a potent and highly selective BCL-2 inhibitor, and a dose-finding results showed that single agent treatment was well tolerated at all tested doses up to 640 mg/d as monotherapy in B-cell malignancies, with no dose-dependent toxicity increase. BGB-11417 monotherapy also showed promising initial efficacy results in R/R chronic lymphocytic leukemia/small lymphocytic lymphoma, with patients achieving responses at lower dose levels.

These results will be presented on Monday, June 5, as a poster presentation from 8:00-11:00 a.m. CT (Abstract #7558).
More details on BeiGene’s abstracts are available on the ASCO (Free ASCO Whitepaper) website.

About BRUKINSA (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 4,900 subjects in 35 trials across 29 markets. To date, BRUKINSA is approved in more than 65 markets around the world, including the United States, China, the European Union, Great Britain, Canada, Australia, South Korea, and Switzerland.

About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the antitumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

The global development program for tislelizumab includes more than 12,000 patients and encompasses more than 20 potentially registration-enabling clinical trials in more than 30 countries and regions. More information on the clinical trial program for tislelizumab can be found at: View Source

Tislelizumab is approved in 11 indications in China, including a recent approval for use in combination with chemotherapy, for the treatment of patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma. Tislelizumab is not currently approved for use outside of China.

About BGB-11417
BGB-11417 is a highly potent and selective Bcl-2 inhibitor designed to produce deeper and more sustained target inhibition.

Compared with venetoclax, BGB-11417 exhibited greater potency (>10-fold) and higher target selectivity and showed signs of overcoming treatment resistance in pre-clinical studies and tumor models. i

About BGB-A445
BGB-A445 is an investigational agonistic antibody directed to the OX40 antigen. BGB-A445 is a non-ligand competing antibody that does not disrupt OX40 to OX40 ligand engagement. Preclinical experiments showed that BGB-A445 had increasing effectiveness at higher doses versus an antibody that was ligand-competing, which showed falling effectiveness at higher doses.

IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB)

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage, including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.6% of patients treated with BRUKINSA monotherapy in clinical trials, with fatalities occurring in 0.3% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 30% of patients.

Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 24% of patients, most commonly pneumonia (11%), with fatal infections occurring in 2.9% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (22%), thrombocytopenia (8%) and anemia (7%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 11% of patients, and Grade 4 thrombocytopenia occurred in 2.8% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 13% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer reported in 7% of patients. Other second primary malignancies included malignant solid tumors (5%), melanoma (1.2%), and hematologic malignancies (0.5%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 3.7% of 1550 patients treated with BRUKINSA monotherapy, including Grade 3 or higher cases in 1.7% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.2% of patients.

Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse Reactions

In this pooled safety population, the most common adverse reactions, including laboratory abnormalities, in ≥30% of patients who received BRUKINSA (N=1550) included decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

INDICATIONS

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:

Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Waldenström’s macroglobulinemia (WM)
Mantle cell lymphoma (MCL) who have received at least one prior therapy
Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
The MCL and MZL indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please see full Prescribing Information at www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at www.beigene.com/PDF/BRUKINSAUSPPI.pdf

ON May 25, 2023 Be Biopharma, Inc. ("Be Bio"), a company pioneering the discovery and development of Engineered B Cell Medicines (BeCMs), reported that Chief Executive Officer, Joanne Smith-Farrell, Ph.D., will present at the Jefferies Healthcare Conference being held in New York, NY, June 7-9, 2023 (Press release, Be Biopharma, MAY 25, 2023, View Source [SID1234632045]). Company management will also be available for one-on-one meetings.

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Presentation Details:

Thursday, June 8, 2023
9:30-9:55 a.m. EST
Track 3
About B Cells – A New Class of Cellular Medicines

Imagine what could "Be?" In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines – Engineered B Cell Medicines (BeCMs). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

On May 25, 2023 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported interim results from an ongoing Phase 1/2 trial of AU-007, as detailed in the online publication of Abstract e14507 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting (Press release, Aulos Bioscience, MAY 25, 2023, View Source [SID1234632044]). The data indicate that AU-007 is well tolerated in patients with unresectable locally advanced or metastatic cancer. AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors.

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"These new interim data support our belief that AU-007 offers a novel mechanism of action among IL-2 therapeutics in development, as demonstrated by AU-007’s pharmacodynamic and safety profile to date," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "In addition, we are further encouraged that, since the data cutoff date, we are seeing early signs of anti-tumor activity in patients, which is consistent with preclinical findings that demonstrate AU-007’s unique ability to bind to IL-2 and redirect it from regulatory T cells, which suppress the immune system, to effector T cells and natural killer cells that can kill tumor cells. AU-007 is the only IL-2 therapy in development that precisely binds to IL-2 instead of the IL-2 receptor, and that turns an immunosuppressive negative feedback loop into a positive feedback loop. This gives AU-007 distinct mechanistic advantages as a potential new cancer therapeutic. As the study continues and we expand the number of trial sites in the United States and Australia, we look forward to presenting additional clinical data in the future."

AU-007 is the first computationally designed human monoclonal antibody in a human clinical trial. Created by Biolojic Design, the antibody binds with exquisite precision to IL-2, preventing IL-2 from binding to the CD25 subunit contained in trimeric IL-2 receptors expressed on immunosuppressive regulatory T cells (Tregs), vascular and pulmonary endothelium, and eosinophils. While AU-007 prevents IL-2 from attaching to Tregs, it doesn’t affect IL-2’s ability to bind to dimeric IL-2 receptors expressed on effector T cells (Teff) and natural killer (NK) cells. This allows Teff and NK cells to expand and kill tumor cells.

The Phase 1/2 clinical trial of AU-007 is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Data shared in the ASCO (Free ASCO Whitepaper) abstract show that AU-007 at doses up to 4.5 mg/kg every two weeks is well tolerated in eight patients (as of the data cutoff date of February 1, 2023), with no dose-limiting toxicities and all treatment-related adverse events mild (Grade 1). Three of the four tumor evaluable patients had a best response of stable disease, and two patients continue treatment as of the data cutoff date.

In addition, all seven patients with available pharmacodynamic data demonstrate overall decreasing Tregs (percentage change and absolute) and eosinophils. This finding is in stark contrast to data from other IL-2 therapeutics, which show increases in Tregs that cannot be controlled and may result in immune suppression instead of activation. Initial pharmacokinetic data (0.5 and 1.5 mg/kg) from the AU-007 trial also demonstrate continued dose proportional serum concentrations of the compound, with characteristics similar to IgG1 therapeutic human monoclonal antibodies. This indicates the antibody is behaving predictably and has a half-life that will allow for dosing every two weeks.

The Phase 1/2 trial of AU-007 consists of three dose escalation arms evaluating AU-007 either as a monotherapy, in combination with a single loading dose of recombinant human IL-2 (aldesleukin), or with both AU-007 and aldesleukin administered once every two weeks. The aldesleukin will be administered subcutaneously, at much lower doses and much less frequently than the approved regimen of intravenously administered aldesleukin. The Phase 2 portion of the trial will evaluate a dosing regimen selected from dose escalation for expansion in specified tumor types to further define the safety and initial efficacy of AU-007. The trial is currently enrolling patients at multiple site locations in the U.S. and Australia.

To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On May 25, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will share new research from across its expanding portfolio of approved and investigational cancer therapies during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6 (Press release, Astellas, MAY 25, 2023, View Source [SID1234632042]). A total of 15 abstracts, covering three approved medicines and one investigational therapy, reported that will be presented underscoring the company’s focus on pursuing targeted therapies for hard-to-treat cancers where few therapies exist, including prostate, urothelial, gastric/gastroesophageal junction (GEJ) and head & neck cancers, as well as acute myeloid leukemia (AML).

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"The research presented at ASCO (Free ASCO Whitepaper) reflects our intense focus on how we are continuing to grow the breadth and utility of our oncology portfolio and pipeline for the oncology community and patients with cancer, particularly those with advanced disease," said Ahsan Arozullah, MD, MPH, Senior Vice President, Head of Oncology Development, Astellas. "Across our clinical development programs, these data add to the growing body of evidence and support our efforts to identify ways we can impact the course of disease, and redefine what is possible for patients who need it most."

Highlights at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting include:

A rapid abstract update presentation of investigational data from the Phase 3 GLOW clinical trial, evaluating the efficacy and safety of zolbetuximab – an investigational first-in-class Claudin-18.2 (CLDN18.2) targeted monoclonal antibody – in combination with CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) for the first-line treatment of patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
The first clinical data from the Phase 1 EV-104 study evaluating intravesical administration of enfortumab vedotin, an antibody-drug conjugate developed in partnership with Seagen, in patients with non-muscle invasive bladder cancer.
The first clinical data from the Phase 2 EV-202 study evaluating enfortumab vedotin monotherapy in previously treated advanced head & neck cancers.
"For the first time, we will present clinical data at ASCO (Free ASCO Whitepaper) investigating the potential of enfortumab vedotin as monotherapy in patients with previously treated advanced head and neck cancers, who have ongoing and unmet therapeutic needs," said Erhan Berrak, MD, Vice President, Medical Affairs, Oncology Therapeutic Area Head, Astellas. "Additionally, Astellas is pleased to share investigational data at ASCO (Free ASCO Whitepaper) that demonstrate continued progress for our zolbetuximab clinical development program in locally advanced or metastatic gastric and GEJ cancers, which have limited effective treatment options."

Astellas Presentations at 2023 ASCO (Free ASCO Whitepaper) Annual Meeting

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

A first-in-human trial of intravesical enfortumab vedotin (EV), an antibody-drug conjugate (ADC), in patients with non-muscle invasive bladder cancer (NMIBC): Interim results of a phase 1 study (EV-104)

A. Kamat

Type: Poster Presentation

Abstract Number: 4596

Date: Sat. June 3, 8:00-11:00 am CDT

Poster Session: Genitourinary Cancer – Kidney and Bladder

Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up

S. Gupta

Type: Oral Presentation

Abstract Number: 4505

Date: Mon. June 5, 12:54 pm CDT

Oral Abstract Session: Genitourinary Cancer – Kidney and Bladder

Enfortumab vedotin in the previously treated advanced head and neck cancer (HNC) cohort of EV-202

P. Swiecicki

Type: Poster Presentation

Abstract Number: 6017

Date: Mon. June 5, 5:04 pm CDT

Poster Session: Head and Neck Cancer

EV-203: Phase 2 trial of enfortumab vedotin in patients with previously treated advanced urothelial carcinoma in China

S. Li

Type: Online-Only Abstract

Abstract Number: e16574

Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H

T. Flaig

Type: Poster Presentation

Abstract Number: 4595

Date: Sat. June 3, 8:00-11:00 am CDT

Poster Session: Genitourinary Cancer – Kidney and Bladder

Enfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data

T. Friedlander

Type: Poster Presentation

Abstract Number: 4568

Date: Sat. June 3, 8:00-11:00 am CDT

Poster Session: Genitourinary Cancer – Kidney and Bladder

Real-world use, dose intensity, and adherence to an antibody-drug conjugate (ADC) in metastatic urothelial cancer (mUC)

K. Tsingas

Type: Online-Only Abstract

Abstract Number: e16567

KEYNOTE-905/EV-303: A phase 3 study to evaluate the efficacy and safety of perioperative pembrolizumab or pembrolizumab plus enfortumab vedotin (EV) for muscle-invasive bladder cancer (MIBC)

A. Necchi

Type: Poster Presentation

Abstract Number: TPS4601

Date: Sat. June 3, 8:00-11:00 am CDT

Poster Session: Genitourinary Cancer – Kidney and Bladder

Enzalutamide

Presentation Title

Lead Author

Presentation Details

Longitudinal transcriptome profiling of localized hormone-sensitive tumors in treatment-naïve ENACT patients with prostate cancer with and without enzalutamide (ENZA)

A. Ross

Type: Poster Presentation

Abstract Number: 5026

Date: Sat. June 3, 8:00-11:00 am CDT

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

Outcomes of patients (pts) with de novo metastatic hormone-sensitive prostate cancer (mHSPC) who progressed to metastatic castration-resistant prostate cancer (mCRPC): a post-hoc analysis of the TRUMPET registry

D. Shevrin

Type: Online-Only Abstract

Abstract Number: e17085

Real-world baseline characteristics and first-line (1L) treatment (Tx) in patients (pts) with de novo metastatic castration-sensitive prostate cancer (mCSPC) by disease volume

S. Freedland

Type: Online-Only Abstract

Abstract Number: e17081

Zolbetuximab

Presentation Title

Lead Author

Presentation Details

Zolbetuximab + CAPOX in 1L claudin-18.2+ (CLDN18.2+)/HER2− locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Primary phase 3 results from GLOW (Rapid abstract update presentation following March 22 Plenary Series session)

R. Xu

Type: Rapid Oral

Abstract Number: N/A

Date: Sat. June 3, 1:06 pm CDT

Session: ASCO (Free ASCO Whitepaper) Plenary Series: Rapid Abstract Updates

Phase 2 trial of zolbetuximab in combination with mFOLFOX6 and nivolumab in patients with advanced or metastatic claudin 18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinomas

K. Shitara

Type: Poster Presentation

Abstract Number: TPS4173

Date: Mon. June 5, 8:00-11:00 am CDT

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

Global prevalence of CLDN18.2 positivity in tumor samples from patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: Biomarker analysis of two zolbetuximab phase 3 studies (SPOTLIGHT and GLOW)

K. Shitara

Type: Poster Presentation

Abstract Number: 4035

Date: Mon. June 5, 8:00-11:00 am CDT

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

Gilteritinib

Presentation Title

Lead Author

Presentation Details

Work Absenteeism and Disability Days after Diagnosis among Patients with AML and Caregivers

T. LeBlanc

Type: Online-Only Abstract

Abstract Number: e19002

On May 25, 2023 Ascendis Pharma A/S (Nasdaq: ASND) reported that the company will host an Oncology program update for the investment community on Wednesday, May 31, 2023 in New York from 10:00 a.m. to 12:00 p.m. Eastern Time (Press release, Ascendis Pharma, MAY 25, 2023, View Source [SID1234632041]).

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The event will feature presentations by an outside oncology expert and Ascendis senior management on the company’s two immuno-oncology product candidates, TransCon IL-2 β/γ and TransCon TLR7/8 Agonist, being investigated as both mono- and combination therapies. Topics will include clinical development strategy and clinical development program updates, including monotherapy clinical data on TransCon IL-2 β/γ used to define the recommended Phase 2 dose.

Those who would like to participate may access the live webcast here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.