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GlaxoSmithKline To Present New Data At ASCO 2020 May 29-31, Will Highlight 26 Abstracts Across 8 Tumor Types

26 abstracts across 8 tumour types, advancing GSK’s goal of maximising outcomes for patients As part of its ongoing work to advance potentially transformational medicines, GlaxoSmithKline plc will

Benzinga · 05/20/2020 13:23

26 abstracts across 8 tumour types, advancing GSK’s goal of maximising outcomes for patients

As part of its ongoing work to advance potentially transformational medicines, GlaxoSmithKline plc will present new data at the upcoming 2020 American Society of Clinical Oncology (ASCO) Annual Meeting from 29-31 May 2020. The depth and breadth of the presentations represent GSK’s progress in helping people affected by cancer achieve better outcomes and build on the recent US Food and Drug Administration (FDA) approval of a new indication for Zejula® (niraparib).

GSK, a leader in oncology R&D, has advanced its innovative pipeline by focusing on science related to the immune system, the use of human genetics and cutting-edge technologies that will advance the next wave of cancer therapies with the potential to transform outcomes for patients. At this year’s ASCO meeting, the company will showcase presentations on investigational therapies, including belantamab mafodotin, an antibody drug conjugate for multiple myeloma,[1] and GSK3359609, an inducible T-cell co-stimulator (ICOS) agonist for patients with recurrent or metastatic head and neck squamous cell carcinoma.

Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: “These are challenging times and while we are working to combat the COVID-19 pandemic, we are also continuing to progress our goal of supporting patients with cancer by developing and delivering transformational medicines that may help to improve survival and bring us closer to potentially achieving cures. We’re pleased to share this progress with our peers at ASCO, with the knowledge that there is more to come as we work to outpace the cancers we fight.”

Investigational Targeting of BCMA in Relapsed/Refractory Multiple Myeloma

B-cell maturation antigen (BCMA) is universally expressed in patients with multiple myeloma, and targeting this cell-surface protein has become an actively researched investigational approach in this cancer.[2] Data from the extensive DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) development programme of belantamab mafodotin will evaluate its potential in different relapsed/refractory and newly diagnosed multiple myeloma treatment settings. Presentations of interest include:

  • Updated nine-month results from the pivotal DREAMM-2 study of single-agent belantamab mafodotin (GSK2857916) in patients with relapsed/refractory multiple myeloma refractory to proteasome inhibitors, immunomodulatory agents and refractory and/or intolerant to anti-CD38 monoclonal antibodies (abstract #8536; presenter, Lonial S).
  • Preliminary data from the DREAMM-6 study on the safety and tolerability of belantamab mafodotin in combination with bortezomib/dexamethasone in relapsed/refractory multiple myeloma (abstract #8502; presenter, Nooka A).

Progress in Ovarian Cancer

In April, the FDA approved Zejula, an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who responded to first-line platinum-based chemotherapy, regardless of biomarker status. At ASCO, five presentations will further explore niraparib’s utility in ovarian cancer.

Ongoing Investigation in Head and Neck Squamous Cell Carcinoma

GSK3359609 is an investigational ICOS agonist antibody that is designed to selectively enhance T-cell function and enable anti-tumour responses in patients. Presentations at ASCO report findings on our ongoing studies into the anti-tumour potential of targeting the ICOS receptor through this agonist antibody alone and in combination with immune checkpoint therapies for the treatment of head and neck squamous cell carcinoma.

  • Updated Analysis of the Inducible T-cell Co-stimulatory Receptor Agonist (ICOS), GSK3359609 (GSK609), Combination with Pembrolizumab (PE) in Patients (pts) with Anti-PD-1/L1 Treatment-naïve Head and Neck Squamous Cell Carcinoma (HNSCC) (abstract #6517; presenter, Angevin E).
  • INDUCE-1: Report on Safety Run-in Cohorts Combining the Inducible T-Cell Co-Stimulatory Receptor (ICOS) Agonist GSK3359609 (GSK609) with Platinum+5-FU Chemotherapy (5-FU/plat), with or without Pembrolizumab (PE), for the Treatment of Advanced Solid Tumors (abstract #6544; presenter, Massarelli E).

Advancing Immuno-Oncology Research in Endometrial Cancer

Dostarlimab is an investigational anti-programmed death-1 (PD-1) monoclonal antibody that has demonstrated clinically meaningful results in women with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer who progressed on or after a platinum-based regimen. Dostarlimab continues to be evaluated as a monotherapy and in combination with other assets across solid tumours. A presentation of interest includes:

  • ENGOT-EN6/NSGO-RUBY: A Phase III, Randomized, Double-blind, Multicentre Study of Dostarlimab + Carboplatin-paclitaxel Versus Placebo + Carboplatin-paclitaxel in Recurrent or Primary Advanced Endometrial Cancer (EC) (abstract #TPS6107; presenter, Mirza M).

Additional GSK presentations from our areas of cancer research can be found below.

Immuno-oncology

Abstract Name

Presenter

Presentation Details

DREAMM-2: Single-Agent Belantamab Mafodotin (GSK2857916) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) and High-Risk (HR) Cytogenetics

 

Cohen A

 

#8541

 

Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

DREAMM-9: Phase III Study of Belantamab Mafodotin Plus VRd versus VRd Alone in Transplant-ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)

 

Usmani S

 

#TPS8556

 

Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

DREAMM-2: Single-Agent Belantamab Mafodotin (GSK2857916) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) and Renal Impairment

Lee H

 

#8519

 

Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

DREAMM-5 Platform Trial: Belantamab Mafodotin in Combination With Novel Agents in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

 

Richardson P

 

#TPS8552

 

Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

INDUCE-3: A Randomized, Double-Blind Study of GSK3359609 (GSK609), an Inducible T-cell Co-Stimulatory (ICOS) Agonist Antibody, Plus Pembrolizumab (PE) Versus Placebo (PL) Plus PE for First-Line Treatment of PD-L1-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

 

Hansen A

#TPS6591

 

Session Title: Head and Neck

 

Two-Year Follow-Up of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, for Second-Line (2L) Treatment of Non-Small Cell Lung Cancer (NSCLC)

 

Cho BC

#9558

 

Session Title: Lung Cancer—Non-Small Cell Metastatic

 

Synthetic Lethality

Abstract Name

Presenter

Presentation Details

ENGOT-OV44/FIRST Study: A Randomized, Double-Blind, Adaptive, Phase 3 Study of Platinum-Based Chemotherapy (CT) ± Dostarlimab Followed by Niraparib ± Dostarlimab Maintenance as First-Line (1L) Treatment of Stage 3 or 4

Ovarian Cancer (OC)

 

Hardy-Bessard AC

 

#TPS6101

 

Session Title: Gynecologic Cancer

Evaluation of an Individualized Starting-Dose of Niraparib in the PRIMA/ENGOT-OV26/GOG-3012 Study

 

Mirza M

#6050

 

Session Title: Gynecologic Cancer

Niraparib Exposure-Response Relationship in Patients (pts) with Newly Diagnosed Advanced Ovarian Cancer (AOC)

Monk B

 

#6051

 

Session Title: Gynecologic Cancer

Pharmacokinetics and Safety Following a Single Oral Dose of Niraparib in Patients with Moderate Hepatic Impairment

Akce M

 

#6054

 

Session Title: Gynecologic Cancer

 

Cell Therapy

Abstract Name

Presenter

Presentation Details

Safety and Activity of Autologous T-Cells with Enhanced NY-ESO-1–Specific T-Cell Receptor (GSK3377794) in HLA-a*02+ Previously-Treated and -Untreated Patients with Advanced Metastatic/Unresectable Synovial Sarcoma: A Master Protocol Study Design (IGNYTE-ESO)

 

D’Angelo SP

 

#TPS11571

 

Session Title: Sarcoma

 

Open-Label Pilot Study of Genetically Engineered NY-ESO-1 Specific T-Cells (GSK3377794) Alone or in Combination with Pembrolizumab in Relapsed and Refractory Multiple Myeloma

Rapoport AP

 

#TPS8555

 

Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination. 

Indications and Important Safety Information for ZEJULA

Indications

ZEJULA is indicated:

  • for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
  • for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
  • for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:
    • a deleterious or suspected deleterious BRCA mutation, or
    • genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.

Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.