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Oncology

GSK Oncology will have a presence at these meetings. Please visit us at our scientific booth or view our scientific information.

Meet Us

ASCO GI | Jan 19-21, 2023 | San Francisco, CA

EMMA | Jan 27-28, 2023 | Vienna, Austria

ESMO GYN | Feb 23-24, 2023 | Barcelona, Spain

SGO | Mar 25-28, 2023 | Tampa, FL

HOPA | Mar 29-Apr 1, 2023 | Phoenix, AZ

NCCN | Mar 31-Apr 2, 2023 | Orlando, FL

AACR | Apr 14-19, 2023 | Orlando, FL

EMN | Apr 20-23, 2023 | Amsterdam, Netherlands

ONS | Apr 26-30, 2023 | San Antonio, TX

MPN MDS US Focus Meeting | Apr 28-29, 2023 | Phoenix, AZ

COMY | May 11-14, 2023| Paris, France

ASCO | Jun 2-6, 2023 | Chicago, IL

EHA | Jun 8-11, 2023 | Frankfurt, Germany

SOHO | Sep 6-9, 2023 | Houston, TX

IASLC (WCLC) | Sep 9-12, 2023 | Singapore

IMS | Sep 27-30, 2023 | Athens, Greece

ESGO | Sep 28-Oct 01, 2023 | Istanbul, Turkey

ESMO | Oct 20-24, 2023 | Madrid, Spain

SITC | Nov 1-5, 2023 | San Diego, CA

JADPRO | Nov 9-12, 2023 | Orlando, FL

ASH | Dec 9-12, 2023 | San Diego, CA

View information about our marketed products Jemperli and Zejula including prescribing information and the material safety data sheets.

ZEJULA

(niraparib)

Material Safety Data Sheets Environmental Risk Assessments Environmental Risk Assessments Important Prescribing Information Dec 2022 Important Prescribing Information Sept 2022






How Supplied/Storage & Handling arrow-down arrow-up
  • ZEJULA is available as capsules having a white body printed with “100 mg” in black ink, and a purple cap printed with “Niraparib” in white ink.
  • Each capsule contains 100 mg of niraparib free base.
  • ZEJULA capsules are packaged as
    • 90-count bottles NDC 69656-103-90
    • 30-count bottles NDC 69656-103-30
  • Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

JEMPERLI

(dostarlimab-gxly)

Material Safety Data Sheets Environmental Risk Assessments







Environmental Risk Assessments
How Supplied/Storage & Handling arrow-down arrow-up
  • JEMPERLI injection is a clear to slightly opalescent, colorless to yellow solution supplied in a carton containing one 500 mg/10 mL (50 mg/mL), single-dose vial (NDC 0173-0898-03).
  • Store vial refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze or shake.

Storage of Infusion Solution

  • Store in the original carton until time of preparation in order to protect from light. The prepared dose may be stored either:
    • At room temperature for no more than 6 hours from the time of preparation until the end of infusion..
    • Under refrigeration at 2°C to 8°C (36ºF to 46ºF) for no more than 24 hours from time of preparation until end of infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration.
  • Discard after 6 hours at room temperature or after 24 hours under refrigeration.
  • Do not freeze.

Our unique R&D approach of Science x Technology x Culture is helping to fight cancer on multiple groundbreaking fronts. View our ongoing research in the areas of immno-oncology, synthetic lethality, cancer epigenetics, and cell therapy.

Download Pipeline Brochure

Immuno-Oncology
Harnessing the Body’s Immune System

The growing understanding of tumor cells’ ability to evade immune surveillance has led to advances in the field of immuno-oncology.1

Malignant cells manipulate a variety of physiological mechanisms involved in antigenicity, immune activation, T-cell priming and recruitment, and upregulation of checkpoint molecules.1 Many of these mechanisms may be impacted simultaneously to promote tumor cell survival.1 Immunotherapies harness the body’s own immune system to fight cancer by using different immunological pathways to enhance antitumor responses.1,2

GSK is exploring different clinical assets aimed at augmenting the immune response, reducing immune suppression, and modulating the tumor microenvironment.3,4

Immuno-Oncology Phase I Phase II Phase III

DREAMM-3: Relapsed/Refractory Multiple Myeloma alone vs Pomalidomide/Dexamethasone

NCT04162210

DREAMM-7: Relapsed/Refractory Multiple Myeloma in Combination with Bortezomib and Dexamethasone vs Daratumumab/Bortezomib/Dexamethasone

NCT04246047

DREAMM-9: Newly Diagnosed Multiple Myeloma in Combination with Lenalidomide, Bortezomib, and Dexamethasone

NCT04091126

DREAMM-4: Relapsed/Refractory Multiple Myeloma in Combination With Pembrolizumab

NCT03848845

DREAMM-5: relapsed/refractory multiple myeloma alone and in combination with GSK3174998 (OX40 agonist antibody) or GSK3359609 (ICOS agonist IgG4 antibody)

NCT04126200

Relapsed/refractory multiple myeloma in Chinese patients

NCT04177823

DREAMM-6: Relapsed/Refractory Multiple Myeloma in Combination With Lenalidomide Plus Dexamethasone or in Combination With Bortezomib Plus Dexamethasone

NCT03544281

Relapsed/Refractory Multiple Myeloma in Japanese Patients

NCT03828292

DREAMM-12: Relapsed/Refractory Multiple Myeloma in Normal or Varying Degrees of Impaired Renal Function

NCT04398745

DREAMM-13: Relapsed/Refractory Multiple Myeloma in Normal or Varying Degrees of Impaired Hepatic Function

NCT04398680

RUBY: Recurrent or Primary Advanced Endometrial Cancer in Combination With Chemotherapy

NCT03981796

GARNET: Mismatch Repair Deficient (dMMR)/Microsatellite Instability High (MSI-H) Non-Endometrial Cancer Solid Tumors, Endometrial Cancer, Ovarian Cancer, and Non-Small Cell Lung Cancer (NSCLC)

NCT02715284

IOLite: Advanced NSCLC and Solid Tumors in Combination With Niraparib (PARP Inhibitor), Cobolimab (Anti-TIM-3 Antibody), Bevacizumab, and/or Platinum-Based Doublet Chemotherapy

NCT03307785

INDUCE-3: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) in Combination with Pembrolizumab

NCT04128696

INDUCE-4: Recurrent/Metastatic HNSCC in Combination with Pembrolizumab and 5-Fluorouracil (5-FU) Platinum Chemotherapy

NCT04428333

ENTREE-Lung: Advanced NSCLC in Combination With Docetaxel

NCT03739710

INDUCE-2: Advanced Solid Tumors in Combination With Tremelimumab

NCT03693612

INDUCE-1: Advanced Solid Tumors Alone and in Combination With Pembrolizumab or Chemotherapy

NCT02723955

AMBER: Melanoma, NSCLC, and Colorectal Cancer Alone and in Combination With Dostarlimab (Anti-PD-1 Antagonist)

NCT02817633

CITRINO: Advanced Solid Tumors Alone and in Combination With Dostarlimab

NCT03250832

Advanced Solid Tumors Alone and in Combination With Pembrolizumab

NCT03843359

INTR@PID BTC 055: First-line treatment in combination with gemcitabine plus cisplatin in locally advanced/metastatic biliary tract cancer (BTC)

NCT04066491

INTR@PID BTC 047: Second-line locally advanced/metastatic BTC

NCT03833661

INTR@PID CERVICAL 017: advanced, unresectable cervical cancer that progressed during or after platinum-containing chemotherapy.

NCT03833661

INTR@PID UROTHELIAL 152: locally advanced/metastatic urothelial cancer that progressed or recurred after platinum-containing chemotherapy

NCT04349280

INTR@PID LUNG 005: Unresectable Stage III NSCLC in Combination With Concurrent Chemoradiation Therapy

NCT03840902

INTR@PID LUNG 024: stage IV NSCLC in combination with chemotherapy

NCT03840915

INTR@PID SOLID TUMOR 001: Locally Advanced or Metastatic Solid Tumors

NCT02517398

INTR@PID SOLID TUMOR 008: Locally Advanced or Metastatic Solid Tumors

NCT02699515

ENGAGE-1: Advanced Solid Tumors Alone and in Combination With Pembrolizumab

NCT02528357

Advanced Solid Tumors in Combination With GSK3174998 (OX40 Agonist), GSK3359609 (ICOS Agonist), or Pembrolizumab

NCT03447314

Advanced NY-ESO-1– and/or LAGE-1a–positive solid tumors

NCT03515551

Advanced Solid Tumors Alone and In Combination with Dostarlimab

NCT04446351
References:
  1. Allard B, Aspeslagh S, Garaud S, et al. Immuno-oncology-101: overview of major concepts and translational perspectives. Semin Cancer Biol. 2018;52(pt 2):1-11.
  2. PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
  3. Tai Y-T, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-1199.
  4. Knudson KM, Hicks KC, Luo X, Chen J-Q, Schlom J, Gameiro SR. M7824, a novel bifunctional anti-PD-L1/TGF trap fusion protein, promotes anti-tumor efficacy as monotherapy and in combination with vaccine. Oncoimmunology. 2018;7(5):e1426519. doi:10.1080/2162402X.2018.1426519.
  • * In-license or other partnership with third party
  • Tesaro acquisition
  • Being developed in a strategic global alliance between GSK and Merck KgaA, Darmstadt, Germany
  • Option-based alliance with Immunocore Ltd. ImmTAC is a registered trademark of Immunocore Ltd.
Synthetic Lethality

Accumulation of DNA damage and genomic instability are pervasive characteristics of human tumors and are caused by defects in DNA repair.1,2 Deficiencies in essential DNA damage repair in cancer cells may increase dependency on an alternate repair pathway for cell survival.2 Synthetically lethal therapies aim to combine pharmacologic inhibition of these alternate repair pathways with inherent defects in DNA damage repair to selectively kill tumor cells while sparing healthy tissue.2-4 GSK is investigating a clinical asset that utilizes the power of synthetically lethal interactions to fight malignant cells in a variety of cancers.

Synthetic Lethality Phase I Phase II Phase III

FIRST: Ovarian Cancer maintenance in combination with or without dostarlimab and bevacizumab following first-line treatment with Platinum-Based Chemotherapy with or without dostarlimab and bevacizumab

NCT03602859

OVARIO: Ovarian Cancer First-Line Maintenance in Combination With Bevacizumab Following Response on Front-Line Platinum-Based Chemotherapy Plus Bevacizumab

NCT03326193

OPAL: Platinum-Resistant Ovarian Cancer Treatment in Combination With Dostarlimab and Bevacizumab

NCT03574779

MOONSTONE: Platinum-Based Ovarian Cancer Treatment in Combination With Dostarlimab

NCT03955471

Neoadjuvant Treatment in HER2- and BRCAmut Localized Breast Cancer

NCT03329937

Pharmacokinetics and Safety in Patients With Advanced Solid Tumors and Normal Hepatic Function or Moderate Hepatic Impairment

NCT03359850

Crossover Bioavailability Study of Niarparib Tablet Compared to Niraparib Capsule in Advanced Solid Tumors

NCT03329001
References:
  1. Lord CJ, Ashworth A. The DNA damage response and cancer therapy. Nature. 2012;481(7381):287-294.
  2. O’Connor MJ. Targeting the DNA damage response in cancer. Mol Cell. 2015;60(4):547-560.
  3. Kelley MR, Logsdon D, Fishel ML. Targeting DNA repair pathways for cancer treatment: what’s new? Future Oncol. 2014;10(7):1215-1237.
  4. O'Neil NJ, Bailey ML, Hieter P. Synthetic lethality and cancer. Nat Rev Genet. 2017;18(10):613-623.
  • * Tesaro acquisition
  • In collaboration with ENGOT, the European Network for Gynaecological Oncological Trial groups
Cancer Epigenetics

Aberrant gene expression, regulated in large part by epigenetic mechanisms, is a hallmark of cancer.1 “Epigenetics” refers to heritable changes in gene expression that arise from changes in chromosomes without altering the DNA sequence.2 DNA methylation and posttranslational modifications of histones play key roles in regulating gene expression.1,3 Deregulation of these epigenetic mechanisms can lead to aberrant expression of oncogenes and tumor suppressors in cancer cells that can enhance proliferative signals, impair cell death, promote angiogenesis, and facilitate metastasis. GSK is investigating compounds that work by altering these epigenetic pathways.

Cancer Epigenetics Phase I Phase II

Relapsed/Refractory Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), and Chronic Myelomonocytic Leukemia (CMML)

NCT03614728

Solid Tumors and Non-Hodgkin's Lymphoma (NHL)

NCT02783300

Relapsed/Refractory Solid Tumors and Diffuse Large B-Cell Lymphoma (DLBCL)

NCT03666988
References:
  1. Kanwal R, Gupta S. Epigenetic modifications in cancer. Clin Genet. 2012;81(4):303-311.
  2. Nebbioso A, Tambaro FP, Dell’Aversana C, Altucci L. Cancer epigenetics: moving forward. PLoS Genet. 2018;14(6):e1007362.
  3. Pérez-Salvia M, Esteller M. Bromodomain inhibitors and cancer therapy: from structures to applications. Epigenetics. 2017;12(5):323-339.
  • * In-license or other partnership with third party
Cell Therapy

The physiologic role of central and peripheral tolerance mechanisms is to limit unchecked immune responses that can lead to autoimmunity.1 In cancer, these mechanisms are major limitations to effective T-cell mediated antitumor immunity.1 Oncology cell therapy uses adoptive transfer of engineered T cells that may mediate antitumor effects. In adoptive cell therapy, T cells are isolated from the patient, engineered to present an enhanced TCR that recognizes a specific antigen, and then reintroduced into the patient.1,2 This innovative approach generates T cells that may be more efficient at targeting cancer cells and may overcome the barriers of tolerance mechanisms2 GSK is developing an engineered TCR T-cell clinical asset designed to target a tumor-specific antigen and eliminate malignant cells in solid tumors and hematologic malignancies.

Oncology Cell Therapy Phase I Phase II Phase III

IGNYTE-ESO: master protocol–advanced NY-ESO-1– and/or LAGE-1a–positive synovial sarcoma and solid tumors

NCT03967223

Relapsed/Refractory NY-ESO-1– and/or LAGE-1a–Positive Multiple Myeloma Alone and in Combination with Pembrolizumab

NCT03168438

Advanced Myxoid/Round Cell Liposarcoma

NCT02992743

Advanced NY-ESO-1– and/or LAGE-1a–Positive NSCLC Alone and in Combination with Pembrolizumab

NCT03709706

Long-Term Follow-up from Previous GSK3377794 Studies


NCT03391778
References:
  1. Perica K, Varela JC, Oelke M, Schneck J. Adoptive T cell immunotherapy for cancer. Rambam Maimonides Med J. 2015;6(1):e0004.
  2. Sharpe M, Mount N. Genetically modified T cells in cancer therapy: opportunities and challenges. Dis Model Mech. 2015;8(4):337-350.
  • * In-license or other partnership with third party

Early Stage Pipeline

Cell Therapy - Coming Soon

View educational videos from GSK Oncology on proposed mechanism of action and mechanism of disease of selected assets.

Niraparib Mechanism of Action (3:48)

Feladilimab Mechanism of Action (2:42)

NY-ESO-1 T-cell Receptor (3:14)

Bintrafusp alfa Mechanism of Action (3:01)

Belantamab Mafodotin Mechanism of Action (3:41)

Dostarlimab Mechanism of Action (3:04)
 

View important resources for health care professions including links to medical organizations and patient advocacy groups.

View important resources for health care professions including links to medical organizations, patient advocacy groups and educational material for ophthalmologists & optometrists regarding BLENREP.

View congress posters, presentations and symposia from GSK oncology to learn about the latest developments in clinical research on GSK oncology assets.

American Society of Hematology (ASH) 2022

December 10-13, 2022 | New Orleans, LA

Society for Immunotherapy of Cancer (SITC) 2022

November 8-12, 2022 | Boston, MA

European Society of Gynaecological Oncology (ESGO)

October 27-30, 2022 | Berlin, Germany

International Congress on Myeloproliferative Neoplasms (MPN)

October 27-28, 2022 | Brooklyn, NY

International Gynecologic Cancer Society (IGCS)

September 29-October 1, 2022 | New York, NY

Society of Hematologic Oncology (SOHO)

September 28-October 1, 2022 | Houston, TX

World Cornea Congress (WCC)

September 28-29, 2022 | Chicago, IL

European Society for Medical Oncology (ESMO)

September 9-13, 2022 | Paris, France

International Myeloma Society (IMS)

August 25-27, 2022 | Los Angeles, CA

IASLC WCLC 2022

August 6-9, 2022 | Vienna, Austria | Virtual

European Hematology Association (EHA)

June 9-12, 2022 | Vienna, Austria | Virtual

American Society of Clinical Oncology (ASCO) 2022

June 3-7, 2022 | Chicago, IL | Virtual

American Association for Cancer Research (AACR)

April 8-13, 2022 | New Orleans, LA

Society of Gynecologic Oncology (SGO)

March 18-21, 2022 | Phoenix, AZ