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Oncology

Meet Us

NRG | Jan 9-11, 2020 | Houston, TX

SGO | Mar 28-31, 2020 | Toronto, Canada

ASCO | May 29-Jun 2, 2020 | Chicago,IL

IGCS | Sep 10-12, 2020 | Rome, Italy

ESMO | Sep 18-20, 2020 | Madrid, Spain

SITC | Nov 11-14, 2020 | Natl Harbor, MD

ASH | Dec 5-8, 2020 | San Diego, CA

ZEJULA

(niraparib)

Material Safety Data Sheets &
Environmental Risk Assessments

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].

Pipeline

Immuno-Oncology

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

Immuno-Oncology Phase I Phase II Phase III

DREAMM-9: Newly Diagnosed Mutiple Myeloma in Combination With Lenalidomide, Bortezomib, and Dexmaethasone

NCT04091126

DREAMM-2: Relapsed/Refractory Multiple Myeloma

NCT03525678

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) or GSK3359609 (ICOS agonist IgG4 antibody).

NCT04126200

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

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

NCT03981796

GARNET: Microsatellite Instability High (MSI-H)Tumors (Including Metastatic Endometrial Cancer), Microsatellite Stable (MSS) Endometrial Cancer, and Non-Small Cell Lung Cancer (NSCLC)

NCT02715284

IOLite: Advanced NSCLC and Solid Tumors in Combination With Niraparib (PARP Inhibitor), TSR-022 (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

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 With Gemcitabine and Cisplatin Alone or in Combination With Bintrafusp Alfa in Biliary Tract Cancer

NCT04066491

INTR@PID BTC 047: Locally Advanced or Metastatic Second Line Biliary Tract Cancer

NCT03833661

INTR@PID LUNG 037: First-Line Treatment in PD-L1-Expressing Advanced NSCLC

NCT03631706

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 NSCLC, Melanoma, Urothelial Carcinoma, and Synovial Sarcoma

NCT03515551
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

PRIMA: Ovarian Cancer First-Line Maintenance Following Response to Front-Line Platinum-Based Chemotherapy

NCT02655016

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

TOPACIO: Advanced or Metastatic Triple Negative Breast Cancer or Recurrent Ovarian Cancer in Combination with Pembrolizumab

NCT02657889

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 Hematologic Malignancies

NCT01943851

HR+/HER2- Breast Cancer in Combination With Fulvestrant

NCT02964507

NUT Midline Carcinoma and Other Cancers

NCT01587703

Castration-Resistant Prostate Cancer (CRPC) in Combination With Androgen Deprivation Therapy and Other Agents

NCT03150056

Relapsed/Refractory Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

NCT03614728

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

NCT02783300

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

NCT03666988

Metastatic Castration-Resistant Prostate Cancer (mCRPC) in Combination With Enzalutamide


NCT02215096
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

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

Unresectable, Metastatic, or Recurrent HLA-A*02+ Synovial Sarcoma

NCT01343043

NY-ESO-1– and/or LAGE-1a–Positive Advanced NSCLC

NCT02588612

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

Belantamab MOA

DNA Damage Response

Immuno-Oncology MOA

Indicible T-Cell Costimulator

No Two Cancers are the same

MY-ESO-1 T-Cell Receptor

Congress Presentations

Society of Gynecologic Oncology (SGO)

March 16-19, 2019 | Honolulu, HI, USA

American Association of Cancer Research (AACR)

March 29-April 3, 2019 | Atlanta, GA, USA

Oncology Nursing Society (ONS)

April 11-14, 2019 | Anaheim, CA, USA

American Society of Clinical Oncology (ASCO)

May 31-June 4, 2019 | Chicago, IL, USA

Western Association of Gynecologic Oncologists (WAGO)

June 12-15, 2019 | Huntington Beach, CA, USA

European Hematology Association (EHA)

June 13-16, 2019 | Amsterdam, Netherlands

NRG Oncology

July 18-20, 2019 | Philadelphia, PA, USA

International Association for the Study of Lung Cancer (IASLC)/World Conference on Lung Cancer (WCLC)

September 7-10, 2019 | Barcelona, Spain

European Society for Medical Oncology (ESMO)

September 27 – October 1, 2019 | Barcelona, Spain

European Society of Gynaecological Oncology (ESGO)

November 2-5, 2019 | Athens, Greece

The Society for Immunotherapy of Cancer (SITC)

November 8-10 2019 | Baltimore, MD, USA

Connective Tissue Oncology Society (CTOS)

November 13-16, 2019 | Tokyo, Japan

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