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Oncology

Meet Us

European Society of Gynaecological Oncology (ESGO) 2019 | November 2- 5 2019 | Athens, Greece

Society for Immunotherapy of Cancer (SITC) | Nov 6-10, 2019 | National Harbor, Maryland, USA

American Society of Hematology (ASH) | Dec 7-10, 2019 | Orlando, Florida, USA

San Antonio Breast Cancer Symposium (SABCS) | Dec 10-14, 2019 | San Antonio, Texas, USA

Hematology/Oncology Pharmacy Association (HOPA) | March 11-14, 2020 | Tampa, FL

Society for Gynecologic Oncology (SGO) | March 28-31, 2020 | Toronto, Canada

American Association for Cancer Research (AACR) | April 24-29, 2020 | San Diego, CA

Oncology Nursing Society (ONS) | April 30-May 3, 2020 | San Antonio, TX

American Society of Clinical Oncology (ASCO) | May 29-June 2, 2020 | Chicago, IL

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].

Late Stage Assets

Immuno-Oncology

The emerging field of immuno-oncology harnesses the body’s own immune system to fight cancer by using different immunological pathways to enhance antitumor responses.1,2 GSK is exploring different therapies aimed at augmenting the immune response, reducing immune suppression, and modulation the tumor microenvironment.3,4

Immuno-Oncology Phase I Phase II Phase III

DREAMM-2: Relapsed/Refractory Multiple Myeloma

NCT03525678

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

NCT03848845

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-1: Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies

NCT02064387
  1. PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
  2. 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.
  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

Defects in DNA repair leading to the accumulation of DNA damage and genomic instability are pervasive characteristics of human tumors.1,2 Harnessing synthetically lethal interactions facilitates indirect targeting of tumorigenic pathways and induces tumor cell death by arresting these processes.3,4 Disruption of pathways that contribute to aberrant DNA repair in cancer cells is a promising area of research for uncovering and expanding therapeutic options.3,4

Synthetic Lethality Phase I Phase II Phase III

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

NCT02655016

FIRST: First-Line Ovarian Cancer Treatment in Combination With Platinum-Based Chemotherapy and Dostarlimab Followed by Maintenance With Niraparib in Combination With Dostarlimab

NCT03602859

NOVA: Recurrent Ovarian Cancer Maintenance Following Response to Last Platinum-Based Chemotherapy

NCT01847274

QUADRA: Recurrent Ovarian Cancer Treatment Following Three or Four Previous Chemotherapy Regimens

NCT02354586

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

NCT03326193

OPAL: Platinum-Resistant Ovarian Cancer Treatment (Second or Third Line) in Combination With Dostarlimab and Bevacizumab

NCT03574779

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

NCT03955471

Neoadjuvant Treatment in HER2- and BRCA 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
  1. PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
  2. 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.
  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.

Early Stage Pipeline

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 and can lead to aberrant expression of oncogenes and tumor suppressors in cancer cells.3 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
  1. PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
  2. 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.
  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.
Immuno-Oncology

The emerging field of immuno-oncology harnesses the body’s own immune system to fight cancer by using different immunological pathways to enhance antitumor responses.1,2 GSK is exploring different therapies aimed at augmenting the immune response, reducing immune suppression, and modulation the tumor microenvironment.3,4

Immuno-Oncology Phase I Phase II Phase III

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

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 (TSR-042, Anti-PD-1 Antibody)

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
  1. PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
  2. 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.
  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.
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 for Immunotherapy of Cancer (SITC)

November 7-11, 2018 | Washington DC, USA

American Society of Hematology (ASH)

December 1-4, 2018 | San Diego, CA, USA

American Society of Health-System Pharmacists (ASHP)

December 2-6, 2018 | Anaheim, CA, USA

San Antonio Breast Cancer Symposium (SABCS)

December 4-10, 2018 | San Antonio, TX, USA

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

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