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)

Prescribing Information

Material Safety Data Sheets &
Environmental Risk Assessments

How Supplied/Storage & Handling

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

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

PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
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.
Tai Y-T, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-1199.
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

PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
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.
Tai Y-T, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-1199.
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

PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
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.
Tai Y-T, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-1199.
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

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

PhRMA. Medicines in development for immuno-oncology 2017 report. https://www.phrma.org/medicines-in-development-immuno-oncology. Accessed January 30, 2019.
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.
Tai Y-T, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-1199.
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.