On May 26, 2022 GSK plc reported that it will present 25 abstracts at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (3-7 June) and nine abstracts at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (9-12 June) focusing on approved therapies, Blenrep (belantamab mafodotin), Jemperli (dostarlimab) and Zejula (niraparib), as well as its investigational medicines (Press release, GlaxoSmithKline, MAY 26, 2022, View Source [SID1234615154]). The data presentations further demonstrate the company’s commitment to evaluate its approved and investigational therapies alone and in combination with other treatments and explore potential opportunities to improve patient care.
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Hesham Abdullah, SVP, Global Head of Oncology Development, GSK said: "We have strategically built a portfolio and pipeline that leverages the science of the immune system, human genetics and advanced technologies to address a variety of tumour types. The data we will be sharing at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) demonstrate how we’re delivering on our commitment to patients through novel approaches in some of the most promising areas of oncology research. We look forward to these important opportunities to come together and to share meaningful scientific updates with the broader oncology community."
Updates from the robust DREAMM clinical trial programme
Key presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include updates from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme evaluating belantamab mafodotin, an anti-BCMA (B-cell maturation antigen) therapy, in combination with both standard of care and investigational agents in earlier lines of therapy. Preliminary data from DREAMM-5 sub-study 3 of low-dose belantamab mafodotin in combination with nirogacestat in patients with relapsed/refractory multiple myeloma (ASCO abstract #8019) will be reported. Nirogacestat, an investigational gamma secretase inhibitor, has been shown to increase target density and reduce levels of soluble BCMA, and as such the potential to enhance the activity of BCMA-targeted therapies like belantamab mafodotin is under investigation.[i]
DREAMM-6 updates report outcomes from several dose cohorts of belantamab mafodotin in combination with lenalidomide and dexamethasone (Rd) in patients with relapsed/refractory multiple myeloma who have received one or more prior lines of treatment (ASCO abstract #8017).
DREAMM-9, evaluating a quadruplet combination treatment regimen of belantamab mafodotin with standard of care (bortezomib, lenalidomide and dexamethasone or VRd) in patients with newly diagnosed multiple myeloma who are transplant ineligible, will also be presented at EHA (Free EHA Whitepaper) (EHA abstract #P942).
Collectively, the data from these trials are evaluating the efficacy and safety of belantamab mafodotin in patients with various lines of therapy, but also aim to assess how dose, scheduling and combination treatment may help to reduce corneal events associated with treatment. These data will be used to help inform further studies evaluating the potential of belantamab mafodotin in the multiple myeloma setting.
Blenrep received accelerated and conditional approvals in the US and EU, respectively, for adult patients with relapsed/refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 antibody, a proteasome inhibitor and an immunomodulatory agent. Studies are ongoing to verify clinical benefit.
Advancing research for patients with mismatch repair-deficient solid cancers
Results from the GARNET trial Cohorts A1 and A2 of dostarlimab, a programmed cell death receptor-1 (PD-1) blocking antibody, in advanced/recurrent (A/R) mismatch repair deficient/microsatellite instability-high or proficient/stable (dMMR/MSI-H or MMRp/MSS) endometrial cancer will be presented during a presentation at ASCO (Free ASCO Whitepaper) (ASCO abstract #5509). These results include the largest cohort of patients with dMMR A/R endometrial cancer treated with a PD-1 inhibitor monotherapy and will inform long-term use of dostarlimab in this patient population. In addition, long-term outcomes from the GARNET trial Cohorts A1 and F will be shared, covering the efficacy and safety profile of dostarlimab in certain patients with dMMR recurrent or advanced solid tumours, including endometrial cancer (ASCO abstract #2587). Results from Cohort A1 of the GARNET trial served as the basis for conditional approval in the EU for the treatment of certain patients with dMMR/MSI-H recurrent or advanced endometrial cancer, and for the accelerated approval in the US for certain patients with dMMR recurrent or advanced endometrial cancer. Additionally, results from Cohorts A1 and F served as the basis for the accelerated approval in the US for certain patients with dMMR recurrent or advanced solid tumours.
Realising the potential of synthetic lethality
GSK will also present real-world analyses from six studies in patients with advanced ovarian cancer at ASCO (Free ASCO Whitepaper), including real-world data evaluating outcomes in patients with advanced ovarian cancer who receive poly (ADP-ribose) polymerase (PARP) inhibitor monotherapy as maintenance compared to those who do not. Insights from the presentations will deepen the understanding of the use of PARP inhibitors for maintenance therapy in advanced ovarian cancer and shed light on differences in treatment practice across geographic locations.
Separately, a phase III PRIME study update will be shared by Zai Lab (a GSK partner) evaluating niraparib (independently manufactured by Zai Lab) in Chinese patients with newly diagnosed advanced ovarian cancer using an individualised starting dose in a poster presentation (ASCO abstract #5551).
Continued research on immuno-oncology investigational agents
GSK will also present findings from its early-stage pipeline assets, including a poster discussion on the AMBER study evaluating cobolimab, an investigational anti-TIM-3 targeting monoclonal antibody, in combination with dostarlimab in patients with advanced or metastatic melanoma (ASCO abstract #9513). TIM-3 is a key immune checkpoint and a novel immuno-oncology target that could play a critical role in the treatment of solid tumours. GSK is evaluating cobolimab for patients with different tumour types through various novel combinations, including doublets and triplets.
Collaborating to improve patient care
GSK is supporting investigator-sponsored studies and fostering scientific collaborations with both experienced investigators and networks, who are involved in the continuum of care of patients living with cancer. At ASCO (Free ASCO Whitepaper), updated data from an investigator-sponsored study from Memorial Sloan Kettering Cancer Center will be featured in a late-breaking oral presentation entitled "Single agent PD-1 blockade as curative-intent treatment in mismatch repair deficient locally advanced rectal cancer" (ASCO abstract #LBA5). Initial data were presented earlier this year at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI). There will be five additional GSK-supported investigator-sponsored studies presented at ASCO (Free ASCO Whitepaper).
At EHA (Free EHA Whitepaper), data from the BelaCarD investigator-sponsored study will report safety, tolerability and preliminary efficacy of belantamab mafodotin in combination with carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma (EHA abstract #P946). Additionally, an oral presentation on updated results from a supported collaborative study will evaluate the safety and efficacy of belantamab mafodotin plus lenalidomide and dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma (EHA abstract #S178).
Full list of GSK’s presentations at ASCO (Free ASCO Whitepaper):
Dostarlimab
Abstract Name
Presenter
Presentation Details
Comparison of Survival Outcomes Between Dostarlimab and Comparator Treatments (tx) in Patients (pts) with Advanced/Recurrent (A/R) Endometrial Cancer (EC) in England: Matching-Adjusted Indirect Comparisons (MAICs)
S. Goulden
Online publication, #e17534
Dostarlimab in Advanced/Recurrent (AR) Mismatch Repair Deficient/Microsatellite Instability–High or Proficient/Stable (dMMR/MSI-H or MMRp/MSS) Endometrial Cancer (EC): The GARNET Study
A. Oaknin
Clinical Science Symposium presentation, #5509
Efficacy and Safety of Dostarlimab in Patients (pts) with Mismatch Repair Deficient (dMMR) Solid Tumors: Analysis of 2 Cohorts in the GARNET Study
T. André
Poster presentation, #2587
Patient-Reported Outcomes from the GARNET Trial in Patients with Advanced or Recurrent Mismatch Repair Deficient (dMMR) Colorectal Cancer (CRC): A Post Hoc Subgroup Analysis
J. Hanlon
Poster presentation, #3558
Survival Outcomes for Dostarlimab and Real-World (RW) Treatment (tx) Paradigms in Post-Platinum Patients (pts) with Advanced/Recurrent (A/R) Endometrial Cancer (EC): The GARNET Trial versus an External Control Arm from the Flatiron Health Database
R. Coleman
Poster presentation, #5593
Understanding Patient Characteristics, Treatment Patterns, and Clinical Outcomes for Advanced and Recurrent Endometrial Cancer in Alberta, Canada
J. McGee
Online publication, #e17624
Belantamab Mafodotin
Abstract Name
Presenter
Abstract Number
Exploring Alternative Dosing Regimens of Single-Agent Belantamab Mafodotin on Safety and Efficacy in Patients with Relapsed or Refractory Multiple Myeloma: DREAMM-14
M. Hultcrantz
Poster presentation, #TPS8073
Safety and Clinical Activity of Belantamab Mafodotin with Lenalidomide Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-6 Arm-A Interim Analysis
H. Quach
Poster discussion, #8017
Safety and Clinical Activity of Belantamab Mafodotin with Pembrolizumab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-4 Study
A. Suvannasankha
Poster discussion, #8018
Synergistic Effects of Low-Dose Belantamab Mafodotin in Combination with a Gamma-Secretase Inhibitor (Nirogacestat) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-5 Study
S. Lonial
Poster discussion, #8019
Niraparib
Abstract Name
Presenter
Presentation Details
MOONSTONE/GOG-3032: Interim Analysis of a Phase 2 Study of Niraparib + Dostarlimab in Patients (pts) with Platinum-Resistant Ovarian Cancer (PROC)
L. Randall
Poster presentation, #5573
Real-World Trends of PARPi Maintenance Treatment Uptake and Progression-Free Survival (PFS) in Patients (Pts) with Newly Diagnosed Advanced Ovarian Cancer (AOC) in the United States
J. Chan
Poster presentation, #6580
Treatment and Outcome of Patients with High Grade Advanced Ovarian Cancer (AOC) – Real World Data in Germany (QS Ovar of the AGO Study Group)
S. Mahner
Online publication, #e17613
Treatment Patterns and Time to Next Treatment Among Patients with OC in a Real-Life Setting in Finland: The OCRWE-Finland Study
H. Rauhamaa
Online publication, #e18806
Pipeline
Abstract Name
Presenter
Presentation Details
AMBER Parts 1C and 1E: A Phase 1 Study of Cobolimab plus Dostarlimab in Patients (pts) with Advanced/Metastatic Melanoma
A. Ribas
Poster discussion, #9513
Phase 1 Trial of TIM-3 Inhibitor Cobolimab Monotherapy and in Combination with PD-1 Inhibitors Nivolumab or Dostarlimab (AMBER)
G. Falchook
Oral presentation, #2504
Primary Efficacy and Safety of Letetresgene Autoleucel (lete-cel; GSK3377794) Pilot Study in Patients with Advanced and Metastatic Myxoid/Round Cell Liposarcoma (MRCLS)
S. D’Angelo
Oral presentation, #11500
Study Design of A Global Molecular Disease Characterization Initiative (MDCI) in Oncology Clinical Trials
D. Downs
Online publication, #e13598
ZENYTH-ESO: Master Protocol to Assess the Safety and Recommended Phase II Dose of Next Generation NY-ESO-1–Specific TCR T-cells in HLA-A*02 Patients with Synovial Sarcoma and Myxoid/Round Cell Liposarcoma [Substudy 3, GSK4427296]
D. Araujo
Poster presentation, #TPS2681
Full list of investigator-sponsored studies at ASCO (Free ASCO Whitepaper):
Abstract Name
Presenter
Presentation Details
AGO-OVAR 28 / ENGOT-ov57: Niraparib vs Niraparib in Combination with Bevacizumab in Patients with Carboplatin-Taxane Based Chemotherapy in Advanced Ovarian Cancer–A Multicentre Randomised Phase III Trial
F. Heitz
Poster presentation, #TPS5612
A Phase II Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
V. Karivedu
Poster presentation, #TPS6105
A Randomized Phase Ib/II Study of Niraparib (Nira) plus Either Nivolumab (Nivo) or Ipilimumab (Ipi) in Patients (Pts) with Platinum-Sensitive Advanced Pancreatic Cancer (aPDAC)
K. Reiss
Poster discussion, #4021
Results of a Phase II Trial of the PARP Inhibitor, Niraparib, in BAP1 and other DNA Damage Response Pathway Deficient Neoplasms
T. George
Poster presentation, #3122
Role of Cytoreductive Surgery for the Second Ovarian Cancer Relapse in Patients Previously Treated with Chemotherapy Alone at First Relapse: A Subanalysis of the DESKTOP III Trial
J. Sehouli
Poster discussion, #5520
Single Agent PD-1 Blockade as Curative-Intent Treatment in Mismatch Repair Deficient Locally Advanced Rectal Cancer
A. Cercek
Late-breaking oral presentation, #LBA5
Full list of GSK’s presentations at EHA (Free EHA Whitepaper):
Abstract Name
Presenter
Presentation Details
DREAMM-9: Phase I Study of Belantamab Mafodotin Plus Standard of Care in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma
S. Usmani
Poster session, #P942
Exploring Alternative Dosing Regimens of Single-Agent Belantamab Mafodotin on Safety and Efficacy in Patients with Relapsed or Refractory Multiple Myeloma: DREAMM-14
M. Hultcrantz
Online publication, #PB2022
Safety and Clinical Activity of Belantamab Mafodotin with Lenalidomide Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-6 Arm-A Interim Analysis
H. Quach
Poster session, #P941
Safety and Clinical Activity of Belantamab Mafodotin with Pembrolizumab in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-4 Study
A. Suvannasankha
Poster session, #P940
Survival Outcomes of Patients with Multiple Myeloma in France: A Cohort Study Using the French National Healthcare Database (SNDS)
X. Leleu
Poster session, #P943
Synergistic Effects of Low Dose Belantamab Mafodotin in Combination with a Gamma-Secretase Inhibitor (Nirogacestat) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-5 Study
A. Nooka
Poster session, #P939
Full list of investigator-sponsored studies at EHA (Free EHA Whitepaper):
Abstract Name
Presenter
Presentation Details
A Phase I/II Single Arm Study of Belantamab Mafodotion, Carfilzomib and Dexamethasone in Patients with Relapsed Multiple Myeloma: AMARC 19-02 BelaCarD Study
M. Lasica
Poster session, #P946
Efficacy and Safety of Belantamab Mafodotin Monotherapy in Patients with Relapsed or Refractory Light Chain Amyloidosis: A Phase 2 Study by the European Myeloma Network
E. Kastritis
Poster presentation, #P914
Safety and Efficacy of Belantamab Mafodotin in Combination with RD in Newly Diagnosed, Transplant Ineligible Multiple Myeloma Patients: A Phase I/II Study by the Hellenic Society of Hematology
E. Terpos
Oral presentation, #S178
About multiple myeloma
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.[ii],[iii] In the US, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease.[iv] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[v]
About ovarian cancer
Ovarian cancer is the 8th most common cancer in women worldwide.[vi] Despite high response rates to platinum-based chemotherapy in the front-line setting, approximately 85% of patients will experience disease recurrence.[vii] Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.
About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. It is the most common gynaecologic cancer in the US and second most common gynaecologic cancer globally.[viii] Approximately 15-20% of women with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.[ix]
Important information for BLENREP in the EU
Indication
BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Refer to the BLENREP Prescribing Information for a full list of adverse events and the complete important safety information in the EU.
About Dostarlimab
Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.[x] In addition to GARNET, dostarlimab is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.
Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: dostarlimab (GSK4057190), a PD-1 antagonist; cobolimab (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these assets under the Agreement.
Important Information for JEMPERLI in the EU
Indication
JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability‑high (MSI‑H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum‑containing regimen.
Refer to the JEMPERLI Prescribing Information for a full list of adverse events and the complete important safety information in the EU.
About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.
Important Information for ZEJULA in the EU
Indication
ZEJULA is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Refer to the ZEJULA Prescribing Information for a full list of adverse events and the complete important safety information in the EU.
GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, tumour cell targeting therapies 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.