On May 26, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported additional efficacy data from the pivotal SORAYA study evaluating mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab) and an integrated safety summary of single-agent mirvetuximab across multiple studies in patients with FRα-positive recurrent ovarian cancer (Press release, ImmunoGen, MAY 26, 2022, View Source [SID1234615088]). These findings will be highlighted in two posters at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 3-7, 2022. The data from SORAYA have been selected for the Best of ASCO (Free ASCO Whitepaper) Program.

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"Treatment options remain limited for patients with platinum-resistant ovarian cancer, particularly for those who have received prior bevacizumab, and are associated with low response rates, short durations of response, and considerable toxicities," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We believe these data further reinforce mirvetuximab’s potential to become a new standard of care in this population. With our biologics license application accepted and filed by FDA with Priority Review, we look forward to bringing mirvetuximab to patients with the most urgent need later this year."

CHARACTERIZATION OF ANTI-TUMOR ACTIVITY IN THE SORAYA STUDY
SORAYA enrolled 106 platinum-resistant ovarian cancer patients with high FRα expression who have been previously treated with 1 to 3 prior systemic treatments, at least one of which included bevacizumab. The primary endpoint was confirmed objective response rate (ORR) as assessed by investigator. Secondary endpoints included duration of response (DOR) as assessed by investigator, CA-125 response, safety and tolerability, progression-free survival (PFS), overall survival (OS); ORR, DOR, and PFS by blinded independent central review were sensitivity analyses. Data from SORAYA were first presented at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting; the updated analyses to be presented at ASCO (Free ASCO Whitepaper) are based on the 120-day cut-off date of April 29, 2022.

ORR by investigator was 32.4% (95% confidence interval [CI]: 23.6%, 42.2%), including 5 complete responses. Median time to response was 1.5 months (range 1.0 to 5.6) and 71.4% of patients demonstrated tumor reduction.
The disease control rate (DCR), defined as complete response (CR), partial response, or stable disease maintained for ≥12 weeks, was 51.4%.
The median DOR was 6.9 months (95% CI: 5.6, 9.7) by investigator, with 5 responders continuing on mirvetuximab as of April 29, 2022.
The median PFS assessed by investigator was 4.3 months (95% CI: 3.7, 5.2).
The preliminary median OS was 13.8 months, with 54% of the evaluable patient population event-free.
In the sensitivity analyses by blinded independent central review, outcomes were similar: ORR 30.2% (95% CI: 21.3%, 40.4%) with 6 CRs; mDOR not reached (95% CI: 5.0, NR); mPFS 5.5 months (95% CI: 3.8, 6.9).
In responders, depth and duration of response did not appear to be affected by dose reductions.
Mirvetuximab was well-tolerated, consistent with previous studies. The most common treatment-related adverse events (TRAE) included blurred vision (41% all grade, 6% grade 3+), keratopathy (29% all grade, 9% grade 3+), and nausea (29% all grade, 0% grade 3+).
TRAEs generally resolved with supportive care or, if needed, dose modifications; the discontinuation rate due to TRAEs was 9%.
Kaplan-Meier plots for PFS and OS to be included in poster.
"I believe these additional analyses from SORAYA further support mirvetuximab’s potential to become the first biomarker-directed agent indicated for patients with platinum-resistant ovarian cancer," said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. "The tumor reduction observed in over 70% of patients, along with the PFS curve and the preliminary median overall survival of 13.8 months, are impressive. If approved, I look forward to being able to offer mirvetuximab to my patients and continuing to support its further development in patients with ovarian cancer."

INTEGRATED SAFETY SUMMARY OF SINGLE-AGENT MIRVETUXIMAB SORAVTANSINE
This retrospective pooled analysis included 464 patients with FRα-positive, recurrent ovarian cancer across three studies: a Phase 1 first-in-human trial, the Phase 3 FORWARD I trial, and the pivotal Phase 3 SORAYA trial.

Mirvetuximab monotherapy has a differentiated safety profile consisting primarily of low-grade gastrointestinal and ocular events; adverse events generally resolved and were managed with supportive care and, if needed, dose modifications. The discontinuation rate due to TRAEs was 7%.
The most common TRAEs included blurred vision (42% all grade, 3% grade 3+), nausea (40% all grade, 2% grade 3+), diarrhea (33% all grade, 2% grade 3+), fatigue (31% all grade, 2% grade 3+), keratopathy (26% all grade, 3% grade 3+), and dry eye (22% all grade, 1% grade 3+).
Mirvetuximab monotherapy did not result in any corneal ulcers or perforations, and no patients had permanent ocular sequelae.
The majority of patients with ocular events did not require dose delay or dose reduction; <1% of patients discontinued mirvetuximab due to an ocular event.
"Having personally treated over 100 patients with mirvetuximab, I have helped my colleagues better understand how to manage the associated ocular events," said Kathleen Moore, Director of the Oklahoma TSET Phase I Program, Professor of the Section of Gynecologic Oncology at The University of Oklahoma College of Medicine, and MIRASOL Principal Investigator. "With prevention and mitigation strategies in place, patients presenting with ocular events have been able to complete their treatment, maintain their responses, and had no permanent sequelae from these events. These data demonstrate mirvetuximab’s differentiated safety profile and I look forward to the potential approval and launch later this year."

POSTER SESSION DETAILS
The following posters will be available on Saturday, June 4 in the ASCO (Free ASCO Whitepaper) Meeting Library:

Additional information can be found at www.asco.org.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

On May 26, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing therapies that combine both targeted and immune-mediated mechanisms, reported positive results from its Phase 1 clinical trial of TPST-1120, a first-in-class1 PPARα antagonist, as a single agent and in combination with nivolumab in patients with advanced solid tumors (Press release, Tempest Therapeutics, MAY 26, 2022, View Source [SID1234615104]). The results will be presented in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL, by Mark Yarchoan, M.D., associate professor of oncology at Johns Hopkins School of Medicine.

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Dr. Yarchoan commented, "The anti-cancer activity observed in these late-stage solid tumor patients is encouraging, particularly in light of their treatment history and the difficult nature of the tumor types. Based on the clinical activity observed with monotherapy, and the responses observed with combination therapy in patients with prior progression on checkpoint inhibitor therapy, a tolerable safety profile and distinct mechanism of action, I see significant potential in multiple tumor types and look forward to the ongoing development of TPST-1120."

Sam Whiting, chief medical officer of Tempest, added, "We are excited to see these positive TPST-1120 results in Tempest’s first presentation of clinical data, especially given the advanced stage and treatment histories of these patients. We look forward to presenting these data at ASCO (Free ASCO Whitepaper) and the continued development of TPST-1120 in the ongoing first-line randomized study in patients with hepatocellular carcinoma."

_______________
1 If approved by the FDA

TPST-1120 Monotherapy Results

In the monotherapy portion of the trial, 19 patients with late-line treatment-refractory solid tumors, including pancreatic, cholangiocarcinoma (CCA), and colorectal cancers, were treated with oral twice-daily TPST-1120. The results showed that 53% (10/19) of patients experienced clinical benefit in the form of disease control, including tumor shrinkage in 21% of the patients. Two patients with late-line CCA, an aggressive tumor type and disease setting usually unresponsive to therapy, including IO therapies, achieved durable stable disease and one of the patients achieved durable tumor shrinkage.

TPST-1120 and Nivolumab Combination Therapy Results

In the combination therapy portion of the trial, 15 patients with heavily-pretreated renal cell carcinoma (RCC), hepatocellular carcinoma (HCC) and CCA were treated with oral twice-daily TPST-1120 and the anti-PD-1 therapy, nivolumab. All of the HCC and RCC patients had received an approved anti-PD-1 therapy in at least one prior line of therapy and discontinued that treatment due to disease progression. Promising objective responses (RECIST v1.1) were observed in two patients with late-line RCC who had previously progressed on anti-PD-1 therapy without an objective response (ORR 50%, n=2/4, in evaluable RCC patients). A third RECIST response was observed in a patient with late-line, heavily pre-treated CCA, a tumor type generally not responsive to anti-PD-1 alone.

Notably, all three responders were treated at the two highest doses of TPST-1120 (ORR 30%, 3/10).

Safety

TPST-1120 was well tolerated as both a monotherapy and in combination with nivolumab. The majority of the treatment-related adverse events were Grade 1 and 2, and included nausea, fatigue and diarrhea. No dose-limiting toxicities were reported during dose escalation.

ASCO Events

Presentations Details

Title: A phase 1 study of TPST-1120 as a single agent and in combination with nivolumab in subjects with advanced solid tumors

Session Typer/Title: Oral Abstract Session, Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Tuesday, June 7, 2022; 9:45 a.m. – 12:45 p.m. CDT
Abstract Number: 3005

Title: A phase 1 study of TPST-1495 as a single agent and in combination with pembrolizumab in subjects with solid tumors

Session Type/Title: Poster Session, Developmental Therapeutics – Immunotherapy
Session Date and Time: Sunday, June 5, 2022; 8:00 a.m. – 11:00 a.m. CDT
Abstract Number: TPST2696

Tempest Investor Event

Tempest will host and webcast an investor event in conjunction with the ASCO (Free ASCO Whitepaper) Annual meeting on Sunday, June 5, 2022 at 6:30 a.m. CDT. Company management will be joined by key thought leaders:

Mark Yarchoan, M.D.
Associate Professor of Oncology
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Susanna V. Ulahannan, M.D., MMEd
Assistant Professor of Medicine
Associate Director, Oklahoma TSET Phase 1 Program
Stephenson Cancer Center at the University of Oklahoma

Jason Luke, M.D.
Associate Professor of Medicine
Director – Immunotherapy and Drug Development Center
UPMC Hillman Cancer Center

Toni K. Choueiri, M.D.
Director, Lank Center for Genitourinary Oncology, Dana Farber Cancer Institute
Jerome and Nancy Kohlberg Chair and Professor of Medicine,
Harvard Medical School

To access the live or archived recording of the investor event, please visit the investor section of the Tempest website at View Source

About TPST-1120

TPST-1120 is a first-in-class2 oral selective PPAR⍺ antagonist with a dual mechanism designed to target both tumor cells directly and suppressive immune cells in the tumor microenvironment. Both types of targeted cells are dependent on fatty acid metabolism, which is regulated by the PPAR⍺ transcription factor. In extensive non-clinical studies, TPST-1120 as a monotherapy and in combination with other anti-cancer drugs resulted in significant reductions in tumor growth and stimulation of durable anti-tumor immunity. In addition to the study being presented at ASCO (Free ASCO Whitepaper), in collaboration with F. Hoffmann La Roche, TPST-1120 is also advancing through a randomized, first-line, global, Phase 1b/2 clinical study in combination with the standard-of-care regimen of atezolizumab and bevacizumab in patients with advanced or metastatic hepatocellular carcinoma.

On May 26, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will be participating in the following investor conferences (Press release, Guardant Health, MAY 26, 2022, View Source [SID1234615120]).

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William Blair 42nd Annual Growth Stock Conference in Chicago, IL
Presentation on Tuesday, June 7th at 11:20 a.m. Central Time
Goldman Sachs 43rd Annual Global Healthcare Conference in Rancho Palos Verdes, CA
Fireside Chat on Tuesday, June 14 th at 9:20 a.m. Pacific Time
Interested parties may access live and archived webcasts of the sessions on the "Investors" section of the company website at: www.guardanthealth.com.

On May 26, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the publication of two abstracts on neratinib to be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Puma Biotechnology, MAY 26, 2022, View Source [SID1234615136]). The ASCO (Free ASCO Whitepaper) Annual Meeting will be held in person at McCormick Place in Chicago, Illinois, and online from June 3 – 7, 2022. The corresponding abstracts of the two posters that Puma will be presenting are now live on the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting website. The full posters will be available on the Puma website following the presentations.

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Full abstracts of the following posters are available online at: ASCO (Free ASCO Whitepaper).org/abstracts.

Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Abstract 4079: Targeting HER2 mutation-positive advanced biliary tract cancers with neratinib: final results from the phase 2 SUMMIT ‘basket’ trial
JJ Harding, S Piha-Paul, RH Shah, JM Cleary, D Quinn, I Braña, V Moreno, M Borad, S Loi, I Spanggaard, J Ford, D DiPrimeo, MF Berger, LD Eli, F Meric-Bernstam, DB Solit, GK Abou-Alfa
Presenter: James J. Harding, MD | Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College
Date/Time: June 4, 2022, at 9:00 am ET
Poster Session: Breast Cancer—Metastatic

Abstract 1028: Neratinib plus fulvestrant plus trastuzumab (N+F+T) for hormone receptor-positive (HR+), HER2-negative, HER2-mutant metastatic breast cancer (MBC): Outcomes and biomarker analysis from the SUMMIT trial
K Jhaveri, JW Goldman, SA Hurvitz, A Guerrero-Zotano, N Unni, A Brufsky, H Park, J Waisman, ES Yang, I Spanggaard, S Reid, M Burkard, A Prat, S Loi, J Crown, A Hanker, C Ma, R Bose, LD Eli, H Wildiers
Presenter: Komal L. Jhaveri, FACP, MD | Memorial Sloan Kettering Cancer Center
Date/Time: June 6, 2022, at 9:00 am ET

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.