TIDMGSK

RNS Number : 0425K

GlaxoSmithKline PLC

23 August 2019

Issued: 23 August 2019, London UK

GSK announces positive headline results from the pivotal DREAMM-2 study for multiple myeloma

Belantamab mafodotin (GSK2857916) on track for regulatory submission by the end of 2019

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916).

The 196 patients in the trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The two-arm study met its primary objective and demonstrated a clinically meaningful overall response rate with belantamab mafodotin in the patient population. The safety and tolerability profile was consistent with that observed in DREAMM-1, the first time in human study of belantamab mafodotin.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said: "I am pleased with the results of the DREAMM-2 study and excited about what these data could mean for patients with multiple myeloma who have exhausted other lines of treatment. We are on track to file belantamab mafodotin later this year and continue to investigate how it could help even more patients with this disease."

Data from the DREAMM-2 study will be the basis for regulatory filings starting later this year.

Multiple myeloma is the second most common blood cancer and is generally considered treatable, but not curable([i]) . Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.

Safety and efficacy results from the DREAMM-2 study will be submitted for presentation at an upcoming scientific meeting. Additional ongoing studies are testing the effect of belantamab mafodotin as third-line monotherapy in relapsed/refractory multiple myeloma and as a combination treatment in the first and second line setting as part of the broader DREAMM clinical development programme.

About B-cell maturation antigen (BCMA)

The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines([ii]) .

About the DREAMM clinical trial programme for belantamab mafodotin (GSK2857916)

Belantamab mafodotin is an immuno-conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using technology licensed from BioWa.

Belantamab mafodotin is currently being investigated in patients with multiple myeloma.

 
 Trial Name      GSK ID/NCT            Status            Design 
                  ID 
 DREAMM-1        117159/ NCT02064387   Active,           A Phase I Open-label Study to 
                                        not recruiting    Investigate the Safety, Pharmacokinetics, 
                                                          Pharmacodynamics, Immunogenicity 
                                                          and Clinical Activity of Belantamab 
                                                          Mafodotin (GSK285791) in Subjects 
                                                          with Relapsed/Refractory Multiple 
                                                          Myeloma and Other Advanced Hematologic 
                                                          Malignancies Expressing BCMA 
                --------------------  ----------------  ------------------------------------------- 
 DREAMM-2        205678/ NCT03525678   Active,           A Study to Investigate the Efficacy 
                                        not recruiting    and Safety of Two Doses of Belantamab 
                                                          Mafodotin (GSK2857916) in Subjects 
                                                          with Relapsed/Refractory Multiple 
                                                          Myeloma Who are Refractory to 
                                                          a Proteasome Inhibitor and an 
                                                          Immunomodulatory Agent and Have 
                                                          Failed Prior Treatment with 
                                                          an Anti-CD38 Antibody 
                --------------------  ----------------  ------------------------------------------- 
 DREAMM-3        207495                Planned           A Phase III Open-Label, Randomized 
                                                          Study to Evaluate the Efficacy 
                                                          and Safety of Belantamab Mafodotin 
                                                          (GSK2857916) Compared to Pomalidomide 
                                                          plus low-dose Dexamethasone 
                                                          (Pom/Dex) in Participants with 
                                                          Relapsed/Refractory Multiple 
                                                          Myeloma 
                --------------------  ----------------  ------------------------------------------- 
 DREAMM-4        205207/ NCT03848845   Recruiting        A Phase I/II Single Arm Open-Label 
                                                          Study to Explore Safety and 
                                                          Clinical Activity of Belantamab 
                                                          Mafodotin (GSK2857916) Administered 
                                                          in Combination with Pembrolizumab 
                                                          in Subjects with Relapsed/Refractory 
                                                          Multiple Myeloma 
                --------------------  ----------------  ------------------------------------------- 
 DREAMM-5        208887                Planned           A Phase I/II, Randomized, Open-label 
                                                          Platform Study of Belantamab 
                                                          Mafodotin (GSK2857916) with 
                                                          Innovative Combination Anti-Cancer 
                                                          Treatments in Participants with 
                                                          Relapsed/Refractory Multiple 
                                                          Myeloma 
                --------------------  ----------------  ------------------------------------------- 
 DREAMM-6        207497/ NCT03544281   Recruiting        A Phase I/II Randomized Study 
                                                          to Evaluate Safety, Tolerability 
                                                          and Clinical Activity of Belantamab 
                                                          Mafodotin (GSK2857916) Administered 
                                                          in Combination with Lenalidomide 
                                                          plus Dexamethasone (Arm A), 
                                                          or in Combination with Bortezomib 
                                                          plus Dexamethasone (Arm B) in 
                                                          Subjects with Relapsed/Refractory 
                                                          Multiple Myeloma 
                --------------------  ----------------  ------------------------------------------- 
 DREAMM-7        207503                Planned           A Phase III Study of Belantamab 
                                                          Mafodotin (GSK2857916) Administered 
                                                          in Combination with Bortezomib 
                                                          plus Dexamethasone versus Daratumumab, 
                                                          Bortezomib, and Dexamethasone 
                                                          in participants with relapsed/refractory 
                                                          multiple myeloma 
                --------------------  ----------------  ------------------------------------------- 
 DREAMM-8        207499                Planned           A Phase III, Multicentre, Open-Label, 
                                                          Randomized Study to Evaluate 
                                                          the Efficacy and Safety of Belantamab 
                                                          Mafodotin (GSK2857916) in Combination 
                                                          with Pomalidomide plus Low-Dose 
                                                          Dexamethasone (BPd) versus Pomalidomide 
                                                          plus Bortezomib and Low-Dose 
                                                          Dexamethasone (PVd) in Participants 
                                                          with Relapsed/Refractory Multiple 
                                                          Myeloma 
                --------------------  ----------------  ------------------------------------------- 
 DREAMM-9        209664                Planned           A Phase III Study of Belantamab 
                                                          Mafodotin (GSK2857916) Administered 
                                                          in Combination with Bortezomib 
                                                          plus Lenalidomide and Low-Dose 
                                                          Dexamethasone (VRd) vs. VRd 
                                                          in Participants with Newly Diagnosed 
                                                          Multiple Myeloma who are Ineligible 
                                                          for Transplant 
                --------------------  ----------------  ------------------------------------------- 
 DREAMM-10       207500                Planned           A Phase III Study of Belantamab 
                                                          Mafodotin (GSK2857916) Administered 
                                                          in Combination with a Novel 
                                                          Agent versus SoC 
                --------------------  ----------------  ------------------------------------------- 
 ISS / GSK       209418                Recruiting        A Phase I/II Dose-escalation 
  Co-Sponsored                                            and Dose-expansion Study of 
  Study                                                   Belantamab Mafodotin (GSK2857916) 
                                                          Administered in Combination 
                                                          with Pomalidomide plus Low-dose 
                                                          Dexamethasone in Patients with 
                                                          Relapsed/Refractory Multiple 
                                                          Myeloma Who Have Received Two 
                                                          or More Prior Lines of Therapy 
                                                          That Must Have Included Lenalidomide 
                                                          and a Proteasome Inhibitor 
                --------------------  ----------------  ------------------------------------------- 
 

Belantamab mafodotin is not currently approved for use anywhere in the world.

GSK in Oncology

GSK is focused on maximizing patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics 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 cells, either alone or in combination.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.

[i] https://www.cancer.net/cancer-types/multiple-myeloma/statistics Last accessed August 2019.

[ii] Robert O. Carpenter, Moses O. Evbuomwan, [...], and James N. Kochenderfer. B-cell Maturation Antigen is a Promising Target for Adoptive T-cell Therapy of Multiple Myeloma. Clin Can Res

 
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