GSK - positive results from pivotal DREAMM-2 study

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.

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