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

London, United Kingdom (Press Release) – 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/about-us.

Cautionary state­ments re­gard­ing for­ward-looking state­ments

GSK cautions in­vestors that any for­ward-looking state­ments or pro­jec­tions made by GSK, in­clud­ing those made in this an­nouncement, are subject to risks and un­cer­tainties that may cause actual re­­sults to differ ma­teri­ally from those pro­jected. Such factors in­clude, but are not lim­ited to, those described under Item 3.D Prin­ci­pal risks and un­cer­tainties in the com­pany's Annual Report on Form 20-F for 2018.

Source: GlaxoSmithKline.