REG - GSK PLC - DREAMM-3 phase III trial for Blenrep

GSKAnnouncement

07/11/2022 07:01

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RNS Number : 4552F  GSK PLC  07 November 2022

Issued: 7 November 2022, London UK

 

GSK provides update on DREAMM-3 phase III trial for Blenrep in
relapsed/refractory multiple myeloma

 

 

GSK plc (LSE/NYSE: GSK) today announced that DREAMM-3, the phase III
open-label, randomised head-to-head superiority trial of Blenrep (belantamab
mafodotin) monotherapy versus pomalidomide in combination with low dose
dexamethasone (PomDex) in patients with relapsed or refractory multiple
myeloma (RRMM), did not meet its primary endpoint of progression-free survival
(PFS).

 

In the DREAMM-3 trial, the primary endpoint of PFS demonstrated a hazard ratio
(HR) of 1.03 (95% CI: 0.72 1.47). The observed median progression-free
survival was longer for belantamab mafodotin vs PomDex (11.2 months vs 7
months). Secondary endpoints include overall response rate (ORR), duration of
response (DOR) and overall survival (OS). The ORR was 41% for belantamab
mafodotin and 36% for PomDex. Belantamab mafodotin demonstrated a deeper
response rate when compared with PomDex (25% VGPR or better with belantamab
mafodotin compared to 8% with PomDex). The median follow-up was 11.5 months
for belantamab mafodotin and 10.8 months for PomDex; the median DOR was not
reached for belantamab mafodotin (95% CI: 17.9, --) vs 8.5 months (95% CI:
7.6, --) for PomDex; DOR rates at 12 months were 76.8% and 48.4% for
belantamab mafodotin and PomDex respectively. The safety and tolerability
profile of belantamab mafodotin was consistent with the known safety profile,
and no new safety signals were identified. Overall rates of grade 3
keratopathy are consistent with prior reported data.

 

At the time of the primary analysis, the OS data had only achieved 37.5%
overall maturity. The median OS was 21.2 and 21.1 months for belantamab
mafodotin and PomDex, respectively, with an HR of 1.14 (95% CI: 0.77, 1.68).

 

Blenrep was granted accelerated approval by the US Food and Drug
Administration (FDA) as a monotherapy for treating adult patients with RRMM
who have received at least four prior therapies, including an anti-CD38
monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
The accelerated approval was based on the results of the DREAMM-2 overall
response rate, DOR and contingent upon a confirmed clinical benefit from a
randomised phase III clinical trial. Data from DREAMM-3 is in the process of
being shared with health authorities. Discussions with health authorities are
currently ongoing.

 

Additional trials within the DREAMM (DRiving Excellence in Approaches to
Multiple Myeloma) clinical trial programme will continue. These trials are
designed to demonstrate the benefit of Blenrep in combination treatment with
novel therapies and standard-of-care treatments in earlier lines of therapy
and dosing optimisation to maintain efficacy while reducing corneal events.
Data from the DREAMM-7 and DREAMM-8 phase III trials are anticipated in the
first half of 2023.

 

About DREAMM-3

The DREAMM-3 phase III trial is an open-label, randomised trial evaluating the
efficacy and safety of single-agent belantamab mafodotin compared to PomDex in
patients with RRMM. A total of 325 participants were randomised in a 2:1 ratio
to receive either single agent belantamab mafodotin administered as a 2.5
mg/kg dose every three weeks (Q3W), or PomDex. Pomalidomide was administered
daily on days 1 to 21 of each 28-day cycle, with dexamethasone administered
once weekly (days 1, 8, 15, and 22 of each cycle). The primary endpoint was
PFS. Secondary endpoints include safety, OS, overall response rate, DOR and
assessment of minimal residual disease.

 

About DREAMM-7

DREAMM-7 is evaluating the safety and efficacy of belantamab mafodotin in
combination with bortezomib and dexamethasone versus daratumumab in
combination with bortezomib and dexamethasone.

 

About DREAMM-8

DREAMM-8 is assessing the efficacy and safety of belantamab mafodotin in
combination with pomalidomide and dexamethasone compared with that of a
combination of pomalidomide, bortezomib and dexamethasone in participants with
relapsed/refractory multiple myeloma.

 

About multiple myeloma

Multiple myeloma is the second most common blood cancer in the US and is
generally considered treatable, but not curable.(( 1 ))(,( 2 )) 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.(( 3 )) Research
into new therapies is needed as multiple myeloma commonly becomes refractory
to available treatments.(( 4 ))

 

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. 5 

 

About Blenrep

Blenrep is an antibody drug conjugate comprising a humanised BCMA monoclonal
antibody conjugated to the cytotoxic agent auristatin F via non-cleavable
linker. The drug linker technology is licensed from Seagen Inc.; monoclonal
antibody is produced using POTELLIGENT Technology licensed from BioWa Inc. a
member of the Kyowa Kirin Group.

 

GSK in oncology

GSK is focused on maximising patient survival through transformational
medicines. GSK's pipeline is focused on immuno-oncology, 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, and
antibody-drug conjugates, either alone or in combination.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com/company
(https://www.gsk.com/en-gb/about-us/) .

 

 

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Cautionary statement 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 in
the Company's Annual Report on Form 20-F for 2021, GSK's Q3 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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 1 CA: A Cancer Journal for Clinicians, Vol. 70, Issue 1, Han/Feb 2020 Pages
7-30.

 2  Kazandjian D. Multiple myeloma epidemiology and survival: A unique
malignancy. Semin Oncol. 2016;43(6):676-681.
doi:10.1053/j.seminoncol.2016.11.004.

 3  SEER Cancer Facts & Figures 2019. Available at:
https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed October 2021.

 4  Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and
refractory multiple myeloma. Blood. 2015;125(20).

 5  Lonial, S, et al. Belantamab mafodotin for relapsed or refractory multiple
myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet
Oncol. 2020; 21(2):207-21.

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