REG - GSK PLC - GSK presents positive DREAMM-7 phase III data

GSKAnnouncement

06/02/2024 07:00

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RNS Number : 0840C  GSK PLC  06 February 2024

Issued: 5 February 2024, London UK

 

DREAMM-7 phase III trial shows Blenrep combination nearly tripled median
progression-free survival versus standard of care combination in patients with
relapsed/refractory multiple myeloma

 

·   59% reduction in risk of disease progression or death observed in
patients with Blenrep combination versus standard of care daratumumab
combination

·   36.6 months of median progression-free survival observed with Blenrep
combination versus 13.4 months in daratumumab combination

·   Strong, clinically meaningful trend in overall survival favouring
Blenrep combination was observed with 43% reduction in risk of death

 

 

GSK plc (LSE/NYSE: GSK) today announced results from an interim analysis of
the DREAMM-7 phase III head-to-head trial evaluating Blenrep (belantamab
mafodotin) combined with bortezomib plus dexamethasone (BorDex) versus
daratumumab plus BorDex in second-line and later treatment of relapsed or
refractory multiple myeloma. These data will be presented at the American
Society of Clinical Oncology (ASCO) Plenary Series on 6 February 2024.

 

In the primary endpoint of progression-free survival (PFS), a statistically
significant and clinically meaningful improvement was observed with the
belantamab mafodotin combination (n=243), showing a 59% reduction in the risk
of disease progression or death (hazard ratio  HR : 0.41 [95% confidence
interval (CI): 0.31-0.53], p-value<0.00001) compared to the daratumumab
combination (n=251). With a median follow-up of 28.2 months, the median PFS
was 36.6 months (95% CI: 28.4-not reached  NR ) with the belantamab mafodotin
combination compared to 13.4 months (11.1-17.5) in the daratumumab
combination. The PFS effect was observed across all prespecified subgroups,
including those who were refractory to lenalidomide and those with high-risk
cytogenetics. The safety and tolerability profile of the belantamab mafodotin
combination was consistent with the known profile of the individual agents.

 

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK,
said: "The substantial progression-free survival benefit and strong overall
survival trend compared to a daratumumab standard of care combination
reinforce our belief in the potential for belantamab mafodotin used in
combination to redefine the treatment of multiple myeloma at or after first
relapse. We plan on sharing these results with health authorities worldwide."

 

The belantamab mafodotin combination also resulted in clinically meaningful
improvements in all secondary efficacy endpoints including a doubling of
complete response rate (stringent complete response plus complete response),
minimal residual disease (MRD) negativity rate and median duration of response
(DOR). A strong and clinically meaningful overall survival (OS) trend was
observed at the interim analysis, with a 43% reduction in the risk of death
(HR: 0.57 [95% CI: 0.40-0.80], p-value=0.00049), which has not yet reached the
interim criteria for statistical significance of OS. OS follow-up continues
and further analyses are planned.

 

María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit,
Haematology Department and Professor of Medicine at the University of
Salamanca, Spain, and DREAMM-7 principal investigator, said: "These results
from DREAMM-7 show how belantamab mafodotin in combination with BorDex
represents a significant improvement over the daratumumab-based regimen in a
second-line multiple myeloma treatment setting. Anti-BCMA therapies are
helping to improve outcomes for patients with multiple myeloma, and having an
off-the-shelf option, like belantamab mafodotin, that can be administered in a
community oncology treatment centre where the majority of patients are treated
has the potential to transform the way we treat myeloma at or after first
relapse."

 

Key secondary endpoint summaries are listed below.

 

 Key Secondary Endpoints
 Endpoint                              belantamab mafodotin + BorDex  daratumumab + BorDex

                                       (n= 243)                       (n=251)
 ORR (overall response rate) (95% CI)  82.7% (77.4-87.3)              71.3% (65.3-76.8)
 sCR (stringent complete response)     14.0%                          5.2%
 CR (complete response)                20.6%                          12.0%
 Very good partial response            31.3%                          29.1%
 Partial response                      16.9%                          25.1%
 MRD negativity rate* (95% CI)         24.7 (19.4, 30.6)              9.6 (6.2, 13.9)
    P-value                            p<0.00001(#)
 Median DOR (95% CI)**                 35.6 months (30.5-NR)          17.8 months (13.8-23.6)
 Overall survival
   HR (95% CI)                         0.57 (0.40-0.80)

                                     p=0.00049***
   P-value ***

* Measured in patients with a sCR or CR.

** An Intent-to-treat restricted mean DOR (RMDoR) analysis comparing DOR
between arms showed a statistically significant benefit in favour of the
belantamab mafodotin combination (p < 0.00001).

*** Has not yet reached criteria for statistical significance (p ≤ 0.00037)
of OS at this interim. Follow-up for OS is ongoing.

(#)Nominal p-value

 

Grade 3 or higher non-ocular adverse events of clinical interest in the
belantamab mafodotin combination and daratumumab combination arms,
respectively, included thrombocytopenia (55% and 35%; exposure-adjusted event
rate: 40 and 29, per 100 person-years), neutropenia (12% and 6%), pneumonia
(12% and 4%; exposure-adjusted event rate: 8 and 3, per 100 person-years), and
anaemia (8% and 10%).

 

Eye-related side effects, a known risk of treatment with belantamab mafodotin,
were generally reversible, manageable with dose modification, and led to low
(9%) treatment discontinuations. Grade 3 or higher ocular adverse events
occurred in 34% of patients receiving the belantamab mafodotin combination and
primarily included blurred vision (22%), dry eye (7%), eye irritation (5%),
and visual impairment (5%). Eighty-two patients (34%) with a best corrected
visual acuity (BCVA) score of 20/25 or better in at least one eye at baseline
had a worsening in both eyes to 20/50 or worse. Almost all these patients'
events (98%) had resolved at the time of this analysis. The median time to
resolution was 22 days.

 

Global health status quality of life (QOL) as measured by the EORTC-QLQ-C30
indicated no difference in global QOL between different treatment arms over
time.

 

The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical
development programme continues to evaluate the potential of belantamab
mafodotin in early lines of treatment and in combination with novel therapies
and standard of care treatments. This includes the ongoing phase III DREAMM-8
trial evaluating belantamab mafodotin in combination with pomalidomide and
dexamethasone versus bortezomib in combination with pomalidomide and
dexamethasone. DREAMM-8 data are expected in the second half of 2024.

 

About DREAMM-7

The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised
trial evaluating the efficacy and safety of belantamab mafodotin in
combination with bortezomib and dexamethasone (BorDex) compared to a
combination of daratumumab and BorDex in patients with relapsed/refractory
multiple myeloma who previously were treated with at least one prior line of
multiple myeloma therapy, with documented disease progression during or after
their most recent therapy.

 

A total of 494 participants were randomised at a 1:1 ratio to receive either
belantamab mafodotin in combination with BorDex or a combination of
daratumumab and BorDex. Belantamab mafodotin was scheduled to be dosed at
2.5mg/kg intravenously every three weeks.

 

The primary endpoint is PFS as per an independent review committee. The key
secondary endpoints include OS, DOR, and MRD negativity rate as assessed by
next-generation sequencing.

 

About multiple myeloma

Multiple myeloma is the third most common blood cancer globally and is
generally considered treatable but not curable.(1,2) There are approximately
176,000 new cases of multiple myeloma diagnosed globally each year.(3)
Research into new therapies is needed as multiple myeloma commonly becomes
refractory to available treatments.(4)

 

About Blenrep

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

 

Refer to the Blenrep EMA Reference Information
(https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep) for a full list of
adverse events and the complete important safety information in the EU.

 

GSK in oncology

Oncology is an emerging therapeutic area for GSK where we are committed to
maximising patient survival with a current focus on haematologic malignancies,
gynaecologic cancers and other solid tumours through breakthroughs in
immuno-oncology and tumour-cell targeting therapies.

 

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.

 

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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 under
Item 3.D "Risk factors" in the company's Annual Report on Form 20-F for 2022,
and Q4 Results for 2023.

 

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References

(1) Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics 2020: GLOBOCAN
Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185
Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660.

(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) Multiple Myeloma: Statistics. Cancer.net. Published February 2022.
https://www.cancer.net/cancer-types/multiple-myeloma/statistics#:~:text=This%20year%2C%20an%20estimated%2034%2C470,with%20multiple%20myeloma%20in%202020.
Accessed 19 October 2023.

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

 

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