Good news for Scottish patients as cutting-edge treatments SVD and SD are approved
Two cutting-edge treatments that could give patients at second line and beyond remissions of up to 13 months have been approved in Scotland.
Both SVD and SD target myeloma in an entirely new way and will be rolled out on the NHS in Scotland over the coming weeks.
The Scottish Medicines Consortium (SMC) approved SVD – selinexor (Nexpovio®), bortezomib (Velcade®) and dexamethasone – for people at second line and beyond whose myeloma has become resistant to lenalidomide (Revlimid®) and for whom an anti-CD38 monoclonal antibody like daratumumab (Darzalex®) is not a viable option.
Evidence to support selinexor plus bortezomib and dexamethasone came from the phase 3, randomised, open-label BOSTON trial which compared SVD to VD (bortezomib and dexamethasone). The company presented data from a post-hoc analysis of the lenalidomide-refractory patients (n=106) which resulted in a hazard ratio 0.52 (95% confidence interval [CI]: 0.31 to 0.88) and showed improvements in progression free survival (PFS) (10.2 months for SVD versus 7.1 months for SD).
The SMC also approved SD for patients at fifth line and beyond. SD will be available to people who have received at least four treatments and whose myeloma has become resistant to a minimum of two proteasome inhibitors – e.g. bortezomib, carfilzomib (Krypolis®) or ixazomib (Ninlaro®) – as well as two immunomodulatory agents such as lenalidomide, thalidomide or pomalidomide (Imnovid®) and an anti-CD38 monoclonal antibody like daratumumab (Darzalex®) or isatuximab (Ninlaro®).
Scott Purdon, Head of Patient Advocacy at Myeloma UK, said:
“This is fantastic news and a major step in the right direction for the myeloma community. Selinexor’s novel mechanism of action means it can fight myeloma in a completely different way to other currently available treatments. SD in particular will make a huge difference to people who have exhausted nearly all other avenues and were facing the prospect of end-of-life care.
“We are hugely grateful to the Scottish Medicines Consortium for working with us and listening to people living with myeloma. The SMC has shown a great deal of flexibility with this decision and has put patient need front and centre from the word go.
“Until we have a cure, it is absolutely vital that all patients are given as many options to control their disease as possible – no matter where they are on their treatment journey.”
Evidence to support selinexor plus dexamethasone came from the phase 2, single-arm, open-label, STORM trial. The final analysis showed that SD resulted in an overall response rate of 25%, in penta-refractory myeloma patients. The median PFS was 2.8 months and the median overall survival 8.4 months.
Selinexor is a new type of drug known as a selective inhibitor of nuclear export (SINE). It tackles myeloma in a completely different way to currently approved drugs and provides an alternative for patients who have relapsed multiple times or do not respond to available treatments.
Selinexor stops a protein called Exportin 1 (XPO1) from working properly. XPO1 is responsible for moving other proteins between different parts of the cell. Myeloma cells exploit XPO1 to get rid of proteins, called tumour suppressor proteins, which would stop them growing and multiplying.
By blocking XPO1, the tumour suppressor proteins build up within the myeloma cells, killing them.
What do these decisions mean for patients?
The approvals mean the drug selinexor is available to eligible myeloma patients as potential treatment option in Scotland.
Patients whose myeloma has become resistant to lenalidomide and an anti-CD38 monoclonal antibody like daratumumab can now receive selinexor in combination with bortezomib and dexamethasone at first relapse (second line) and beyond.
Patients whose myeloma has become resistant to two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody can now receive selinexor in combination with dexamethasone at fourth relapse (fifth line) and beyond.
This means patients whose myeloma has become resistant to previous myeloma treatments access to an innovative treatment which kills the myeloma cells in a new way.
Does this decision affect patients based in England, Wales and Northern Ireland?
In England, the National Institute for Health and Care Excellence makes decisions about which treatments to fund through the NHS. NICE approved selinexor for use on the NHS earlier this year.
In Wales, decisions about which treatments to fund through the NHS are made by the All Wales Medicines Strategy Group (AWMSG) and NICE. As NICE has approved selinexor for use on the NHS, the treatments can be used in Wales.
In Northern Ireland, the Department for Health makes decisions on which treatments to fund through the NHS. It usually follows guidance issued by NICE.
Useful resources:
MHRA: Selinexor summary of product characteristics (SPC)
MHRA: Selinexor patient information leaflet (PIL)
Information for patients:
