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Over a thousand people with multiple myeloma may be eligible for treatment with Nexpovio▼ (selinexor) following NICE recommendation addressing ‘significant unmet need’ for this incurable blood cancer

April 22, 2024 – Biotechnology, Pharmaceutical – Menarini Group, Menarini Stemline UK, NICE, multiple myeloma

NEXPOVIO has been recommended for use in the NHS, offering the opportunity to improve patient outcomes in this challenging and complex cancer
NEXPOVIO has the potential to address significant treatment pathway gaps due to a novel treatment mechanism of action
Multiple myeloma is one of the most common blood cancers in the UK.

23 April 2024 — London, UK — Menarini Stemline UK today welcomed the publication of final draft guidance from the National Institute for Health and Care Excellence (NICE) recommending the use of NEXPOVIO (selinexor), in combination with bortezomib and dexamethasone, as a treatment for eligible multiple myeloma patients who have received 1 or 2 prior treatments. This guidance follows recent NICE guidance recommending NEXPOVIO, in combination with dexamethasone, for eligible myeloma patients who have had four or more prior treatments. These recommendations address significant gaps at three critical points in the treatment pathway, meaning hundreds of patients may now be eligible for a treatment that has the potential to delay the progression of this cancer and prolong survival.

Today’s guidance states that NEXPOVIO is recommended for patients who have had 1 previous line of treatment and who are refractory to both daratumumab and lenalidomide or who have had 2 previous lines of treatment and are refractory to lenalidomide. The recent guidance recommends NEXPOVIO for patients whose disease has progressed after 4 or more previous lines of treatment and who are refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents and an anti-CD38 monoclonal antibody.

“This decision is a remarkable step forward in addressing significant unmet needs in myeloma,” said Dr Neil Rabin, consultant haematologist at University College London Hospitals, UK. “Being able to use different treatments that work in a variety of ways is critically important to help evade and overcome the cancer’s defence mechanisms. Today’s news has enabled just that and means we now have a new way to treat this complex and challenging blood cancer.”

Despite advances in treatment, multiple myeloma (often referred to as ‘myeloma’) remains incurable in the majority of patients; most patients relapse and will require multiple lines of treatment. Therefore, it is critical to have as many different treatment options as possible that target the cancer cells in different ways to maximise the possibility of patients responding to treatment, and helping keep the cancer at bay.

Myeloma is one of the most common forms of blood cancer in the UK, with over 4,500 new patients diagnosed each year. The majority of people with myeloma will be diagnosed after the age of 65, however, many patients can be diagnosed much younger. Around half (49.6%) of patients are still alive five years after their diagnosis.

“This is a hard-earned victory for everyone involved and a major step in the right direction for the myeloma community. This treatment’s novel mechanism of action means it can help fight myeloma in a completely different way to other currently available treatments. Until we have a cure, it is absolutely vital that all patients are given as many options to tackle their cancer as possible – no matter where they are on their treatment journey,” said Shelagh McKinlay, director of Research and Advocacy at Myeloma UK.

NEXPOVIO works by restoring some of the body’s own anti-cancer defence mechanisms. It does this by making sure that certain proteins that suppress tumour growth are kept within the nucleus of the cell where they can prevent the cancer cell from growing uncontrollably. Specifically, NEXPOVIO blocks the action of a protein, called exportin 1 (XPO1). XPO1 is found in high amounts in myeloma cells and, when left unchecked, takes critical tumour-prevention proteins out of the nucleus where they have little effect.

“Today’s announcement is a significant development for the myeloma community and shows what is possible with true collaboration between industry, NICE and the myeloma patient and physician community,” said Rick Coope, general manager at Menarini Stemline UK. “We are incredibly proud that in Menarini Stemline’s first engagement with NICE, we have successfully reached an agreement for two appraisals – and three lines of therapy – in such a short period of time. Now, our focus shifts to obtaining equal access to NEXPOVIO across the UK and progressing research to bring further innovation to patients with haematological and oncological conditions.”

About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.4bn and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation and analgesia. With 18 production sites and 9 Research and Development centres, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com.