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NEXPOVIO (selinexor) - Multiple myeloma

Opinions on drugs - Posted on May 12 2023

Reason for request

Inclusion

First assessment.

Key points

Favourable opinion for reimbursement “in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose
disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression during the last therapy”.

Unfavourable opinion for reimbursement “in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy”.

 

Role in the care pathway?

In the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Considering:

  • Data is limited to comparison versus the bortezomib and dexamethasone combination, which is not the current standard of care as second-line therapy,
  • the evolution of the care pathway, with the inclusion of daratumumab from the first line of treatment and, consequently, a patient profile in the BOSTON study that differs from those patients seen in clinical practice in France,

The Committee deems that NEXPOVIO (selinexor) has no role in the care pathway for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

In the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease
progression on the last therapy.

NEXPOVIO (selinexor) in combination with dexamethasone is a fifth or later-line treatment option for relapsed and refractory multiple myeloma in patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

The exact role of the selinexor + dexamethasone combination versus the currently recommended regimens from the third line of treatment, in particular CAR-T therapies indicated from the fourth line of treatment is not known.


Clinical Benefit
Low

The clinical benefit of NEXPOVIO (selinexor) is low in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Insufficient

The clinical benefit of NEXPOVIO (selinexor) is insufficient in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy to justify public funding.

Clinical Added Value
no clinical added value

Considering:

  • efficacy data from a subgroup analysis in a phase 2b non-comparative study, with an overall response rate of 25.3% [CI95%: 16.4-36.0] on the ITT population, in a life-threatening situation;
  • uncertainties concerning the clinical relevance of the primary endpoint used (overall response rate) and its transposability to overall survival time or improvement of quality of life;
  • the absence of robust data on overall survival and quality of life,
  • the safety profile marked by the occurrence of grade ≥ 3 adverse events, serious adverse events, in particular haematologic adverse events, and numerous adverse events having led to dosage adjustment or interruption;
  • and despite the benefit of having access to a medicinal product having been assessed following the failure of prior therapy including two immunomodulatory agents, two proteasome inhibitors and an anti-CD38 antibody;

the Committee deems that NEXPOVIO (selinexor) 20 mg film-coated tablets provide no clinical added value (CAV V) in the treatment of adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Not applicable

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