KPTI

Selinexor

Multiple myeloma (Relapsed/Refractory) | BOSTON

FDA Decision of sNDA

Exp Date

Q1 2021

Amp Volatility Score

Catalyst Info & Data Links

COMPETITORS

  • Proteasome inhibitors (PIs):

               Velcade® (bortezomib)

                         Competitor Endeavor Trial (Velcade+Dex arm good benchmark for BOSTON results)

                         Endeavor Published Data

                         Endeavor Results Press Release

               Kyprolis® (carfilzomib)

  • Immunomodulatory agents (IMiDs):

               Revlimid® (lenalidomide)

               Pomylast® (pomalidomide)

  • Monoclonal antibodies (mAbs):

               Darzalex®(daratumumab)

               Empliciti® (elotuzumab)

               Belantamb mafodotin (GlaxoSmithKline)

  • Nuclear export inhibitor:

               XPOVIO® (selinexor):

                         is the only drug in this class and is currently approved in heavily pretreated patients

  • Anti-BCMA therapies

               See this Evaluate article

               CART-T

               Bispecific antibodies

MARKET

32,000 new multiple myeloma (MM) cases/yr in U.S. (2019)*

130,000 MM patients living with disease (2019)*

69,000 MM patients treated per yr (2019)**

31,000 1L

20,000 2L

12,00 3L

6,000 4L+

Earlier line - longer treatment

60,000+ patients not on active treatment or in long-term remission during 2019

Mid-single digit Increases in patient numbers annually (aging population & patients living longer      on treamtents)


*Source - Slide 23 of KPTI investor slide deck May 2020 

**Source - Slide 26 of KPTI investor slide deck May 2020

MECHANISM OF ACTION/RATIONALE

  • Nuclear export inhibitor

  • Inhibits XPO1 (see slide 5), which is believed to impact tumor cells in 3 ways

1. Increases nuclear levels and activation of tumor suppressor proteins 

2. Traps oncoprotein mRNA in the nucleus leading to reduced oncoprotein levels 

3. Retains activated glucocorticoid receptor in the nucleus

Last Updated by HC

KPTI, Selinexor, XPOVIO, multiple_myeloma, sNDA_filing_acceptance

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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