KPT-330 in treatment of mCRPC

Earlier this year, Karyopharm Therapeutics initiated a Phase II clinical trial of KPT-330 in treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) who had progressed on treatment with drugs like abiraterone acetate and enzalutamide.

Last Monday, at the annual meeting of the European Society for Medical Oncology (ESMO) in Madrid, the company reported data from a Phase I trial of KPT-330 that included 15 men with mCRPC. Some of these data are available in a corporate media release.

Basically, in the Phase I trial, it appears that KPT-330 (also known as Selinexor), when used as a single agent, was able to

  • Lower PSA levels by 27 to 60 percent in a group of 15 men with chemotherapy-refractory mCRPC.
  • Among these patients
    • 9/15 patients (60 percent) achieved stable disease.
    • 2/15 patients (13 percent) had progressive disease.
    • 4/15 patients (27 percent) were not evaluable for response.
    • Time to progression ranged from 31 to 502 days on study.
  • KPT-330 was generally well-tolerated with manageable side effects (primarily including nausea, fatigue and anorexia).

KPT-330 is a first-in-class type of product known as an oral, selective inhibitor of nuclear export or SINE compound. It has also shown early signs of clinical activity in other solid tumors.

The Phase II trial announced earlier this year is enrolling up to 50 patients exclusively at the M. D. Anderson Cancer Center in Houston, Texas. Patients enrolled receive an initial oral dose of KPT-330 at 50 mg/m2 twice weekly (e.g., on  Monday and Wednesday each week) per cycle, and each full treatment cycle is 28 days.

There are no data as yet to suggest that treatment with KPT-330 is able to extend the survival of men with mCRPC that have already progressed on chemotherapy or on a drug like enzalutamide or abiraterone acetate.

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