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Treatment Resistant Cancers02:56

Treatment Resistant Cancers

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Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
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Repurposing leflunomide for relapsed/refractory multiple myeloma: a phase 1 study.

Michael Rosenzweig1, Joycelynne Palmer2,3, Ni-Chun Tsai2

  • 1Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope, Duarte, CA, USA.

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|April 10, 2020
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Summary

Leflunomide, an immunomodulatory drug, showed a good safety profile in a Phase 1 trial for multiple myeloma (MM). Most patients achieved stable disease, suggesting potential for future MM treatment strategies.

Keywords:
Leflunomideclinical trialmultiple myelomarelapsed/refractory

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Area of Science:

  • Oncology
  • Immunology
  • Pharmacology

Background:

  • Leflunomide is an established immunomodulatory drug for rheumatoid arthritis.
  • Pre-clinical studies indicate leflunomide has activity against multiple myeloma (MM).

Purpose of the Study:

  • To evaluate the safety and tolerability of single-agent leflunomide in patients with relapsed/refractory multiple myeloma.
  • To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of leflunomide in this patient population.

Main Methods:

  • A Phase 1 clinical trial (NCT02509052) was conducted.
  • Patients with relapsed/refractory MM (≥3 prior therapies) received escalating doses of leflunomide (20, 40, and 60 mg).
  • Safety, tolerability, and disease response (stable disease - SD) were assessed.

Main Results:

  • No dose-limiting toxicities (DLTs) were observed at 20 mg and 40 mg leflunomide.
  • One patient at 60 mg experienced elevated alanine aminotransferase; no further DLTs occurred upon enrollment of three additional patients at this dose.
  • Toxicities were generally infrequent and manageable.
  • Nine out of 11 patients achieved stable disease (SD), with two experiencing SD for one year or longer.

Conclusions:

  • Single-agent leflunomide demonstrates a tolerable safety profile in patients with relapsed/refractory multiple myeloma.
  • The observed disease stabilization warrants further investigation of leflunomide.
  • Future studies may explore leflunomide in combination therapies or for smoldering MM progression delay.