ASCO-SITC 2019—Lenvatinib + pembrolizumab yields 25% ORR in advanced urothelial cancer


  • Melissa Pandika
  • Univadis
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Takeaway

  • Combination of lenvatinib and pembrolizumab showed activity in phase 1b/2 trial of advanced urothelial cancer patients.

Why this matters

  • Urothelial cancer accounts for >90% of bladder cancers.
  • Tyrosine kinase inhibitors such as lenvatinib, which has shown activity in urothelial cancer, may reverse immunosuppressive environment that results in immunotherapy failure.
  • Findings suggest further investigation of lenvatinib+pembrolizumab in this setting.

Study design

  • Phase 1b/2 multicenter, open-label study.
  • Metastatic urothelial cancer patients received lenvatinib 20 mg/day orally + pembrolizumab 200 mg/3 weeks intravenously.
  • Primary endpoint: Objective response rate (ORR) at week 24 based on immune-related RECIST (irRECIST).
  • Funding: Eisai Inc.

Key results

  • 20 patients enrolled at 3/1/2018 data cutoff.
    • 11 and 5 patients had received 1 and 2 lines of prior anticancer therapy, respectively.
    • None had received prior immunotherapy.
  • ORR at week 24: 25% (95% CI: 8.7-49.1).
  • Median PFS (based on irRECIST): 5.4 months (95% CI: 1.3-not estimable).
    • Median follow-up for PFS: 11.7 months (95% CI: 2.7-17.7).
  • 4 patients (3 still on study) remain in complete remission.
  • 18 patients had >1 treatment-related adverse event (TRAE).
    • Most common any-grade TRAEs: proteinuria, diarrhea, fatigue, hypertension, hypothyroidism.

Limitations

  • 1 fatal TRAE (gastrointestinal hemorrhage).

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