AACR 2019—Ipilimumab-nivolumab yields 42% response rate in high-grade neuroendocrine cancer


  • Keren Landman, MD
  • Univadis
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Takeaway

  • Dual therapy with ipilimumab and nivolumab was associated with a 42% overall response rate (ORR) among patients with high-grade neuroendocrine cancer.

Why this matters

  • Current treatment options for high-grade neuroendocrine carcinomas are limited to aggressive chemotherapy regimens.

Study design

  • 33 patients with rare neuroendocrine tumors enrolled in the multicohort, prospective, open-label, multicenter phase 2 clinical trial, Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART). 
  • 18 patients (56%) had high-grade disease, and the most common tumor sites were gastrointestinal (47%; n=15) and lung (19%; n=6). Pancreatic neuroendocrine tumors were studied separately. 
  • Patients had received a median of 2 prior lines of therapy.
  • Patients received ipilimumab (1 mg every 6 weeks) and nivolumab (240 mg every 22 weeks).
  • Funding: NIH, Bristol-Myers Squibb.

Key results

  • ORR was 24% (1 complete response [CR], 7 partial responses [PR]).
  • All responses occurred among patients with high-grade disease (ORR, 42%; CR, 5%; PR, 37%).
  • 6-month PFS was 30%; median OS was 11 months.
  • Most common toxicities included fatigue (30%) and nausea (27%).
  • Most common immune-related adverse event was grade 3-4 abnormal liver function; no grade 5 events observed.

Limitations

  • No central pathology review.
  • High-grade vs low/intermediate-grade analysis not prespecified.
  • Small, single-arm, nonrandomized cohort.

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