Breakthrough in Solid Cancer Treatment: Ulevostinag Shows Promise in Combination Therapy

Strategic Insights -

Current study results on solid cancer have been published, detailing the efficacy of ulevostinag, a cyclic dinucleotide stimulator of IFN genes (STING) agonist, in combination with pembrolizumab in treating advanced or metastatic solid tumors or lymphomas. The research, conducted by the Institute for Cancer Research, involved two clinical trials: a phase I study and a phase II study. The studies aimed to evaluate the safety, tolerability, and antitumor activity of ulevostinag in combination with pembrolizumab.

Key Takeaways:

  • The phase I study (NCT03010176) included 156 participants with advanced/metastatic solid tumors or lymphomas, who received intratumoral ulevostinag (+/- intravenous pembrolizumab). The most common adverse event was pyrexia (70%).
  • The recommended phase II dose for intratumoral ulevostinag was 540 μg, which was determined by dose-limiting toxicities and dose-dependent pharmacokinetics.
  • In the phase II study (NCT04220866), 4 of 8 participants treated with combination therapy had a complete or partial response, and the most common adverse event was pyrexia (n = 5).
  • The combination therapy showed antitumor activity in participants with untreated metastatic or unresectable, recurrent HNSCC.
  • The research has been peer-reviewed and published in Clinical Cancer Research (2025;31(16):3400-3411).

Statistics:

  • 156 participants were enrolled in the phase I study (NCT03010176).
  • 540 μg was the recommended phase II dose for intratumoral ulevostinag.
  • 4 of 8 participants treated with combination therapy had a complete or partial response.
  • 5 participants had pyrexia (n = 5) as the most common adverse event.
  • The primary objective of the phase II study (NCT04220866) was antitumor activity.

Sources:

  • Clinical Cancer Research, 2025;31(16):3400-3411.
  • Institute for Cancer Research, Div Radiotherapy & Imaging, London, United Kingdom.
  • NewsRx. Findings from Institute for Cancer Research Yields New Data on Solid Cancer (Phase I and II Clinical Studies of the Sting Agonist Ulevostinag With and Without Pembrolizumab In Participants With Advanced or Metastatic Solid Tumors or Lymphomas). Immunotherapy Weekly. September 24, 2025; p 980.