Key Highlights

  • Invion completed patient treatments and closed recruitment in its Phase 1 non-melanoma skin cancer trial of INV043.
  • The Safety Review Committee found no serious adverse events, dose-limiting toxicities or pain across 14 patient readouts.
  • Preliminary efficacy showed a 79% disease control response rate across SCC and BCC lesions, including one complete response.
  • Final results await 12-month patient follow-up and an independent audit.

Invion Limited (ASX:IVX) announced on 19 October 2026 that it has completed patient treatments and closed recruitment in its Phase 1 non-melanoma skin cancer (NMSC) trial of INV043, which uses its Photosoft photodynamic therapy platform.

Safety findings

The primary endpoints of the Phase 1 trial focus on safety. Preliminary unaudited findings from 14 patient treatment readouts showed no serious adverse events and no dose-limiting toxicities. There were eight cases of mild to moderate adverse events, such as mild headache, urinary tract infection and skin abrasion, all assessed by the Safety Review Committee (SRC) as not related or unlikely related to treatment. The SRC found consistent safety readouts, including in more recently treated basal cell carcinoma (BCC) patients.

Efficacy signals

Tumour responses were assessed using calliper measurements consistent with RECIST 1.1 principles, using longest diameter and percentage change from baseline. Across squamous cell carcinoma (SCC) and BCC lesions, there was a 79% positive disease control response rate, including one complete response. Invion believes the preliminary findings are sufficient to meet the primary safety endpoints and show encouraging efficacy signals.

Status of the data

Results will be finalised only after the 12-month patient follow-up and independent audit, so the figures reported are preliminary and unaudited. The data come from a small number of patients in an early-phase trial.

Next steps

Based on the SRC review, Invion decided to advance to a Phase II trial. Planning has started for a trial that would incorporate dose optimisation and may target advanced skin cancers, including rare cancers with unmet clinical need. The announcement did not give a start date, size or funding for Phase II.