eBioMedicine, a Lancet Discovery Science journal, has published Intensity Therapeutics’ Phase I/II IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers.  

According to the data, in heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved a disease control rate of 75% (48/64 patients) and median overall survival (mOS) of 11.9 months. These results compare favourably in Phase I/II studies that historically reported an mOS of four to seven months. 

In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months. 

In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient’s total tumour burden (TTB) compared to those treated with less than 40% of their TTB, the: 

  • Disease control rate was 83.3% (40/48) compared to 50% (8/16) 
  • Median overall survival was 18.7 months compared to 3.1 months with a hazard ratio (HR) of 0.17 
  • Improved survival was consistent across a range of low to high tumour burden and tumour sizes

Approximately 20% of patients in the >40% group had uninjected tumours shrink, abscopal effects. Fifteen of 64 patients survived for more than 21 months. INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumours and a qualitative increase in activated T-cells infiltrating the tumour microenvironment.

No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events. Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumours.

A new approach to cancer treatment

“The article describes the development of a new technology to destroy tumours using molecular agents that can disperse potent anti-cancer compounds within injected tumours and deliver them into cancer cells. We believe these are the first clinical results where a locally administered therapy used alone could potentially extend survival for patients with metastatic disease,” said Lewis Bender, Founder, President, and CEO of Intensity Therapeutics. 

“Given the drug’s mechanism of action and the data reported in this paper from over 20 types of metastatic solid cancers, such as breast, sarcoma, pancreatic, lung, and head and neck, we believe the study results show the potential of INT230-6 to achieve clinical benefit for metastatic patients of multiple cancer types with or without the use of radiation, systemic drugs or immunotherapy. As a result, we have initiated randomised controlled studies, including a Phase III study in sarcoma.”

Diana Turner, Deputy Editor, DDW