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DETAILS RESULTS OF PHASE I

The following is a summary of the more detailed results of the study. The results were published in Clinical Cancer Research 23, no. 4 (February 15, 2017): 908–17. doi:10.1158/1078-0432.CCR-16-1297. The article can be downloaded at the bottom.

01
CONFIRMED FEASIBILITY OF INTRATUMORAL INJECTION

 

The intratumoral injection procedure was performed under local anesthesia and pre-medication with analgesic and sedative products. The feasibility was demonstrated at different dose levels and 10% of NBTXR3 intratumor injection followed by radiotherapy was chosen as the recommended dose for the act.in.sarc registration study (this means that a patient with a 100 mL tumor will receive an injection of 10 mL NBTXR3).

02
TREATMENT WAS SAFE

 

No early dose-limiting toxicity (DLT) was observed. Patients received the complete planned radiotherapy scheduled and dose. No grade 3-4 toxicity related to NBTXR3 occurred. Main grade 1-2 adverse events included injection pain/reaction, pyrexia, abdominal pain, pruritus and paresthesia.

03
DEMONSTRATED ADEQUATE BIOAVAILABILITY

 

Results confirmed that a single injection provides adequate bioavailability of NBTXR3 within the tumor over the five weeks of radiotherapy. No leakage of NBTXR3 to the healthy tissues was observed.

The CT scans below show the tumor and NBTXR3 after injection in the tumor. The left images are taken 24 hours after injection, the right images were taken before surgery, approximately 6 weeks after the end of radiotherapy, which is approximately 11 weeks after NBTXR3 was injected. This shows that NBTXR3 is persistent over time and bioavailable for all sessions of radiotherapy.

24h POST IT INJECTION | POST ALL RT SESSIONS
24h POST IT INJECTION | POST ALL RT SESSIONS
Pt 18
Pt 21
Pt 14
Pt 15
04
PROMISING SIGNS OF ANTITUMOR ACTIVITY

 

Promising signs of antitumor activity were observed in different sarcoma subtypes.

The basis of the management of the Soft Tissue Sarcoma patients is surgery. The wider the local excision, the lower the probability of cancer recurrence and amputation need. Currently and despite of pre-operative radiotherapy, surgery is still very challenging in the subset of patients with locally advanced soft tissue sarcoma of the extremity and trunk wall.

In this population, NBTXR3 activated by radiotherapy showed promising signs of antitumor activity in different sarcoma subtypes. The following is a summary of results published in Clinical Cancer Research 23, no. 4 (February 15, 2017): 908–17. doi:10.1158/1078-0432.CCR-16-1297:

At 10% volume of NBTXR3, the median percentage of residual malignant viable cells was of 26% (range, 10%–90%)

At 10% volume of NBTXR3, the  median tumor volume change was of -40% (-71% to +22%)

All patients treated in the study had a wide surgical resection of the tumor

You may download the full article here:

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