NANOBIOTIX ANNOUNCES PUBLICATION OF PHASE III SOFT TISSUE SARCOMA DATA FOR FIRST-IN-CLASS NBTXR3 IN THE LANCET ONCOLOGY
- Previously reported data from the registration study (Act.In.Sarc) in advanced Soft Tissue Sarcoma (STS) patients demonstrated a significant advantage in both pathological complete response (pCR) and rate of margin-negative resection (R0) for those treated with NBTXR3 activated by standard of care radiation therapy (RT) versus RT alone
- Data showed that an increase in efficacy was achieved with the addition of NBTXR3 without a significant difference in the safety profile compared to RT alone
- The trial validates the clinical application of the mode of action of this new class of treatment, which supports further investigation in a larger field of indications
“Act.In.Sarc results published in The Lancet Oncology show clear superiority of NBTXR3 activated by radiation therapy versus radiation alone as evidenced by the significant increase in complete response. As I have stated previously, NBTXR3 is an innovation that could bring real benefits to patients and change the standard of care. It is an honor to have this potential recognized by our scientific peers.” – Pr. Sylvie Bonvalot, MD, PhD, Head of Sarcoma and Complex Tumor Surgery at the Curie Institute and Global Principal Investigator of the Act.In.Sarc Study.
“The data published in The Lancet Oncology represent another important moment for our company, our partners, and our patients. As members of the global scientific community we have a responsibility to make positive and substantial contributions to our field. Achievement of first European market approval provided validation for our contribution from a regulatory perspective, but recognition from our peers is especially rewarding.” – Edwina Baskin-Bey, MD, Chief Medical Officer of Nanobiotix.
Paris, France and Cambridge, Massachusetts, USA, July 9, 2019 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced that the previously reported results from the Phase II/III Act.In.Sarc trial evaluating NBTXR3 in patients with advanced STS have been published online in The Lancet Oncology.
The registration study met its primary (pCR) and secondary (R0 rate) endpoints. The increased proportion of patients with pCR among those given NBTXR3 as a single injection prior to standard of care RT when compared to RT alone (approximately twice as many), provides robust justification for the efficacy of nanoparticle-enhanced tumor cell death. The overall safety profile of NBTXR3 activated by RT was similar to RT alone, with manageable and reversible transient immune reactions observed in those treated with NBTXR3 and RT. More detail on the results can be found here.
The data from the Act.In Sarc trial were the basis for first European market approval (CE marking) of NBTXR3 in advanced STS of the extremity and chest wall, under the brand name Hensify®. With STS results validating the efficacy and safety profile of the product, the company will continue its development strategy to evaluate NBTXR3 in multiple global (US, EU and APAC) clinical trials with a focus including but not limited to: head and neck, liver, lung and prostate cancer, as well as tumors that may benefit from NBTXR3 in combination with immune-oncology agents.
- Marion Janic