NANOBIOTIX: POSITIVE PHASE II/III RESULTS
FOR NBTXR3 IN SOFT TISSUE SARCOMA PRESENTED AT ESMO
- Dr. Sylvie Bonvalot, Head of Sarcoma and Complex Tumor
Surgery Unit at Institut Curie - Paris, presented
first-in-class NBTXR3 positive Phase II/III
results during the Sarcoma Proffered Paper Oral session at
ESMO
- NBTXR3 is the first radiotherapy enhancer to
demonstrate clinically meaningful benefit for patients with locally
advanced Soft Tissue Sarcoma compared to radiotherapy
alone
- The Primary and main Secondary Endpoints were met:
pathological Complete Response Rate, R0 Resection Margin and
percentage of Necrosis/Infarction
- In the subgroup of patients having an advanced disease,
4-times more patients achieved a pathological Complete Response in
the NBTXR3 arm compared to the control arm
Paris, France, and Cambridge,
Massachusetts (USA) October 19 2018 – NANOBIOTIX
(Euronext : NANO – ISIN : FR0011341205), a late
clinical-stage nanomedicine company pioneering new approaches in
the treatment of cancer, presented NBTXR3 positive Phase II/III
Act.in.sarc results in patients with locally advanced Soft Tissue
Sarcoma at the European Society for Medical Oncology (ESMO) 2018
Congress (Munich, Germany) during the Proffered Paper Oral
presentation of the Sarcoma Section (LBA66).
NBTXR3 is a first-in-class product with a new
mode of action designed to physically destroy cancer cells when
activated by radiation therapy (RT). NBTXR3 is designed to directly
destroy tumors and activate the immune system for both local
control and systemic disease treatment.
Dr. Sylvie Bonvalot, Head of Sarcoma and Complex
Tumor Surgery Unit at Institut Curie, Paris, France and Global
Principal Investigator commented: “The medical community was very
enthusiastic about the results, presented at ESMO, one of the
largest international multicentric studies carried out in Soft
Tissue Sarcoma patients following guidelines from the EORTC-
European Organization for Research and Treatment of Cancer. The
results show unequivocally that NBTXR3 improves current radiation
therapy. This should change the standard of care in the treatment
of sarcoma but also potentially of other cancers.”
In the Phase II/III Act.in.sarc study, a total
of 180 adult patients with locally advanced Soft Tissue Sarcoma of
the extremities or trunk wall were randomly allocated, in a 1:1
ratio, to either (i) Arm A, and received a single intratumoral
injection of NBTXR3 at the recommended dose (10% of baseline tumor
volume) followed by radiation therapy or (ii) Arm B, the control
arm, and treated with radiation therapy alone. In both arms,
radiotherapy was followed by surgery. The primary efficacy analysis
was performed on the intent-to-treat population following the Full
Analysis Set principle (ITT-FAS) population as per protocol.
Pathological Complete Response Rate
(pCRR): the study met its primary endpoint The study met
its primary endpoint with a pathological complete response (<5%
viable cancer cells) rate of 16.1% in the NBTXR3 arm vs 7.9% in the
control arm (p=0.0448).
In addition, in the subgroup of patients with a
more advanced disease (histologic grade 2 and 3) pathological
complete response was achieved in 4 times more patients in the
NBTXR3 arm than in the control arm (17.1% vs 3.9%).
An increase in the proportion of patients with a
pathological response regardless of the pre-defined cut-off was
observed in Arm A. The proportion of patients with pathological
nearly complete response (<7% of viable cancer cells) and
pathological response with 10% or less of viable cells were 24.7%
and 34.6%, respectively, in the NBTXR3 arm vs 14.8% and 19.8% in
the control arm.
R0 resection margin: the study met its
main secondary endpointThe main secondary endpoint of
carcinologic resection was also met with R0 resection margin
achieved in 77% of the patients who received NBTXR3 compared to 64%
of patients in the control arm (p=0.0424).
Tumor necrosis/infarction: the study
also met this secondary endpoint Histologic analysis
showed that the mean percentage of tumor necrosis/infarction was
also increased in the NBTXR3 arm compared to the control arm (28.8%
vs 19.2%; p=0.014).
Safety profile similarity across study
armsSimilar safety profiles were observed in the NBTXR3
arm and the radiation therapy alone arm. NBTXR3 did not impact the
patients’ ability to receive the planned dose of radiotherapy and
the radiotherapy safety profile was similar in both arms, including
the rate of postsurgical wound complications. NBTXR3 was associated
with grade 3-4 acute immune reactions in 7.9% of patients, which
were manageable and of short duration.
NBTXR3 showed a good local tolerance and no
impact on the severity or incidence of radiotherapy-related adverse
events.
Long-term follow-up of the patients is
ongoing to evaluate the Time-to-Local/Distant
Recurrence and Local/Distant Recurrence Rate (LRR/DRR) at 12 and 24
months.
***
About
Act.in.sarc study The Phase
II/III study was a prospective, randomized (1:1), multinational,
open label and active controlled two arm study of the efficacy and
safety of NBTXR3 activated by radiotherapy compared to radiotherapy
alone in patients with locally advanced Soft Tissue Sarcoma (STS)
of the extremity or trunk wall. Patients have been treated with the
standard dose of radiation, a total dose of 50 Gy given in 25
fractions of 2 Gy over 5 weeks, followed by surgical resection of
the tumor. The primary objective was to evaluate the pathological
complete response rate (pCRR)* in both arms. The secondary
endpoints included a safety profile and assessment of carcinologic
resection rate** in terms of margin status. Efficacy endpoints have
been measured on surgically resected tumors by a pathological
central review board. The primary efficacy analysis was planned to
be performed on the intent-to-treat (ITT) population***. The
ITT-FAS population (176 patients) was used for the analysis, and 4
patients were excluded from the ITT-FAS: 3 did not have STS (2 in
Arm A, 1 in Arm B) and 1 (in Arm A) was not eligible for
preoperative RT.
*A pathological Complete Response is defined as
the presence of less than 5% of residual malignant viable cells in
the surgically removed tissue. The primary endpoint compared the
proportion of patients presenting pathological Complete Response
(pCR) between the two arms. This was determined by an independent
pathological central review according to EORTC score (Wardelmann et
al., 2016).
** The resection margin status is an evaluation
of the quality of surgery. Surgery remains the mainstay of care for
locally advanced soft tissue sarcoma. The primary surgical
objective is the complete removal of the tumor with negative
resection margins (R0). Several retrospective studies suggest that
surgical margin status predicts the risk of local and distant
recurrence. In particular, negative surgical margins are
significantly correlated to increased patient survival.
*** Intent-to-treat (ITT) population includes
all patients with an informed consent given and a successful and
confirmed randomization number allocation through the treatment
allocation system (IWRS) with a non-missing date of randomization.
All analysis using this population is based on the treatment
assigned by randomization. ITT population following the Full
Analysis Set principle (ITT-FAS) is considered with specific
attention paid to the following cases: Patients randomized and
having received no treatment / Patients without any data
post-randomization / Patients randomized in spite of the
non-satisfaction of a major entry criterion (eligibility
violation).
About NBTXR3NBTXR3 is a
first-in-class product designed to destroy, when activated by
radiotherapy:
- tumors through physical cell death
- metastasis due to immunogenic cell death leading to activation
of the immune system
NBTXR3 has a high degree of biocompatibility,
requires one single administration before the whole radiotherapy
treatment and Nanobiotix believes it has the ability to fit into
current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 10
patient populations evaluated in 7 clinical trials.In June 2018,
Nanobiotix established human proof of concept for this
first-in-class product in its Soft Tissue Sarcoma (STS) Phase III
clinical trial.
NBTXR3 is actively being evaluated in head and
neck cancer with locally advanced squamous cell carcinoma of the
oral cavity or oropharynx in elderly and frail patients that are
unable to receive chemotherapy or cetuximab and have very limited
therapeutic options. Promising results have been observed from the
ongoing Phase I/II trial regarding the local control of tumors.
Nanobiotix is running an Immuno-Oncology
development program. In the United States, Nanobiotix has received
approval from the U.S. Food and Drug Administration (FDA) to launch
a clinical study of NBTXR3 activated by radiotherapy in combination
with anti-PD1 antibodies in lung, and head and neck cancer patients
(head and neck squamous cell carcinoma and non-small cell lung
cancer).
The other ongoing NBTXR3 trials are treating
patients with liver cancers (hepatocellular carcinoma and liver
metastasis), locally advanced or unresectable rectal cancer in
combination with chemotherapy, head and neck cancer in combination
with concurrent chemotherapy, and prostate adenocarcinoma.
The first market authorization process (CE
Marking) is ongoing in Europe in the STS indication.
About
NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading, late clinical-stage
nanomedicine company pioneering new approaches to significantly
change patient outcomes by bringing nanophysics to the heart of the
cell.
The Nanobiotix philosophy is one rooted in
designing pioneer physical based approaches to bring highly
effective and generalized solutions to address high unmet medical
needs and challenges.
Nanobiotix’s first-in-class, proprietary lead
technology, NanoXray, aims to expand radiotherapy benefits for
millions of cancer patients. Furthermore, Nanobiotix’s
Immuno-Oncology program has the potential to bring a new dimension
to cancer immunotherapies.
Nanobiotix is listed on the regulated market of
Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg:
NANO: FP). The Company’s headquarters are based in Paris, France,
with a U.S. affiliate in Cambridge, MA, and European affiliates in
Spain and Germany.
Contact
Nanobiotix |
Sarah
GaubertDirector, Communication & Public Affairs+33
(0)1 40 26 07 55sarah.gaubert@nanobiotix.com
/contact@nanobiotix.com |
Noël
Kurdi Director, Investor Relations +1 (646) 241-4400
noel.kurdi@nanobiotix.com / investors@nanobiotix.com |
Ricky
Bhajun Investor Relations Europe +33 (0)1 79 97 29 99
ricky.bhajun@nanobiotix.com / investors@nanobiotix.com |
Media relations |
|
France - Springbok
ConsultantsMarina Rosoff+33 (0)6 71 58 00
34marina@springbok.fr |
|
United States –
RooneyPartners Marion Janic +1
(212) 223-4017mjanic@rooneyco.com |
|
|
Disclaimer
This press release contains certain
forward-looking statements concerning Nanobiotix and its business.
Such forward-looking statements are based on assumptions that
Nanobiotix considers to be reasonable. However, there can be no
assurance that the estimates contained in such forward-looking
statements will be verified, which estimates are subject to
numerous risks including the risks set forth in the reference
document of Nanobiotix filed with the French Financial Markets
Authority (Autorité des Marchés Financiers) under number D.17-0470
on April 28, 2017 as well as in its 2017 annual financial report
filed with the French Financial Markets Authority on March 29, 2018
(a copy of which is available on www.nanobiotix.com) and to the
development of economic conditions, financial markets and the
markets in which Nanobiotix operates. The forward-looking
statements contained in this press release are also subject to
risks not yet known to Nanobiotix or not currently considered
material by Nanobiotix. The occurrence of all or part of such risks
could cause actual results, financial conditions, performance or
achievements of Nanobiotix to be materially different from such
forward-looking statements. This press release and the information
that it contains do not constitute an offer to sell or subscribe
for, or a solicitation of an offer to purchase or subscribe for,
Nanobiotix shares in any country. At the moment NBTXR3 does not
bear a CE mark and is not permitted to be placed on the market or
put into service until NBTXR3 has obtained a CE mark.
- Nanobiotix_PR_NBTXR3-301_2018.10.19_VF
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