NANOBIOTIX ANNOUNCES POSITIVE PHASE
II/III TOPLINE DATAIN SOFT TISSUE SARCOMA WITH
NBTXR3
- Trial achieved its primary endpoint of
pathological Complete Response Rate
- Trial achieved its secondary endpoint in operability
(R0 rate)
- NBTXR3 demonstrated significant superiority and
clinical benefits for patients versus standard of
care
- Safety profile confirmed
- Randomized trial validated the first-in-class mode of
action of NBTXR3
Paris, France and Cambridge, Massachusetts,
June 21, 2018 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering new approaches in the treatment of cancer, announced
today positive topline results of the Phase II/III act.in.sarc
trial evaluating NBTXR3 in Soft Tissue Sarcoma (STS).
"Data are exceptional and show without any doubt
an improvement of radiation therapy impact with a significant
number of complete response. NBTXR3 can bring real benefit to
patients and it can change the standard of care. This innovation
will play a role in many other indications and particularly where
radiotherapy is used alone." Pr. Sylvie Bonvalot, MD, Head of
Sarcoma and Complex Tumor Surgery Unit at Institut Curie, Paris,
France and Global Principal Investigator of the PII/III study
NBTXR3 is a first-in-class product with a new
mode of action physically destroying cancer cells when activated by
radiation therapy. NBTXR3 is designed to directly destroy
tumors and activate the immune system for both local control and
systemic disease treatment.
The Phase II/III study was a prospective,
randomized (1:1), multinational, open label and active controlled
two-armed study of 180 patients with locally advanced STS. The
objective of the Phase II/III trial was to evaluate the efficacy
and the safety of NBTXR3 activated by radiotherapy compared to the
standard of care (radiotherapy alone). Patients have been treated
with the standard dose of radiation (25x2 Gy) and efficacy
endpoints have been measured on surgically resected tumors.
Primary endpoint achieved in the
intend-to-treat population (ITT)The primary endpoint is the
pathological Complete Response Rate (pCRR) defined as the rate of
patients showing less than 5% of residual viable cancer cells in
the tumor post treatment. This primary endpoint is related to
NBTXR3's mode of action and product efficacy. Twice as many
patients (16.1% vs 7.9%) achieved a pathological Complete Response
(pCR) with NBTXR3 compared to the control arm (p = 0.0448). The
significant difference observed between both arms validates the
superiority of the treatment with NBTXR3 versus radiation
alone.
Secondary Endpoint achieved in the ITT -
Resection margins status and operabilityThe main secondary
endpoint is the resection margin status evaluating the quality of
surgery. The main objective is to achieve compartmental clean
margins (negative margin defined as R0) i.e. no more cancer cells
found within the surgical margins. NBTXR3 demonstrated a
statistically significant increase in R0 surgical margin rate
compared to radiotherapy alone (relative increase of 20%, p =
0.042). The resection with negative margins is a validated
surrogate endpoint for systemic and long-term benefit for patients
such as local progression free survival (PFS) and distant
PFS.
Pr Jean-Yves Blay, MD, Director of the Centre
Léon Bérard, Lyon, France, commented, "I am amazed by the
difference of Response Rate, it is extremely uncommon to double the
Rate of Complete histological Response and I do not see any other
strategy able to accomplish that. Even more impressive is the R0
rate, which is increased by more than 20% compared to an average
rate of 64%. This difference is really impressive, considering that
R0 impacts patients relapses and survival."
Safety and feasibilityNBTXR3 demonstrated
a good local tolerance among this patient's population. Findings
showed a very similar radiation-related safety in both arms. The
patients in both the control and tested arms of the study received
the planned radiotherapy (dose and schedule).
Notably, feasibility and follow-up of surgery
were also equivalent. Acute immune adverse events of short duration
observed in 7.9% of patients.
The Injection site caused pain in 13.5% of
patients. In addition, 6.7% of patients experienced grade 1
injection site hematoma / ecchymosis.
Regarding long-term toxicity, less serious
adverse events were reported for NBTXR3 arm.
Regulatory strategy and CE markThe
positive results from this study support and further validate the
European regulatory strategy of the previously submitted CE marking
application in STS. The company will submit the new data as a
supplement to the European Notified Body in a timely manner.
Next stepsThe Company will present the
results at an upcoming international medical conference.
The clinical validation of NBTXR3's physical
mode of action in a very heterogeneous and hard-to-treat disease
strengthens the universal profile of the product and confirms the
development strategy in multiple indications.
Currently, the company is evaluating NBTXR3 in
seven clinical trials with a focus on head and neck cancers and
Immuno-Oncology programs.
David Raben MD, Professor of Radiation Oncology,
University of Colorado Cancer Center, CO, USA, commented, "These
results from a Phase III study are impressive in a notoriously
difficult disease like Soft Tissue Sarcoma. These cancers are
generally less sensitive to radiation and previous attempts to
improve local control with chemo-radiation regimens were considered
too toxic. This study substantiates the medical benefit of safely
enhancing the effect of radiation therapy with novel physics-based
approaches delivered locally within the cancer. In addition, this
product may potentiate a pro-inflammatory environment suitable for
immune enabling or DNA damage inhibitor drugs. These findings set
the foundation for additional studies in areas such as head and
neck cancer and perhaps in areas such as high-risk prostate,
bladder or pancreas cancer."
Webcast and dial-in (English) June 22 at 4pm
Paris time:
https://origin.yuca.tv/en/nanobiotix/press-conference-2018
For more information about the STS study:
www.clinicaltrial.gov (Identifier: NCT02379845)
http://www.actinsarc.com/
***
About PII/III clinical trial (act.in.sarc
study)Nanobiotix and its partner, PharmaEngine recruited 180
patients in 43 sites across 13 countries in Europe and Asia. The
Global Principal Investigator is Pr. Sylvie Bonvalot, MD, PhD
(Institut Curie, Paris, France).
Primary endpoint Pathological complete
response rate (pCRR): 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).
Main secondary endpointResection
margin status: The resection margin status is evaluating 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 predict the risk of local and distant
recurrence. In particular, negative surgical margins are
significantly correlated to increased patients' survival.
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 has the ability to fit into current worldwide
standards of radiation care.
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 unable to
receive chemotherapy or cetuximab with very limited therapeutic
options. The Phase I/II trial has already delivered very promising
results regarding the local control of the tumors.
Nanobiotix is running an Immuno-Oncology
development program . In the U.S., the Company received the FDA's
approval 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 studies 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 soft tissue sarcoma
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.
The Company's first-in-class, proprietary lead
technology, NanoXray, aims to expand radiotherapy benefits for
millions of cancer patients. Furthermore, the Company'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 |
|
|
DisclaimerThis 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.
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