- Data show favorable safety and feasibility in 68 heavily pre-treated patients with R/M-HNSCC (Intention-to-Treat population; “ITT”) who received RT-activated NBTXR3 followed by anti-PD-1 as a second-or-later line treatment
- 48% ORR in evaluable anti-PD-1 naïve patients (n=25); 28% ORR in evaluable anti-PD-1 resistant patients (n=25) as per RECIST 1.1
- 76% DCR in evaluable naïve patients; 68% DCR in evaluable resistant patients as per RECIST 1.1
- Preliminary review of survival data in ITT anti-PD-1 naïve patients (n=33) showed mPFS of 7.3 months and mOS of 26.2 months
- ITT anti-PD-1 resistant patients (n=35) showed mPFS of 4.2 months and mOS of 7.8 months
- Following the ASCO presentation,
Nanobiotix will host an investor event onSunday, June 2 nd at 12:00 PM EDT / 6:00 PM CEST to review the presented results
“Novel approaches to improving response rates and reversing resistance to anti-PD-1 are an urgent unmet need for patients with recurrent or metastatic head and neck cancer,” said Study 1100 Coordinating Investigator
Abstract #6035: Early signs of efficacy in patients with anti-PD-1 naïve and anti-PD-1 resistant HNSCC treated with NBTXR3/SBRT in combination with nivolumab and pembrolizumab in the phase 1 trial Study 1100
Consistently Favorable Safety and Injection Feasibility
At the data cutoff, NBTXR3 injection followed by standard RT and anti-PD-1 therapy was feasible and well tolerated in 68 heavily pretreated patients with 2L+ R/M-HNSCC (Intention-to-Treat population; “ITT”)
- Serious Grade 3+ adverse events related to the combined therapeutic regimen (injection procedure, RT, NBTXR3, or anti-PD-1) occurred in 8.8% (6/68) of patients.
Early Signals of Efficacy
Anti-PD-1 Naïve Patients
Anti-PD-1 Naïve Population Evaluable for Tumor Response (n=25)
- 48.0% (12/25) overall response rate (“ORR”) as per RECIST 1.1(3 CR; 9 PR)
- 76.0% (19/25) disease control rate (“DCR”) as per RECIST 1.1
- 48.0% (12/25) all target lesions response (≥ 30% change in target lesion sum of diameters; see below)
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/efeea2d8-b14d-4d5e-910a-c00b6a139cce
Anti-PD-1 Naïve ITT Population for Preliminary Survival Analysis (n=33)
- 7.3 months mPFS
- 26.2 months mOS
- Median follow up of 99 days at data cutoff
Notable Baseline Characteristics in the Anti-PD-1 Naïve Population
- 75.0% of anti-PD-1 naïve patients for whom CPS testing data were available (12/16) had CPS < 20
- 10 anti-PD-1 naïve patients for whom HPV status data were available had HPV-positive R/M-HNSCC of the oropharynx
- At least 33.3% (11/33) of anti-PD-1 naïve patients had at least 2 prior lines of therapy
Anti-PD-1 Resistant Patients
Anti-PD-1 Resistant Population Evaluable for Tumor Response (n=25)
- 28.0% (7/25) ORR as per RECIST 1.1 (2 CR; 5 PR)
- 68.0% (17/25) DCR as per RECIST 1.1
- 36.0% (9/25) all target lesions response (see below)
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ec2a6ae8-756b-4e60-8827-d78245fa55c7
*One patient is in pathological complete response and has been included as a complete response in this figure
Anti-PD-1 Resistant ITT Population for Preliminary Survival Analysis (n=35):
- 4.2 months mPFS
- 7.8 months mOS
- 31.8 months mOS2 (OS from first anti-PD-1 dose prior to joining Study 1100)
- Median follow up of 90 days at data cutoff
Notable Baseline Characteristics in the Anti-PD-1 Resistant Population
- 57.7% of anti-PD-1 resistant patients for whom CPS testing data were available (15/26) had CPS < 20
- 12 anti-PD-1 resistant patients for whom HPV status data were available had HPV-positive R/M-HNSCC of the oropharynx
- At least 88.6% (31/35) of anti-PD-1 resistant patients had at least 2 prior lines of therapy
- At least 83.0% (29/35) of anti-PD-1 resistant patients had progressive disease when entering Study 1100
“We are excited to see the emergence of several innovative therapeutic approaches to improving treatment outcomes for patients with recurrent or metastatic head and neck cancer in clinical trials. However, it is clear that many of these new product candidates are prioritizing patients in specific settings, while NBTXR3 remains active regardless of several prior prognostic factors such as lines of therapy, CPS score, HPV status, and resistance to therapy,” said Louis Kayitalire,
Investigators concluded that promising early signals of efficacy were observed in Study 1100 patients with naïve or resistant 2L+ R/M-HNSCC who received RT-activated NBTXR3 followed by anti-PD-1. Disease control was observed in both naïve and resistant R/M-HNSCC patients, highlighting the potential for NBTXR3 in this population. Overall, these results warrant further exploration in randomized trials for both naïve and resistant R/M-HNSCC patients.
“These new data from Study 1100 continue to provide encouraging signals that radiotherapy-activated NBTXR3 followed by anti-PD-1 could potentially improve response rates and reverse resistance to anti-PD-1 in patients with recurrent or metastatic head and neck cancer,” said Study 1100 Coordinating Investigator
Nanobiotix Investor Call
Details for the call are as follows:
Audio-only dial-in link: click here
Webcast link: click here
Participants can use the audio-only link above to register and obtain dial-in instructions to listen to the presentation via phone and ask questions during the Q&A session, or participants can use the webcast link to register and listen and watch the slide presentation online; the replay version will be available under the same webcast link shortly after the presentation and will be archived on the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior to the event start. Participants are invited to email their questions in advance to investors@nanobiotix.com.
About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA,
Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In
Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3,
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Disclaimer
This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the
Contacts
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Attachments
- 2024-06-02 -- NBTX -- Ph1 Study 1100 of NBTXR3 @ ASCO -- FINAL
- Figure 1
- Figure 2
Figure 1
Best Change in All Target Lesions Diameter Sum from Baseline
Figure 2
Best Change in All Target Lesions Diameter Sum from Baseline
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