NANOBIOTIX Reports Updated Phase 1 Anti-PD-1 Combination Data That May Support the Immune Stimulation Potential of Radioenhancer NBTXR3 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer
- Data show that radiotherapy-activated NBTXR3 followed by anti-PD-1 was feasible and well tolerated in the complete dose escalation part of the Company’s phase 1 immunotherapy study with a recommended phase 2 dose established at 33% of gross tumor volume in all 3 cohorts
- Results include 5 additional patients of 21 evaluable as of the data cutoff on
22 August 2022and continue to suggest local control and immune stimulation regardless of prior anti-PD-1 exposure
- Objective reduction from baseline in all target lesions (“objective reduction”) was observed in 71.43% of evaluable patients (15/21) and objective reduction of more than 30% was observed in 42.86% of evaluable patients (9/21)
- Objective reduction was observed in 66.66% of evaluable patients with cancer resistant to anti-PD-1 (10/15)
- As of the cutoff, systemic disease control was durable and had sustained for more than 6 months in 38.10% of evaluable patients (8/21)
“Immune checkpoint inhibitors such as anti-PD-1 are the backbone of cancer immunotherapy and expanding the benefits of these therapies to more patients by improving response rates is one of the most urgent challenges facing the oncology community today,” said
NBTXR3 Activated By Radiotherapy In Combination With Nivolumab Or Pembrolizumab In Patients With Advanced Cancers: Results From An Ongoing Dose Escalation Phase I Trial — Abstract #684
Summary of Updated Data
Reported data included 28 patients, with 21 evaluable for early signs of efficacy at the data cutoff on
Objective reduction from baseline in target lesions (“objective reduction”) was observed in 71.43% of evaluable patients (15/21). 42.86% of evaluable patients (9/21) showed objective reduction greater than 30%. 71.43% of evaluable patients (15/21) had cancer resistant to prior anti-PD-1 exposure and tumor regression was observed in 66.66% of these patients (10/15).
As of the data cutoff, systemic disease control was durable and had sustained for more than 6 months in 38.10% of evaluable patients (8/21). Delayed objective reduction has been observed in several patients, suggesting the potential for anti-cancer immune activity over time.
The recommended phase 2 dose (“RP2D”) of RT-activated NBTXR3 followed by anti-PD-1 was established at 33% of gross tumor volume in all 3 cohorts at the completion of the Study 1100 dose escalation part. The dose expansion part of the study is ongoing in
The Company plans to submit a registrational phase 3 protocol for the evaluation of RT-activated NBTXR3 plus anti-PD-1 in patients with LRR or R/M HNSCC resistant to anti-PD-1 to the
Conference Call Information
The updated data to be presented at SITC will be discussed during a conference call and live audio webcast on Thursday, November 10, 2022, at 8:00 AM ET / 2:00 PM CET.
The live webcast of the call may be accessed by visiting the investors section of the company’s website at www.nanobiotix.com. Participants may register for the call here. They will be able to join the call via dial-in or one-click dial-out. The Company recommends that participants join 10 minutes prior to the start of the call.
A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company's website.
About Study 1100
Study 1100 is a phase 1, multicenter, dose escalation and dose expansion study in
The dose expansion part of Study 1100 is now ongoing with a protocol amended for robust evaluation of NBTXR3 plus anti-PD-1 in patients with LRR or R/M HNSCC that is either naïve to prior anti-PD-1 exposure or resistant to prior anti-PD-1 exposure. The protocol includes three amended cohorts: (i) LRR or R/M HNSCC amenable to reirradiation that is resistant to prior anti-PD-1 exposure; (ii) LRR or R/M HNSCC amenable to reirradiation that is naïve to prior anti-PD-1 exposure; and (iii) non-small cell lung cancer, malignant melanoma, hepatocellular carcinoma, renal cell carcinoma, urothelial cancer, cervical cancer, triple-negative breast cancer that has metastasized to soft tissues, lung metastases, or liver metastases that is resistant to prior anti-PD-1 exposure.
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. 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,
NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study was launched in 2021. In
Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3,
Incorporated in 2003,
This press release contains certain “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “at this time,” “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designated to,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “objective,” “shall,” “should,” “scheduled,” and “will,” or the negative of these and similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical and clinical studies and their potential implications. Such forward-looking statements are made in light of information currently available to us and based on assumptions that
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Source: Nanobiotix S.A.