Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 01

658P - First-in-human phase I trial of oncolytic herpes simplex virus ONCR-177 alone or in combination with pembrolizumab in advanced solid tumors

Date

14 Sep 2024

Session

Poster session 01

Topics

Clinical Research;  Targeted Therapy;  Immunotherapy

Tumour Site

Presenters

Cátia Fava Gaspar

Citation

Annals of Oncology (2024) 35 (suppl_2): S482-S535. 10.1016/annonc/annonc1589

Authors

C. Fava Gaspar1, J.C. Park2, G.S. Falchook3, R. Wesolowski4, H. Soliman5, P.A. Ott6, M.A. Bilen7, M. Mckean8, V. Villaflor9, L.Q.M. Chow10, A. Yanez11, C. Dupont11, J. Shepherd11, T. Cheema11, J.M. Goldberg11, I. Puzanov12, A. Spreafico1

Author affiliations

  • 1 Medical Oncology And Hematology Dept., UHN - University Health Network - Princess Margaret Cancer Center, M5G 2M9 - Toronto/CA
  • 2 Medicine Department, MGH - Massachusetts General Hospital, 02114 - Boston/US
  • 3 Medical Oncology, Sarah Cannon Research Institute (SCRI) at HealthONE, 80218 - Denver/US
  • 4 Medical Oncology Department, Ohio State University Medical Center, 43210 - Columbus/US
  • 5 Medical Oncology, Moffitt Cancer Center and Research Institute, 33612 - Tampa/US
  • 6 Medical Oncology Department, Dana Farber Cancer Institute, 02215 - Boston/US
  • 7 Oncology Department, Winship Cancer Institute of Emory University, 30322 - Atlanta/US
  • 8 Medical Oncology, Sarah Cannon Research Institute - Cancer Centre, 37203 - Nashville/US
  • 9 Medical Oncology, City of Hope Comprehensive Cancer Center, 91010 - Duarte/US
  • 10 Livestrong Cancer Institutes. Dept Of Oncology, Dell Medical School - The University of Texas at Austin - Laboratory of Affective Neurogenetics, 78712 - Austin/US
  • 11 Clinical Development Department, Oncorus, Inc., 02139 - Cambridge/US
  • 12 Medicine Department, Roswell Park Comprehensive Cancer Center, 14263 - Buffalo/US

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 658P

Background

Oncolytic viruses have the potential to synergize with immune checkpoint inhibitors (ICI), especially when engineered to express immunomodulatory payloads. ONCR-177 is a next-generation oncolytic Herpes Simplex Virus-1 (oHSV-1) intended for intratumoral (IT) administration, developed to target solid tumors, in monotherapy and in combination with ICI.

Methods

A first-in-human phase 1 trial (NCT04348916) of IT ONCR-177 alone and in combination with pembrolizumab in patients (pts) with advanced cutaneous, subcutaneous or metastatic solid tumors (surface lesions), and liver metastases (visceral lesions) was performed. Primary objectives were safety, tolerability, and determination of the recommended Phase 2 dose (RP2D) of ONCR-177 alone and in combination with pembrolizumab. Secondary objectives were anti-tumor activity (RECIST v1.1), viral shedding and cytokine levels detection.

Results

A total of 66 pts, with a median age of 63, 55% females and with 13 different tumor types (most frequent breast cancer 30%) were enrolled (N=56 in surface and N=10 in visceral lesions cohort). Sixty-two pts were evaluable for safety. No dose-limiting toxicities (DLTs) were reported through different dose levels (DL) up to 4x108 PFU in 4ml, which was defined as RP2D. The most common treatment-related adverse events (TRAEs) were cytokine release syndrome (CRS), in 14 pts (23%) or symptoms of fever, hypotension, and chills in 32 pts (52%). Only 1 pt had grade (G)3 CRS. Other TRAEs included G1/2 fatigue (37%). A total of 61 pts were evaluable for response, with 5 responders, all at RP2D and in surface lesions, 3 (5%) complete responses (CR) and 2 (3%) partial responses (PR), all previously exposed to ICI. Two CR were achieved in combination cohort. At RP2D, a trend towards higher plasma IFNγ levels and CRS-related AEs was observed, although no payload above physiologically relevant levels was detected.

Conclusions

ONCR-177 was safe to administer to surface and visceral lesions either as monotherapy or in combination with Pembrolizumab. Local responses were observed, although sustainable efficacy could not be achieved in a systemic manner in these heavily pretreated pts.

Clinical trial identification

NCT04348916.

Editorial acknowledgement

Legal entity responsible for the study

Oncorus.

Funding

Oncorus.

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.