Phase 1b & 2 Study With GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (VIRO-15)

Trial ID # NCT02759588; VIRO-15
Phase Ib/II
Drug Class Oncolytic Viruses
Drug Name Olvimulogene nanivacirepvec
Alternate Drug Names light-emitting oncolytic vaccinia virus GL-ONC1, GLV-1h68, GL-ONC1
Drugs in Trial Carboplatin, Docetaxel, Gemcitabine, Liposomal doxorubicin, Olvimulogene nanivacirepvec, Paclitaxel, Bevacizumab
Eligible Participant

Platinum resistant or platinum refractory ovarian cancer

Patients Enrolled

Phase I: 12 patients; Phase II: 27 patients, median 4 prior therapies (2-9); 48% Pt-R, 52% Pt-Rf

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, PFS, evaluated per RECIST

Efficacy

Olvi-Vec alone: 12 patients, median 5 prior therapies (2-10)
ORR: 9% (1PR, n=11)
DCR: 73% (1PR, 7SD, n=11)
PFS: 3.9 months

Olvi-Vec+CarboPt-based therapy w/ or w/o Bev:
ORR: 54% (2CR, 11PR, n=24)
DCR: 87.5% (2CR, 11PR, 8SD, n=24)
DoR: 7.6 months
PFS: 11.0 months
PFS (6 months): 77%

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE:

Conclusion

Patients treated with IP Olvi-Vec-primed immunochemotherapy combined with standard carboplatinum based therapy shows ORR and PFS exceeding historical comparisons and patients’ own last prior therapy. The majority of patients benefit from apparent reversal of platinum resistance

Reference

Holloway RW et al. Phase II VIRO-15 trial of olvimulogene nanivacirepvec (Olvi-Vec)-primed immunochemotherapy in platinum-resistant/refractory ovarian cancer (PRROC) (NCT02759588). SGO (2020) abstract 139
https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/15668

Holloway RW et al. Phase Ib study of oncolytic vaccinia virus GL-ONC1 in recurrent ovarian cancer (ROC).  J Clin Oncol (2018) 36 (suppl; abstr 5577)
https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.5577

Holloway RW et al. Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in PlatinumResistant/Refractory Ovarian Cancer. IGCS (2020) Plenary III, abstract 12
https://www.clearityfoundation.org/wp-content/uploads/2020/09/Olvi-Vec-IGCS-2020-abstract.pdf

Manyam M et al. A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer. Gynecol Oncol (2021) 163(3):481-489
https://pubmed.ncbi.nlm.nih.gov/34686353/

Contact Us
Contact Us

We are here to help! Send us a message below or give us a call at (858) 657-0282.