ASCO 2016 - HF10 (an HSV-1 derived oncolytic virus) given intralesionally with systemic ipi - still enrolling!!!!

Not to be confused with T-VEC,(You can read more about it here:  ASCO 2016: T-VEC: Talimogene laherparepvec (previously - OncoVEX GM-CSF) - now - with pembro and still enrolling! ) an intralesional treatment also derived from the herpes virus...we now have HF10 used intralesionally with IV ipi:

Preliminary results from phase II study of combination treatment with HF10, a replication-competent HSV-1 oncolytic virus, and ipilimumab in patients with stage IIIb, IIIc, or IV unresectable or metastatic melanoma.  ASCO 2016.  #9543.  J Clin Oncol 34, 2016.  Andtbacka, Ross, Agarwala, et al.

Background: HF10 is a replication-competent oncolytic virus derived from HSV-1. We report on preliminary safety data and antitumor activity of HF10 + ipilimumab (ipi) combination in an ongoing Phase 2 trial in melanoma. Methods: Key entry criteria: age 18 yrs or older, ECOG greater than/= to 2, Stage IIIB, IIIC or IV unresectable/unresected melanoma, ipi naïve (IV administration) and measurable non-visceral lesion(s) suitable for injection. HF10 injected into single or multiple tumors (1 x 10⁷ TCID50/mL/dose, up to 5mL depending on tumor size and number); 4 injections q1wk; then up to 15 injections q3wk. Four ipi IV infusions (3 mg/kg; concurrent with HF10) are administered at q3wk. AEs assessed per CTCAE 4.0. Tumor responses assessed per mWHO and irRC at 12, 18 and 24 wks and at 36 and 48 wks, for patients (pts) continuing on HF10 monotherapy. Primary endpoint is Best Overall Response Rate (BORR) at 24 wks. Dose limiting toxicity defined as greater than/=to, G3 nonhematologic/hematologic toxicity, greater than/= to, G2 neurologic toxicity or allergic event occurring within 1^st 3wks of therapy. Results: Of 43 pts enrolled and treated at abstract data cut-off 01Feb16: 58% men, age range 29 to 92 yrs, disease stage 21% IIIB, 44% IIIC and 35% IV and 49% with ≥ 1 prior cancer therapy. Majority of HF10-related AEs are ≤ G2, similar to HF10 monotherapy and consistent with other oncolytic viruses. No DLTs or ≥ G4 AEs were reported. G3 AEs were experienced by 11.6% of pts. Of 3 pts with HF10-related G3 AEs, 1 had left groin pain, a thromboembolic event and lymphedema, 1 had hypoglycemia and 1 had diarrhea. Of 37 efficacy evaluable pts, BORR by irRC at 24 weeks is 37.8%  and disease stability rate is 56.8% (18.9% SD). Enrollment and treatment are ongoing. Conclusions: The combination with HF10 does not appear to exacerbate ipi toxicity. Efficacy evaluation (overall and local) suggests that HF10+ipi has both local and systemic antitumor activity and substantially improves the response rate of ipi alone. Intratumoral HF10 serial injections are safe and well-tolerated in combination with ipi and are a potential novel therapeutic approach for metastatic melanoma.

Go ratties, go!!! - c