Vienna Conference Looks Promising, page-5

VLA are also making another presentation at the European Cancer Conference re advanced melanoma responses.

FYI I searched "A21" on the following link:-

http://www.europeancancercongress.org/Scientific-Programme/Searchable-Programme#anchorScpr

   (the presentation copy and pasted by Bellas also comes up in the search!).

Intralesional administration of Coxsackievirus A21 (CVA21) oncolytic virus immunotherapy in patients with advanced melanoma induces durable tumor responses
Poster Spotlight: R. Andtbacka (USA)
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Background: CVA21 (CAVATAK)is a novel bio-selected oncolytic and immunotherapeutic strain of Coxsackievirus A21. Intratumoral (IT) CVA21 injection can induce preferentialtumor cell infection, tumor immune-cell infiltration, up-regulation of interferon gamma response genes, cell lysis and enhancement of a systemic anti-tumor immune response. Pre-clinical studies in an immune-competent mouse model of melanoma have revealed that combinations of intralesional CVA21 and anti-PD-1 oranti-CTLA-4 mAbs mediated significantly greater antitumor activity compared to use of either agent alone. Presented are the final response and safety data of the open-label, multicenter Phase II CALM (CAVATAKin Latestage Melanoma) study.
Methods: The Phase 2 CALM study investigated the efficacy and safety of IT CVA21 in 57 patients (pts) with treated or untreated unresectable Stage IIIC-IVM1c melanoma. Pts received up to 3×10⁸ TCID₅₀CVA21 IT on study days 1, 3, 5, 8, 22, and then every three weeks for a further 6 injections. Pts displaying immune-related progression-free survival (irPFS) or better at 6 mos were eligible for 9 additional injections. Key eligibility criteria were ≥18 yrs old, ECOG PS 0–1, and at least 1 injectable cutaneous, subcutaneous, or nodal melanoma metastasis ≥1.0cm. The primary endpoint was to achieve >9 of 54 evaluable pts with irPFS at 6 mos. Secondary endpoints included irRECIST overall response rate, durable response rate (continuous response ≥6mos), median time to response and 1-year survival.
Results: The primary endpoint of the study was achieved with 22 of 57 (38.6%) evaluable pts displaying irPFS at 6mos with a median irPFS of 4.2 mos. The overall response rate (irRECIST) was 28.1% (16 of 57 evaluable pts) with a ≥6 mos durable response rate of 19.3%(11 of 57 pts). The median time to response was 2.8 mos, and the 1-year survival rate 75.4% (43 of 57 pts). After a median follow-up of 16.5 mos, median duration of response in responders and median OS for all pts was not reached. The mean number of CVA21 injection visits was 8.5 per pt, with the most common AE's being Grade 1 fatigue, chills, local injection site reactions and fever. No Grade 3 or 4 product-related AE's were observed.
Conclusions: Intralesional CVA21 is a promising novel oncolytic immunotherapeutic agent for the treatment of unresectable Stage IIIC-IVM1c melanoma. Pre-clinical studies suggest that the durable response rate of approximately 20% mediated by CVA21 intralesional administration in the presented study may be notably improved when CVA21 treatment is used in combination with immune checkpoint blockade. Such clinical studies are now being initiated.
No conflict of interest.