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CALM study: A phase II study of an intratumorally delivered oncolytic immunotherapeutic agent, coxsackievirus A21, in patients with stage IIIc and stage IV malignant melanoma.
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Background: Coxsackievirus A21 is an oncolytic immunotherapy consisting of a bio-selected oncolytic strain of Coxsackievirus A21. Following intratumoral injection, preferential tumor infection causes cell lysis and enhancement of a systemic anti-tumor immune response. We present interim findings of the open-labeled, multicenter Phase II Coxsackievirus A21 in Late stage Melanoma (CALM) study. Methods: The CALM study investigated the efficacy and safety of intratumoral Coxsackievirus A21 in 57 patients with treated or untreated unresectable Stage IIIC-IVM1c melanoma. Patients received up to 3 x 108 TCID50Coxsackievirus A21intratumorally on study days 1,3,5 and 8 and then every three weeks for a further 6 injections. Patients displaying immune-related progression-free survival (irPFS) or better at 6 months were eligible for 9 additional injections. Key eligibility criteria were ≥ 18 yrs old, ECOG 0-1, and at least 1 injectable cutaneous, subcutaneous, or nodal melanoma metastasis >1.0 cm. The primary endpoint was to achieve >9 of 54 evaluable patients with irPFS at 6 months. The irPFS was calculated as the proportion of patients demonstrating a Complete Response, Partial Response or Stable Disease by immune-related RECIST 1.1 (irRECIST 1.1) criteria 6 months after the initiation of treatment. Secondary endpoints included 1-year survival, irRECIST1.1 best overall response and safety. Results: The primary endpoint of the study was achieved with 14 of 40 (35%) evaluable patients displaying irPFS at 6 months. The number of patients surviving 1-year from the initial treatment is 13 of 21 (62%). Best overall response rate (irRECIST 1.1) is 24% (9 of 38 evaluable patients). Patients received on average 8.3 series of injections, with the most common side effects being Grade 1 fatigue, chills, local injection site reactions and fever. There were no Grade 3 or 4 product-related AE’s. Conclusions: Intralesional Coxsackievirus A21 is a promising novel oncolytic immunotherapeutic agent in the treatment of unresectable Stage IIIC-IV M1c melanoma based on good patient tolerability, with both local and distant tumor responses. A randomized phase 2 clinical trial is planned. Clinical trial information: NCT01227551.
Abstracts by Robert Hans Ingemar Andtbacka:
Patterns of durable response with intralesional talimogene laherparepvec (T-VEC): Results from a phase III trial in patients with stage IIIb-IV melanoma.Meeting: 2014 ASCO Annual Meeting | Abstract No: 9026
Phase I trial of intratumoral therapy using HF10, an oncolytic HSV-1, demonstrates safety in HSV+/HSV- patients with refractory and superficial cancers.Meeting: 2014 ASCO Annual Meeting | Abstract No: 6082