Viralytics Reports Positive Final Results from CAVATAKTM Phase 2 Melanoma Trial
Viralytics Limited provided positive final data from the Phase 2 CALM clinical trial of Viralytics’ lead drug candidate, CAVATAKTM, at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015. CAVATAK is an investigational cancer immunotherapy based on a proprietary bioselected common cold virus that has been shown to preferentially infect and attack cancer cells.
Dr Robert Andtbacka of the Huntsman Cancer Institute, University of Utah, and Lead Study Investigator, presented a poster detailing the final results from the Phase 2 CALM clinical trial, confirming earlier promising results in difficult-to-treat, late-stage melanoma patients.
The final CALM results showed that 22 of the 57 (38.6%) patients achieved the irPFS endpoint, more than doubling the target of 10 of 54 evaluable patients reporting irPFS at six months after the first dose of CAVATAK.
Investigators also reported an overall response rate in 16 of 57 (28%) patients. Of these, eight patients achieved a complete response and disappearance of their total tumour burden and the other eight achieved a partial response being at least a 30% reduction in the tumour burden.
Durable responses, persisting for 6 months or more, were seen in 21% of patients. Notably, durable response was the FDA approved endpoint for the pivotal Phase 3 trial of Amgen’s oncolytic virus talimogene laherparepvec (T-VEC) which recently gained recommendation for approval from the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) with a 16.3% durable response rate.
Responses have been observed in patients who have progressed on other agents such as T-Vec and the checkpoint inhibitor ipilimumab.
Promising anti-cancer activity was demonstrated in non-injected distant cancers, including lung and liver metastases. A response rate of 37.5% was recorded in individual target lesions at these sites – suggestive of CAVATAK’s ability to trigger an anti-tumour immune response.
The one-year survival rate of 75% (43 of 57 patients) with a median overall survival of 26 months was achieved in a challenging population with advanced, intractable disease.
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