Viralytics Limited has achieved the primary endpoint in its Phase 2 clinical trial of Cavatak in the treatment of late stage melanoma patients (the CALM study).
The Phase 2 trial is a single arm study being conducted at 10 U.S. sites and is designed to investigate the safety and efficacy of intratumoral Cavatak (Coxsackievirus A21) in 54 evaluable patients with late stage (IIIc and IV) malignant melanoma.
The primary endpoint measured is immune related Progression Free Survival (irPFS) at 6 months after first dose of Cavatak. Progression Free Survival is the length of time, during and after treatment, that the patient lives with the cancer without it worsening. It includes patients that achieve a complete tumour response, partial tumour response or stable disease.
The primary endpoint of the study was to have 10 patients from a total of 54 evaluable patients (18.5 percent) reporting irPFS at six months after the first dose of Cavatak. This was achieved after only 30 evaluable patients, representing an irPFS rate so far of 33 percent.
“Achieving the primary endpoint of the CALM study before patient recruitment has been completed is very encouraging. In addition to the positive irPFS data we have observed responses in both injected and non-injected lesions,” said Dr. Robert Andtbacka, lead study investigator from the Huntsman Cancer Institute in the United States.
Dr. Malcolm McColl, chief executive officer of Viralytics said: “We are delighted to achieve this major milestone in the development of Cavatak. Given the excellent progress achieved to date and the encouraging feedback from key opinion leaders in the melanoma field we also believe it is now timely to consider the design of a randomised study in melanoma patients.”
Other study endpoints include durable response rate, one year survival and overall survival. These will be reported on as sufficient data are generated and analysed.
As reported on July 19, the independent Data Monitoring Committee (DMC) of the trial met to review data from the first 35 patients in the study (Stage 1). It concluded that Cavatak had met the safety, tolerability and response criteria and thus the study could progress to full enrollment. Cavatak has been well tolerated by patients with no reports of serious adverse events or grade 3/4 adverse events related to the Cavatak treatment.
There are now 44 patients enrolled in the study with full enrolment forecast by the end of 2013.
Date: September 18, 2013