iSCIB1+ has received fast track designation from the regulatory agency as a potential therapeutic options for patients with advanced melanoma.
The FDA has granted fast track designation to the oncolytic vaccine iSCIB1+ for the treatment of patients with advanced melanoma.1
The agent is under investigation in the ongoing phase 2 SCOPE trial (NCT04079166), which has shown a 20-month progression-free survival (PFS) rate of 77% in the target population of patients with HLA-positive advanced melanoma, significantly surpassing the 20-month PFS rate of 43% associated with standard nivolumab (Opdivo) and ipilimumab (Yervoy) in the pivotal phase 3 CheckMate-067 trial (NCT01844505).
“This designation is a major achievement for Scancell and important recognition not only of the potential of iSCIB1+, but also of the significant need for new and improved treatment options for patients with advanced melanoma. We are very pleased with how the phase 2 SCOPE data [are] maturing and [we] are advancing plans for a global registrational phase 3 trial, which we expect to initiate in the second half of 2026,” Phil L’Huillier, PhD, MBA, CEO of Scancell, said in a news release.1
SCOPE is a multicenter, open-label study evaluating the
Key end points include disease control rate (DCR), duration of response (DOR), PFS, and overall survival (OS).
To be eligible for enrollment, patients must be 18 years or older, have a histologically confirmed diagnosis of unresectable stage III or stage IV melanoma, and not have undergone prior systemic treatment for advanced disease. Prior neoadjuvant or adjuvant treatment, defined as treatment prior to or following resection of all detectable disease, is allowed if the last dose was received at least 24 weeks prior to the first dose of SCIB1 or iSCIB1+.
Patients must also be candidates to receive checkpoint inhibition with either nivolumab plus ipilimumab or pembrolizumab. Patients must also undergo BRAF testing prior to enrollment, though prior exposure to BRAF inhibition is not required in the presence of indolent disease.
Additional enrollment criteria include at least 1 measurable lesion per RECIST 1.1 criteria by CT scan or MRI, and positive HLA-A2 and HLA-DR4, HLA-DR7, HLA-DR53, or HLA-DQ6 markers for cohorts 1 through 3. Routine criteria also require a life expectancy of more than 3 months, an ECOG performance status of 0 or 1, and adequate organ function as defined by protocol-specified laboratory values.
Patients who are eligible to receive the combination of nivolumab and ipilimumab will be enrolled into cohort 4 with iSCIB1+, assuming the target HLA haplotype does not match the aforementioned markers, or they are unable to wait for HLA screening results prior to enrollment, or cohort 1 and cohort 3 have stopped accrual.
Eligible patients will receive up to 11 doses of either SCIB1 or iSCIB1+ using PharmaJet’s needle-free injection devices.
The agent will be subject to further study in a registrational phase 3 trial in patients with HLA-positive advanced melanoma in the second half of 2026.
Further PFS data and preliminary OS data from the phase 2 trial are expected in the first half of 2027.
