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SCIB1/iSCIB1+ plus ipilimumab and nivolumab displayed T-cell responses in treatment-naive, unresectable melanoma.
The off-the-shelf cancer vaccines SCIB1 and iSCIB1+ in combination with ipilimumab (Yervoy) and nivolumab (Opdivo) produced robust T-cell responses in patients with untreated advanced unresectable melanoma, according to data from the phase 2 SCOPE trial (NCT04079166) presented during the
Among patients who received SCIB1 plus ipilimumab and nivolumab (n = 32), 22 achieved a complete response (CR) or a partial response (PR). Patients with a CR/PR had high-magnitude T-cell responses at a rate of 73% (n = 11/15). In the group that received iSCIB1+ in place of SCIB1 (n = 34), 19 patients achieved a CR/PR and the high-magnitude T-cell response rate was 73% (n = 11/15).
“These data support that SCIB1 and iSCIB1+ induces significant potent T-cell responses, resulting in positive clinical responses,” Kate Young, MD, MBBS, MRCP, and her coauthors wrote in a poster presentation of the data. “Strong vaccine induced T-cell responses are associated with better tumor control.”
Young is a consultant medical oncologist and the unit lead of the Acute Oncology Service at the Royal Marsden Hospital NHS Foundation Trust in London, England.
SCOPE is an ongoing, open-label single-arm study that is examining SCIB1 or iSCIB1+ in combination with nivolumab with ipilimumab or SCIB1 with pembrolizumab (Keytruda) for the treatment of patients with advanced melanoma.3 The study is enrolling adult patients with unresectable stage III or IV melanoma who have not received prior systemic treatment for advanced disease; previous neoadjuvant or adjuvant treatment are permitted. Other key eligibility criteria include a life expectancy of over 3 months, an ECOG performance status of 0 or 1, at least 1 measurable lesion per RECIST 1.1 criteria, and adequate organ function.
Patients in cohort 1 are treated with SCIB1 plus ipilimumab and nivolumab and those in cohort 3 are given iSCIB1+ in combination with ipilimumab and nivolumab.1,3 Patients will receive up to 11 doses of either SCIB1 or iSCIB1+ for up to 85 weeks.3 Ipilimumab and nivolumab are initiated 1 week after the first dose of the cancer vaccine and are administered via standard treatment protocols.
The study’s primary end points are safety and ORR. Secondary end points include duration of response, PFS rate, and overall survival. Immune response and marker expression serve as exploratory end points.
Further data from SCOPE revealed that patients who experienced a T-cell response to both gp100 and TRP2 peptides post-vaccination with iSCIB1+ exhibited better tumor control. Nine patients who receive SCIB1 had a T-cell response to 1 antigen: 6 patients responded to TRP2 only and 3 responded to gp100 only. In total, 67% of patients had a poorer outcome with stable disease or disease progression.
“Vaccine induced T-cell responses correlate with decrease in tumor size, as noted at the first scans, as well as with a durable response, reflected in improved PPFS,” Young and her coauthors concluded.
Disclosures: Young reported being an invited speaker for BMS, Eisai and Ipsen. She received personal, consultancy fees from Merck Serono and financial support from Aveo Pharmaceuticals and Erasca. She reported financial interests in Scancell and Ultimovacs.
