New Treatment Combo Improves Advanced Melanoma Outcomes

SCIB1/iSCIB1+ immunotherapies combined with checkpoint inhibitors may set a new benchmark for treating advanced melanoma, according to a news release from Scancell Holdings.

Positive data comes from the phase 2 SCOPE trial.

“The addition of SCIB1 or iSCIB1+ to standard-of-care checkpoint inhibitors has demonstrated extremely exciting early signals, including improved overall response rates and progression-free survival to date, without a meaningful increase in treatment-related toxicity,” Dr. Heather Shaw, principal investigator of the trial, said in the news release.

Shaw is also the lead for the Medical Oncology Skin Cancer Service at University College London Hospital, London.

Shaw continued, “These findings highlight the real potential for a significant clinical benefit for patients with advanced melanoma, where there is an unmet need. As the progression-free survival and overall survival data matures, expediting the planned registrational randomised controlled trial will be critical. This study will have the potential to redefine current treatment paradigms for a disease that remains challenging for many patients.”

Patients in cohorts 1 and 3 received SCIB1 or iSCIB1+ alongside the standard treatment of Yervoy (ipilimumab) and Opdivo (nivolumab). Among the 67 evaluable patients in these cohorts, the overall response rate was 68.6%, with a disease control rate of 88% and a complete response rate of 17.9%. In cohort 2, which tested SCIB1 with Keytruda (pembrolizumab), results were similar among the nine patients enrolled before the cohort was stopped due to a change in standard treatment in the UK. These findings suggest a notable improvement over the previously reported response rates of about 50% in the CheckMate 067 trial and 48% in real-world use of Yervoy and Opdivo alone, as per the release.

Patients in cohort 1 achieved 64.6% progression-free survival at 12 months, while cohort 3 showed 80.8% at 11 months. These results compare favorably with the previously reported 12-month rate of 43.9% for Yervoy plus Opdivo.

The safety profile of SCIB1/iSCIB1+ with standard treatment was similar to that of Yervoy and Opdivo alone, suggesting immunobody did not add new safety concerns and was well tolerated.

“iSCIB1+ has shown meaningful benefits in terms of responses, disease control, progression-free survival and immune responses, which offer a potentially huge improvement for patients,” Dr Nermeen Varawalla, chief medical officer of Scancell, said in the news release. “Furthermore, its strong safety profile suggests that iSCIB1+ could be used in addition to SoC without adding toxicities. These data demonstrate the potential of iSCIB1+ in patients with metastatic melanoma as well as highlight the significant potential in earlier stage resectable disease when administered in the neoadjuvant/adjuvant setting. The results also provide the option of a biomarker to predict responders which could be a significant advantage in selecting participants in a future registrational study.”

The SCOPE study is a phase 2 trial in the United Kingdom evaluating SCIB1 and iSCIB1+ in combination with standard checkpoint inhibitors for patients with stage 3 or 4 unresectable melanoma. The open-label trial will enroll more than 140 patients across four groups and is designed to assess how well the DNA Immunobody® therapies work, how long their effects last and how safe they are when added to standard treatment.

Participants may receive SCIB1 or iSCIB1+ up to 11 times over an 85-week period. These therapies will be given alongside the standard treatments, which follow their approved dosing schedules. SCIB1 and iSCIB1+ are delivered using a needle-free injection device in the upper arm or leg.

Before beginning treatment, patients will go through screening tests within 28 days of starting to confirm eligibility. During the 85-week treatment period, patients will have regular hospital visits along with some video or phone check-ins. All procedures and check-ups are explained in the study materials patients receive before they provide consent to take part.

Reference

1. “Scancell reports Phase 2 data showing strongly improved outcomes in Late-Stage Melanoma with its Immunobody® iSCIB1+,” by Scancell. July 22.

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