ASCO 2021: INDUCE-1 Trial of Feladilimab Plus Pembrolizumab in Urothelial Carcinoma
Posted: Thursday, June 24, 2021
During the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, Arjun Vasant Balar, MD, of Perlmutter Cancer Center at NYU Langone Health, New York, and colleagues presented preliminary results from the INDUCE-1 study—the first-in-human trial to evaluate the IgG4 inducible T-cell co-stimulatory receptor agonist feladilimab alone and in combination with pembrolizumab in urothelial carcinoma (Abstract 4519). These researchers reported single-agent activity with feladilimab and “promising clinical activity and manageable safety” when combined with pembrolizumab, although further research is warranted.
This trial enrolled 45 patients with recurrent or metastatic urothelial carcinoma who received no more than six previous systemic therapies. Participants who had previously received PD-1/L1 inhibitors (n = 13) were administered 0.3 or 1 mg/kg of feladilimab alone, and patients who had not received prior anti–PD-1/L1 treatment (n = 32) received 0.3 mg/kg of feladilimab and 200 mg of pembrolizumab; treatment continued up to 35 cycles, disease progression, or unacceptable toxicity.
In the monotherapy arm, the median age of patients was 69, and 85% received at least two lines of prior therapy in the metastatic setting. The median duration of follow-up was 10.6 months, and the duration of response was 6.1 months. In this cohort, the overall response rate, disease control rate, and median overall survival were 8%, 23%, and 14.5 months, respectively; at 6 months, 74% of patients were still alive.
In the combination- therapy arm, the median age was 70, and 72% received at least one line of previous therapy. The median duration of follow-up was 9.6 months, and the duration of response was 8.3 months. Overall, the disease control rate, overall response rate, and median overall survival were 63%, 22%, and 10.7 months, respectively; 64% of patients were alive at 6 months. Additionally, grade 3 or greater treatment-related adverse events affected 9% of patients given the combination therapy and 0% of those given monotherapy.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.