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INDUCE-1 is the first human clinical study evaluating feladilimab (a T cell inducible costimulatory [ICOS] molecular receptor inhibitor) ± pembrolizumab for urothelial cancer
.
The expansion cohort includes patients with urothelial cancer, whose ICOS is highly expressed and has relevant characteristics that can be used for immunotherapy
.
Feladilimab can induce IFNγ and increase the expression of PD-1 or PD-L1
.
Preclinical studies have shown that Feladilimab+Pembrolizumab can enhance anti-tumor activity
.
At this year's ASCO conference, researchers announced the preliminary efficacy, safety, and molecular marker results of the INDUCE-1 urothelial cancer expansion cohort
.
Methods: Eligible patients had recurrent/metastatic urothelial carcinoma of the upper urethra or lower urethra.
They had previously received ≤ 6-line system therapy, had measurable lesions, and had no active autoimmune diseases
.
Enrolled patients received feladilimab (0.
3 or 1 mg/kg) (previously received PD-1/PD-L1 inhibitors) (single-agent group) or feladilimab (0.
3 mg/kg) + pembrolizumab (200 mg) ( Have not received PD-1/PD-L1 inhibitors) (combined group) (Q3W, up to 35 cycles) until the disease progresses, or unacceptable toxicity occurs
.
Disease evaluation was conducted every 9 weeks for the first 54 weeks, and then every 12 weeks.
Fresh biopsy tumor tissues were collected for biomarker analysis and safety evaluation
.
Results: As of March 16, 2021, the median age of patients in the single-agent group was 69 years, 92% of patients were male, and 85% of patients had previously received ≥2 line therapy
.
The median age of patients in the combination group was 70 years, 75% of patients were male, and 72% of patients received ≥1 line therapy
.
The median duration of follow-up (DoF) of the single-agent group was 12.
6 months, the overall response rate (ORR) was 7%, 1 case had a partial response, the disease control rate (DCR) was 21%, and the response or disease was stable for more than 9 weeks.
The median overall survival (OS) was 14.
5 months, and 77% of patients were still alive at 6 months
.
The median DoF of the combined group was 9.
6 months, ORR was 22%, median DoR was 8.
3 months, DCR rate was 63%, median OS was 10.
7 months, and 64% of patients were still alive at 6 months
.
The incidence of grade 3 and above adverse events in the single-agent group and the combination group were 0 and 9%, respectively
.
PD-L1 expression and ICOS specific biomarkers are being evaluated, and it has been preliminarily observed that it has clinical application prospects
.
Conclusion: Feladilimab is the first ICOS inhibitor used in previous immune checkpoint inhibitors and relapsed/refractory urothelial cancer
.
Feladilimab+pembrolizumab shows good anti-tumor activity and controllable safety in patients with relapsed/refractory urothelial cancer who have not received immune checkpoint inhibitors
.
Still need further research and exploration
.
Clinical trial information: Study 204691 (NCT02723955) Reference: Inducible T-cell co-stimulatory (ICOS) receptor agonist, feladilimab (fela), alone and in combination (combo) with pembrolizumab (P): Results from INDUCE-1 urothelial carcinoma (UC) expansion cohorts (ECs).
abstract 4519.
Oral Abstract Session
.
The expansion cohort includes patients with urothelial cancer, whose ICOS is highly expressed and has relevant characteristics that can be used for immunotherapy
.
Feladilimab can induce IFNγ and increase the expression of PD-1 or PD-L1
.
Preclinical studies have shown that Feladilimab+Pembrolizumab can enhance anti-tumor activity
.
At this year's ASCO conference, researchers announced the preliminary efficacy, safety, and molecular marker results of the INDUCE-1 urothelial cancer expansion cohort
.
Methods: Eligible patients had recurrent/metastatic urothelial carcinoma of the upper urethra or lower urethra.
They had previously received ≤ 6-line system therapy, had measurable lesions, and had no active autoimmune diseases
.
Enrolled patients received feladilimab (0.
3 or 1 mg/kg) (previously received PD-1/PD-L1 inhibitors) (single-agent group) or feladilimab (0.
3 mg/kg) + pembrolizumab (200 mg) ( Have not received PD-1/PD-L1 inhibitors) (combined group) (Q3W, up to 35 cycles) until the disease progresses, or unacceptable toxicity occurs
.
Disease evaluation was conducted every 9 weeks for the first 54 weeks, and then every 12 weeks.
Fresh biopsy tumor tissues were collected for biomarker analysis and safety evaluation
.
Results: As of March 16, 2021, the median age of patients in the single-agent group was 69 years, 92% of patients were male, and 85% of patients had previously received ≥2 line therapy
.
The median age of patients in the combination group was 70 years, 75% of patients were male, and 72% of patients received ≥1 line therapy
.
The median duration of follow-up (DoF) of the single-agent group was 12.
6 months, the overall response rate (ORR) was 7%, 1 case had a partial response, the disease control rate (DCR) was 21%, and the response or disease was stable for more than 9 weeks.
The median overall survival (OS) was 14.
5 months, and 77% of patients were still alive at 6 months
.
The median DoF of the combined group was 9.
6 months, ORR was 22%, median DoR was 8.
3 months, DCR rate was 63%, median OS was 10.
7 months, and 64% of patients were still alive at 6 months
.
The incidence of grade 3 and above adverse events in the single-agent group and the combination group were 0 and 9%, respectively
.
PD-L1 expression and ICOS specific biomarkers are being evaluated, and it has been preliminarily observed that it has clinical application prospects
.
Conclusion: Feladilimab is the first ICOS inhibitor used in previous immune checkpoint inhibitors and relapsed/refractory urothelial cancer
.
Feladilimab+pembrolizumab shows good anti-tumor activity and controllable safety in patients with relapsed/refractory urothelial cancer who have not received immune checkpoint inhibitors
.
Still need further research and exploration
.
Clinical trial information: Study 204691 (NCT02723955) Reference: Inducible T-cell co-stimulatory (ICOS) receptor agonist, feladilimab (fela), alone and in combination (combo) with pembrolizumab (P): Results from INDUCE-1 urothelial carcinoma (UC) expansion cohorts (ECs).
abstract 4519.
Oral Abstract Session
