S-588210 / OncoTherapy, Shionogi, University of Chicago - LARVOL DELTA

Durvalumab Plus Vaccine Therapy Elicits ‘Encouraging’ DFS in BCG-Unresponsive NMIBC (OncLive) - P1b/2 | N=64 | DURANCE (NCT04106115) | "Durvalumab plus vaccine therapy demonstrated evidence of preliminary antitumor activity without substantial additive toxicity in BCG-unresponsive NMIBC....As of the data cutoff date of October 21, 2024, the 3- and 6-month disease-free survival (DFS) rates were 71% and 57%, respectively. Additionally, 8 patients––2 of 6 with baseline carcinoma in situ (CIS), 5 of 6 with baseline T1 tumors, and 1 of 2 with baseline Ta tumors––were disease free at the 24-week assessment following the end of treatment."

P1/2 data • Bladder Cancer

DURANCE: A phase Ib/II study to assess the safety and activity of durvalumab (MEDI4736) in combination with S-488210/S-488211 vaccine in non-muscle invasive bladder cancer (ESMO Asia 2024) - P1/2 | "Conclusions Co-administration of durvalumab and S-488210/S-488211 vaccine is safe and well tolerated. The encouraging response rate at the first cystoscopy assessment warrants further investigation of this combination in the phase II trial."

Clinical • Combination therapy • P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

First in human study of S-488210/S-488211, a cancer peptide vaccine, in patients with advanced solid tumours (SITC 2022) - P1 | "Conclusions S-488210/S-488211 was generally well tolerated and led to a robust CTL response in a range of solid tumours. S-488210/S-488211 is being taken forward in a phase 2 study in combination with PD-L1 blockade."

Clinical • P1 data • Lung Cancer • Oncology • Solid Tumor • DEPDC1 • HLA-A

DURANCE: DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr (clinicaltrials.gov) - P1/2 | N=64 | Recruiting | Sponsor: University College, London | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HLA-A

First-in-human Study of S-588210 (S-488210+S-488211) (clinicaltrials.gov) - P1; N=10; Completed; Sponsor: Shionogi; Recruiting ➔ Completed

Trial completion • Bladder Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Mesothelioma • Oncology • Solid Tumor • Urothelial Cancer

DURANCE: DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr (clinicaltrials.gov) - P1/2; N=64; Not yet recruiting; Sponsor: University College, London; Trial completion date: Sep 2028 ➔ Mar 2029; Trial primary completion date: Aug 2024 ➔ Mar 2025

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HLA-A • MRI • PCR

DURANCE: DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr (clinicaltrials.gov) - P1/2; N=64; Not yet recruiting; Sponsor: University College, London; Trial completion date: Jul 2027 ➔ Sep 2028; Trial primary completion date: Jul 2023 ➔ Aug 2024

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • PCR

First-in-human Study of S-588210 (S-488210+S-488211) (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Shionogi; Trial completion date: Oct 2020 ➔ Oct 2021; Trial primary completion date: Oct 2020 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Bladder Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Mesothelioma • Oncology • Solid Tumor • Urothelial Cancer

First-in-human Study of S-588210 (S-488210+S-488211) (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Shionogi

Clinical • New P1 trial