TAS0313 / Otsuka - LARVOL DELTA

TAS0313 Plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor-Naïve Locally Advanced or Metastatic Urothelial Carcinoma. (PubMed, Mol Cancer Ther) - "No grade ≥3 treatment-related AEs occurred in ≥10% of patients. TAS0313 plus pembrolizumab combination therapy showed promising efficacy and manageable safety in locally advanced/metastatic urothelial carcinoma."

Checkpoint inhibition • IO biomarker • Journal • Metastases • Oncology • Solid Tumor • Urothelial Cancer • CD8 • PD-1 • PD-L1

Evaluation of the efficacy and safety of TAS0313 in adults with recurrent glioblastoma. (PubMed, Cancer Immunol Immunother) - "TAS0313, a multi-epitope long peptide vaccine, demonstrated promising efficacy and acceptable safety in patients with recurrent GBM."

Journal • Brain Cancer • Dermatology • Glioblastoma • Glioma • Immunology • Oncology • Pruritus • Solid Tumor

[VIRTUAL] Phase I/II study to evaluate the efficacy of TAS0313, a cancer peptide vaccine, combined with pembrolizumab for locally advanced or metastatic urothelial carcinoma. (ASCO 2021) - "This study confirmed the tolerability, safety, and immune response of TAS0313 combined with pembrolizumab in cohorts C1 and C2 . We observed promising efficacy in pts with ICI-naïve UC in cohort C1; however, in pts with pembrolizumab-refractory UC in cohort C2, limited efficacy was seen . Therefore, a large-scale randomized study is needed to clarify the benefits of TAS0313 combined with ICI in ICI-naïve pts."

Clinical • P1/2 data • Immune Modulation • Inflammation • Oncology • Solid Tumor • Urothelial Cancer

[VIRTUAL] Efficacy finding cohort of a cancer peptide vaccine, TAS0313, in treating recurrent glioblastoma. (ASCO 2021) - "Eligible patients were those who received standard radiotherapy and temozolomide, had a confirmed first or second recurrence, or progression with measurable disease outcomes with good performance status (Karnofsky Performance Status score > 70) . TAS0313 showed promising efficacy with expected immune responses and favorable safety and tolerability in patients with recurrent GBM . Further investigation of TAS0313 is warranted to validate our findings."

Clinical • Brain Cancer • Glioblastoma • Gliosarcoma • Immunology • Oncology • Sarcoma • Solid Tumor • ABCC3 • EGFR

First-in-human study of the cancer peptide vaccine, TAS0313, in patients with advanced solid tumors. (PubMed, Cancer Sci) - "Further evaluation of TAS0313's efficacy as monotherapy or in combination with pembrolizumab is underway. The study is registered at www.clinicaltrials.jp (JapicCTI-183824)."

Clinical • Journal • P1 data • Oncology • Solid Tumor

First-in-human study of the cancer peptide vaccine, TAS0313, in patients with advanced solid tumors: Phase I dose-finding part results. (ASCO-SITC 2020) - "TAS0313 demonstrated safety, tolerability, and immunological responses in pts with advanced solid tumors in the 9 and 27mg groups. A phase II part, evaluating the efficacy of combination therapy with pembrolizumab in pts with urothelial carcinoma and monotherapy in glioblastoma pts, is currently underway. Clinical trial information: JapicCTI-183824."

Clinical • P1 data

First-in-human study of the cancer peptide vaccine, TAS0313, in patients with advanced solid tumors: Phase I dose-finding part results. (ASCO-SITC 2020) - "TAS0313 demonstrated safety, tolerability, and immunological responses in pts with advanced solid tumors in the 9 and 27mg groups. A phase II part, evaluating the efficacy of combination therapy with pembrolizumab in pts with urothelial carcinoma and monotherapy in glioblastoma pts, is currently underway. Clinical trial information: JapicCTI-183824."

Clinical • P1 data

First-in-human study of the cancer peptide vaccine, TAS0313, in patients with advanced solid tumors: phase I dose finding part results. (SITC 2019) - "TAS0313 demonstrated safety, tolerability, and immunological responses in patients with advanced solid tumors in the 9mg and 27mg groups. A phase II part, evaluating the efficacy of combination therapy with pembrolizumab in patients with urothelial carcinoma and monotherapy in glioblastoma patients, is currently underway."

Clinical • P1 data

TAS0313, a novel cocktail vaccine of multivalent HLA-A2-, A24- and A3 superfamily-restricted epitopes, demonstrates a synergistic antitumor effect with anti-PD-1 antibody (SITC 2019) - "We demonstrated that TAS0313 can enhance CTL induction and antitumor effects in vivo. In addition, the combination therapy of TAS0313 and anti-PD-1 mAb resulted in a synergistic antitumor effect by increasing the infiltration of epitope-specific CTLs into tumors. Based on these results, Phase I/II studies evaluating the efficacy of combination therapy with pembrolizumab in urothelial carcinoma patients and monotherapy in glioblastoma patients are currently underway."