DCVAC/LuCa / Sotio - LARVOL DELTA

DCVAC/LuCa with chemotherapy in patients with stage IV, non-squamous NSCLC without EGFR/ALK aberrations: Five-Year Survival Update (ELCC 2023) - "Background Our study was the first clinical trial showing the safety and efficacy of DCVAC/LuCa (dendritic cell vaccines for lung cancer) combined with chemo in Chinese NSCLC patients (Zhong R, Ling X, et al...Patients were treated with carboplatin/pemetrexed for up to 6 cycles, followed by pemetrexed maintenance for up to 21 cycles...Conclusions The combination of DCVAC/LuCa and chemo continued to provide long-term benefits as a first-line treatment in Chinese patients with stage IV, non-squamous NSCLC without EGFR/ALK aberrations. The long-term benefits and the good safety profile support the conduct of a validation trial in a larger population with greater diversity."

Clinical • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Evaluation of Safety and Efficacy of DCVAC/LuCa (Immunotherapy of Lung Cancer) in Patients With Metastatic Lung Cancer (clinicaltrials.gov) - P1/2 | N=105 | Completed | Sponsor: SOTIO a.s. | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Single-Arm Phase II Study to Evaluate Efficacy and Safety of First-Line Treatment With DCVAC/LuCa, Standard of Care Chemotherapy and Shenqi Fuzheng Injection in Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer Patients. (PubMed, Integr Cancer Ther) - "DCVAC/LuCa, combined with standard of care chemotherapy and Shenqi Fuzheng injection exhibited good benefit in Chinese patients with recurrent metastatic or advanced (stage IIIB/IV) NSCLC, and also significantly improved Qi insufficiency constitution. There were no related adverse events with DCVAC/LuCa treatment."

Journal • P2 data • Cardiovascular • Heart Failure • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Safety and efficacy of dendritic cell-based immunotherapy (DCVAC/LuCa) combined with carboplatin/pemetrexed for patients with advanced non-squamous non-small-cell lung cancer without oncogenic drivers. (PubMed, ESMO Open) - "In treatment-naïve stage IV nsq NSCLC patients without oncogenic drivers, the combination of carboplatin/pemetrexed and DCVAC/LuCa was well tolerated and showed promising efficacy. Therefore, a study to prove our immunotherapeutic concept in a randomized phase III trial is planned."

Clinical • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Dendritic-cell vaccine (DCVAC) with first-line chemotherapy in patients with stage IV NSCLC: Finalanalysis of phase II, open label, randomized, multicenter trial. (ASCO 2019) - P1/2; " This study evaluated the efficacy and safety of DCVAC/LuCa (active cellular immunotherapy based on dendritic cells) concomitantly added to ct (carboplatin/paclitaxel) - Arm A (A) vs DCVAC/LuCa + immune modulators (IFN-α and hydroxychloroquine) - Arm B (B)+ct vs ct - Arm C (C) in NSCLC patients (pts). Addition of DCVAC-based immunotherapy to the standard of care chemotherapy significantly improved OS in stage IV NSCLC. Clinical trial information: NCT02470468"

Clinical • P2 data

[VIRTUAL] Efficacy and safety of DCVAC/LuCa with chemotherapy for patients with stage IV NSCLC: A prospective, open-label, single-arm, phase 2 study (ELCC 2021) - P2 | "No DCVAC-induced AEs were observed.Conclusions In stage IV, non-squamous NSCLC without genetic variants, the combination therapy of DCVAC/LuCa with pemetrexed plus carboplatin has a clinical activity and a favorable tolerability profile. Our Results are a foundation for further randomized controlled clinical trials of this therapy."

Clinical • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Autologous dendritic cell-based immunotherapy (DCVAC/LuCa) and carboplatin/paclitaxel in advanced non-small cell lung cancer: A randomized, open-label, phase I/II trial. (PubMed, Cancer Treat Res Commun) - "DCVAC/LuCa in combination with carboplatin and paclitaxel extended OS and was well tolerated."

Clinical • Journal • P1/2 data • Alopecia • Fatigue • Hematological Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] Efficacy and safety of DCVAC/LuCa Treatment plus standard chemotherapy and TCM in patients with advanced non-small cell lung cancer: A single-arm phase II study. (ASCO 2020) - "DCVAC/LuCa, combined with standard chemotherapy and TCM had exhibited the potential to improve the survival in patients with advanced NSCLC, and decrease the occurrence of adverse events. But the sample size of this study is small, a further clinical investigation is needed. Research Funding: SOTIO"

Clinical • P2 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lung Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Thoracic Cancer • ALK • EGFR

SOTIO’s DCVAC/LuCa significantly improves survival in patients with stage IV non-small cell lung cancer (Businesswire) - P1/2, N=105; SLU01 (NCT02470468); Sponsor: Sotio a.s; “SOTIO…presented new statistically and clinically significant results from its Phase I/II clinical trial evaluating DCVAC/LuCa…in patients with stage IV non-small cell lung cancer. The final analysis of the data confirmed the promising clinical efficacy of DCVAC/LuCa. SLU01 clinical trial results were presented…at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago today….Patients that received DCVAC in combination with chemotherapy have a 46% lower risk of dying compared to those who received chemotherapy alone. Furthermore, the 3.7-month longer survival with the DCVAC/chemo combination is statistically and clinically significant. Treatment was very well tolerated and there were no serious adverse events solely related to DCVAC/LuCa.”

P1/2 data

Sotio to present final phase I/II DCVAC/LuCa data at ASCO 2019 Annual Meeting (PharmiWeb) - P1/2, N=105; SLU01 (NCT02470468); Sponsor: Sotio a.s; “SOTIO…announces that final data from the SLU01 Clinical Trial with DCVAC/LuCa will be presented in poster session at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago on June 2, 2019. Final analysis of SLU01 data confirmed promising clinical efficacy of DCVAC/LuCa active cellular immunotherapy product in patients with stage IV non-small cell lung cancer.”

P1/2 data

Evaluation of Safety and Efficacy of DCVAC/LuCa (Immunotherapy of Lung Cancer) in Patients With Metastatic Lung Cancer (clinicaltrials.gov) - P1/2; N=105; Active, not recruiting; Sponsor: Sotio a.s.; Trial completion date: Nov 2018 ➔ Nov 2021

Clinical • Trial completion date