Abstract 45P
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. ESMO Open 2022). The OS data was not mature in our last report. Here, we present a survival update based on 33 months of additional follow-up.
Methods
Patients with stage IV, non-squamous NSCLC, no known EGFR/ALK aberrations, and who had not received systemic therapy for NSCLC prior to treatment, were enrolled in this study. Patients were treated with carboplatin/pemetrexed for up to 6 cycles, followed by pemetrexed maintenance for up to 21 cycles. Non-progression patients after two cycles of chemotherapy, assessed as mITT population, received DCVAC/LuCa subcutaneously (s.c.) on day 15 of cycle 3, and thereafter q3w (day 15 of chemotherapy cycles) for up to 15 doses. The dose of DCVAC/LuCa s.c. depended on the baseline number of leucocytes of each patient.
Results
A total of 61 patients were enrolled. At the clinical cutoff date (14 Dec 2022), the median follow-up was 64 months. In the mITT population (n = 44), the median OS was 27.4 months (95% CI, 18.1 to 36.7 months), the 3-year OS rate was 37.2% and the 5-year OS rate was 23.4%. Among the 15 patients who completed 15 cycles of DC vaccination, 6 (40%) remained alive at a 5-year follow-up. Patients who received higher-dose DCVAC/LuCa had a better prognosis than patients who received lower-dose DCVAC/LuCa.
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.
Legal entity responsible for the study
SOTIO Medical Research (Beijing) Co., Ltd.
Funding
SOTIO Medical Research (Beijing) Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.