116P - A randomized study to evaluate safety of DCVAC/LUCA added to chemotherapy with carboplatin and pemetrexed vs. chemotherapy alone in patients with s...

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Thoracic malignancies
Non-small-cell lung cancer
Presenter hua Zhong
Citation Annals of Oncology (2017) 28 (suppl_2): ii28-ii51. 10.1093/annonc/mdx091
Authors H. Zhong1, R. Zhong2, B. Yan2
  • 1Department Of Pulmonary Medicine, Shanghai Chest Hospital, 200030 - Shanghai/CN
  • 2Department Of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai/CN

Abstract

Background

DCVAC/LuCa is an active autologous cellular immunotherapy consisting of autologous dendritic cells (DCs) loaded with NSCLC antigens (whole tumor cell antigens of tumor cell lines, like Her2/neu, MAGE-A3 and Survivin, et al.). DCVAC has the ability to induce an immune response, including cytotoxic CD8+ T cells, against tumor-associated antigens expressed by patients’ cancer cells. However, advanced-stage NSCLC with a heavy tumor burden establishes a harsh landscape for immunotherapy due to immune tolerance towards tumor antigens. Combination of DC treatment and chemotherapy is anticipated to achieve stronger immune responses than either of the treatments alone. AEs were collected in this study to evaluate the safety of DCVAC/LuCa added to chemotherapy with pemetrexed and carboplatin vs. chemotherapy alone in patients with stage IV non-small cell lung cancer.

Methods

This is a randomized, open-label study. A total of 20 newly diagnosed stage IV, non-squamous, wild-type EGFR, ALK-negative or unknown NSCLC patients treated between January 2016- December 2016 in Shanghai Chest Hospital were enrolled.10 patients were randomized to group A: DCVAC/LuCa + chemotherapy (4-6 cycles of pemetrexed/carboplatin followed by pemetrexed as maintenance therapy); 10 patients were randomized to group B: 4-6 cycles of pemetrexed/carboplatin followed by pemetrexed as maintenance therapy.Patients in the group A started with DCVAC/LuCa (5 × 106 DCs/aliquots) treatment on Day 15 (+/- 3 days) of chemotherapy Cycle 3.The initial 5 doses of DCVAC/LCa were administered at a 3-week interval. The DCVAC/LuCa was then injected every 6 weeks up to the maximum number of 15 doses (75 × 106 DCs/15 aliquots). AEs were collected and analyzed.

Results

The common adverse events in both group were chemotherapy related leukopenia, hemoglobin decrease etc. All AEs were grade 1 or 2 according to CTCAE V4.03, and there were no grade 4 toxicities or treatment-related deaths. One patient in group A got non-infectious fever and returned to normal without treatment.

Conclusions

In patients with stage IV NSCLC, DCVAC/LuCa therapy was well tolerated with the favorable safety profile.

Clinical trial identification

Legal entity responsible for the study

Shanghai Chest Hospital

Funding

Sotio Medical Research (Beijing) Co., Ltd

Disclosure

All authors have declared no conflicts of interest.