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

June 26, 2021
Source: Cancer Treat Res Commun. 2021 Jun 26;28:100427. doi: 10.1016/j.ctarc.2021.100427.

Authors: Milada Zemanova, Marketa Cernovska, Libor Havel, Tomas Bartek, Sarka Lukesova, Jitka Jakesova, Jaroslav Vanasek, Pavel Reiterer, Juraj Kultan, Igor Andrasina, Lenka Siskova, Leona Koubkova, Jana Skrickova, Frantisek Salajka, Milos Pesek, Petr Klepetko, Juraj Beniak, Harald Fricke, Pavla Kadlecova, Roman P Korolkiewicz, Marek Hraska, Jirina Bartunkova, Radek Spisek .

Purpose: To investigate the efficacy and safety of an active cellular immunotherapy (DCVAC/LuCa) and chemotherapy in patients with stage IV non-small cell lung cancer (NSCLC).

Patients and methods: SLU01 was a multicenter, open-label, parallel-group, randomized, phase I/II trial. NSCLC patients were randomized in a ratio of 1:1:1 to receive: DCVAC/LuCa and chemotherapy (carboplatin and paclitaxel; Group A); DCVAC/LuCa, chemotherapy, pegylated interferon-α2b, and hydroxychloroquine (Group B); or chemotherapy alone (Group C). DCVAC/LuCa was administered subcutaneously every 3-6 weeks (up to 15 doses). The primary endpoint was overall survival (OS). During the study, enrollment into Group B was discontinued for strategic reasons.

Results: Forty-five patients were randomized to Group A, 29 patients to Group B, and 38 patients to Group C. The median OS in the modified intention-to-treat (mITT) population was 3.7 months longer in Group A than in Group C (15.5 vs. 11.8 months; p = 0.0179; hazard ratio = 0.54; 95% confidence interval: 0.32-0.91). This OS effect was consistent across subgroups of the mITT population (females, males, current smokers, former smokers, and patients with non-squamous and squamous cell histology). The most common treatment-emergent adverse events of any grade reported in Groups A, B, and C, respectively, were neutropenia (50.0%, 29.6%, and 20.6%), fatigue (40.0%, 18.5%, and 20.6%), anemia (35.0%, 44.4%, and 32.4%), paresthesia (27.5%, 25.9%, and 17.6%), and alopecia (25.0%, 29.6%, and 41.2%).

Conclusion: DCVAC/LuCa in combination with carboplatin and paclitaxel extended OS and was well tolerated.