The safety and tolerability of ex vivo TKD/IL-2 stimulated, autologous NK cells
(ENKASTIM-ev) has previously been demonstrated in patients with metastasized colorectal and non-small cell lung cancer (NSCLC) in a phase I clinical trial.
Based on promising clinical results of the previous study, a multi-centre randomised phase II clinical study has been undertaken. The primary objective of this multi-center 'proof-of-concept' trial is to examine whether an adjuvant treatment of patients with non small lung cell carcinoma (NSCLC) after platinum-based radiochemotherapy (RCTx) with TKD/IL-2 activated, autologous NK cells is clinically effective. As we have already shown that a membrane Hsp70-positive tumor phenotype is associated with poor clinical outcome, only patients that have membrane Hsp70-positive tumors have been recruited into the trial.
The primary endpoint of this study is a comparison of progression-free survival of patients treated with ex vivo activated NK cells with that of patients who were treated with RCTx alone. Secondary endpoints in both study groups are overall survival, toxicity, quality-of-life, and biological responses.
This randomised multi-centre Phase II clinical trial in patients with Stage IIIb inoperable non-small lung cell carcinoma (NSCLC) following radio(chemo)therapy has demonstrated that ENKASTIM-ev delivered clinical benefit in 5 out of 7 patients (71%), with one complete response, in contrast to 2 out of 7 patients (28%) in the control group (Multhoff et al., 2020).
Clinical Case Study: Lung Cancer
ENKASTIM-ev followed by second-line PD-1 inhibition has been shown to deliver long-term disease control in a patient with lung cancer (Kokowski et al., Strahlentherapie und Onkologie 2019, 195: 352-361)