On November 15, 2021 NKGen Biotech, a subsidiary of NKMax, harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that data from a Phase 1/2a clinical trial, sponsored by NKMax, evaluating SNK01 (autologous natural killer cells) plus pembrolizumab in Non-Small Cell Lung Cancer (NSCLC) patients in Korea was presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held November 10 – 14, 2021, in Washington, D.C (Press release, NKMax America, NOV 15, 2021, View Source [SID1234595595]).
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The poster "Phase I/IIa randomized trial evaluating safety and efficacy of SNK01 plus pembrolizumab in patients with Stage IV Non-Small Cell Lung Cancer (NSCLC) who have failed first-line platinum-based therapy" was presented by NKMax on November 10th at the Industry Program Reception.
"We are extremely pleased to share promising clinical data showing safety and superior efficacy of our SNK01 autologous NK cell therapy in combination with pembrolizumab," said Sangwoo Park, Chief Executive Officer of NKGen Biotech. "The results of the trial demonstrate that SNK01 can be safely combined with checkpoint inhibitors, resulting in meaningfully improved clinical outcomes, especially compared to the checkpoint inhibitor alone. We look forward to seeing similar results in other solid tumor settings as we continue the clinical development of SNK01."
In this trial, eighteen patients with advanced Stage IV NSCLC who failed prior frontline platinum-based therapy were randomized 2:1 to received pembrolizumab every three weeks with +/- 6 weekly infusions of SNK01. Two dosing groups for SNK01 were evaluated in combination with pembrolizumab: 2×109 cells/dose and 4×109 cells/dose. The primary endpoint was safety and secondary endpoints were objective response rate (ORR), progression-free survival (PFS), overall survival, and quality of life.
The median PFS was superior in the SNK01 combination group and results were statistically significant (6.2 months vs. 1.6 months; p = 0.001). Furthermore, a dose response was noted as PFS in the higher 4×109 cells/dose SNK01+ pembrolizumab combination arm was 9.4 months compared to 1.6 months for the pembrolizumab only group. No new safety signals were seen when SNK was added to pembrolizumab.
In this trial, combination of SNK01 and pembrolizumab enhanced antitumor activity in advanced NSCLC patients, and suggests possible utilization of combining SNK01 with pembrolizumab. NKGen Biotech/NKMax will continue to explore SNK01 in various tumor settings, including the combination approach with different modalities.