ImmunityBio’s immunotherapy drug Anktiva (nogapendekin alfa inbakicept) has shown success in combination with a checkpoint inhibitor in two non-small cell lung cancer (NSCLC) trials.
Across 151 patients spanning first-, second-, and later-line disease, Anktiva demonstrated statistically significant immune restoration and a consistent association between lymphocyte recovery and improved survival in checkpoint-experienced patients.
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In the Phase III QUILT-2.023 (NCT03520686) trial, which was conducted in first-line NSCLC, Anktiva plus a checkpoint inhibitor led to a statistically significant and sustained increase in absolute lymphocyte count (ALC) from baseline compared to treatment with a checkpoint inhibitor alone.
In the second-line or later-line therapy setting, in the Phase IIb single-arm QUILT-3.055 trial (NCT03228667), patients who received the combination of Anktiva and a checkpoint inhibitor demonstrated restoration or maintenance of ALC ≥1.0 × 10³ cells/µL in 77% of patients.
There was also a significantly longer overall survival (OS) compared with non-responders, with a median OS of 16.2 months vs 11.8 months. In patients who achieved higher immune competence, there was an additional survival benefit, with a median OS of 21.1 months.
Checkpoint inhibitors such as MSD’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s (BMS’s) Opdivo (nivolumab) are used in lung cancer, but ImmunityBio said that clinical benefit is often transient, and effective treatment options remain limited once patients progress after first-line treatment.
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By GlobalDataDr Patrick Soon-Shiong, founder and executive chairman of ImmunityBio, said: “The default standard of care for these patients remains cytotoxic chemotherapy such as docetaxel, which is associated with substantial toxicity and limited survival benefit. The results from these studies support a potential paradigm shift toward what we define as Immunotherapy 2.0, which is the coordinated activation of the innate immune system through natural killer cells and the adaptive immune system through T cells to restore immune competence and extend survival.”
Detailed results from QUILT-2.023 and QUILT-3.055 are being prepared for peer-review publication and future scientific presentations.
The company is already running a Phase III confirmatory trial (NCT06745908) comparing Anktiva plus checkpoint inhibitors versus docetaxel in second-line NSCLC.
According to GlobalData, the NSCLC market was valued at $24.1bn in 2022 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan), however, this is set to rise to $56.5bn by 2032.
GlobalData is the parent company of Clinical Trials Arena.
