A confirmatory randomized phase 3 trial will evaluate nogapendekin alfa inbakicept-pmln (Anktiva, ImmunityBio) plus tislelizumab (Tevimbra, BeiGene) in certain patients with non–small cell lung cancer (NSCLC), according to an announcement from ImmunityBio.
The phase 3 ResQ201A-NSCLC study (NCT06745908) aims to confirm safety and efficacy findings from the phase 2 QUILT 3.055 trial and “provide evidence of the potential for these two immunotherapeutic agents to improve overall survival” in patients with advanced or metastatic NSCLC who have acquired resistance to immune checkpoint inhibitor (CPI) therapy, officials said.
The IL-15 superagonist, also known as N-803, has previously demonstrated “the capability of rescuing T cells, and thus CPI efficacy,” through its “unique mechanism of action,” according to ImmunityBio.
John Wrangle, MD, MPH, presented data from the QUILT 3.055 trial at the IASLC 2024 World Conference on Lung Cancer, showing that the median overall survival (OS) was 14.1 months, with 57% of patients alive at one year.
“Importantly, patients who had stable disease as their best prior response to prior checkpoint inhibition were able to get into partial responses… indicating that with the addition of N-803, prior stable disease with immunotherapy was able to be converted to responsive disease,” Dr. Wrangle told Lung Cancers Today in an interview at the conference.
The design of the phase 3 confirmatory trial is “based on the synergistic potential already demonstrated in the QUILT 3.055 study that a CPI and ANKTIVA, an IL-15 superagonist, prolongs overall survival (OS) in the study population compared to historical controls in this setting,” according to the announcement.
The primary endpoint of the study is OS, with secondary endpoints including disease control rate, progression-free survival, objective response rate, and safety. The confirmatory study will be conducted globally at multiple sites, with 462 participants expected when fully enrolled.
Dr. Patrick Soon-Shiong, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, explained that the confirmatory trial is important because the “challenge oncologists face in the next five years is how to manage the many patients who do not respond to CPI therapy after an initial response.”
“Currently, options are limited for these second- and third-line patients with NSCLC whose cancer continues to progress on CPIs. The finding that these ‘cold’ tumors, which have evaded T cells, can now be rendered ‘hot’ through the activation of natural killer cells with ANKTIVA, is exciting,” Dr. Soon-Shiong said in a statement. “To our knowledge, ANKTIVA is the first approved cytokine to address low white cell count (lymphopenia), which occurs following chemo-immunotherapy and radiotherapy. On the basis of ANKTIVA’s mechanism of action of proliferating T cells as well as NK cells, ANKTIVA has the potential to serve as the foundational cytokine to address loss of activity in the multiple tumors in which CPIs are approved.”
The phase 3 trial is being conducted by ImmunityBio under a collaboration and supply agreement with BeiGene, according to the announcement.
“ImmunityBio and BeiGene share a similar vision to advance the next generation of oncology immunotherapies to address unmet needs. We are excited to explore the potential of our PD-1 [programed cell death 1] inhibitor, tislelizumab, in combination with ANKTIVA,” said John V. Oyler, co-founder, chairman, and CEO of BeiGene, in a statement. “I’ve admired Dr. Soon-Shiong’s bold approach to medicine and look forward to working with him and his team as the ResQ201A-NSCLC study gets underway. Together, we hope to help metastatic lung cancer patients who may have few options left.”
ImmunityBio intends to file a Biologics License Application for nogapendekin alfa inbakicept-pmln plus a CPI in second/third-line NSCLC with progression on CPI therapy, officials said.
Source: ImmunityBio
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