Here's the abstract details I copied from searching the 2025 World Lung Conference being held September 6-9 in Barcelona, Spain. We may be presenting other info but I have yet to find anything else. The site search is not very good (brings up two much unrelated information):
- Abstract details
- NAI, An IL-15 Superagonist, A New Class Of Lymphocyte Stimulating Agent (LSA) Prolongs OS In NSCLC By Reversing Lymphopenia
Introduction: Prior to the approval of Nogapendekin alfa inbakicept (NAI), an IL-15 superagonist which stimulates lymphocytes important in immunogenic cell death (Natural killer cells, CD4+ CD8+ T cells and memory T cells), no treatment existed to address lymphopenia as measured by the absolute lymphocyte count (ALC) in the CBC differential. Severe lymphopenia (ALC<1,000), associated with the adverse effects of chemotherapy, radiation, steroids and CPI, significantly lowers overall survival in NSCLC. While absolute neutrophil count (ANC) is widely used to identify neutropenic fever risk, ALC has been largely ignored by clinicians since no therapy existed to treat lymphopenia. To test the hypothesis that NAI, a novel immunotherapy and first-in-class lymphocyte stimulating agent (LSA), prolongs OS by reversing lymphopenia and maintains median ALC=1,200, a Phase 2 study was conducted wherein patients with NSCLC with acquired resistance to CPI therapy were treated with the same CPI+NAI, a chemo-free combination (QUILT-3.055 NCT03228667). The effect of reversing lymphopenia and maintaining ALC=1,500 was studied to examine the hypothesis that proliferating NK and T cells with improved ALC results in prolonged OS.
Methods: The change in ALC (absolute cell count and percentage change from baseline) with NAI and CPI during study and its relationship to median OS was the primary endpoint for LSA. Statistical differences between the OS in patients who failed to achieve ALC=1,000 versus those who overcame severe lymphopenia (ALC<1,000) and those who maintained ALC=1,500 were measured.
Results: The median OS for 2nd line (51%) and 3rd line+ (49%) was 14.3 months (95% CI 11.7, 17.4) with 23 of 86 subjects alive at data cutoff (Dec 2024). With NAI, 69/86 (80%) exceeded the median ALC 1,200 with a median OS of 15.8 months (12.6, 21.9). Of these 69 subjects, 44/69 (64%) maintained an average ALC=1,500 throughout study therapy with median OS 21.1 months (13.9, 42.1) and significantly prolonged (HR: 0.33 [0.16, 0.65], p=0.0009) compared to subjects who failed to achieve ALC 1,200 with median OS 11.5 months (4.2, 13.3).
Conclusions: For the first time, ALC is an actionable accessible biomarker to recognize and treat lymphopenia induced by chemotherapy, radiation, steroids and immunotherapy and to prolong OS with NAI. Lymphopenia is addressed for the first time with availability of this new class of lymphocyte stimulating agent (LSA), NAI. When ALC is maintained =1,500 with NAI, the immune system is effectively activated (chemo-free), and median OS is significantly prolonged at 21.1 months, HR: 0.33 (95% CI:0.16,0.65) P=0.0009.  |
