2333-P: Inhaled Insulin Assessment of Incident Lung Cancer Risk among Adults with Type 2 Diabetes (T2D) Compared with Other Therapies for Diabetes Using Real-World Evidence

Introduction and Objective: Technosphere Insulin (TI) is an ultra rapid-acting insulin and the only inhaled insulin currently approved by the US FDA. Literature reviews have not identified an increased risk of post-exposure lung cancer. This real-world evidence (RWE) study aimed to evaluate post-exposure lung cancer risk among TI users compared with other T2D cohorts using adjudicated health plan claims data and electronic medical record (EMR) abstractions. Methods: A retrospective cohort study using closed claims and structured EMR linked via tokenization (January 2017-August 2025) was utilized to assign adults with T2D without prior lung cancer to mutually exclusive treatment cohorts, with the primary comparison between TI and injectable rapid-acting insulins (RAA). Additional contextual cohorts included: no treatment, oral agents, GLP-1s, and long-acting insulins. Time at risk began at index treatment (or T2D diagnosis for the no-therapy cohort). The primary outcome was incident lung cancer identified by ICD-10 codes in adjudicated claims and EMR abstractions. Incidence proportions were described; multivariable Cox regression adjusting for demographics and clinical covariates is prespecified in the protocol. Results: The analytic dataset included 7,494,072 adults with T2D across all 50 states, having commercial, Medicare or Medicaid insurances. RWE analytics identified 2,056 patients who received TI. Among 2,056 TI users, 10 incident lung cancers occurred (0.49%). In the RAA cohort, incidence was 1.17%, of 8,936 users. Incidence in the other comparators was: no therapy 1.12%, non-insulin 0.68%, oral agents 0.81%, GLP-1 0.33%, and long-acting insulin 0.78%. Mean time at risk in TI was 1,941.9 days, longer than all comparator cohorts reported. Conclusion: This interim RWE analysis did not demonstrate increased incident lung cancer proportions in TI users versus multiple other T2D cohorts. Disclosure J.R. Singer: Consultant; Current; MannKind Corporation, HealthCore Inc. Consultant; Ended; Bluejay Diagnostics. K. Jaffe: None. J. Sylvan: Employee; Current; MannKind Corporation. K. Kaiserman: Employee; Current; MannKind Corporation. Stock/Shareholder; Current; MannKind Corporation.