Panbela Therapeutics, Inc. announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as first quarter of 2025. This delay in the projected date for analysis comes as a result of the trial's current event rate, which is lower than initially anticipated, indicating that patients have lived longer than expected. The ASPIRE trial, which is evaluating the efficacy and safety of Panbela's lead product candidate, ivospemin (SBP-101), in combination with gemcitabine and nab-paclitaxel (Abraxane) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC), requires 33% of the total expected events to occur before the interim analysis can be conducted.

As of the latest assessment, less than half of the required events for the interim analysis have occurred. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months.

The incremental benefits in median survival have been modest in the past 11 years with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9 month survival benefit compared to the approval of gemcitabine and nab-paclitaxel which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela will continue to monitor the progress of the ASPIRE trial and provide updates as appropriate.