The trial enrolled 38 patients, whereof 32 were evaluable for response. All patients had previously received platinum-based chemotherapy and checkpoint inhibitor (CPI). The primary endpoint was overall response rate (ORR) and duration of response (DOR) based on institutional iRECIST review. Secondary objectives included safety, progression free survival (PFS) and overall survival (OS). NAP safety was acceptable and consisted of mostly grade 1-2 infusion related reactions, were generally easily manageable and rapidly reversable in line with previous reports.

Five patients had partial response (PR), 2 of them unconfirmed, and overall response rate (ORR) was 16%. Two patients had prolonged responses: one lasted for 22 months and the second had complete response in target lesions lasting for 24 months despite CNS progression. One patient had initial pseudo-progression in target lesions with a subsequent PR, suggesting a possible immune response. Mean DOR was 7.3 months (1.3 – 20.8). Mean PFS was 4.6 months, 18 pts (56%) had stable disease, disease-control rate was 72%, with mean duration of 5.3 months. Median OS was 8 months with 11 pts (34%) still alive at database lock and 3 patients receiving NAP under individual expanded access protocol.

The results of the combination of NAP and docetaxel show preliminary evidence of activity with acceptable safety in heavily pre-treated NSCLC patients. Further trials of NAP in combination, including CPIs are planned.

Details on the poster presentation:

1. Abstract Title: Clinical Activity and Safety of Naptumomab Estafenatox (NAP) and Docetaxel in Patients (pts) with Checkpoint Inhibitor (CPI) Pre-treated Advanced/ Metastatic Non-Small Cell Lung Cancer (NSCLC) - Preliminary Results, P2 Trial
2. Abstract Number: 8615
3. Session Type and Title: Poster Session – Lung Cancer—Non-Small Cell Metastatic
4. Session Date & Time: Monday June 3, 2024 1:30 PM-4:30 PM CDT 

For more information on the trial, visit www.clinicaltrials.gov NCT04880863 and www.neotx.com