Naptumomab in Combination with Docetaxel in NSCLC

An open label clinical phase IIa study in US testing naptumomab in combination with docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC) previously treated with checkpoint inhibitors is completed and results were presented at the American Society of Clinical Oncology in June 2024. The primary endpoint of the study is objective response rate.

The trial enrolled 38 patients with NSCLC previously treated with platinum and checkpoint-inhibitor (CPI) therapy. Safety of NAP was acceptable with mostly grade 1-2 infusion related reactions, were generally easily manageable and rapidly reversable.

32 patients were evaluable for response. Five patients had partial response (PR), two of them unconfirmed, and overall response rate (primary endpoint) was 16%. Two patients had prolonged responses: one lasted for 22 months and the second had a complete response lasting for 24 months despite CNS progression. Mean duration of response was 7.3 months (1.3 – 20.8). Mean PFS was 4.6 months, 18 patients (56%) had stable disease, disease-control rate was 72%, with mean duration of 5.3 months.

Median OS was 8 months with 11 patients (34%) still alive at database lock. Pretreatment with obinutuzumab successfully eliminated anti-drug antibodies (ADAs), which enables prolonged naptumomab exposure. In conclusion, the combination of NAP and docetaxel show preliminary evidence of activity but no increase in overall response rate (primary endpoint) compared to docetaxel alone. The safety of the combination was acceptable in these heavily pretreated NSCLC patients.

For more information about the trial, visit clinicaltrials.gov (NCT04880863) and at neotx.com.