- The disease
- Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for the large majority of lung cancer diagnoses. Advanced-stage NSCLC (Stage IIIB and Stage IV) is typically not amenable to surgical removal and is associated with poor long-term outcomes. Treatment options include chemotherapy, targeted therapies, and immune checkpoint inhibitors (drugs that release brakes on the immune system to help it attack cancer cells). The trial enrolled patients with Stage IIIB or Stage IV NSCLC across several tumour subtypes (per ClinicalTrials.gov NCT04432207).
- What the asset is trying to do
- PD1-Vaxx (also referred to as IMU-201) is described as a B-cell immunotherapy and is classified as a cancer vaccine. The approach is designed to prompt the patient's own immune system to generate antibodies targeting the PD-1 (programmed cell death protein 1) pathway, which cancer cells can exploit to evade immune attack. This differs from approved checkpoint inhibitors, which are manufactured monoclonal antibodies administered directly to the patient rather than stimulating the body to produce its own immune response. The trial also included combination arms with atezolizumab (an approved PD-L1 checkpoint inhibitor) and standard-of-care chemotherapy (per ClinicalTrials.gov NCT04432207).
- What the trial is measuring, and why it matters
- The trial (NCT04432207) was a Phase 1 study with a primary completion date of 8 October 2024 and a target enrolment of 24 patients (per ClinicalTrials.gov NCT04432207). Phase 1 studies in oncology are primarily designed to assess safety and tolerability and to identify an appropriate dose level for further study. The trial tested three dosing regimens of IMU-201 in combination with atezolizumab and standard-of-care chemotherapy (per ClinicalTrials.gov NCT04432207).
- Efficacy benchmarks in this setting
- In the approved checkpoint inhibitor setting for advanced NSCLC, pembrolizumab monotherapy in patients with PD-L1 tumour proportion score of 50% or greater achieved a 5-year overall survival rate of 31.9% and an objective response rate of 46.1% in the KEYNOTE-024 trial (Reck et al, NEJM 2016; Reck et al, JCO 2021). Atezolizumab combined with chemotherapy achieved a median overall survival of 18.6 months in the IMpower130 trial in non-squamous NSCLC (West et al, Lancet Oncol 2019). PD1-Vaxx is in early-stage (Phase 1) development, and any figures from this trial are not statistically comparable to those from randomised, controlled trials of approved therapies.