Breakthrough Clinical Results

Biodesix announced new data from the INSIGHT study (NCT03289780) on the VeriStrat® Host Immune Classifier (HIC) test, to be presented at the 2025 ASCO Annual Meeting. The data demonstrates the test's ability to predict overall survival in non-small cell lung cancer (NSCLC) patients treated with immunotherapy. The study showed a statistically significant improvement in overall survival for patients with a VeriStrat Poor result who received immunotherapy combined with chemotherapy compared to immunotherapy alone. Patients with a VeriStrat Good result had comparable survival regardless of treatment regimen. Preliminary results from another study suggest similar indications in other solid tumors.

Incidence and Prevalence

Global Incidence and Prevalence of Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer deaths worldwide. Among all lung cancer cases, Non-small cell lung cancer (NSCLC) represents a significant proportion, accounting for 80-85% of all lung cancer cases according to one estimate, while another source indicates it constitutes 70% of lung cancer cases.

The worldwide annual incidence of NSCLC is approximately 1.3 million cases. This substantial burden underscores the global impact of this disease.

Despite significant advancements in chemotherapy and targeted therapies over recent decades, the 5-year survival rate has remained stagnant at 16% for the past forty years. This poor prognosis is largely attributable to the fact that the majority of NSCLC patients are diagnosed with advanced disease, which substantially limits treatment efficacy and outcomes.

The late-stage diagnosis pattern continues to be a critical challenge in NSCLC management, as most patients present with advanced disease at the time of initial diagnosis. This late detection significantly contributes to the persistently poor survival rates observed globally.

Emerging Mechanism of Action

Study Design Parameters

Study Design Parameters and Endpoints in Key NSCLC Trials

Study Design Parameters

Gefitinib Trial in Advanced NSCLC

• Time period: November 2003 to May 2005
• Sample size: 91 patients with advanced NSCLC who failed previous first-line chemotherapy

• Patient characteristics:

• 74.7% (68/91) had received second-line chemotherapy

• 83.5% (76/91) had stage IV disease

• 46.2% (42/91) had metastases at minimum two sites

• Treatment regimen: Gefitinib 250 mg daily until disease progression or severe toxicity
• Statistical analysis: Chi-square test, Log-rank test, Cox regression, Kaplan-Meier

Avelumab Plus Cetuximab Trial in Squamous NSCLC

• Phase: 2a trial of first-line treatment
• Sample size: 43 patients with recurrent or metastatic squamous NSCLC

• Treatment regimen:

• Avelumab 800 mg (d 1 and 8)

• Cetuximab 250 mg/m² (d 1) and 500 mg/m² (d 8)

• Cisplatin 75 mg/m² (d 1)

• Gemcitabine 1250 mg/m² (d 1 and 8) for four 3-week cycles

• Followed by avelumab 800 mg and cetuximab 500 mg/m² every 2 weeks

• Median follow-up: 6.6 months (primary analysis), 9.2 months (efficacy analysis)

Selpercatinib in RET Fusion-Positive NSCLC

• Trial name: LIBRETTO-001
• Design: Global, open-label, phase I/II study

• Sample size: 253 patients categorized as:

• Treatment-naïve: 39

• One prior line: 64

• Two or more prior lines: 136

• Assessment tool: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) v3.0
• Assessment timing: Baseline (cycle 1, day 1), every other 28-day cycle until cycle 13, every 12 weeks thereafter
• Evaluation threshold: ≥10 points change from baseline considered clinically meaningful

Network Meta-Analysis of ICI Combinations

• Analysis type: Systematic review
• Scope: 11 trials, 12 therapies, and 6,130 patients with non-squamous NSCLC
• Data sources: PubMed, Embase, MEDLINE, ClinicalTrials.gov, international conference publications
• Analysis method: Royston-Parmar model for extrapolation and comparison of long-term outcomes

Endpoints

Gefitinib Trial in Advanced NSCLC

• Primary endpoints:

• Overall response rate (20.9%)

• Disease control rate (63.7%)

• Secondary endpoints:

• Symptom improvement (72.7%)

• Median time to progression (5.0 months)

• 1-year survival rate (56.4%)

Avelumab Plus Cetuximab Trial in Squamous NSCLC

• Primary endpoint: Best overall response

• Secondary endpoints:

• Progression-free survival

• Duration of response

• Overall survival

• Safety

• Results:

• Objective response rate 34.9%

• Median duration of response 7.1 months

• Median PFS 6.1 months

• Median OS 10.0 months

Network Meta-Analysis of ICI Combinations

• Outcome measures:

• Restricted mean survival time (RMST) for PFS (12 months)

• Restricted mean survival time for OS (18 months)

Drug used in other indications

Based on the provided context, there is no information available about VeriStrat® test being trialled for any indications, including non-small cell lung cancer (NSCLC) or other conditions. The context does not mention VeriStrat® at all.

The context primarily contains information about various treatments and intervention models for NSCLC including:

• Targeted therapy with tyrosine kinase inhibitors (TKIs) used in early and advanced-stage NSCLC
• Adjuvant targeted therapy as demonstrated in the ADAURA and ALINA trials
• Combination therapies for patients in first-line setting
• Antibody-drug conjugates showing central nervous system efficacy
• Immune checkpoint inhibitors (PD1/PD-L1) which impact the tumor immune microenvironment
• EGFR-TKIs (erlotinib, gefitinib) for patients with EGFR-mutated NSCLC
• Atezolizumab (anti-PD-L1 immunotherapy) tested in the POPLAR and OAK studies

Specific trial models mentioned include: - BR.21 trial: randomized placebo-controlled trial of erlotinib - POPLAR: phase 2 study with 287 patients - OAK: phase 3 study with 1225 patients - Companion diagnostic tests for EGFR-TKIs - Molecular Tumor Board approach for treatment recommendations

Dosing models include: - Atezolizumab: 1200 mg fixed dose every 3 weeks - Docetaxel: 75 mg/m² every 3 weeks - Pembrolizumab: 2 mg/kg every 3 weeks

However, none of this information relates to VeriStrat® testing.