Breakthrough Clinical Results
Vergent Bioscience announced positive Phase 2B VISUALIZE trial results for abenacianine (VGT-309), a tumor-targeted fluorescent imaging agent. The trial, involving 89 patients undergoing lung cancer surgery, met its primary endpoint, demonstrating that abenacianine significantly improved tumor visualization during surgery compared to standard techniques. Abenacianine helped surgeons locate lesions missed by standard methods, identify additional cancers, assess surgical margins, and detect cancerous lymph nodes, leading to improved surgical outcomes in 45% of cases. The drug was well-tolerated, with no drug-related serious adverse events. Vergent plans to initiate a Phase 3 trial.
Key Highlights
- Phase 2B VISUALIZE trial met primary efficacy endpoint.
- Abenacianine improved tumor visualization during lung surgery, leading to better surgical outcomes.
- 45% of patients experienced at least one clinically significant event due to abenacianine's use.
- Abenacianine was well-tolerated with no drug-related serious adverse events.
Study Design Parameters
Study Design Parameters and Endpoints in Key Lung Cancer Trials
Study Design Parameters
NCT02818920 (Phase 2 neoadjuvant pembrolizumab trial)
- Patient population: Untreated clinical stage IB to IIIA non-small cell lung cancer
- Treatment protocol: Two cycles of pembrolizumab (200 mg) before surgery, followed by four cycles of adjuvant pembrolizumab
- 35 patients enrolled, 30 received neoadjuvant pembrolizumab, 25 underwent lung resection
SWOG Cancer Research Network clinical trials (S0027, S9509, S0421)
- Methodology: Secondary analysis of completed trials incorporating Functional Assessment of Cancer Therapy (FACT) questionnaires
- Primary independent variable: FACT-Trial Outcome Index (FACT-TOI)
- Patient population: 1,295 patients with advanced non-small cell lung cancer and hormone-refractory prostate cancer
Three-arm randomized trial comparing chemotherapy regimens
- Study design: Randomized trial with 218 patients (March 2006-May 2008)
- Patient population: Stage IIIB (with pleural effusion) or IV non-small cell lung cancer with performance status 0 or 1
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Treatment arms:
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Arm A: Pemetrexed-carboplatin-enzastaurin
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Arm B: Pemetrexed-carboplatin without enzastaurin
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Arm C: Docetaxel-carboplatin
OAK Study (Phase III)
- Evaluated efficacy and safety of atezolizumab versus docetaxel as second-line or third-line treatment
- 421 patients received atezolizumab and 402 received docetaxel
- Registration: NCT02008227
KEYNOTE-189 Study (Phase III)
- Multicentre, double-blind, randomized, placebo-controlled trial conducted at 126 cancer centers in 16 countries
- Eligible patients: aged 18+ with histologically/cytologically confirmed metastatic non-squamous NSCLC without sensitizing EGFR or ALK alterations, measurable disease per RECIST v1.1, ECOG status 0-1
- Randomization: 2:1 to pembrolizumab (200mg) or placebo every 3 weeks for up to 2 years
- All patients received pemetrexed (500mg/m²) with carboplatin or cisplatin for 4 cycles, followed by pemetrexed maintenance
- Randomization stratified by PD-L1 expression, platinum choice, and smoking status
- 616 patients enrolled (Feb 2016-Mar 2017)
- Registration: NCT02578680
Meta-analysis of PD-1/PD-L1 Trials
- Included 41 distinct trials with 6,664 patients
- Investigated nivolumab, pembrolizumab, atezolizumab, durvalumab, and avelumab in advanced solid tumors
- Used DerSimonian-Laird random effects model
Edatrexate Trial
- Multicenter cooperative oncology group trial
- Included previously untreated (extensive stage) or patients who failed one prior chemotherapy regimen
PD-1/PD-L1 plus Anti-angiogenic Agents
- Meta-analysis included 19 studies (16 non-comparative single-arm clinical trials and 3 RCTs)
- Used random effect model to calculate pooled parameters
Endpoints
NCT02818920 (Phase 2 neoadjuvant pembrolizumab trial)
- Primary endpoint: Safety of neoadjuvant pembrolizumab
- Secondary endpoints: Efficacy and correlative science
- Results: Major pathologic response observed in 7 of 25 patients (28%), R0 resection achieved in 22 patients (88%)
SWOG Cancer Research Network clinical trials
- Focus: Association between health-related quality of life (HRQOL) and progression-free survival (PFS)
- Results: Higher baseline FACT-TOI scores corresponded to better PFS in univariable analysis across all three trials
Three-arm randomized trial comparing chemotherapy regimens
- Primary endpoint: Time to disease progression (TTP)
- Results: Median TTP was 4.6 months (Arm A), 6.0 months (Arm B), and 4.1 months (Arm C) with differences not statistically significant
OAK Study (Phase III)
- Primary endpoints: Fast progression (FP) rates and associated baseline factors
- FP defined as ≥50% increase in sum of largest diameters within 6 weeks or death due to cancer progression within 12 weeks
KEYNOTE-189 Study (Phase III)
- Primary endpoints: Overall survival and progression-free survival
- PRO endpoints: Change from baseline in QLQ-C30 global health status/quality of life score, time to deterioration in cough, chest pain, or dyspnea
Meta-analysis of PD-1/PD-L1 Trials
- Primary endpoint: Objective response rates
Edatrexate Trial
- Primary endpoints: Clinical response and toxicity to edatrexate
- All patients observed for survival
PD-1/PD-L1 plus Anti-angiogenic Agents
- Outcomes measured: Overall response rate, disease control rate, progression-free survival, overall survival, and adverse events
Recent Studies
Recent Studies on Lung Cancer: Interventions and Outcomes
Study 1: EGFR Mutations and TKI Treatment
This study examined differential survival outcomes to first-line tyrosine kinase inhibitors (TKI) in patients with metastatic non-small-cell lung cancer. The study investigated 170 patients with EGFR mutations who received TKI as first-line treatment. Key findings revealed that different subtypes of EGFR mutations showed varying survival outcomes: - Patients with exon 19 18-nucleotide deletion had shortest median progression-free survival (PFS) of 6.5 months - Exon 19 deletions starting on codon E746 had better median PFS (14.2 months) than those starting on L747 (6.5 months) - Exon 21 L858R showed longer median PFS than L861R/L861Q (11.4 vs 2.1 months)
Study 2: ESCAP-2011-CPHG Cohort Study
This real-life study analyzed therapeutic strategies for non-small-cell lung cancer (NSCLC) in 3418 patients with a mean age of 65.4 years. With a mean follow-up of 13.2 months, researchers found that: - 62% of patients received chemotherapy in first strategy, 74% in second strategy - Chemotherapy alone increased from 6% to 56% with advancing cancer stage
Celecoxib Efficacy Study
This meta-analysis of 11 randomized clinical trials with 2570 patients evaluated the addition of celecoxib to standard treatments: - Addition of celecoxib significantly increased overall response rate (RR=1.20) - For NSCLC specifically, response rate was RR=1.29 - However, celecoxib increased risk of cardiovascular events (RR=1.78) and anemia (RR=1.88)
CAMF Combination Chemotherapy Study
This pilot study used cyclophosphamide, adriamycin, methotrexate and folinic acid rescue for advanced lung cancer in 48 patients with unresectable tumors: - Major toxicities were myelosuppression, nausea and vomiting - Overall response rate was 29.4% (10/34 patients) - Responding patients had median survival of 10.5 months vs 4 months for non-responders
Nintedanib Plus Docetaxel Study
This study evaluated nintedanib plus docetaxel as second-line treatment in 38 patients: - Overall response rate was 7.9%, disease control rate 47.3% - Median progression-free survival was 3.7 months - Used novel Ga-DOTA-E-[c(RGDfK)] PET/CT imaging to assess response
PD-1/PD-L1 Inhibitors Network Meta-analysis
This analysis included 13 trials with 9,154 patients with wild-type advanced non-small cell lung cancer: - Chemotherapy combined with pembrolizumab and atezolizumab showed significantly better overall survival (HR=0.63; HR=0.85) and progression-free survival (HR=0.52; HR=0.63) in PD-L1 nonselective cohorts - For patients with PD-L1≥50%, pembrolizumab alone provided the best overall survival benefit (HR=0.67) - Pembrolizumab plus chemotherapy showed more obvious OS benefit in nonsquamous patients (HR=0.56) with fewer adverse events
Geriatric Patients Study
This multicenter international study of 928 geriatric patients (aged ≥80 years) treated with immune checkpoint inhibitors found: - Objective response rates for NSCLC patients were 32.2% - Median progression-free survival and overall survival were 6.7 and 10.9 months for NSCLC - 41.3% of patients experienced immune-related adverse events, with 12.2% being grade 3-4
Drug used in other indications
Based on the provided context, there is no information available about Abenacianine for Injection (VGT-309) or its clinical trials for lung cancer or any other indications. The context does not contain any data about VGT-309, Abenacianine, or intervention models for trials related to this specific drug.