9051 Background: Immunotherapy for induction of tumor cell specific immune responses destroying tumor cells, has emerged as a promising treatment modality in lung cancer (LuCa). Autologous DCVAC can present tumor antigens to elicit a durable immune response. We hypothesized that adding DCVAC to the standard of care chemotherapy (ct) could prolong progression-free survival (PFS) and overall survival (OS). Methods: This study evaluated the efficacy and safety of DCVAC/LuCa (active cellular immunotherapy based on dendritic cells) concomitantly added to ct (carboplatin/paclitaxel) - Arm A (A) vs DCVAC/LuCa + immune modulators (IFN-α and hydroxychloroquine) - Arm B (B) vs ct - Arm C (C) in NSCLC patients (pts). Randomization 1:1:1; pts in A and B received up to 15 doses of DCVAC, ct was given 4-6 cycles in A and C. Stage IV NSCLC was confirmed histologically or cytologically, ECOG 0-1 pts were eligible. Stratification was done by histology subtype and smoking history. Primary efficacy analysis compared A vs C only as enrollment to B was closed early based on Sponsor’s assessment of further clinical development potential, there were no safety concerns or signals. Results: 112 pts at 12 sites were randomized (A/45 B/29 C/38). Patients characteristics were comparable across the study groups with the exception of gender (m/f, %: 50/50 (A) and 26/74 (C) and smoking history (75 % of smokers in A, 97 % in C). Median follow up time was 14.1 months, range 0.032-29,765. Median OS was 15.5 months in A compared to 11.8 months in C, hazard ratio (HR) 0.56, p-value 0.05, 95% CI, data maturity 65%. Median PFS was 6.73 in A and 5.65 months in C HR 0.64, p-value 0.05, 95% CI, data maturity 81%. Overall response rate was 45% in A vs 22.9% in C. Most TEAEs were related to ct (anemia [37%-A, 32%-C], neutropenia [48% in A, 21%-C], thrombocytopenia [28% in A, 27% in C]). There were no grade ≥ 3 TEAEs solely related to DCVAC. Most common leukapheresis-related AEs were haematoma and hypotension. Conclusions: Addition of DCVAC-based immunotherapy to the standard of care chemotherapy significantly improved OS in stage IV NSCLC. Clinical trial information: EudraCT 2014-003084-37.
Aim: To compare survival outcomes in patients with non-small cell lung cancer (NSCLC) treated with modern-era drugs (antifolates, antiangiogenics, tyrosine kinase and anaplastic lymphoma kinase inhibitors, immunotherapy) with treatment initiation in 2011-12 and 2015-16, respectively. Patients and Methods: Prospective data from Czech TULUNG Registry (960 patients from 2011-12 and 512 patients from 2015-16) were analyzed. Kaplan-Meier analysis was used to estimate overall survival (OS) and progression-free survival (PFS); Cox proportional hazards model to assess factors associated with 2-year survival. Results: Survival at 2 years was more frequent in cohort 2015-16 compared to cohort 2011-12 (43.2% vs. 24% for adenocarcinoma; p<0.001 and 28.7% vs. 11.8% for squamous-cell lung carcinoma; p=0.002). Assignment to cohort 2015-16 and treatment multilinearity (two or more lines in sequence) were associated with higher probability of 2-year survival (hazard ratio=0.666 and hazard ratio=0.597; p<0.001). Comparison of 2-year survivors from both cohorts showed no differences. Conclusion: Survival at 2 years probability in stage IIIB-IV NSCLC doubled between 2011-12 and 2015-16; advanced-stage NSCLC may be considered a chronic disease in a large proportion of patients.
<p>Prevalence of PD-L1 expression on TC and IC in the PD-L1 BEP. *Includes patients whose tumors had <1% PD-L1 expression on TCs or ICs, but not absolute zero.</p>
<p>Subgroup analysis of confirmed ORR by PD-L1 TC and IC expression for (A) durvalumab plus tremelimumab plus EP versus EP and (B) durvalumab plus EP versus EP. In each panel, the shaded band shows the confidence interval for the ITT population; circle sizes are proportional to the number of responses. Groups are not plotted when there are ≤5 responses across both arms.</p>
In a group of 233 patients with advanced non-squamous NSCLC who
were treated with pemetrexed in first line and in combination
with cisplatin, the therapy was well tolerated: termination of
treatment due to adverse events was reported only in 3.8% of
patients. Median overall was 11.6 months, median
progression-free survival was 4.2 months.
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