Osimertinib may be considered a cost-effective treatment option compared with PDC in the second-line setting in patients with EGFR-T790M mutation-positive NSCLC from a UK payer perspective. Further data from the ongoing AURA clinical trial program will reduce the inherent uncertainty in the analysis.
Background and objectiveAn adjusted indirect comparison was conducted to assess efficacy outcomes, particularly overall survival (OS), of osimertinib versus platinum-based doublet chemotherapy in patients with epidermal growth factor receptor-mutated (EGFRm) T790M mutation-positive non-small-cell lung cancer (NSCLC) who had progressed following an EGFR tyrosine kinase inhibitor (TKI). Analysis of treatment effect from two separate trials had the potential to more accurately estimate the magnitude of OS benefit due to absence of confounding due to treatment switching from the control arm to the osimertinib arm of the ongoing randomized control trial, AURA3.MethodsTwo non-randomized individual datasets were compared: pooled patients from the AURA extension and AURA2 trials (osimertinib 80 mg, n = 405, with a confirmed T790M mutation using tissue samples), and patients from the control arm of the IMPRESS study (platinum-based doublet chemotherapy, n = 61, with a confirmed T790M mutation using plasma circulating tumour DNA [ctDNA]). A propensity score-based approach was used to account for differences in baseline demographics and disease characteristics.ResultsAfter adjustment for baseline differences between the two groups, osimertinib demonstrated a statistically significant improvement in progression-free survival (PFS) versus platinum-based doublet chemotherapy (hazard ratio [HR] = 0.278, 95% confidence interval [CI] 0.188–0.409, p < 0.0001; median PFS 10.9 vs. 5.3 months). Improvements were also observed for objective response rate (ORR) and disease control rate (DCR) (ORR: 64.3 vs. 33.3%; odds ratio [OR] = 5.31, 95% CI 2.47–11.40, p < 0.001; DCR: 92.1 vs. 75.0%; OR = 4.72, 95% CI 1.92–11.58, p < 0.001). Similar results were obtained for patients who received osimertinib as second-line treatment only. A statistically significant improvement in OS was observed for the osimertinib group (HR = 0.412, 95% CI 0.273–0.622, p < 0.0001). Median OS for osimertinib was not reached.ConclusionsIn this indirect comparison, osimertinib showed a statistically significant improvement in efficacy outcomes versus platinum-based doublet chemotherapy in patients with EGFRm T790M NSCLC who had progressed after EGFR-TKI therapy.Electronic supplementary materialThe online version of this article (10.1007/s40261-017-0611-3) contains supplementary material, which is available to authorized users.
A 3 4 7 -A 7 6 6 A745 since few incidences of grade 3 or higher AEs were observed at HRQOL assessment points. Results: In 380 patients with all baseline scores, total of 562 EQ-5D and 564 GHS scores were observed at 3, 6, and 12 months during the study treatment. Mean EQ-5D and GHS scores at baseline were 0.767 and 60.2, respectively. In EQ-5D analysis, G2 fatigue (−0.048), G1 and G2 mucositis (−0.068 and −0.107), G1 nausea (−0.057), G1 and G2 edema (−0.065 and −0.082), G2 motor neuropathy (−0.186), G2 sensory neuropathy (−0.084), and G2 myalgia (−0.117) were significantly (P < 0.05) associated with decreased scores. In GHS analysis, G1 and G2 fatigue (−7.6 and −7.2), G1 mucositis (−8.8), and G2 sensory neuropathy (−9.1) were significantly associated with decreased scores. ConClusions: Appropriate care for these AEs would lead to better HRQOL of patients in the target population. Model-based cost-effectiveness analysis should account for these AEs as well.
This analysis suggests a diagnostic technology capable of identifying whether men with biochemical recurrence after radical prostatectomy have localized versus metastatic disease would be a cost-effective alternative to current standard work-up. The results support additional investment in development and validation of such a diagnostic.
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