Osimertinib in Advanced EGFR-T790M Mutation-positive Non-small Cell Lung Cancer Patients Treated Within the Special Use Medication Program in Spain. OSIREX-spanish Lung Cancer Group

Abstract

Background: AURA study reported 61% objective response rate and progression-free survival of 9.6 months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain.Methods: Post-authorization, non-interventional Special Use Medication Program, multicenter, retrospective study in advanced EGFR/T790M+ non-small cell lung cancer. 155 patients were enrolled (August 2016-December 2018) from 30 sites. Primary objective: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources.Results: 70% women, median age 66. 63.9% were non-smokers and 99% had adenocarcinoma. Most had received at least one prior treatment (97%), 91.7% had received previous EGFR-tyrosine kinase inhibitors and 2.8% osimertinib as first-line treatment. At data cutoff, median follow-up was 11.8 months. 155 patients were evaluable for response, 1.3% complete response, 40.7% partial response, 31% stable disease and 11.6% progressive disease. Objective response rate was 42%. Median progression-free survival was 9.4 months. 49% reported an adverse event, the majority of which (78%) were grade 1 or 2. The resource cost study indicates early use is warranted. Conclusion: This study to assess the real-world clinical impact of osimertinib showed high drug activity in pretreated advanced EGFR/T790M+ non-small cell lung cancer, with manageable adverse events.Clinical trial registration number: NCT03790397

The Real-Life Efficacy And Safety of Osimertinib In Pretreated Advanced Non-Small Cell Lung Cancer Patients With T790M Mutation: A Turkish Oncology Group Study

“…In this context, the survival outcomes of other real-life studies varied between median 9.4 and 14.5 months of PFS, in the second-line treatment of advanced NSCLC with T790M mutation (9)(10)(11)(12)(13)(14). The Spanish Lung Cancer Group reported a median of 9.4 months PFS in 155 patients, and this was a very close to the PFS reported in the pivotal phase 3 trial (6, 10).…”

“…In our study, ORR was higher (82%) and DCR was similar with 95%. Studies from Europe already reported lower rates with approximately 40-50% of ORR (10,12). No data was indicating that the Turkish population might be more "sensitive" to this treatment than Western population.…”

Factors associated with outcomes of second-line treatment for EGFR-mutant non-small-cell lung cancer patients after progression on first- or second-generation EGFR-tyrosine kinase inhibitor treatment

“…This result is comparable to or even better than the results of previous retrospective real-world studies, which showed a PFS of 9.4 to 10.1 months and OS of 24 to 47.3 months for osimertinib as a second-line or subsequent treatment. (21)(22)(23) The better PFS and OS in this study may be due to the relatively small number of patients and the focus on only those treated with osimertinib as the second-line therapy.…”