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. One hundred-fifty five 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 patients 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. One hundred-fifty five patients were evaluable for response, 1.3% complete response, 40.6% partial response, 31% stable disease and 11.6% disease progression. Objective response rate was 42%. Median progression-free survival was 9.4 months. Of the 155 patients who received treatment, 76 (49%) did not reported any adverse event, 51% presented some adverse event, most of which 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. Trial registration 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.…”

Effects of Osimertinib Combined With Pulmonary Rehabilitation and Health Care Training on Pulmonary Function, Complications, and Quality of Life in Patients After Radical Resection of Lung Cancer

“…After the previous EGFR-TKI treatment, patients in the disease progression received the simertinib, with a disease control rate of 92.0%. Therefore, osimertinib is certified as a groundbreaking therapy drug for NSCLC by the FDA (26,27). The mechanism of osimertinib is that the acrylamide contained in osimertinib can form the covalent bonding with C797 at the edge of the ATP binding site in the catalytic domain of the EGFR gene, and then the irreversible binding occurs with the specific EGFR mutations, to solve the problem of abnormal signal transduction pathway in downstream cells caused by EGFR mutation, inhibit the excessive proliferation and mutation of tumor cells due to the EGFR mutation, and reduce the metastasis rate.…”

Efficacy of osimertinib for preventing leptomeningeal metastasis derived from advanced EGFR-mutated non-small cell lung cancer: a propensity-matched retrospective study

“…Osimertinib significantly prolonged the progression-free survival in treatment-naïve patients with EGFRm advanced NSCLC and in patients with EGFR T790M NSCLC after disease progression with prior EGFR-TKIs treatment [ 21 – 23 ]. Osimertinib also demonstrated superior CNS efficacy in T790M-positive NSCLC [ 24 ].…”