Real-World Data on Osimertinib in Chinese Patients with Pretreated, EGFR T790M Mutation Positive, Advanced Non-Small Cell Lung Cancer: A Retrospective Study

Abstract

Purpose As a third-generation EGFR TKI has been taken orally, Osimertinib effectively inhibits mutant EGFR, including T790M EGFR resistance mutations. Here, we examined real-world efficacy and tolerability of Osimertinib among Chinese patients with advanced EGFR T790M-mutant NSCLC. Patients and Methods A total of 106 advanced NSCLC patients who were taking Osimertinib following disease progression after EGFR-TKIs or other treatments were retrospectively recruited in this study. The PFS and OS after Osimertinib treatment were analyzed as the primary endpoints. Results Osimertinib was used as a second line and ≥3rd line treatment in 22.6% and 77.4% of the patients, respectively. DCR and ORR were 93.4% and 57.5%, respectively. Median PFS was 12.4 12 (95% CI, 10.5–13.5) months. The PFS was 11 (8.0, 14.0) and 12 (10.3,13.7) months ( p = 0.373), in patients with and without CNS metastasis, respectively. PFS in 2nd and ≥3rd line treatment was 11 (9.0, 13.0) and 12.4 12 (8.9, 15.1) months ( p = 0.799), respectively. In patients with EGFR exon 19 deletion and exon 21 L858 mutation, the median PFS was 11 (9.2, 12.8) and 12 (9.2, 14.8) months, respectively ( p = 0.833). Median PFS in the monotherapy group and combined anti-angiogenesis group was 11 (9.9,12.1) and 14 (11.2,16.8) months, respectively. Median OS after Osimertinib initiation was 27 (19.6, 34.4) months: 15 (6.9, 23.1) and 27 (22, 32) months in patients with and without CNS metastasis (p=0.027), 27 (20.3,33.7) months and (undefined) as second line or ≥3rd line of treatment ( p = 0.421), respectively. In patients with exon 19 deletion, the median OS was not reached, and in patients with exon 21 L858 mutations, the median OS was 23 (19.1,29.9) months (p=0.027). Median OS in the monotherapy group was 27 (21.7,32.3) months, and in combined anti-angiogenesis group was not reached (p=0.68). Conclusion Osimertinib can effectively treat advanced NSCLC with T790M mutations independently of previous treatment lines.

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).…”

“…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). Other studies from different regions and ethnicities like China, Japan, France, and Poland demonstrated slightly better real-life outcomes than the AURA3 trial with approximately median 11-14 months of PFS (9,(11)(12)(13)(14). In general, outcomes of reallife experiences with the different classes of drugs just like cytotoxic chemotherapy, barely exceed the success of pivotal studies.…”

Real‐world data on efficacy and safety of osimertinib in non‐small cell lung cancer patients with EGFR T790M mutation detected by first and repeat rebiopsy

“…Intriguingly, osimertinib showed similar mPFS and mOS in T790M‐positive patients detected by first or repeat rebiopsy. Previous certain studies showed that osimertinib has comparable mPFS and mOS in pretreated advanced NSCLC with T790M mutation patients independently of previous treatment lines, but it was unclear which rebiopsy detected EGFR T790M mutation, and the patients treated by chemotherapy in the first line were included 23,24 . Though a study demonstrated that osimertinib would produce similar mPFS regardless of the timing of T790M detection, it remained unclear whether the patients make similar mOS, and treatments before osimertinib were not clear 17 .…”

Dynamics of disease progression during treatment with Osimertinib in patients with EGFR T790M‐positive non‐small cell lung cancer

“…Despite osimertinib being the treatment of choice for EGFR T790M‐positive NSCLC, the pattern of osimertinib resistance and the appropriate subsequent treatment guidelines are limited in the real‐world setting. 14 , 15 , 16 , 17 , 18 This study aimed to determine the effective treatment direction after osimertinib administration by analyzing the pattern of PD in patients with NSCLC who were treated with osimertinib after first‐line EGFR‐TKI therapy.…”