489P - Overall survival in patients with EGFRm+ NSCLC receiving sequential afatinib and osimertinib: Updated analysis of the GioTag study

Background

Identifying the optimal sequence of EGFR TKIs is important to maximise survival in EGFR mutation-positive (EGFRm+) NSCLC. The observational GioTag study (NCT03370770) investigated outcomes in patients (pts) with EGFRm+ NSCLC who were treated with sequential afatinib and osimertinib in a ‘real-world’ clinical setting, including pts with poor prognosis (ECOG PS ≥ 2: 15%; stable brain metastases: 10%).¹ In the primary analysis, time to treatment failure (TTF) was 27.6 months in the overall population, 30.3 months in Del19-positive pts, and 46.7 months in Asians. Here we report overall survival (OS) and updated TTF.

Methods

Data were retrospectively collected from Dec 2017–June 2018 for 203 pts with EGFRm + (Del19, L858R) NSCLC who were T790M positive after first-line afatinib and subsequently received osimertinib. TTF was the primary outcome; OS analysis was exploratory. Data were collected from electronic health records (EHRs; n = 126) or medical charts (n = 77). For logistical reasons, this interim analysis includes updated data (at April 2019) from pts with available EHRs (all USA; n = 94); final analysis with updated data from manual chart reviews is anticipated in early 2020.

Results

After median follow-up of 30.3 months, median OS was 41.3 months (90% CI: 36.8–46.3) in the overall dataset (n = 203) and 45.7 months (90% CI: 45.3–51.5) in Del19-positive pts (n = 149); 2-year OS was 80%. OS in Asians was immature. Updated median TTF was 28.1 months (90% CI: 26.8–30.3) in all pts, and 30.6 months (90% CI: 27.6–32.0) in Del19-positive pts. Median TTF with osimertinib was 15.6 months (90% CI: 13.8–17.1) in the overall dataset, and 16.4 months (90% CI: 14.9–17.9) in Del19-positive pts. Median time from osimertinib discontinuation to death was 8 months. In 168 pts starting on afatinib 40 mg, median OS was 45.3 months (90% CI: 37.6–47.6); median TTF was 28.1 months (90% CI: 26.8–30.6).

Conclusions

Encouraging OS and TTF was seen in pts with EGFR T790M-positive NSCLC with sequential afatinib and osimertinib, especially Del19-positive pts. Of note, prior afatinib treatment did not preclude prolonged TTF with second-line osimertinib. 1. Hochmair MJ, et al. Future Oncol. 2018;14:2861–74.

Clinical trial identification

NCT03370770.

Editorial acknowledgement

Lynn Pritchard of GeoMed, an Ashfield company, part of UDG Healthcare plc.

Legal entity responsible for the study

Boehringer Ingelheim.

Funding

Boehringer Ingelheim.

Disclosure

M.J. Hochmair: Honoraria (self): AstraZeneca; Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Merck Sharp & Dohme; Honoraria (self): Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis. A. Morabito: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Merck Sharp and Dohme. D. Hao: Advisory / Consultancy, Research grant / Funding (self): Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (self): AstraZeneca. R.A. Soo: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Ignyta; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Taiho; Honoraria (self), Advisory / Consultancy: Takeda; Honoraria (self), Advisory / Consultancy: Yuhan. J.C-H. Yang: Honoraria (self): Merck Sharp and Dohme; Advisory / Consultancy: Merck Serono; Honoraria (self): Novartis; Advisory / Consultancy: Celgene; Advisory / Consultancy: Merrimack; Advisory / Consultancy: Yuhan Pharmaceuticals; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Ono pharmaceuticals; Advisory / Consultancy: Daiichi Sankyo; Advisory / Consultancy: Hansoh Pharmaceuticals; Advisory / Consultancy: Takeda Pharmaceuticals; Advisory / Consultancy: Blueprint Medicines; Advisory / Consultancy: G1 Therapeutics; Honoraria (self): Pfizer. B. Halmos: Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy, Research grant / Funding (self): Pfizer; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy, Research grant / Funding (self): Merck Sharp and Dohme; Advisory / Consultancy, Research grant / Funding (self): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (self): Boehringer Ingelheim; Advisory / Consultancy: Genentech; Advisory / Consultancy: Spectrum; Advisory / Consultancy: Ignyta; Research grant / Funding (self): Takeda; Research grant / Funding (self): Guardant Health; Research grant / Funding (self): Mirati; Research grant / Funding (self): AbbVie; Research grant / Funding (self): Novartis; Research grant / Funding (self): GSK; Advisory / Consultancy: Foundation Medicine; Advisory / Consultancy: Guardant Health. L. Wang: Full / Part-time employment: Boehringer Ingelheim. A. Märten: Full / Part-time employment: Boehringer Ingelheim. T. Cufer: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Merck Sharp and Dohme; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim. All other authors have declared no conflicts of interest.