Sequential TKI Treatment Improves OS in EGFR T790M-Positive NSCLC

Sequential afatinib (Gilotrif) and osimertinib (Tagrisso) improved median overall survival (OS) by almost 3.5 years in patients with EGFR T790M-positive non-small cell lung cancer (NSCLC), with an even greater benefit seen in those with Del19-positive disease, according to study findings presented at the International Association for the Study of Lung Cancer (IASLC) 2019 North America Conference on Lung Cancer.

“These data support the feasibility of this sequential regimen,” concluded the authors, led by Christoph Weinlinger of the Otto Wagner Hospital in Vienna.

The global, observational GioTag study (NCT03370770) evaluated sequential afatinib and osimertinib in a ‘real-world’ clinical setting among patients with EGFR mutant-positive NSCLC, including patients with poor prognosis (ECOG prognosis score ≥2, 15%) and stable brain metastases (10%).

The findings are based on existing medical records retrospectively collected between December 2017 and June 2018.

Treatment of the 203 patients included afatinib as the first-line treatment, followed by osimertinib in case the T790M resistance mutation was developed.

In the primary analysis, time to treatment failure (TTF) was 27.6 months in all patients, 30.3 months in Del19-positive patients, and 46.7 months in Asian patients.

In this analysis, the researchers reported OS and updated TTF. The trial is ongoing and is expected to be completed this November.

After a median follow-up of 30.4 months, the median OS observed was 41.3 months (90% CI, 36.8-46.3), which increased to 45.6 months for the Del19-positive patients (n = 149; 90% CI, 45.3-51.5).

Median TTF was 28.1 months (90% CI, 26.8-30.3) in the overall data set and 30.6 months (90% CI, 27.6-32.0) in the Del19-positive patients. Once reaching treatment with osimertinib, median TTF was 15.6 months (90% CI, 13.8-171) for the overall dataset, and 16.4 months (90% CI, 14.9-17.9) in the Del19-positive patients.

The scientists concluded that the results show promise.

“In patients with EGFR T790M-positive NSCLC, we observed encouraging median OS of almost 3.5 years with sequential afatinib and osimertinib, with even greater benefit seen in Del19-positive patients,” they wrote. “Notably, prolonged TTF of 15.6 months was seen with second-line osimertinib, despite all patients having received prior afatinib treatment. The final analysis, anticipated in early 2020, will provide further insights into the long-term survival of patients treated with sequential afatinib (plus) osimertinib, including Asians.”

Final analysis is expected in early 2020.

References:

Mochmair M, Morabito A, Hao D, et al. Overall Survival in Patients with EGFRM+ NSCLC Receiving Sequential Afatinib and Osimertinib: An Update of the GioTag Study. Presented at: IASLC 2019 North America Conference on Lung Cancer; October 11, 2019; Chicago, Ill. Abstract OA03.09.