Sequential afatinib and osimertinib in patients with EGFR M+ NSCLC who acquired a T790M mutation

Final TOT and OS analysis of the real-world, retrospective, observational GioTag study

Giotag

GIOTRIF® (afatinib) as monotherapy is indicated for the treatment of patients with : 

  • locally advanced or metastatic non-squamous non-small cell lung carcinoma with adenocarcinoma is predominantly, Epidermal Growth Factor Receptor (EGFR) exon 19 deletions, exon 21 (L858R and L861Q) substitutions, exon 18 (G719X) substitutions, or exon 20 (S7681) substitution mutations, TKI-naïve adult patients.
  • Locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.

EGFR=epidermal growth factor receptor; NSCLC=non-small cell lung cancer; TKI=tyrosine kinase inhibitor.

1. GIOTRIF® Product Information in Indonesia, 2019

For Health care professional only

PC-ID-100811

Sequential afatinib and osimertinib in patients with EGFR M+ NSCLC:* final TOT and OS analysis of the observational GioTag study1

This was a real-world, retrospective, observational study.1

For the final analysis, data were co lected from 203 EGFR-TKI-naïve patients with T790M-acquired resistance, including:1

149

patients with a Del19 mutation

50

patients of Asian ethnicity

At baseline, 10% of patients had CNS metastases and 15% of patients had ECOG performance status ≥21

This final analysis represents the most mature analysis to date of OS with sequential afatinib and osimertinib1

  • 59% maturity for overall population; 50% maturity for patients of Asian ethnicity

Final results show that afatinib followed by osimertinib was an effective therapeutic strategy in a broad, real-world population of patients with EGFR M+ NSCLC,* with a pronounced benefit in patients with a Del19 mutation and patients of Asian ethnicity1

*Patients who acquire a T790M mutation on progression with afatinib.

CNS=central nervous system; Del19=deletion 19; ECOG=Eastern Cooperative Oncology Group; EGFR M+=epidermal growth factor receptor mutation positive; NSCLC=non-small cell lung cancer; OS=overall survival; TKI=tyrosine kinase inhibitor; TTF=time to treatment failure.

Reference: 1. Hochmair M, et al. Future Oncol 2020. In press.

Overall survival and time on treatment with sequential afatinib and osimertinib in the overall population*

OS in the overall population1*†

OS in the overall population magnifying_icon

Adapted from Hochmair MJ, et al. 2020.

At time of analysis, total number of events was 120.

TOT in the overall population1*†

TOT in the overall population magnifying_icon

Adapted from Hochmair MJ, et al. 2020.

At time of analysis, total number of events was 161.

Results in the broad overall study population confirm the findings of the primary and interim analyses, with a median OS of over 3 years1

*Patients who acquire a T790M mutation on progression with afatinib

CI=confidence interval; Del19=deletion 19; OS=overall survival; TTF=time to treatment failure.

†At the start of treatment with afatinib, 73.5% of patients had a Del19 mutation. ‡59% maturity.

Reference: 1. Hochmair M, et al. Future Oncol 2020. In press.

Overall survival and time on treatment with sequential afatinib and osimertinib in patients with a Del19 mutation*

OS in patients with a Del19 mutation1*

OS in patients with a Del19 mutation magnifying_icon

Adapted from Hochmair MJ, et al. 2020.

TOT in patients with a Del19 mutation1*

TOT in patients with a Del19 mutation magnifying_icon

Adapted from Hochmair MJ, et al. 2020.

Results in the broad overall study population confirm the findings of the primary and interim analyses, with a median OS of over 3 years1

*Patients who acquire a T790M mutation on progression with afatinib.

CI=confidence interval; Del19=deletion 19; OS=overall survival; TTF=time to treatment failure.

Reference: 1. Hochmair M, et al. Future Oncol 2020. In press.

Overall survival and time on treatment with sequential afatinib and osimertinib in patients of Asian ethnicity*

OS in patients of Asian ethnicity1*

OS in patients of Asian ethnicity magnifying_icon

Adapted from Hochmair MJ, et al. 2020.

In patients of Asian ethnicity with a Del19 mutation* (n=31), median OS was 45.7 months (90% CI: 38.2–57.8)1

TOT in patients of Asian ethnicity1*

TOT in patients of Asian ethnicity magnifying_icon

Adapted from Hochmair MJ, et al. 2020.

At time of analysis, total number of events was 36.

In patients of Asian ethnicity with a Del19 mutation* (n=31), median TOT was 40.0 months (90% CI: 36.4–45.0)1

There was a pronounced OS and TOT benefit in patients of Asian ethnicity,* with both subgroups having a median OS of over 3.5 years1

*Patients who acquire a T790M mutation on progression with afatinib.

CI=confidence interval; Del19=deletion 19; OS=overall survival; TTF=time to treatment failure.

†50% maturity.

Reference: 1. Hochmair M, et al. Future Oncol 2020. In press.