Boehringer reports positive data from afatinib’s real-world study

5th August 2019 (Last Updated August 13th, 2019 04:51)

Boehringer Ingelheim has reported positive interim results from the real-world GioTag study of afatinib (Giotrif/Gilotrif) in EGFR Del19 and T790M mutation-positive non-small-cell lung cancer (NSCLC).

Boehringer reports positive data from afatinib’s real-world study
Boehringer reports improved overall survival in the real-world GioTag study. Credit: © Boehringer Ingelheim.

Boehringer Ingelheim has reported positive interim results from the real-world GioTag study of afatinib (Giotrif/Gilotrif) in EGFR Del19 and T790M mutation-positive non-small-cell lung cancer (NSCLC).

According to the data, initial therapy with afatinib followed by osimertinib led to overall survival (OS) of 45.7 months during the retrospective, observational, and unblinded study.

Previous data from the study showed OS rates of two years and 2.5 years.

Analysis of updated findings from a subset of patients who had electronic health records in the US revealed a median OS rate of 41.3 months after a median follow-up of 30.3 months.

Boehringer added that the updated two-year OS rate was 80%.

Patients with Del19-positive tumours experienced a median OS rate of 45.7 months, while the two-year OS rate was 82%.

New analysis revealed median time-on-therapy with sequential afatinib and osimertinib of 28.1 months in the overall population and 30.6 months in participants with Del19-positive tumours.

Median time on osimertinib treatment after afatinib therapy was 15.6 months and 16.4 months for Del19 mutations.

Boehringer Ingelheim Oncology Medicine corporate vice-president and global head Dr Victoria Zazulina said: “The continued clinical development of new EGFR TKIs provides additional treatment options for patients with EGFR M+ NSCLC, and raises questions about their optimal sequence.

“Real-world data from the GioTag study supports the argument for sequential use of afatinib and osimertinib for patients with EGFR M+ NSCLC who are Del19-positive.”

Zazulina also said that the lack of targeted treatments following the failure of osimertinib indicates the need for the drug to be used as a second-line treatment following second-generation EGFR TKIs.

Final analysis of the GioTag study is scheduled to take place early next year and will include data from Asian and European countries.