ECOG-ACRIN 5162: A phase II study of osimertinib 160 mg in NSCLC with EGFR exon 20 insertions.

 

Abstract No : 9513

Abstract Type : Poster Discussion Session

Indication : NSCLC with EGFR exon 20 insertions

Intervention : Osimertinib

Company : U.S. National Institutes of Health

Technology : Small molecule

 

Results:

Results: 21 pts were enrolled between 4/2018 and 7/2019 (median age 65; 15 female, 6 male; median 2 prior therapies); 1 patient did not meet eligibility criteria due to laboratory studies obtained 1 day out of window. As of 1/21/20, 6 pts remain on treatment. Among the 20 eligible pts, the best response was PR in 4 pts and CR in one pt, for a confirmed ORR of 25%; 12 (60%) pts had SD. The median PFS was 9.7 months (95% CI, 4.07, NA), median duration of response (DOR) was 5.7 months (95% CI, 4.73, NA.) Grade . 3 treatment-related adverse events (TRAE) observed in . 1 pt included anemia (n=2), fatigue (n=2), prolonged QT interval (n=2.) One pt had grade 4 respiratory failure, there were no grade 5 TRAEs. One pt discontinued study treatment due to grade 3 anemia.

 

Conclusion:

Osimertinib 160mg daily is well-tolerated and showed clinical activity in EGFR ins20-mutant NSCLC with a response rate of 25%, disease control rate of 85%, and mPFS of 9.7 months. The adverse events with osimertinib 160 mg QD in this cohort were consistent with other reports of this regimen; grade 3 rash and diarrhea were not observed.

 

Commentary:

Osimertinib has now also shown activity in NSCLC patients with EGFR exon 20 insertions which comprise 4-10% of EGFR-mutant NSCLC. Osimertinib is already approved in NSCLC patients with exon 19 deletions or exon 21 L858R mutations.

The therapeutics segment is experiencing significant NSCLC clinical trial activity, which is further expected to drive Non-Small Cell Lung Caner market growth in the coming years.

Refer to Epidermal Growth Factor Receptor - Non Small Cell Lung Cancer Market report for detailed Insights.