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K.H. Lee
Author of
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OA 05 - Next Generation TKI (ID 657)
- Event: WCLC 2017
- Type: Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:James Chih-Hsin Yang, Fiona Blackhall
- Coordinates: 10/16/2017, 15:45 - 17:30, Room 301 + 302
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OA 05.01 - First-Line Dacomitinib versus Gefitinib in Advanced Non-Small-Cell Lung Cancer with EGFR Mutation Subgroups (ID 8555)
15:45 - 15:55 | Author(s): K.H. Lee
- Abstract
- Presentation
Background:
The ARCHER 1050 study (NCT01774721) demonstrated benefits of dacomitinib compared with gefitinib as first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) and EGFR-activating mutation. Here, we present the results of a prospective subgroup analysis by EGFR mutation subtype.
Method:
In this ongoing phase 3, open-label study, eligible patients with newly diagnosed stage IIIb/IV or recurrent NSCLC and EGFR-activating mutation (exon 19 deletion or L858R mutation ± T790M mutation) with an Eastern Cooperative Oncology Group performance status of 0–1 were randomized (1:1) to receive dacomitinib or gefitinib, stratified by race and EGFR mutation subtype. The primary endpoint was progression-free survival (PFS) by blinded independent radiologic central (IRC) review. Secondary endpoints included overall survival and objective response rate (ORR), as determined by IRC and investigators’ assessments.
Result:
A total of 452 patients were randomized (dacomitinib, n=227; gefitinib, n=225). Among the dacomitinib and gefitinib arms, respectively, 134 (59%) and 133 (59%) had exon 19 deletions and 93 (41%) and 92 (41%) had L858R mutations. The Table shows PFS, ORR, and duration of response by EGFR mutation per IRC. Results based on investigators’ assessments were consistent with those based on IRC review. Overall survival data are immature.Exon 19 Deletion L858R Mutation Dacomitinib (n=134) Gefitinib (n=133) Dacomitinib (n=93) Gefitinib(n=92) PFS per IRC Median, months (95% CI) 16.5 (11.3–18.4) 9.2 (9.1–11.0) 12.3 (9.2–16.0) 9.8 (7.6–11.1) Hazard ratio (95% CI) 1-sided P value 0.551 (0.408–0.745) <0.0001 0.626 (0.444–0.883) 0.0034 ORR per IRC CR, n (%) 7 (5.2) 3 (2.3) 5 (5.4) 1 (1.1) PR, n (%) 95 (70.9) 90 (67.7) 63 (67.7) 67 (72.8) ORR (CR + PR), n (%) (95% CI) 102 (76.1) (68.0–83.1) 93 (69.9) (61.4–77.6) 68 (73.1) (62.9–81.8) 68 (73.9) (63.7–82.5) 1-sided P value 0.1143 0.5395 DoR in responders per IRC Median, months (95% CI) 15.6 (13.1–19.6) 8.3 (7.9–10.1) 13.7 (9.2–17.4) 7.5 (6.5–10.2) Hazard ratio (95% CI) 1-sided P value 0.454 (0.319–0.645) <0.0001 0.403 (0.267–0.607) <0.0001 CI, confidence interval; CR, complete response; DoR, duration of response; PR, partial response.
Conclusion:
By IRC and investigators’ assessments, PFS with dacomitinib was superior to that with gefitinib in patients with either EGFR mutation. Despite a similar ORR among the treatment and EGFR mutation subgroups, duration of response was longer with dacomitinib for both mutations.
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