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H. Huang
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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.01-005 - Overall Survival (OS) After Disease Progression (PD) on Brigatinib in Patients With Crizotinib-Refractory ALK+ NSCLC in ALTA (ID 8546)
09:30 - 16:00 | Author(s): H. Huang
- Abstract
Background:
Brigatinib, a next-generation ALK inhibitor, has been associated with a median progression-free survival of approximately 16 months in ALTA, a randomized phase 2 trial (NCT02094573) investigating 2 brigatinib regimens in patients with crizotinib-refractory, advanced ALK+ NSCLC. This post hoc analysis explores the clinical benefit of continuing brigatinib beyond PD in ALTA.
Method:
Patients were randomized to arm A (brigatinib 90 mg qd; n=112) or B (brigatinib 180 mg qd with 7-day lead-in at 90 mg; n=110). Patients in arm A were permitted to escalate to 180 mg qd after RECIST PD. 107 patients who had PD on brigatinib, did not have PD as their best response, and survived ≥21 days post-PD were analyzed here.
Result:
As of February 21, 2017, 84 patients continued and 23 discontinued brigatinib treatment post-PD. Estimated 1-year OS after first PD and OS hazard ratios (HRs; unadjusted and adjusted) are shown in the table. Unadjusted HRs indicated significantly longer OS in patients who continued brigatinib vs those who did not (HR: 0.32 [95% CI, 0.17–0.62]), particularly those who continued at 180 mg. Patients who were more heavily pretreated, had longer duration of brigatinib therapy before PD, did not progress due to new lesions, had confirmed objective response, and had better ECOG performance status at PD were more likely to continue brigatinib post-PD. Adjusted HRs indicated numerically longer OS in patients who continued brigatinib (HR: 0.53 [95% CI, 0.26–1.08]). Number of prior regimens (2 vs ≥3), shorter time to investigator-assessed PD, PD due to new lesions only, and ECOG performance status at PD (≥2 vs 0) were independently associated with worse OS (P<0.05).
Conclusion:
Survival was better among patients who continued vs discontinued brigatinib after PD. Continuing brigatinib, especially at 180 mg, could be one of many factors associated with longer OS after PD in these patients.Patients With PD on Brigatinib (n=107) n 1-Year OS Post-PD,[a] % (95% CI) Unadjusted HR (95% CI) Adjusted HR[b] (95% CI) Continued brigatinib 84 66(53–99) 0.32(0.17–0.62) 0.53(0.26–1.08) At 90 mg qd (arm A without escalation) 23 62(38–99) 0.49(0.22–1.11) 0.61(0.25–1.46) At 180 mg qd 61 68 (51–99) 0.26(0.13–0.54) 0.48(0.21–1.06) Arm A with escalation 23 70(44–99) 0.29(0.12–0.72) 0.51(0.19–1.33) Arm B 38 66(44–99) 0.25(0.11–0.57) 0.45(0.18–1.16) Did not continue brigatinib 23 31(13–100) Reference Reference [a]Kaplan-Meier estimate from time of first PD [b]Adjusted for duration of prior crizotinib exposure, number of prior treatment regimens (1, 2, or ≥3), time to investigator-assessed PD, PD due to new lesions only (yes/no), and ECOG performance status at PD (0, 1, or ≥2)
