Abstract 4580
Background
Combining atezolizumab (atezo; anti–PD-L1) and chemotherapy (chemo) may further improve outcomes in NSCLC by enhancing immunomodulatory effects. IMpower131 (NCT02367794) is a randomised Ph III trial of atezo + chemo vs chemo alone in 1L Stage IV squamous NSCLC. In the primary analysis, PFS benefit was seen with atezo + carboplatin (carbo) + nab-paclitaxel (nab-pac) vs carbo + nab-pac (HR, 0.71; 95% CI: 0.60, 0.85; P = 0.0001), with a tolerable safety profile. Here we report updated results at the second interim OS analysis (Arm B vs C).
Methods
1021 pts were randomised 1:1:1 to Arm A (atezo 1200 mg q3w + carbo AUC 6 q3w + paclitaxel 200 mg/m2 q3w), Arm B (atezo + carbo + nab-pac 100 mg/m2 qw) or Arm C (carbo + nab-pac). Pts received chemo ± atezo for 4 or 6 cycles per investigator choice, followed by atezo maintenance (Arms A and B). Pts had chemo-naive, Stage IV squamous NSCLC and were stratified by sex, baseline liver metastases and PD-L1 expression. Coprimary endpoints are investigator-assessed PFS and OS in the ITT population.
Results
At data cutoff (20 April 2018), minimum follow-up was 12.8 mo. Median OS was 14.6 mo in Arm B vs 14.3 mo in Arm C (HR, 0.92; 95% CI: 0.76, 1.12; P = 0.41; Table). Median PFS was 6.5 mo in Arm B vs 5.6 mo in Arm C (HR, 0.74; 95% CI: 0.62, 0.87). Treatment-related AEs occurred in 95% (Arm B) and 91% (Arm C) of pts and were Grade 3-4 in 68% (Arm B) and 57% (Arm C) of pts. Region of enrolment was balanced between treatment arms; 6% (Arm B) and 43% (Arm C) of pts received cancer immunotherapy in second or later lines.
Conclusions
At this second interim OS analysis, OS remained comparable in Arm B vs C; OS did not cross the boundary and continues to be followed. IMpower131 continued to show improved PFS in Arm B vs C. The safety of atezo + carbo + nab-pac was consistent with the profile for each agent, with no new or unexpected signals.
|
| Arm B atezo + carbo + nab-pac N = 343 | Arm C carbo + nab-pac N = 340 |
| Region of enrolment, % Eastern Europe Rest of Europe North America/Australia Central/South America Asia Pacific | 21.9 33.8 25.4 7.0 12.0 | 22.6 36.5 23.8 6.8 10.3 |
| ≥ 1 subsequent anti-cancer Immunotherapy | 33.8 5.5 | 57.6 42.6 |
| Median PFS, moa | 6.5 | 5.6 |
| HR (95% CI) | 0.74 (0.62, 0.87) | |
| Median OS, mo | 14.6 | 14.3 |
| HR (95% CI); P value | 0.92 (0.76, 1.12); 0.41 | |
| Confirmed ORR, % | 49.4 | 41.3 |
| Median DOR, mo | 7.5 | 5.2 |
| HR (95% CI) | 0.57 (0.45, 0.74) | |
| CI, confidence interval; DOR, duration of response; HR, hazard ratio; ORR, objective response rate; a PFS was updated as a post-hoc analysis. | ||
Clinical trial identification
NCT02367794
Editorial Acknowledgement
Kia Walcott, PhD, of Health Interactions, Inc.
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