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Rachel E Sanborn
Author of
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OA05 - Clinical Trials in IO (ID 899)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 13:30 - 15:00, Room 106
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OA05.07 - IMpower132: PFS and Safety Results with 1L Atezolizumab + Carboplatin/Cisplatin + Pemetrexed in Stage IV Non-Squamous NSCLC (ID 12389)
14:35 - 14:45 | Author(s): Rachel E Sanborn
- Abstract
- Presentation
Background
In addition to the combination of atezolizumab (anti–PD-L1)+platinum+taxane±bevacizumab, non-squamous NSCLC patients may derive benefit from adding atezolizumab to platinum+pemetrexed. The randomized Phase III IMpower132 study (NCT02657434) evaluated first-line pemetrexed+carboplatin or cisplatin±atezolizumab in patients with stage IV non-squamous NSCLC without EGFR or ALK driver mutations.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients were randomized 1:1 to receive 4 or 6 cycles of carboplatin AUC 6 mg/mL/min or cisplatin 75 mg/m2 + pemetrexed 500 mg/m2 Q3W alone (arm PP) or in combination with atezolizumab 1200 mg Q3W (arm APP), followed by pemetrexed (arm PP) or atezolizumab + pemetrexed (arm APP) maintenance. Atezolizumab could be continued beyond disease progression per protocol guidelines. PFS and OS were co-primary endpoints. Efficacy by PD-L1 expression was an exploratory endpoint. Here, we present investigator-assessed PFS per RECIST v1.1 (final analysis), OS (interim analysis) and safety data.
4c3880bb027f159e801041b1021e88e8 Result
292 pts were enrolled in arm APP and 286 pts in arm PP. 43% and 40% in arms APP and PP, respectively, had ECOG PS 0. At the data cutoff (22 May 2018), median follow-up was 14.8 mo overall. PFS analysis showed a statistically significant improvement between arm APP vs PP (median PFS 7.6 vs 5.2 mo; HR=0.596; 95% CI: 0.494, 0.719; P<0.0001). Interim analysis showed a numerical but non-statistically significant OS improvement (Table). Efficacy results were consistent across all key clinical subgroups. Grade 3-4 TRAEs occurred in 53.6% of patients (APP) vs 39.1% (PP). 7.2% of patients (APP) vs 5.1% (PP) had a Grade 5 AE, 3.8% (APP) vs 2.6% (PP) were treatment related. 48.5% of patients (APP) vs 38.0% (PP) experienced AEs of special interest specific to atezolizumab.
8eea62084ca7e541d918e823422bd82e Conclusion
IMpower132 met its co-primary endpoint of investigator-assessed PFS in the ITT. Interim OS data (not fully mature) showed numerical improvement. Atezolizumab+pemetrexed+carboplatin or cisplatin was well tolerated, and no new safety signals were identified.
Table. IMpower132 Efficacy Analyses APP Arm
(atezolizumab+pemetrexed+ carboplatin or cisplatin)PP Arm
(pemetrexed+carboplatin or cisplatin)ITT n=292 n=286 Median PFS (95% CI), mo 7.6 (6.6, 8.5) 5.2 (4.3, 5.6) HRa (95% CI; P value) 0.596 (0.494, 0.719; P < 0.0001) 12-Month PFS (95% CI), % 33.7% (28.2, 39.2) 17.0% (12.6, 21.4) Median OS (95% CI), mo 18.1 (13.0, NE) 13.6 (11.4, 15.5) HRa (95% CI; P value) 0.813 (0.644, 1.025; P = 0.0797) 12-Month OS (95% CI), % 59.6% (53.9, 65.3) 55.4% (49.5, 61.2) ORR (confirmed, inv-assessed), % 46.9% 32.2% DOR (95% CI), mo 10.1 (7.2, 13.3) 7.2 (5.7, 9.0) PD-L1–highb n=25 n=20 Median PFS (95% CI), mo 10.8 (7.9, NE) 6.5 (2.4, 10.6) HR (95% CI; P value) 0.464 (0.224, 0.960; P = 0.0339) PD-L1–lowb n=63 n=73 Median PFS (95% CI), mo 6.2 (4.4, 8.4) 5.7 (4.2, 7.9) HR (95% CI; P value) 0.804 (0.556, 1.163; P = 0.2462) PD-L1–negativeb n=88 n=75 Median PFS (95% CI), mo 8.5 (6.1, 11.2) 4.9 (4.2, 5.8) HR (95% CI; P value) 0.448 (0.313, 0.642; P < 0.0001) DOR, duration of response; HR, hazard ratio; inv, investigator; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.
a Stratified. b Baseline tissue available in 60% of patients. PD-L1–high (TC3/IC3): patients with PD-L1 expression in ≥50% of tumor cells or ≥10% of tumor-infiltrating immune cells; PD-L1–low (TC12/IC12): patients with PD-L1 expression in ≥1% and <50% of tumor cells or ≥1% and <10% of tumor-infiltrating immune cells; and PD-L1–negative (TC0/IC0): patients with PD-L1 expression in <1% of tumor cells and <1% of tumor-infiltrating immune cells.
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