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P. He
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MA 10 - Immunotherapy I (ID 664)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:S. Wang, Robert Pirker
- Coordinates: 10/17/2017, 11:00 - 12:30, Room 303 + 304
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MA 10.03 - 3-Year Survival and Duration of Response in Randomized Phase II Study of Atezolizumab vs Docetaxel in 2L/3L NSCLC (POPLAR) (ID 8703)
11:00 - 12:30 | Author(s): P. He
- Abstract
- Presentation
Background:
Atezolizumab (anti–PD-L1) has demonstrated OS benefit over docetaxel in a randomized Phase II study, POPLAR, in patients with advanced NSCLC. This benefit has been confirmed in the randomized Phase III study OAK (Rittmeyer, 2017). The 3-year survival analysis of the POPLAR study presented here describes the longest survival follow-up reported to date of an all-comer randomized PD-L1/PD-1 immunotherapy trial in 2L+ NSCLC.
Method:
Patients were randomized 1:1 to receive atezolizumab (1200 mg) or docetaxel (75 mg/m[2]) IV q3w. Tumors were prospectively evaluated for tumor cell (TC) or tumor-infiltrating immune cell (IC) PD-L1 expression using the VENTANA SP142 IHC assay. Landmark OS was estimated using the Kaplan-Meier method. Data cutoff, April 7, 2017; minimum follow-up, 3 years.
Result:
The 2-year and 3-year survival with atezolizumab vs docetaxel were 32.2% vs 16.6% and 18.7% vs 10.0%, respectively. The long-term OS benefit of atezolizumab vs docetaxel was observed across histology and PD-L1 expression subgroups (Table). While the TC3 or IC3 subgroup derived the greatest OS benefit, the TC0 and IC0 subgroup also had improved long-term OS with atezolizumab vs docetaxel. The ITT ORR was 15% in both atezolizumab and docetaxel arms, but the median duration of response was 3 times longer with atezolizumab (22.3 months [95% CI: 11.6, 31.1] vs 7.2 months [95% CI: 5.8, 12.2] with docetaxel). Seven of the 11 docetaxel-arm 3-year survivors received subsequent non-protocol therapy with anti–PD-L1/PD-1 agents. Atezolizumab had a favorable safety profile compared with docetaxel that was consistent with previous reports.
Conclusion:
Atezolizumab demonstrates superior 2-year and 3-year OS benefit compared with docetaxel, and this benefit is observed across histology and PD-L1 expression subgroups (including TC0 and IC0). Atezolizumab is well tolerated, and responses are highly durable. These results are consistent with long-term OS results from OAK, presented separately.Table. Landmark OS in the ITT, PD-L1 expression, and histology subgroups in POPLAR Population (n, atezolizumab vs docetaxel) 2-year OS rate, % 3-year OS rate, % Atezolizumab Docetaxel P value[a] Atezolizumab Docetaxel P value[a] ITT (144 vs 143) 32.2% 16.6% 0.0027 18.7% 10.0% 0.0419 PD-L1 Expression Subgroups TC3 or IC3 (24 vs 23) 41.7% 19.9% 0.1003 37.5% 14.9% 0.0724 TC2/3 or IC2/3 (50 vs 55) 36.1% 13.8% 0.0082 21.2% 9.9% 0.1166 TC1/2/3 or IC1/2/3 (93 vs 102) 36.0% 19.8% 0.0124 18.0% 11.0% 0.1759 TC0 and IC0 (51 vs 41) 25.0% 6.8% 0.0202 20.5% 6.8% 0.0693 Histology Subgroups Non-squamous (95 vs 95) 32.2% 21.1% 0.0960 23.3% 12.4% 0.0585 Squamous (49 vs 48) 32.7% 7.8% 0.0020 9.4% 5.2% 0.4603 [a ]For descriptive purpose only. TC3 or IC3 = PD-L1 ≥ 50% TC or 10% IC; TC2/3 or IC2/3 = PD-L1 ≥ 5% TC or IC; TC1/2/3 or IC1/2/3 = PD-L1 ≥ 1% on TC or IC; TC0 and IC0 = PD-L1 < 1% on TC and IC. NCT01903993.
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OA 17 - Immunotherapy II (ID 683)
- Event: WCLC 2017
- Type: Oral
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:Yuichiro Ohe, Anne Tsao
- Coordinates: 10/18/2017, 14:30 - 16:15, Room 301 + 302
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OA 17.07 - Long-Term Survival in Atezolizumab-Treated Patients with 2L+ NSCLC from Ph III Randomized OAK Study (ID 8663)
14:30 - 16:15 | Author(s): P. He
- Abstract
- Presentation
Background:
Atezolizumab (anti–PD-L1) inhibits PD-L1 binding to PD-1 and B7.1, restoring anti-cancer immunity. OAK, a Phase III study of atezolizumab vs docetaxel demonstrated superior OS of atezolizumab. The characteristics of the long-term survivors (LTS) in the OAK primary population (n = 850) are evaluated and describe the largest cohort of cancer immunotherapy-treated NSCLC LTS yet reported.
Method:
Patients received IV q3w atezolizumab (1200 mg) until PD / loss of clinical benefit or docetaxel (75 mg/m[2]) until PD / unacceptable toxicity. No crossover was allowed. LTS were defined as patients with OS ≥ 24 months and non-LTS as those who died within 24 months of randomization. Patients with OS censored prior to 24 months were not included. Data cutoff, January 23, 2017.
Result:
A higher 2-year survival rate was observed for the atezolizumab-arm (31%) vs docetaxel-arm (21%). After a minimum follow-up of 26 months, there were 119 LTS vs 279 non-LTS in the atezolizumab-arm and 77 LTS vs 299 non-LTS in the docetaxel-arm. Characteristics of atezolizumab-arm LTS and non-LTS are shown (Table). Atezolizumab-arm LTS were enriched for non-squamous histology and high PD-L1–expressing tumors, but also included low/no PD-L1–expressing tumors (40.3%). Atezolizumab-arm LTS had higher ORR (39.5%) than non-LTS (5.0%) but included LTS subjects with PD. 52.9% atezolizumab-arm vs 71.4% docetaxel-arm LTS received anti-cancer non-protocol therapy (NPT) after discontinuation of protocol-defined therapy. 51.9% of docetaxel-arm LTS vs 12.7% non-LTS received non-protocol immunotherapy. Median treatment exposure in atezolizumab-arm LTS was 18.0 months. Atezolizumab-arm LTS had a comparable safety profile to all atezolizumab-treated population.
Conclusion:
Atezolizumab provides superior 2-year OS benefit vs docetaxel and is well tolerated. The majority of docetaxel-arm LTS received a checkpoint inhibitor as NPT. Atezolizumab LTS appeared to have favorable prognostic factors, including non-squamous histology, but notably were not limited to patients with RECIST v1.1 response or with PD-L1 expression.Table. Characteristics of Atezolizumab-Arm Long-Term Survivors (LTS) vs Non-Long Term Survivors (Non-LTS) Atezolizumab LTS (n = 119) n (%) Atezolizumab Non-LTS (n = 279) n (%) Sex Male 61 (51.3) 183 (65.6) Female 58 (48.7) 96 (34.4) Tobacco use history Never smoker 29 (24.4) 47 (16.8) Current/previous smoker 90 (75.6) 232 (83.2) Histology Non-squamous 101 (84.9) 195 (69.9) Squamous 18 (15.1) 84 (30.1) No. of prior therapies, 1 89 (74.8) 209 (74.9) ECOG performance status at baseline 0 60 (50.4) 89 (31.9) 1 59 (49.6) 190 (68.1) EGFR mutation status, positive 11 (9.2) 26 (9.3) PD-L1 IHC subgroup TC3 or IC3 28 (23.5) 39 (14.0) TC1/2/3 or IC1/2/3 71 (59.7) 156 (55.9) TC0 and IC0 48 (40.3) 119 (42.7) Best overall response Complete response 5 (4.2) 0 (0) Partial response 42 (35.3) 14 (5.0) Stable disease 47 (39.5) 97 (34.8) Progressive disease 25 (21.0) 142 (50.9) IC, tumor-infiltrating immune cell; TC, tumor cell. TC3 or IC3 = PD-L1 ≥ 50% TC or 10% IC; TC1/2/3 or IC1/2/3 = PD-L1 ≥ 1% on TC or IC; TC0 and IC0 = PD-L1 < 1% on TC and IC. NCT02008227.
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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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P1.01-052 - Patient-Reported Outcomes (PROs) in OAK: A Phase III Study of Atezolizumab vs Docetaxel in Non-Small-Cell Lung Cancer (NSCLC) (ID 9903)
09:30 - 16:00 | Author(s): P. He
- Abstract
Background:
The phase III OAK study in NSCLC (NCT02008227) demonstrated prolonged overall survival with atezolizumab (an anti-programmed death-ligand 1 antibody) versus docetaxel (median 13.8 vs 9.6 months; HR:0.73, 95% CI 0.62–0.87; p=0.0003). PROs were collected to support documentation of clinical benefit. We report data regarding symptom burden, functioning, and health-related quality of life (HRQoL).
Method:
Patients (n=850) with squamous/non-squamous, previously treated NSCLC, ≥18 years, with measurable disease (RECIST), and ECOG PS 0–1 were randomized to receive atezolizumab 1200mg or docetaxel 75mg/m[2] q3w. PROs were collected using two questionnaires: EORTC QLQ-C30 and its lung module, QLQ-LC13. Analyses included time-to-confirmed-deterioration (TTD) in lung cancer symptoms, physical and role function, HRQoL, longitudinal analyses of mean scores change from baseline to Cycles 5 and 6, proportion of patients with clinically meaningful worsening (≥10-point change from baseline) by Cycles 5 and 6.
Result:
High completion rates were observed throughout treatment (>80% for most cycles). Atezolizumab delayed TTD in physical (HR:0.75, 95% CI 0.58–0.98) and role function (HR:0.79, 95% CI 0.62–1.00). Prolonged TTD in chest pain (HR:0.71, 95% CI 0.49–1.05) was observed with atezolizumab; no differences in TTD were seen for other lung cancer symptoms and HRQoL. Longitudinal analyses demonstrated average changes from baseline in favor of atezolizumab for lung cancer symptoms (Cycle 6: dyspnea, fatigue), domains of functioning (Cycle 6: physical function, social function), HRQoL (Cycle 5); see Table. Fewer atezolizumab-treated patients experienced clinically meaningful worsening in possible treatment-related symptoms during treatment (Cycle 6: diarrhea [OR:0.51, p<0.0001], sore mouth [OR:0.40, p<0.0001], dysphagia [OR:0.61; p=0.0052], peripheral neuropathy [OR:0.50, p<0.0001], alopecia [OR:0.02; p<0.0001]).
Conclusion:
In OAK, atezolizumab delayed the time until NSCLC patients experience limitations in physical and role functioning versus docetaxel. Patient-reported data indicate atezolizumab maintained/improved lung cancer symptom burden and HRQoL compared with baseline, while demonstrating improved tolerability, versus docetaxel.By Cycle 5 By Cycle 6 LS means difference between treatment arms (average change from baseline) P value LS means difference between treatment arms (average change from baseline) P value EORTC QLQ-C30 Global Health Status and Function Scales (positive values indicate greater improvement with atezolizumab over docetaxel) Global Health Status 4.32* p=0.0151 3.08 p=0.1257 Physical Function 3.33* p=0.0290 6.64* p<0.0001 Role Function 2.93 p=0.1959 4.72 p=0.0542 Emotional Function 2.66 p=0.1110 1.92 p=0.2868 Cognitive Function -0.67 p=0.6790 -1.08 p=0.5309 Social Function 3.25 p=0.1159 4.68* p=0.0319 EORTC QLQ-C30 Symptom Scales (negative values indicate greater improvement with atezolizumab over docetaxel) Fatigue -6.27* p=0.0015 -7.66* p=0.0003 Nausea/Vomiting -0.37 p=0.7824 -0.18 p=0.9040 Pain 1.44 p=0.5132 -1.67 p=0.4727 Dyspnea -4.70* p=0.0317 -5.92* p=0.0138 Insomnia 3.50 p=0.1675 0.83 p=0.7564 Appetite Loss -2.94 p=0.1994 -4.49 p=0.0586 Constipation -0.31 p=0.8772 -0.33 p=0.8816 Diarrhea -3.14* p=0.0482 -2.05 p=0.1748 EORTC QLQ-LC13 Symptom Scales (negative values indicate greater improvement with atezolizumab over docetaxel) Dyspnea -1.66 p=0.3146 -4.80* p=0.0140 Coughing -2.60 p=0.2572 -1.38 p=0.5772 Sore Mouth -7.29* p<0.0001 -9.23* p<0.0001 Dysphagia -0.08 p=0.9595 -2.01 p=0.1575 Peripheral Neuropathy -12.98* p<0.0001 -15.71* p<0.0001 Hemoptysis -0.24 p=0.7365 -0.91 p=0.2080 Alopecia -50.59* p<0.0001 -47.04* p<0.0001 Chest Pain -0.91 p=0.6064 -0.58 p=0.7779 Arm/Shoulder Pain -2.27 p=0.3177 -0.58 p=0.8109 Pain in Other Parts 0.94 p=0.7197 -1.05 p=0.7034 *Values that are significantly in favor of atezolizumab versus docetaxel
