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Poster Discussion session - NSCLC, metastatic 2

4580 - IMpower131: Progression-free survival (PFS) and overall survival (OS) analysis of a randomised Phase III study of atezolizumab + carboplatin + paclitaxel or nab-paclitaxel vs carboplatin + nab-paclitaxel in 1L advanced squamous NSCLC

Date

21 Oct 2018

Session

Poster Discussion session - NSCLC, metastatic 2

Topics

Cytotoxic Therapy;  Immunotherapy

Tumour Site

Presenters

Mark Socinski

Authors

M.A. Socinski1, A. Rittmeyer2, D. Shapovalov3, F. Orlandi4, M. McCleod5, R.A. Soo6, R. Palmero7, T. Kozuki8, M.R. Migliorino9, K.D. Koynov10, H. Berard11, B.G.M. Hughes12, W. Yu13, V. Graupner14, S.W. Sun15, M. Kowanetz16, T. Hoang17, W. Lin18, R.M. Jotte19

Author affiliations

  • 1 Medical Oncology, Florida Hospital Cancer Institute, 32803 - Orlando/US
  • 2 Medical Oncology, LKI Lungenfachklinik Immenhausen, 34376 - Immenhausen/DE
  • 3 Department Of Surgery Of Tumors Of The Chest, Communal Non-Profit Enterprise Regional Center of Oncology, Kharkiv/UA
  • 4 Chile And Prosalud Oncología, Instituto Nacional del Tórax, Santiago de Chile/CL
  • 5 Medical Oncology, Florida Cancer Specialists, Fort Myers/US
  • 6 Haematology-oncology, National University Hospital, 119074 - Singapore/SG
  • 7 Medical Oncology, Hospital Duran i Reynalds, Barcelona/ES
  • 8 Department Of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 9 Oncology Department, San Camillo Forlanini Hospital, 00152 - Roma/IT
  • 10 Department Of Medical Oncology, Multiprofile Hospital for Active Treatment Serdika, 1000 - Sofia/BG
  • 11 Service De Pneumologie, Hôpital Sainte-Anne, 83000 - Toulon/FR
  • 12 Medical Oncology, The Prince Charles Hospital and University of Queensland, Brisbane/AU
  • 13 Biostatistics, Genentech, Inc., South San Francisco/US
  • 14 Product Development Oncology - Clinical Science, F. Hoffmann - La Roche Ltd, 4070 - Basel/CH
  • 15 Product Development Development Oncology, Genentech, Inc., South San Francisco/US
  • 16 Oncology Biomarker Development, GENENTECH, INC, 94080 - South San Francisco/US
  • 17 Product Development Oncology, Genentech Inc. - Roche - USA, 94080 - South San Francisco/US
  • 18 Product Development Oncology, Genentech, Inc., South San Francisco/US
  • 19 Medical Oncology / Hematology, Rocky Mountain Cancer Centers, Denver/US
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Resources

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
therapy, %

  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;
PFS, progression-free survival.

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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