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E-Poster Display

1311P - First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) + chemotherapy (chemo) in Asian patients (pts) with advanced non-small cell lung cancer (NSCLC) from CheckMate 9LA

Date

17 Sep 2020

Session

E-Poster Display

Topics

Cytotoxic Therapy;  Immunotherapy

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Thomas John

Citation

Annals of Oncology (2020) 31 (suppl_4): S754-S840. 10.1016/annonc/annonc283

Authors

T. John1, H. Sakai2, S. Ikeda3, Y. Cheng4, K. Kasahara5, Y. Sato6, Y. Nakahara7, M. Takeda8, H. Kaneda9, H. Zhang10, M. Maemondo11, K. Minato12, T. Hisada13, Y. Misumi14, M. Satouchi15, K. Hotta16, A. Li17, A. Oukessou18, S. Lu19

Author affiliations

  • 1 Department Of Medical Oncology, Austin Hospital, 3084 - Heidelberg/AU
  • 2 Thoracic Oncology Department, Saitama Cancer Center, Saitama/JP
  • 3 Department Of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama/JP
  • 4 Department Of Thoracic Oncology, Jilin Cancer Hospital, Changchun/CN
  • 5 Respiratory Medicine, Kanazawa University Hospital, Kanazawa/JP
  • 6 Department Of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe/JP
  • 7 Department Of Thoracic Oncology, Kanagawa Cancer Center, Yokohama/JP
  • 8 Medical Oncology, Kindai University Hospital, Osaka/JP
  • 9 Department Of Clinical Oncology, Osaka City University Hospital, Osaka/JP
  • 10 Department Of Oncology, Tangdu Hospital, Xi'an/CN
  • 11 Division Of Pulmonary Medicine, Allergy, And Rheumatology, Department Of Internal Medicine, Iwate Medical University Hospital, Yahaba/JP
  • 12 Department Of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota/JP
  • 13 Department Of Respiratory Medicine, Gunma University Hospital, Maebashi/JP
  • 14 Department Of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama/JP
  • 15 Department Of Thoracic Oncology, Hyogo Cancer Center, Akashi/JP
  • 16 Center For Innovative Clinical Medicine, Okayama University Hospital, Okayama/JP
  • 17 Biometrics And Data Sciences, Bristol-Myers Squibb Company, Princeton/US
  • 18 Oncology Clinical Development, Bristol-Myers Squibb Company, Princeton/US
  • 19 Oncology Department, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai/CN

Resources

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Abstract 1311P

Background

In the randomized, phase 3 CheckMate 9LA study (NCT03215706), NIVO + IPI + 2 cycles of chemo significantly improved overall survival (OS) vs chemo in 1L advanced NSCLC. Here we present results in the Asian subpopulation.

Methods

Adults with treatment-naive, histologically confirmed stage IV/recurrent NSCLC, ECOG performance status 0–1, and no known sensitizing EGFR/ALK alterations were randomized 1:1 to NIVO (360 mg every 3 wk) + IPI (1 mg/kg every 6 wk) + 2 cycles of histology-based chemo or 4 cycles of chemo. Pts were stratified by PD-L1 expression (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous). Pemetrexed maintenance was optional for pts with non-squamous NSCLC in the chemo-only arm. Pts received immunotherapy until disease progression, unacceptable toxicity, or for ≤ 2 y. The primary endpoint was OS. The Asian subpopulation included pts from China and Japan.

Results

Of 58 pts in the Asian subpopulation, 28 were randomized to NIVO + IPI + chemo and 30 to chemo. At database lock (March 9, 2020), minimum follow-up for OS was 12.7 mo. In the NIVO + IPI + chemo arm, 57.1% of pts receieved subsequent chemo and in the chemo arm, 66.7% of pts received subsequent immunotherapy. The hazard ratio (HR) for OS was 0.33 (95% CI, 0.14–0.80) in favor of NIVO + IPI + chemo; additional efficacy results are shown in the table. Grade 3–4 treatment-related adverse events (TRAEs) occurred in 57.1% (NIVO + IPI + chemo) and 60.0% (chemo) of pts, and any-grade TRAEs leading to discontinuation in 21.4% and 16.7%. Among TRAEs typically associated with chemo, the most common were anemia (NIVO + IPI + chemo vs chemo: 28.6% vs 50.0%), alopecia (21.4% vs 26.7%), and neutropenia (7.1% vs 13.3%).

Conclusions

The Asian subpopulation of CheckMate 9LA, although small, demonstrated improved efficacy including OS for 1L NIVO + IPI + chemo vs chemo alone, despite high rates of subsequent immunotherapy in the chemo arm, with a manageable safety profile Table: 1311P

Efficacy in the Asian subpopulation of CheckMate 9LA

Outcome NIVO + IPI + chemo (n = 28) Chemo (n = 30)
OS, median (95% CI), mo HR (95% CI) NR (15.4–NR) 0.33 (0.14–0.80) 13.3 (8.2–NR) –
6-mo OS, % 100 83
12-mo OS, % 93 60
PFS, median (95% CI), mo HR (95% CI) 8.4 (4.2–13.7) 0.47 (0.24–0.92) 5.4 (2.8–6.9) –
6-mo PFS, % 62 35
12-mo PFS, % 35 12
Objective response rate, n (%) 16 (57) 7 (23)
Disease control rate, n (%) 25 (89) 23 (77)

mo, months; NR, not reached; PFS, progression-free survival.

.

Clinical trial identification

NCT03215706; July 12, 2017.

Editorial acknowledgement

Writing and editorial assistance was provided by Laura Yee, of Caudex, funded by Bristol-Myers Squibb Company.

Legal entity responsible for the study

Bristol-Myers Squibb Company.

Funding

Bristol-Myers Squibb Company.

Disclosure

T. John: Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: AstraZeneca ; Advisory/Consultancy: Roche; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Merck. H. Sakai: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb Company; Speaker Bureau/Expert testimony: Ono Pharmaceutical; Speaker Bureau/Expert testimony: Chugai Pharmaceutical; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Merck & Co; Speaker Bureau/Expert testimony: Merck KGaA. K. Kasahara: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: Eli Lilly; Speaker Bureau/Expert testimony: Chugai Pharmaceuticals; Speaker Bureau/Expert testimony, Research grant/Funding (self): Boehringer Ingelheim. Y. Sato: Speaker Bureau/Expert testimony: Chugai Phamaceuticals; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: Ono Pharmaceutical; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Taiho Pharmaceutical. Y. Nakahara: Honoraria (self): Ono Pharmaceutical; Honoraria (self), Research grant/Funding (self): Bristol-Myers Squibb Company; Honoraria (self), Research grant/Funding (self): Eli Lilly; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Boehringer Ingelheim GmbH; Honoraria (self): Merck Sharp & Dohme; Research grant/Funding (self): Takeda Pharmaceutical Company Limited. M. Takeda: Speaker Bureau/Expert testimony: Ono Pharmaceutical ; Speaker Bureau/Expert testimony: Boehringer Ingelheim Japan Inc.; Speaker Bureau/Expert testimony: Novartis Pharma K.K. H. Kaneda: Honoraria (self): Bristol-Myers Squibb Company. M. Maemondo: Speaker Bureau/Expert testimony: Bristol-Myers Squibb Company; Speaker Bureau/Expert testimony: Ono Pharmaceutical. M. Satouchi: Honoraria (self): AstraZeneca; Honoraria (self): MSD; Honoraria (self): Chugai ; Honoraria (self): Taiho; Honoraria (self): Pfizer; Honoraria (self): Nippon kayaku; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Bristol-Myers Squibb Company; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Eli Lilly; Honoraria (self): AbbVie; Honoraria (self): Ignyta; Honoraria (self): Takeda; Honoraria (self): Novartis. K. Hotta: Honoraria (self): Pfizer; Honoraria (self), Research grant/Funding (self): Eli Lilly; Honoraria (self), Research grant/Funding (self): MSD; Honoraria (self), Research grant/Funding (self): AstraZeneca; Honoraria (self), Research grant/Funding (self): Bristol-Myers Squibb Company; Honoraria (self), Research grant/Funding (self): Ono Pharmaceutical; Honoraria (self): NipponKayaku; Honoraria (self): Taiho; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (self): Chugai; Honoraria (self): Novartis; Honoraria (self): DaiichiSankyo; Honoraria (self): Kyorin; Honoraria (self): KyowahHakko-Kirin; Research grant/Funding (self): Astellas. A. Li: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb Company. S. Lu: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Research grant/Funding (self): Hutchison ; Advisory/Consultancy: MediPharma; Advisory/Consultancy: Simcere; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Roche; Speaker Bureau/Expert testimony: Hanseng; Research grant/Funding (self): Bristol-Myers Squibb Company; Research grant/Funding (self): Heng Rui ; Advisory/Consultancy: Hutchison MediPharma. All other authors have declared no conflicts of interest.

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