Atezolizumab in Japanese Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study

Hida, Toyoaki; Kaji, Ryuji; Satouchi, Miyako; Ikeda, Norihiko; Horiike, Atsushi; Nokihara, Hiroshi; Seto, Takashi; Kawakami, Tomohisa; Nakagawa, Shintaro; Kubo, Toshio

doi:10.1016/j.cllc.2018.01.004

Cited by 55 publications

(100 citation statements)

References 24 publications

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“…However, most participants in clinical trials of immune‐checkpoint inhibitors have come from western countries, with Asian/East Asian patients accounting for only 3%–25.2% of the study populations in clinical trials of PD‐1/PD‐L1 inhibitors for NSCLC . Few studies have thus reported on the efficacy of immunotherapy and the related characteristics in Asian patients …”

Section: Introductionmentioning

confidence: 99%

“…0.52 [0.38–0.72]), though pembrolizumab showed similar pharmacokinetic characteristics in Asians and Caucasians . Two Phase II studies of later‐line nivolumab and a subgroup analysis of atezolizumab in Japanese patients all demonstrated a greater objective response rate (ORR), progression‐free survival (PFS) and overall survival (OS) compared to the overall population . Nivolumab resulted in a median OS of 16.3–17.1 months in Japanese patients with advanced or recurrent squamous or nonsquamous NSCLC, with ORRs of 25.7 and 22.4%, respectively .…”

Section: Introductionmentioning

confidence: 99%

“…In a subgroup analysis of the OAK study, Japanese patients receiving atezolizumab had a higher median OS than the overall population (21.3 vs . 13.8 months) . In the latest released results of the IMpower132 trial, the median PFS among patients receiving atezolizumab was longer for Asian patients compared to non‐Asian patients (10.2 vs .…”

Section: Introductionmentioning

confidence: 99%

“…3,4,6,10 Few studies have thus reported on the efficacy of immunotherapy and the related characteristics in Asian patients. [11][12][13][14] Current evidence from clinical trials suggests that PD-1/PD-L1 inhibitors may have comparable or better efficacy in Asian patients compared to white patients with advanced NSCLC. An East Asian population demonstrated greater sensitivity to firstline treatment with pembrolizumab (KEYNOTE-024) than a non-East Asian population (hazard ratio [HR] for disease progression or death: 0.35 [0.14-0.91] vs. 0.52 [0.38-0.72]), though pembrolizumab showed similar pharmacokinetic characteristics in Asians and Caucasians.…”

Section: Introductionmentioning

confidence: 99%

“…3,15 Two Phase II studies of later-line nivolumab and a subgroup analysis of atezolizumab in Japanese patients all demonstrated a greater objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) compared to the overall population. [11][12][13] Nivolumab resulted in a median OS of 16.3-17.1 months in Japanese patients with advanced or recurrent squamous or nonsquamous NSCLC, with ORRs of 25.7 and 22.4%, respectively. 11,12 In a subgroup analysis of the OAK study, Japanese patients receiving atezolizumab had a higher median OS than the overall population (21.3 vs. 13.8 months).…”

Section: Introductionmentioning

confidence: 99%

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Racial differences in characteristics and prognoses between Asian and white patients with nonsmall cell lung cancer receiving atezolizumab: An ancillary analysis of the POPLAR and OAK studies

Qian

Nie

Lü

et al. 2019

Intl Journal of Cancer

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This study aimed to compare the differences in characteristics and prognoses between Asian and white patients receiving immunotherapy for nonsmall cell lung cancer (NSCLC). We studied 390 patients who received atezolizumab as part of the POPLAR or OAK trial, and analyzed the differences in baseline characteristics, outcomes and genetic mutations in blood samples between Asian and white patients. Overall survival (OS) was longer in Asian compared to white patients (median OS: 18.7 vs. 11.1 months; p = 0.005). Race was identified as an independent prognostic factor for OS (Asian vs. white: hazard ratio 0.647, 95% confidence interval 0.447–0.936, p = 0.021), together with performance status, histology, baseline sum of the longest tumor diameters (BLSLD) and number of metastatic sites. The two groups also differed in terms of characteristics including smoking history, BLSLD, epidermal growth factor receptor (EGFR) mutation frequency, programmed death‐ligand 1 expression and blood‐based tumor‐mutation burden. Blood mutations of STK11, EGFR, KEAP1, POLE, GRM3, ATM and STAG2 were associated with treatment response, and TP53, KEAP1, APC, RB1, CREBBP, EPHA5 and STAG2 mutations were associated with OS. The blood‐based mutation profiles differentiated between Asian and white patients, especially in relation to EGFR (23.8 vs. 8.5%), TP53 (30.2 vs. 46.9%) and STK11 (1.6 vs. 12.3%) mutations (all p < 0.05). The different clinicopathological features and mutation profiles in Asian and white patients may explain the superior outcome following atezolizumab treatment in Asian patients with NSCLC. The results of this study have important implications for further studies on racial disparities in relation to immunotherapy.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Racial differences in characteristics and prognoses between Asian and white patients with nonsmall cell lung cancer receiving atezolizumab: An ancillary analysis of the POPLAR and OAK studies

Qian

Nie

Lü

et al. 2019

Intl Journal of Cancer

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Safety and Efficacy of First-Line Pembrolizumab in Black Patients with Metastatic Non-Small Cell Lung Cancer

et al. 2021

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Introduction. Pembrolizumab, an immune checkpoint inhibitor (ICI), has become an integral part of front-line treatment of metastatic non-small-cell lung cancer (NSCLC). However, pivotal trials had significant underrepresentation of Black patients (pts). Lack of sufficient evidence regarding safety and efficacy of ICIs among minority racial groups poses a challenge in delivery of optimal cancer directed care. Methods. We retrospectively reviewed pts with stage IV NSCLC treated with first-line pembrolizumab across three MedStar facilities between January 1st, 2014 and May 31st, 2019. Progression-free survival (PFS) and overall survival (OS) were primary endpoints and were calculated using the Kaplan-Meier method. Immune-related adverse events (irAEs) were assessed according to CTCAE v5.0. Results. 136 pts were identified with 74 (54.4%) White, 53 (39%) Black, 2 (1.5%) Asian and 7 (5.1%) other racial groups. Median age in White pts was 70 years and 65 years in Black pts (p<0.01). There was no difference in median PFS (5.7 vs 5.9 months, p= 0.651) or OS (11.8 vs 12.4 months, p= 0.949) between White and Black pts. In the subset of patients whose tumors had high programmed death-ligand 1 (PD-L1) expression (≥ 50%), there was still no difference in efficacy by race. Median PFS (8.7 vs 3.9 months, p= 0.843) and OS (14.7 vs 11.3 months, p= 0.581) in White versus Black pts were not different. Incidence of irAEs in White versus Black pts was 24.3% and 22.6%, respectively (p=0.83). Conclusions. We found no major differences in either safety or efficacy of first-line pembrolizumab between White and Black pts. Use of first-line pembrolizumab-based treatment in Black pts with stage IV NSCLC is safe and efficacious, based on these real-world data. The Oncologist 2021;9999:• • Implications for Practice: Immunotherapy has revolutionized treatment of solid and hematological malignancies. There are certain populations of patients underrepresented in the original trials including minority racial groups, patients with autoimmune diseases and those with chronic viral illnesses. Our study focuses on Black patients with metastatic lung cancer who received pembrolizumab and concludes similar safety and response to treatment when compared to White patients. Black patients are an important demographic group in clinical practice often facing systemic healthcare disparities. Our study paves a path for future studies in underrepresented populations receiving immunotherapy across various malignancies.

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Anticancer Immunotherapy: Prospects and Challenges

Sachdeva

Singh

Bose

et al. 2019

Unravelling Cancer Signaling Pathways: A Multidisciplinary Approach

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Atezolizumab in Japanese Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study

Abstract: Atezolizumab was effective and well tolerated in pretreated Japanese patients with NSCLC. Results are consistent with the primary analysis of OAK.

Cited by 55 publications

References 24 publications

Racial differences in characteristics and prognoses between Asian and white patients with nonsmall cell lung cancer receiving atezolizumab: An ancillary analysis of the POPLAR and OAK studies

Racial differences in characteristics and prognoses between Asian and white patients with nonsmall cell lung cancer receiving atezolizumab: An ancillary analysis of the POPLAR and OAK studies

Safety and Efficacy of First-Line Pembrolizumab in Black Patients with Metastatic Non-Small Cell Lung Cancer

Anticancer Immunotherapy: Prospects and Challenges

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