Final overall survival analysis from the phase III J-ALEX study of alectinib versus crizotinib in ALK inhibitor-naïve Japanese patients with ALK-positive non-small-cell lung cancer

Hotta, Katsuyuki; Hida, Toyoaki; Nokihara, Hiroshi; Morise, Masahiro; Kim, Y.H.; Azuma, Koichi; Seto, Takashi; Takiguchi, Yuichi; Nishio, Makoto; Yoshioka, Hiroshige; Kumagai, Toru; Watanabe, Satoshi; Goto, Kōichi; Satouchi, Miyako; Kozuki, Toshiyuki; Shukuya, Takehito; Nakagawa, Kazuhiko; Mitsudomi, Tetsuya; Yamamoto, Nobuyuki; Asakawa, T.; Yoshimoto, Takuya; Takata, S.; Tamura, Tomohide

doi:10.1016/j.esmoop.2022.100527

Cited by 28 publications

(18 citation statements)

References 17 publications

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“…Alectinib shows superiority in PFS, but whether PFS can be converted into survival benefits remains to be explored. J-ALEX recently announced a 5-year overall survival rate, the result did not show superiority of alectinib to crizotinib ( 24 ).…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of alectinib in ALK-positive non-small cell lung cancer and blood markers for prognosis and efficacy: a retrospective cohort study

Jiang¹,

Shi²,

Liu³

et al. 2022

Transl Lung Cancer Res

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Background: Alectinib is a second generation of ALK-tyrosine kinase inhibitors (ALK-TKIs), which has attracted much attention in the treatment of ALK-positive non-small cell lung cancer (NSCLC). At present, there are few reports on the efficacy and safety of alectinib in Chinese population. Moreover, biomarkers reflecting prognosis and efficacy are exceedingly needed. This study assessed the efficacy of alectinib in patients with ALK-positive NSCLC and analyzed the prognostic factors. Methods: Patients with ALK-positive NSCLC who were confirmed by histopathology or cytology at the Affiliated Cancer Hospital of Nanjing Medical University between October 2018 and October 2021 were enrolled. All patients were treated with alectinib. The clinical characteristics and circulating tumor biomarkers before and after treatment were collected. Kaplan-Meier test was used to calculate the progression-free survival (PFS). Univariate and multivariate Cox regression analyses were used to explore the influencing factors on PFS. Incidence of adverse events was observed. Results: Twenty patients progressed after first-line treatment (n=59) with alectinib, and 21 patients progressed following second-line treatment (n=36) with alectinib. The median PFS of first-line treatment patients was not achieved, and the median PFS of patients undergoing second-line treatment was 15.0 months ^ ORCID:

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of alectinib in ALK-positive non-small cell lung cancer and blood markers for prognosis and efficacy: a retrospective cohort study

Jiang¹,

Shi²,

Liu³

et al. 2022

Transl Lung Cancer Res

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“…This lower dose was utilised for regulatory reasons following a phase I/II study in Japanese patients and did not appear to impact efficacy, with a HR 0.34 (99.7% CI: 0.17–0.71, stratified log-rank test P<0.0001) in favour of alectinib ( Table 2 ) ( 14 , 20 ). There was no difference in overall survival (HR 1.03, 95% CI: 0.67–1.58, P=0.9105), noting that cross-over was allowed in this study ( 21 ).…”

Section: Discussion/summarymentioning

confidence: 70%

Optimal first-line treatment for metastatic ALK+ non-small cell lung cancer—a narrative review

Chazan¹,

Solomon²

2023

Transl Lung Cancer Res

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Background and Objective: First-line treatment options for patients with advanced non-small cell lung cancer (aNSCLC) whose tumors harbour anaplastic lymphoma kinase (ALK) gene rearrangements have rapidly evolved from chemotherapy, to the first in class ALK-targeted tyrosine kinase inhibitor (TKI) crizotinib in 2011, and now include no fewer than five FDA-approved ALK inhibitors. However, while superiority to crizotinib has been established, head-to-head clinical trials comparing newer generation ALK inhibitors are lacking, and decisions on optimal first-line treatment must be based on analysis of the relevant trials, with attention to systemic and intracranial efficacy, toxicity profile as well as consideration of patient factors and preferences. Here we aim to synthesise findings from review of these trials and to describe options for optimal first-line treatment for ALK+ NSCLC.Methods: A literature review of relevant randomised clinical trials was undertaken using Embase database. There were no limitations to time frame or language applied.

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“…Similar to data from the global population, 4 the 5‐year survival rates in Japanese patients with resectable NSCLC range from 73%–77% for stage IB to 32%–48% for stage IIIA (AJCC Cancer Staging Manual 7th edition, pathological stages) 25,26 . However, studies have reported variations, including genetic characteristics, differences in health‐care systems, and epidemiological and demographic differences, between Asian and non‐Asian populations that could influence course of disease and response to treatments for NSCLC 27–30 . Given the potential for differences in treatment outcomes and safety in Asian patients, it is important to evaluate the efficacy of therapies in Japanese patients to guide treatment decisions.…”

Section: Introductionmentioning

confidence: 84%

Neoadjuvant nivolumab plus chemotherapy in resectable non‐small‐cell lung cancer in Japanese patients from CheckMate 816

Mitsudomi,

Ito,

Okada

et al. 2023

Cancer Science

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In the open‐label, phase III CheckMate 816 study (NCT02998528), neoadjuvant nivolumab plus chemotherapy demonstrated statistically significant improvements in event‐free survival (EFS) and pathological complete response (pCR) versus chemotherapy alone in patients with resectable non‐small‐cell lung cancer (NSCLC). Here we report efficacy and safety outcomes in the Japanese subpopulation. Patients with stage IB–IIIA, resectable NSCLC were randomized 1:1 to nivolumab plus chemotherapy or chemotherapy alone for three cycles before undergoing definitive surgery within 6 weeks of completing neoadjuvant treatment. The primary end‐points (EFS and pCR) and safety were assessed in patients enrolled at 16 centers in Japan. Of the Japanese patients randomized, 93.9% (31/33) in the nivolumab plus chemotherapy arm and 82.9% (29/35) in the chemotherapy arm underwent surgery. At 21.5 months' minimum follow‐up, median EFS was 30.6 months (95% confidence interval [CI], 16.8–not reached [NR]) with nivolumab plus chemotherapy versus 19.6 months (95% CI, 8.5–NR) with chemotherapy; hazard ratio, 0.60 (95% CI, 0.30–1.24). The pCR rate was 30.3% (95% CI, 15.6–48.7) versus 5.7% (95% CI, 0.7–19.2), respectively; odds ratio, 7.17 (95% CI, 1.44–35.85). Grade 3/4 treatment‐related adverse events were reported in 59.4% versus 42.9% of patients, respectively, with no new safety signals identified. Neoadjuvant nivolumab plus chemotherapy resulted in longer EFS and a higher pCR rate versus chemotherapy alone in Japanese patients, consistent with findings in the global population. These data support nivolumab plus chemotherapy as a neoadjuvant treatment option in Japanese patients with resectable NSCLC.

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Final overall survival analysis from the phase III J-ALEX study of alectinib versus crizotinib in ALK inhibitor-naïve Japanese patients with ALK-positive non-small-cell lung cancer

Cited by 28 publications

References 17 publications

Efficacy and safety of alectinib in ALK-positive non-small cell lung cancer and blood markers for prognosis and efficacy: a retrospective cohort study

Efficacy and safety of alectinib in ALK-positive non-small cell lung cancer and blood markers for prognosis and efficacy: a retrospective cohort study

Optimal first-line treatment for metastatic ALK+ non-small cell lung cancer—a narrative review

Neoadjuvant nivolumab plus chemotherapy in resectable non‐small‐cell lung cancer in Japanese patients from CheckMate 816

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