Efficacy and safety of first-line checkpoint inhibitors-based treatments for non-oncogene-addicted non-small-cell lung cancer: a systematic review and meta-analysis

Siciliano, Maria Anna; Caridà, Giulio; Ciliberto, Domenico; D’Apolito, Maria; Pelaia, Corrado; Caracciolo, Daniele; Riillo, Caterina; Correale, Pierpaolo; Galvano, Antonio; Barbieri, Vito; Tassone, Pierfrancesco; Tagliaferri, Pierosandro

doi:10.1016/j.esmoop.2022.100465

Cited by 25 publications

(18 citation statements)

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“…The occurrence of drug‐related and immunotherapy‐related adverse events remained at a low level. Importantly, these adverse events were found to be preventable and manageable through appropriate monitoring and intervention strategies 14,15 …”

Section: Resultsmentioning

confidence: 99%

A multicenter, real‐world study on effectiveness and safety of first‐line modified PD‐1 inhibitors with chemotherapy in advanced non‐small cell lung cancer (aNSCLC) with drive gene‐negative

Li,

Chen,

Liu

et al. 2024

Cancer Medicine

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ObjectivesThe use of immune checkpoint inhibitors, particularly PD‐1 inhibitors, has revolutionized the treatment of advanced tumors and shown significant improvements in patient survival rates. However, which PD‐1 inhibitor is more effective and safer for a specific indication remains unclear. To address this problem, our study aimed to evaluate the effectiveness and safety of different PD‐1 inhibitors in combination with chemotherapy as first‐line therapy for individuals with advanced non‐small‐cell lung cancer (NSCLC) without driver genes in the real world.Materials and MethodsWe conducted a retrospective study of individuals diagnosed with aNSCLC who received immune checkpoint inhibitors (ICIs) with modified PD‐1 inhibitors, including Sintilimab, Toripalimab, Tislelizumab, Camrelizumab, or Pembrolizumab as first‐line treatment between March 5th, 2016 and October 20th, 2022. We assessed demographic and clinical information and analyzed clinical response, survival outcomes, and safety profiles. The primary endpoint was overall survival (OS), and the secondary endpoints included progression‐free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety.ResultsAs of the date cut‐off on October 20th, 2022, the median follow‐up time was 20.62 months. A total of 204 patients were enrolled in the study, including 56 (27.5%) patients receiving modified PD‐1 inhibitors (Sintilimab, Toripalimab, Tislelizumab, or Camrelizumab) in combination with chemotherapy and 148 (72.5%) patients receiving Pembrolizumab in combination with chemotherapy. In the overall cohort, the median overall survival (OS) was 26.9 months (95%CI, 22.3–31.6), the median progression‐free survival (PFS) was 8.4 months (95%CI, 6.9–9.8), and the objective response rate (ORR) and disease control rate (DCR) were 47.6% (95%CI, 29.9–43.6) and 84.3% (95%CI, 78.4–88.9). The mOS of modified PD‐1 inhibitors group and Pembrolizumab group were 30.7 (95%CI, 17.3–44.4) months and 26.8 (95%CI, 22.2–31.4) months. The mPFS of two groups were 8.3(95%CI, 6.9–9.6) months and 8.8 (95%CI, 6.9–10.7) months, respectively. There was no statistical difference between the two groups in terms of OS or PFS. The ORR for the two groups was 48.2% (95%CI, 34.8–61.8) and 47.3% (95%CI, 39.1–5.6), respectively. However, due to the limited sample size, the difference was not statistically significant. On the other hand, the DCR tended to be higher in the Pembrolizumab group (86.5%; 95%CI, 79.7–91.4) compared to the modified PD‐1 inhibitors group (78.6%; 95%CI, 65.2–87.9), and this difference was statistically significant (p = 0.006). In terms of safety, both groups exhibited favorable clinical safety profiles. The only two types of potentially immune‐related adverse events reported were pneumonitis and reactive cutaneous capillary endothelial proliferation (RCCEP).ConclusionsThe modified PD‐1 inhibitors showed comparable survival outcomes and manageable safety profiles in NSCLC compared to Pembrolizumab. Moreover, these inhibitors exhibited improved accessibility and economic outcomes compared to Pembrolizumab. While there were similarities in drug‐related and immunotherapy‐related adverse reactions between the modified PD‐1 inhibitors and Pembrolizumab, there were some slight differences. Further prospective and retrospective studies would be necessary to validate these findings beyond the scope of the CTONG1901 study.

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Section: Resultsmentioning

confidence: 99%

A multicenter, real‐world study on effectiveness and safety of first‐line modified PD‐1 inhibitors with chemotherapy in advanced non‐small cell lung cancer (aNSCLC) with drive gene‐negative

Li,

Chen,

Liu

et al. 2024

Cancer Medicine

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“…Although different drugs with the same indications may provide multiple treatment options, lacking a head‐to‐head clinical trial comparison makes it difficult to inform the advantages or shortcomings among different ICIs. Some scholars conducted a lot of studies to compare the efficacy, safety, and economic effects of different ICIs (eg, pembrolizumab, nivolumab, atezolizumab) in several types of tumors, which could help clinicians select the most appropriate treatment regimens for patients 41‐45 . However, more research programs, such as indirect comparison or real‐world data analysis, should be encouraged to conduct to help understand more about profiles of various ICIs and to guide physicians' choice of the best regimen for patients.…”

Section: Discussionmentioning

confidence: 99%

The regulatory approvals of immune checkpoint inhibitors in China and the United States: A cross‐national comparison study

Yan

Zhang

et al. 2023

Intl Journal of Cancer

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Immune checkpoint inhibitors (ICIs) are currently one of the most popular treatment methods for cancers. Several ICIs have been approved in China and the United States. We created a database of approved ICIs by extracting the information of interest from the drug labels and reviewing documents disclosed on the official websites of the US Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and compared the difference between the marketed ICIs in China and the United States regarding the number of indications, tumor types, review time, treatment setting, and so forth. Until June 30, 2022, 9 and 15 ICIs had been approved for 86 and 58 indications in the United States and China, involving 20 and 14 types of tumors, respectively. The correlation between indications and disease incidence was higher in China (r = 0.64) than in the United States (r = 0.45). About half of the indications were approved as first-line therapies in combination with chemotherapy, target therapy, or immunotherapy. Over 30% of indications were approved under accelerated or conditional approval in the two countries. A shorter regulatory review time was required by the FDA (median:181 days) compared to the NMPA (median: 279 days) for the new indication approval. Five ICIs marketed in China were approved by the FDA before the NMPA, with the median launch delay for the same indication of 344 days in China. A differentiated clinical development program that focuses on meeting unmet needs may bring new success for subsequent ICI products.

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“…84 While there are no head-to-head trials comparing various ICIs, a recent meta-analysis has compared various approved ICI regimens and suggested that there may be differences in outcomes based on the PD-L1 status and metastatic sites of patients. 85 There is a palpable need to move the needle forward in the treatment of metastatic NSCLC by unlocking the potential of other immune checkpoints. There have been several ongoing trials targeting other pathways with emerging results.…”

Section: Current State Of Immune-checkpoint Inhibitors and The Utilit...mentioning

confidence: 99%

Immune checkpoint inhibitors in metastatic NSCLC: challenges and future directions (CME article)

Sridhar

Singh

Parikh

2023

International Journal of Cancer Care and Delivery

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The treatment metastatic non-small cell lung cancer (NSCLC) is largely influenced by the incorporation of immune checkpoint inhibitors (ICI) in the frontline setting. There are several ICI approved for the management of NSCLC based on the PD-L1 expression of the tumors. PD-L1 is a controversial biomarker with various inconsistencies in expression owing to temporal and spatial heterogeneity. Tumor mutational burden is another much studied biomarker associated with its own challenges and questionable concordance with tumor PD-L1 expression. In this article, we aim to discuss the challenges associated with the existing biomarkers, highlighting the need for emerging biomarkers that can help with decision making in the management of this there where several therapeutic options exist. There are emerging “me too” PD-1/PD-L1 drugs which may serve its purpose in many counties where there is limited access to current approved ICIs. What is increasingly apparent is the need to move the needle forward in the treatment of NSCLC and we will discuss the challenges associated with the current therapeutic landscape and the emerging checkpoints and the future directions that are being explored in the management of metastatic NSCLC.

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Efficacy and safety of first-line checkpoint inhibitors-based treatments for non-oncogene-addicted non-small-cell lung cancer: a systematic review and meta-analysis

Cited by 25 publications

References 50 publications

A multicenter, real‐world study on effectiveness and safety of first‐line modified PD‐1 inhibitors with chemotherapy in advanced non‐small cell lung cancer (aNSCLC) with drive gene‐negative

A multicenter, real‐world study on effectiveness and safety of first‐line modified PD‐1 inhibitors with chemotherapy in advanced non‐small cell lung cancer (aNSCLC) with drive gene‐negative

The regulatory approvals of immune checkpoint inhibitors in China and the United States: A cross‐national comparison study

Immune checkpoint inhibitors in metastatic NSCLC: challenges and future directions (CME article)

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