10MO EMPOWER-Lung 1: Cemiplimab (CEMI) monotherapy as first-line (1L) treatment of patients (pts) with brain metastases from advanced non-small cell lung cancer (aNSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50% — 3-year update

Kilickap, S.; Özgüroğlu, M.; Sezer, A.; Gumus, M.; Bondarenko, I.; Gogishvili, M.; Türk, H.M.; Cicin, I.; Bentsion, D.; Gladkov, O.A.; Clingan, P.; Sriuranpong, V.; He, X.; Pouliot, J-F.; Seebach, F.; Lowy, I.; Gullo, G.; Rietschel, P.

doi:10.1016/s1556-0864(23)00264-2

Cited by 5 publications

(5 citation statements)

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“…In squamous tumors, OS was numerically higher with PD-L1 inhibitors (Table 5). -------------------------------------- ------------------------------------- ≥65 years HR = 0.48 (95% CI [0.30, 0.76]) [18] ---------------------------------------Men HR = 0.50 (95% CI [0.36, 0.69]) [18] Women HR = 1.11 (95% CI [0.49, 2.52]) [18] ---------------------------------------ECOG PS score = 0 HR = 0.77 (95% CI [0.41, 1.44]) [18] ECOG PS score = 1 HR = 0.54 (95% CI [0.38, 0.76]) [18] - --------------------------------------Squamous HR = 0.48 (95% CI [0.30, 0.77]) [18] Non-squamous HR = 0.60 (95% CI [0.44, 0.83]) [18] ---------------------------------------Brain metastases HR = 0.42 (95% CI [0.20, 0.87]) [27] No brain metastases HR = 0.60 (95% CI [0.44, 0.83]) [18] ---------------------------------------Locally advanced HR = 0.67 (95% CI [0.38, 1.17]) [28] <65 years HR = 0.60 (95% CI [0.38, 0.96]) [20] ≥65 years HR = 0.64 (95% CI [0.42, 0.98]) [20] <75 years HR = 0.71 (95% CI [0.59, 0.87]) [26] ≥75 years HR = 0.41 (95% CI [0.23, 0.73]) [26] ---------------------------------------Men HR = 0.54 (95% CI [0.36, 0.79]) [20] Women HR = 0.95 (95% CI [0.56, 1.62]) [20] - --------------------------------------ECOG PS score = 0 HR = 0.78 (95% CI [0.44, 1.37]) [20] ECOG PS score = 1 HR = 0.56 (95% CI [0.39, 0.81]) [20] - --------------------------------------Squamous HR = 0.73 (95% CI [0.28, 1.39]) [20] Non-squamous HR = 0.58 (95% CI [0.41, 0.83]) [20] ---------------------------------------Brain metastases HR = 0.73 (95% CI [0.20, 2.62]) [20] No brain metastases HR = 0.64 (95% CI [0.46, 0.88]) [20] Progressionfree survival -<65 years HR = 0.51 (95% CI [0.37, 0.69]) [18] ≥65 years HR = 0.60 (95% CI [0.43, 0.84]) [18] ---------------------------------------Men HR = 0.50 (95% CI [0.40, 0.64]) [18] Women HR = 0.79 (95% CI [0.43, 1.46]) …”

Section: Main Results In Predefined Patient Subgroups In the Pivotal ...mentioning

confidence: 99%

“…The CEMI and PEMBRO pivotal trials included patients with treated and clinically stable brain metastases at baseline [17,18]. OS was significantly higher with CEMI than with chemotherapy in patients with brain metastases (median follow-up 33.3 months, HR = 0.42, 95% CI [0.20, 0.87]) [27]. The ORR was also improved with CEMI (41.2%, 95% CI [24.6, 59.3]) versus chemotherapy (8.8%, 95% CI [1.9, 23.7]) [29].…”

Section: Main Results In Predefined Patient Subgroups In the Pivotal ...mentioning

confidence: 99%

“…The CEMI and PEMBRO trials included patients with treated and clinically stable brain metastases, accounting for approximately 10% of the enrolled patients [17,18]. CEMI was significantly superior to chemotherapy in OS and ORR [18,27], while PEMBRO only demonstrated a positive tendency over chemotherapy regarding OS [17,20]. However, these results should be interpreted with caution due to the small sample size.…”

Section: Discussionmentioning

confidence: 99%

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PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement

Isla,

Sánchez,

Casal

et al. 2023

JCM

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Introduction: There are currently three first-line immunotherapy options used as monotherapy in advanced non-small cell lung cancer (NSCLC) patients with high programmed death ligand 1 (PD-L1) expression (≥50%). This manuscript aims to evaluate the available data on atezolizumab (AT), cemiplimab (CEMI), and pembrolizumab (PEMBRO) and to study the results obtained during pivotal trials, especially regarding patient subgroups. Methods: Nominal group and Delphi techniques were used. Eight Spanish experts in lung cancer (the scientific committee of the project) analyzed the use of immunotherapy monotherapy as first-line treatment in patients with NSCLC and high PD-L1 expression. The expert scientific committee formulated several statements based on a scientific review and their own clinical experience. Subsequently, 17 additional Spanish lung cancer experts were selected to appraise the committee’s statements through two Delphi rounds. They completed a Delphi round via an online platform and voted according to a scale from 1 (strongly disagree) to 10 (strongly agree). The statements were approved if ≥70% of experts voted 7 or more. Results: A total of 20 statements were proposed covering the following areas: (1) general characteristics of pivotal clinical trials; (2) overall main outcomes of pivotal clinical trials; and (3) subgroup analysis. All statements reached consensus in the first round. Conclusions: AT, CEMI, and PEMBRO as monotherapy can be considered the standard of care in patients with advanced NSCLC and high PD-L1 expression (≥50%). Moreover, some differences noted among the drugs analyzed in this document might facilitate treatment decision-making, especially in clinically relevant patient subgroups, when using PD-1/PD-L1 inhibitors. The high level of agreement reached among experts supports the proposed statements.

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Section: Main Results In Predefined Patient Subgroups In the Pivotal ...mentioning

confidence: 99%

Section: Main Results In Predefined Patient Subgroups In the Pivotal ...mentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement

Isla,

Sánchez,

Casal

et al. 2023

JCM

View full text Add to dashboard Cite

show abstract

“…PFS was 12.5 months in the cemiplimab group versus 5.3 months in the chemotherapy group (HR 0.34; 95% CI 0.18–0.63). 9 Tumor response was 55.9% in the cemiplimab group versus 11.4% in the chemotherapy group (OR 9.27; 95% CI 2.62–32.74; p =0.0002). In these subgroups, which are often excluded in trials on NSCLC involving immunotherapy, cemiplimab continued to demonstrate its clinically relevant efficacy and tolerability.…”

Section: Empower-lungmentioning

confidence: 93%

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations

Ahn¹,

Nagasaka²

2023

CMAR

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In metastatic non-small cell lung cancer (NSCLC), tumors that do not harbor driver mutations in EGFR or gene fusions in ALK and ROS, PD-1 and PD-L1 inhibitors have become a cornerstone in first line treatment, either as monotherapy or in combination with chemotherapy. This paper reviews cemiplimab-rwlc, the third PD-1/L1 inhibitor to be approved in the setting for first line treatment in NSCLC, as monotherapy or in combination therapy with chemotherapy, to provide a perspective on the subtle differences in patient population for the cemiplimab studies and consideration of its primary and subgroup results in the context of first line therapies for NSCLC.

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“…At the same time, ICIs demonstrated a potential intracranial activity for NSCLC patients both when used alone (ORR range: 16.4–55.9%) [ 133 , 134 , 135 , 136 , 137 , 138 ] and in association with chemotherapy [ 139 , 140 ].…”

Section: Srs and Systemic Therapy (St)mentioning

confidence: 99%

Modern Stereotactic Radiotherapy for Brain Metastases from Lung Cancer: Current Trends and Future Perspectives Based on Integrated Translational Approaches

Levis,

Gastino,

De Giorgi

et al. 2023

Cancers

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Brain metastases (BMs) represent the most frequent metastatic event in the course of lung cancer patients, occurring in approximately 50% of patients with non-small-cell lung cancer (NSCLC) and in up to 70% in patients with small-cell lung cancer (SCLC). Thus far, many advances have been made in the diagnostic and therapeutic procedures, allowing improvements in the prognosis of these patients. The modern approach relies on the integration of several factors, such as accurate histological and molecular profiling, comprehensive assessment of clinical parameters and precise definition of the extent of intracranial and extracranial disease involvement. The combination of these factors is pivotal to guide the multidisciplinary discussion and to offer the most appropriate treatment to these patients based on a personalized approach. Focal radiotherapy (RT), in all its modalities (radiosurgery (SRS), fractionated stereotactic radiotherapy (SRT), adjuvant stereotactic radiotherapy (aSRT)), is the cornerstone of BM management, either alone or in combination with surgery and systemic therapies. We review the modern therapeutic strategies available to treat lung cancer patients with brain involvement. This includes an accurate review of the different technical solutions which can be exploited to provide a “state-of-art” focal RT and also a detailed description of the systemic agents available as effective alternatives to SRS/SRT when a targetable molecular driver is present. In addition to the validated treatment options, we also discuss the future perspective for focal RT, based on emerging clinical reports (e.g., SRS for patients with many BMs from NSCLC or SRS for BMs from SCLC), together with a presentation of innovative and promising findings in translational research and the combination of novel targeted agents with SRS/SRT.

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10MO EMPOWER-Lung 1: Cemiplimab (CEMI) monotherapy as first-line (1L) treatment of patients (pts) with brain metastases from advanced non-small cell lung cancer (aNSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50% — 3-year update

Cited by 5 publications

References 0 publications

PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement

PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations

Modern Stereotactic Radiotherapy for Brain Metastases from Lung Cancer: Current Trends and Future Perspectives Based on Integrated Translational Approaches

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