Multicenter Comparison of 22C3 PharmDx (Agilent) and SP263 (Ventana) Assays to Test PD-L1 Expression for NSCLC Patients to Be Treated with Immune Checkpoint Inhibitors

Marchetti, Antonio; Barberis, Massimo; Franco, Renato; Luca, Graziano De; Pace, Marta; Staibano, Stefania; Volante, Marco; Buttitta, Fiamma; Guerini-Rocco, Elena; Righi, Luisella; D’Antuono, Tommaso; Scagliotti, Giorgio Vittorio; Pinto, Carmine; Rosa, Gaetano De; Papotti, Mauro

doi:10.1016/j.jtho.2017.07.031

Cited by 91 publications

(76 citation statements)

References 23 publications

(37 reference statements)

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“…PD-L1 protein expression, evaluated by immunohistochemistry staining, both in tumor and immune cells, has been investigated as a potential predictive biomarker [1], even in prospective trials [2], but its correlation with ICIs efficacy is still debated [3][4][5]. Different companion diagnostics, with different immunohistochemistry techniques and platforms were used in clinical trials, creating difficulties in routine use in clinical practice, despite the efforts of many 'harmonization' studies [6][7][8][9]. PD-L1 expression is probably a dynamic process influenced by many events, such as previous and/or concomitant treatments, and has a wide intra-/inter-patient variability [10][11][12].…”

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Family History of Cancer as Surrogate Predictor for Immunotherapy with Anti-Pd1/Pd-L1 Agents: Preliminary Report of the Fami-L1 Study

et al. 2018

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Aim: Tumors related to hereditary susceptibility seem to have an immunosensitive phenotype. Materials & methods : We conducted a multicenter retrospective study, to investigate if family history of cancer, multiple neoplasms and early onset of cancer could be related to clinical outcomes of anti-PD-1/PD-L1 therapy. Activity and efficacy data of 211 advanced cancer patients (kidney, non-small-cell lung cancer, melanoma, urothelium, colorectal and HeN), treated at seven Italian centers with anti-PD-1/PD-L1 agents, were analyzed. Results: In this preliminary report at multivariate analyses, positive family history of cancer showed a statistically significant relationship with a better objective response rate (p = 0.0024), disease control rate (p = 0.0161), median time to treatment failure (p = 0.0203) and median overall survival (p = 0.0221). Diagnosis of multiple neoplasms significantly correlates only to a better disease control rate, while interestingly non-early onset of cancer and sex (in favor of female patients) showed significant correlation with a better median overall survival (p = 0.0268 and p = 0.0272, respectively). Conclusion: This pilot study seems to individuate easily available patient's features as possible predictive surrogates of clinical benefit for anti-PD-1/PD-L1 treatments. These preliminary results need to be confirmed with a greater sample size, in prospective trials with immunotherapy.

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Family History of Cancer as Surrogate Predictor for Immunotherapy with Anti-Pd1/Pd-L1 Agents: Preliminary Report of the Fami-L1 Study

et al. 2018

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“…Examples of PD‐L1 expression in cytology CBs and matched histology slides are shown in Figure . When comparing PD‐L1 expression rates in cytology CBs and matched surgical resection specimens according to the therapeutic guidelines of immunotherapeutic agents, a positive percent agreement was 94.34% and a negative percent agreement was 100% at a cut‐off value for positivity of 1% PD‐L1 expression (Table ). All CBs that were scored as positive (score 1‐3) showed positive PD‐L1 expression in matched resection specimens without exception.…”

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confidence: 99%

Cell‐blocks are suitable material for programmed cell death ligand‐1 immunohistochemistry: Comparison of cell‐blocks and matched surgical resection specimens in lung cancer

Pak

Roh

2019

Cytopathology

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Objective Programmed cell death ligand‐1 (PD‐L1) has emerged as a predictive biomarker in lung cancer. PD‐L1 immunohistochemistry (IHC) assay predicts the response to immunotherapy, but cytology specimens are often the only samples available in a considerable proportion of advanced lung cancer patients. We delineate practical feasibility and efficacy of cytology cell‐block (CB) specimens for PD‐L1 expression and concordance between cytology CBs and surgical resection specimens. Methods In total, 58 eligible patients with primary lung cancer who received computed tomography‐guided percutaneous needle aspiration and surgery were included. PD‐L1 IHC (clone SP263) was performed on CBs prepared from residual liquid‐based cytology material and matched surgical resection specimens. PD‐L1 positive tumour cell proportion was categorised in four score groups: (a) <1%; (b) ≤1% to <10%; (c) ≤10% to <50%, (d) ≥50%. Results Comparison of PD‐L1 expression in cytology CBs and matched surgical resection specimens showed a high concordance (κ value 0.65). According to the therapeutic guideline of immunotherapeutic agents, a positive percent agreement was 94.34%, and a negative percent agreement was 100% at a cut‐off value for positivity of 1% PD‐L1 expression. There was a significant difference observed with regard to rates of PD‐L1 positivity when comparing smoking history (P = 0.02), age (P = 0.04) and pathological TNM stage (P = 0.04). Conclusions The results show that cytology CBs evaluated for PD‐L1 IHC assay have high concordance with matched surgical resection specimens and can be used for assessing PD‐L1 expression. Also, we propose that CBs are suitable materials for evaluating PD‐L1 expression while simultaneously performing both diagnostic and molecular tests.

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“…They block the binding between PD-1 receptor and its natural ligands, PD-L1 and PD-L2 (1). All these MoAbs have shown a very promising activity in clinical studies, achieving an overall response rates (ORR) of about 20% in unselected and in heavily pre-treated NSCLC patients (1).…”

Section: Editorialmentioning

confidence: 99%

“…In recent times, pembrolizumab has also been recommended by both the U.S. and European agencies for the first-line therapy of NSCLCs with advanced disease. Furthermore, two other drugs as durvalumab (MEDI4736, AstraZeneca) and avelumab (MSB0010718C, Merck KGaA & Pfizer) are being examined for the treatment of NSCLC patients (1).…”

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Why anti-PD1/PDL1 therapy is so effective? Another piece in the puzzle

2017

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Multicenter Comparison of 22C3 PharmDx (Agilent) and SP263 (Ventana) Assays to Test PD-L1 Expression for NSCLC Patients to Be Treated with Immune Checkpoint Inhibitors

Cited by 91 publications

References 23 publications

Family History of Cancer as Surrogate Predictor for Immunotherapy with Anti-Pd1/Pd-L1 Agents: Preliminary Report of the Fami-L1 Study

Family History of Cancer as Surrogate Predictor for Immunotherapy with Anti-Pd1/Pd-L1 Agents: Preliminary Report of the Fami-L1 Study

Cell‐blocks are suitable material for programmed cell death ligand‐1 immunohistochemistry: Comparison of cell‐blocks and matched surgical resection specimens in lung cancer

Why anti-PD1/PDL1 therapy is so effective? Another piece in the puzzle

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