Neoadjuvant pembrolizumab (Pembro) for early stage non-small cell lung cancer (NSCLC): Initial report of a phase I study, MK3475-223

Nun, Alon Ben; Golan, Nir; Ofek, Efrat; Urban, Damien; Kamer, Iris; Simansky, David; Onn, Amir; Ackerstein, Aliza; Raskin, Stephen; Shulimzon, Tiberiu; Zeitlin, Nona; Redinsky, Ilanit; Halperin, Sharon; Jurkowicz, Menucha; Bar, Jair

doi:10.1093/annonc/mdy290.011

Cited by 7 publications

(8 citation statements)

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“…In NCT02259621, two preoperative doses of nivolumab (3 mg/kg) were administered every 2 weeks among 21 patients with stage I, II, or IIIA NSCLC; neoadjuvant nivolumab resulted in an ORR of 9.5% (2/21) and a DCR of 95.2% (20/21) among enrolled patients, with 42.9% (9/ 21) achieving MPR (39). In a phase I study MK3475-223, two doses of pembrolizumab (200 mg) was administered in stage I and II NSCLC patients, achieving an MPR of 40% (4/10) (40,41). Sintilimab seems to have a similar efficacy to nivolumab and pembrolizumab in resectable NSCLC patients when used preoperatively.…”

Section: Efficacy Of Sintilimab In Non-small Cell Lung Cancermentioning

confidence: 99%

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Sintilimab: A Promising Anti-Tumor PD-1 Antibody

et al. 2020

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Sintilimab (Tyvyt®) is a monoclonal antibody against programmed cell death protein 1 (PD-1). It could block the interaction between PD-1 and its ligands and help the anti-tumor effect of T-cells to recover. Sintilimab is developed by Innovent Biologics and Eli Lilly and Company and has been approved to treat relapsed or refractory classical Hodgkin lymphoma in patients who have undergone two or more lines of systemic chemotherapy by the National Medical Products Administration of China. Recently, sintilimab has been reported in plenty of literature and shows satisfying anti-tumor effect. Meanwhile, there are some reports showing its side effects. Overall, sintilimab has similar anti-tumor effects and a better safety profile compared to nivolumab and pembrolizumab in Hodgkin lymphoma, natural killer/T cell lymphoma and advanced non-small cell lung cancer. In this review, we aim to briefly describe the mechanisms, pharmacological characteristics, anti-tumor effects, predictive parameters of efficacy and side effects of sintilimab, providing valuable information of sintilimab for decision-making in the treatment of tumors in the future.

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Section: Efficacy Of Sintilimab In Non-small Cell Lung Cancermentioning

confidence: 99%

“…In NCT02259621, the incidences and rate were 22.7% (5/22), 4.5% (1/22), and 0 (39). In MK3475-223, the data were not available (40,41). Although the safety profile of sintilimab in NSCLC seems worse than nivolumab when used preoperatively, the conclusion needs more evidence since the sample size of the latter is small.…”

Section: Adverse Effects Of Sintilimabmentioning

confidence: 99%

Sintilimab: A Promising Anti-Tumor PD-1 Antibody

et al. 2020

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“…A pilot study using neoadjuvant nivolumab in patients with early stage NSCLC demonstrated a 43% response rate as determined by major pathologic response at time of surgery 41–43. More recently a phase I study is underway testing pembrolizumab for Stage I and II NSCLC in the neoadjuvant setting and has demonstrated promising results 44…”

Section: Resultsmentioning

confidence: 99%

<p>Combination pembrolizumab plus chemotherapy: a new standard of care for patients with advanced non-small-cell lung cancer</p>

Weinberg¹,

Gadgeel²

2019

LCTT

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Until recently, the treatment of patients with advanced non-small-cell lung cancer (NSCLC) whose tumors did not have a targetable genetic alteration was cytotoxic chemotherapy alone. This treatment provided only modest survival benefit. The introduction of immune checkpoint inhibitors targeting programmed cell death 1 protein (PD-1) signaling pathway in the treatment of patients with NSCLC has had significant effect on patient survival. Atezolizumab, nivolumab and pembrolizumab have been shown to be superior to chemotherapy in patients with recurrent NSCLC. Recently, pembrolizumab has been combined with chemotherapy in the front-line setting and has demonstrated an improvement in overall survival in NSCLC patients as compared to chemotherapy alone. In this review we will focus on the clinical trials that led to approval of combination pembrolizumab and chemotherapy as first-line treatment for patients with advanced NSCLC as well as discuss other combinations of immunotherapy and chemotherapy that have also been evaluated.

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“…There were no significant safety issues, and 45% achieved a major pathological response (MPR) (27). In the same year, previous results from the NEOSTAR study (28), a preoperative phase II study of nivolumab plus ipilimumab, and results from the MK3475-223 study (29), a phase I study of pembrolizumab, were reported, both of which had similar safety and MPR values of 20-30%. Other Phase II and Ib studies of various drugs (atezolizumab and durvalumab, an anti-PD-L1 antibody, and sintilimab, a recently emerging anti-PD-1 antibody) in combination with chemotherapy have been reported, all of which have shown similar results (30)(31)(32).…”

Section: Perioperative Treatment With Molecular Targeted Agentsmentioning

confidence: 89%

Current state and prospect of the perioperative strategy for non-small cell lung cancer

Takumida

Takeda

Naka

2021

GHM

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This paper provides an overview of perioperative treatment for non-small cell lung cancer (NSCLC), including the current widespread use of cytotoxic anticancer agents, promising molecular targeted agents, and immuno-checkpoint inhibitors. Multiple clinical trials have confirmed that postoperative chemotherapy with cytotoxic anticancer agents should be given for stage IIB to III (according to the 8 th edition of the TNM classification for NSCLC) if possible, and preoperative treatment also is recommended for patients with N2 or higher stage. However, advances in concurrent chemoradiotherapy are expected to change the significance of neoadjuvant therapy. Perioperative treatment with molecular targeted agents appears to extend disease-free survival, but there is currently no evidence that it can extend overall survival. Perioperative treatment with immune checkpoint inhibitors requires further evidence but is likely to be effective. Although perioperative treatment of NSCLC could be costly it continues to evolve in hopes of a cure.

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Neoadjuvant pembrolizumab (Pembro) for early stage non-small cell lung cancer (NSCLC): Initial report of a phase I study, MK3475-223

Cited by 7 publications

References 0 publications

Sintilimab: A Promising Anti-Tumor PD-1 Antibody

Sintilimab: A Promising Anti-Tumor PD-1 Antibody

<p>Combination pembrolizumab plus chemotherapy: a new standard of care for patients with advanced non-small-cell lung cancer</p>

Current state and prospect of the perioperative strategy for non-small cell lung cancer

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