VP3-2022: Pembrolizumab (pembro) versus placebo for early-stage non-small cell lung cancer (NSCLC) following complete resection and adjuvant chemotherapy (chemo) when indicated: Randomized, triple-blind, phase III EORTC-1416-LCG/ETOP 8-15 – PEARLS/KEYNOTE-091 study

Paz-Ares, L.; O’Brien, M.; Mauer, M.; Dafni, Urania; Oselin, Kersti; Havel, Libor; González, Emilio Esteban; Isla, Dolores; Martinez-Martí, Alex; Faehling, Martin; Tsuboi, Masahiro; Js, Lee; Nakagawa, Kouichi; Yang, Jinggang; Keller, Steven M.; Jha, Nitish; Marréaud, Sandrine; Stahel, R.A.; Peters, S.; Besse, Benjamin

doi:10.1016/j.annonc.2022.02.224

Cited by 71 publications

(47 citation statements)

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“…By contrast, in the PEARLS trial of adjuvant pembrolizumab, PD-L1 expression levels lacked predictivity. However, it is my opinion that longer follow-up in the latter study is needed to accurately assess the role of PD-L1 as a biomarker of benefit from anti PD-1/PD-L1 therapy ( 28 ).…”

Section: Discussionmentioning

confidence: 99%

“…In addition, current evidence is against the use of adjuvant PD-1/PD-L1 treatment in resected patients who are not candidates for adjuvant chemotherapy based on the fact that it was mandatory in the Impower010 trial and that in the PEARLS trial, adjuvant pembrolizumab appeared to be detrimental versus placebo for patients who did not receive adjuvant chemotherapy [N=167; HR =1.25 (0.76–2.05)] ( 28 ).…”

Section: Discussionmentioning

confidence: 99%

“…The KEYNOTE-091 trial was a randomized, phase 3 trial (ClinicalTrials.gov; NCT02504372) evaluating pembrolizumab compared to placebo for the adjuvant treatment of patients with stage IB (≥4 cm) to IIIA NSCLC following surgical resection and adjuvant chemotherapy ( 28 ). The dual primary endpoints were DFS in the overall population and in those whose tumors expressed PD-L1 [tumor proportion score (TPS) ≥50%].…”

Section: Consensus 4: Adjuvant Immunotherapy For Nsclc Patientsmentioning

confidence: 99%

See 2 more Smart Citations

Expert consensus on perioperative treatment for non-small cell lung cancer

Duan¹,

Tan²,

Bi³

et al. 2022

Transl Lung Cancer Res

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Consensus 4: Adjuvant Immunotherapy For Nsclc Patientsmentioning

confidence: 99%

See 1 more Smart Citation

Expert consensus on perioperative treatment for non-small cell lung cancer

Duan¹,

Tan²,

Bi³

et al. 2022

Transl Lung Cancer Res

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“…Of note, conventional therapy combined with immunotherapy based on a pretreatment pro le of the immune system of the host could be a valuable tool to increase the survival of early stage NSCLC (30). Finally, positive results have been obtained in advanced disease studies with immune checkpoints; there are several phase III studies currently ongoing (31,32) that are evaluating the role of these drugs in adjuvant treatment for I to III NSCLC. Additionally, results on disease-free survival are already available in EGFR-positive patients' stage IB to IIIA (33).…”

Section: Discussionmentioning

confidence: 99%

Clinical Factors Influencing Long-term Survival in a Real-life Cohort of Early Stage Non-small-cell Lung Cancer Patients

Torrente

Sousa

Guerreiro

et al. 2022

Preprint

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BACKGROUND The impact of prognostic stratification of early stage non-small-cell lung cancer (NSCLC) patients with poor prognosis after surgery is of considerable clinical relevance. The objective of this study was to identify clinical factors associated with long-term overall survival (OS) in early stage NSCLC patients and develop a prognostic model that identifies features associated with poor prognosis and stratifies patients by risk. METHODS This is a cohort study including 505 patients, diagnosed with stage I-II NSCLC, who underwent curative surgical procedures at a tertiary hospital in Madrid, Spain. RESULTS Median survival was 62.4 in patients submitted to surgery and 65 in patients submitted to surgery plus adjuvant treatment. From the univariate analysis we estimated that a female diagnosed with NSCLC has a 0.967 (95% CI 0.936–0.999) probability of survival one year after diagnosis and a 0.784 (95% CI 0.712–0.863) five years after diagnosis. For males, these probabilities drop to 0.904 (95% CI 0.875–0.934) and 0.613 (95% CI 0.566–0.665), respectively. Multivariable analysis shows that sex, age at diagnosis, type of treatment, ECOG-PS, and Stage are statistically significant variables (p < 0.10). According to the Cox regression model, age over 50, ECOG-PS 1 or 2, and stage ll are risk factors for survival (HR > 1) while adjuvant chemotherapy is a good prognostic variable (HR < 1). CONCLUSIONS Surgery plus adjuvant chemotherapy was associated with the best long-term OS in our patients. The prognostic model identified Age, Sex, Stage and ECOG-PS as significant factors to explain the probability of survival.

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“…Not surprisingly, patients who received pembrolizumab experienced more grade ≥3 adverse events than those who did not (34.1% vs 25.8%). There was also a treatment discontinuation rate of 19.8% in the pembrolizumab arm compared to 5.9% in the placebo arm ( 49 ), suggesting that the DFS benefit must be considered in context of the relatively favorable safety and tolerability profile of this agent.…”

Section: The Current Immunotherapy Landscape For the Treatment Of Nsclcmentioning

confidence: 99%

Immunotherapy in non-small cell lung cancer: Past, present, and future directions

et al. 2022

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Many decades in the making, immunotherapy has demonstrated its ability to produce durable responses in several cancer types. In the last decade, immunotherapy has shown itself to be a viable therapeutic approach for non-small cell lung cancer (NSCLC). Several clinical trials have established the efficacy of immune checkpoint blockade (ICB), particularly in the form of anti-programmed death 1 (PD-1) antibodies, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies and anti-programmed death 1 ligand (PD-L1) antibodies. Many trials have shown progression free survival (PFS) and overall survival (OS) benefit with either ICB alone or in combination with chemotherapy when compared to chemotherapy alone. The identification of biomarkers to predict response to immunotherapy continues to be evaluated. The future of immunotherapy in lung cancer continues to hold promise with the development of combination therapies, cytokine modulating therapies and cellular therapies. Lastly, we expect that innovative advances in technology, such as artificial intelligence (AI) and machine learning, will begin to play a role in the future care of patients with lung cancer.

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VP3-2022: Pembrolizumab (pembro) versus placebo for early-stage non-small cell lung cancer (NSCLC) following complete resection and adjuvant chemotherapy (chemo) when indicated: Randomized, triple-blind, phase III EORTC-1416-LCG/ETOP 8-15 – PEARLS/KEYNOTE-091 study

Cited by 71 publications

References 0 publications

Expert consensus on perioperative treatment for non-small cell lung cancer

Expert consensus on perioperative treatment for non-small cell lung cancer

Clinical Factors Influencing Long-term Survival in a Real-life Cohort of Early Stage Non-small-cell Lung Cancer Patients

Immunotherapy in non-small cell lung cancer: Past, present, and future directions

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