FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1

Sul, Joohee; Blumenthal, Gideon M.; Jiang, Xiaoping; He, Kun; Keegan, Patricia; Pazdur, Richard

doi:10.1634/theoncologist.2015-0498

Cited by 303 publications

(231 citation statements)

References 13 publications

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“…176,179,197 Pembrolizumab inhibits the PD-1 receptor. 193 A randomized phase II/III trial (KEYNOTE-010) assessed pembrolizumab in patients with previously treated advanced nonsquamous and squamous NSCLC who were PD-L1 positive (≥1%); most patients were current or former smokers.…”

Section: Immunotherapeutic Agentsmentioning

confidence: 99%

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Non–Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Ettinger¹,

Wood²,

Aisner³

et al. 2017

J Natl Compr Canc Netw

1,073

1,005

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Section: Immunotherapeutic Agentsmentioning

confidence: 99%

“…197 The FDA has approved a companion diagnostic biomarker test for assessing PD-L1 expression and determining which patients are eligible for pembrolizumab therapy. Other immunotherapeutic agents are being investigated.…”

Section: Immunotherapeutic Agentsmentioning

confidence: 99%

Non–Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Ettinger¹,

Wood²,

Aisner³

et al. 2017

J Natl Compr Canc Netw

1,073

1,005

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“…232,234,235 The most common immune-mediated side effects are to the skin, liver, kidneys, gastrointestinal tract, lungs, and endocrine systems. [236][237][238] Pneumonitis, occurring in approximately 3% to 7% of patients on pembrolizumab or nivolumab, is one of the most serious side effects of PD-1 inhibitors.…”

mentioning

confidence: 99%

Colon Cancer, Version 1.2017, NCCN Clinical Practice Guidelines in Oncology

Benson¹,

Venook²,

Cederquist³

et al. 2017

J Natl Compr Canc Netw

725

515

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OverviewColorectal cancer (CRC) is the fourth most frequently diagnosed cancer and the second leading cause of cancer death in the United States. In 2016, an estimated 95,270 new cases of colon cancer and approximately 39,220 cases of rectal cancer will occur. During the same year, an estimated 49,190 people will die of colon and rectal cancer combined. AbstractThis portion of the NCCN Guidelines for Colon Cancer focuses on the use of systemic therapy in metastatic disease. Considerations for treatment selection among 32 different monotherapies and combination regimens in up to 7 lines of therapy have included treatment history, extent of disease, goals of treatment, the efficacy and toxicity profiles of the regimens, KRAS/NRAS mutational status, and patient comorbidities and preferences. Location of the primary tumor, the BRAF mutation status, and tumor microsatellite stability should also be considered in treatment decisions. J Natl Compr Canc Netw 2017;15(3): 370-398 NCCN Categories of Evidence and ConsensusCategory 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate. Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate. These guidelines are also available on the Internet. For the latest update, visit NCCN.org.

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“…46,47 While pembrolizumab was granted accelerated approval on the basis of ORR of significant magnitude and duration in the phase 1 (KEYNOTE-001) trial, interim results from the phase III KEYNOTE-010 trial were included in the final risk-benefit analysis, and confirmed benefit for pembrolizumab over docetaxel. 46 In contrast, nivolumab was approved by the FDA in the second-line treatment of NSCLC solely on the basis on the interim analysis of OS in the CheckMate 057. 47 In this trial there was a 6 month delay before the benefit of nivolumab became apparent in Kaplan-Meier analysis.…”

Section: Statistical Designmentioning

confidence: 99%

Standard of care in immunotherapy trials: Challenges and considerations

Rivalland

Scott

John

2017

Human Vaccines & Immunotherapeutics

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The success of immunotherapeutics over the past decade has fundamentally altered the therapeutic landscape in melanoma and non-small cell lung (NSCLC) cancer care. Multiple clinical trials have confirmed significant improvements in survival with a variety of immunotherapeutic strategies. The careful and appropriate selection of standard of care (SOC) therapies is key to the successful design and interpretation of these trials. To date immunotherapeutic trials have used best supportive care, matched placebo, chemotherapy, targeted therapy or, more recently, established immunotherapeutics in melanoma clinical trials as SOCs. Each of these SOC choices has a fundamental impact on the selection and validity of response assessment criteria and clinical endpoints. As yet there is no established approach, thus new data must be interpreted with an understanding of the limitations of the current paradigm. Additionally, the pace of development has mandated the use of novel clinical trial designs, answering multiple therapeutic questions simultaneously and designed to expedite regulatory approval. This review addresses the most important challenges in the selection of SOC in immunotherapeutic trials and the current and future challenges in trial design.

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FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1

Cited by 303 publications

References 13 publications

Non–Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Non–Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Colon Cancer, Version 1.2017, NCCN Clinical Practice Guidelines in Oncology

Standard of care in immunotherapy trials: Challenges and considerations

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