SAKK 16/14: Anti-PD-L1 antibody durvalumab (MEDI4736) in addition to neoadjuvant chemotherapy in patients with stage IIIA(N2) non-small cell lung cancer (NSCLC)—A multicenter single-arm phase II trial.

Rothschild, Sacha I.; Zippelius, Alfred; Savic, Spasenija; Gonzalez, Michel; Weder, W.; Xyrafas, A.; Rusterholz, Corinne; Pless, Miklos

doi:10.1200/jco.2016.34.15_suppl.tps8573

Cited by 6 publications

(13 citation statements)

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“… 20 II Single-arm cohort study 9 b 11/22/67 Nivolumab Three cycles 3 mg/kg IV Q2W Safety Ipilimumab One cycle 1 mg/kg IV Q6W Chemotherapy with ICI Rothschild et al. 21 II Single-arm cohort study 67 0/0/100 Durvalumab Two cycles 750 mg IV Q2W EFS at 12 months Zhao et al. 11 II Single-arm cohort study 33 0/0/100 Toripalimab Three cycles 240 mg Q3W MPR Forde et al.…”

Section: Resultsmentioning

confidence: 99%

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Neoadjuvant immune checkpoint inhibitors in resectable non-small-cell lung cancer: a systematic review

Ulas

Dickhoff²,

Schneiders

et al. 2021

ESMO Open

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Background The neoadjuvant use of immune checkpoint inhibitors (ICIs) in resectable non-small-cell lung cancer (NSCLC) is currently an area of active ongoing research. The place of neoadjuvant ICIs in the treatment guidelines needs to be determined. We carried out a systematic review of published data on neoadjuvant ICIs in resectable NSCLC to study its efficacy and safety. Patients and methods A literature search was carried out using the MEDLINE (PubMed) and Embase databases to retrieve articles and conference abstracts of clinical trials measuring the efficacy [major pathological response (MPR) and pathological complete response (pCR)] and safety (failure to undergo resection, surgical delay, treatment-related adverse events (trAEs) grade ≥3) of neoadjuvant immunotherapy in resectable NSCLC until July 2021. Results Nineteen studies with a total of 1066 patients were included in this systematic review. Neoadjuvant immunotherapy was associated with improved pathological response rates, especially in combination with chemotherapy. Using mono ICI, dual therapy–ICI, chemoradiation–ICI, radiotherapy–ICI, and chemo–ICI, the MPR rates were 0%-45%, 50%, 73%, 53%, and 27%-86%, respectively. Regarding pCR, the rates were 7%-16%, 33%-38%, 27%, 27%, and 9%-63%, respectively. Safety endpoints using monotherapy–ICI, dual therapy–ICI, chemoradiation–ICI, radiotherapy–ICI, and chemo–ICI showed a failure to undergo resection in 0%-17%, 19%-33%, 8%, 13%, and 0%-46%, respectively. The trAEs grade ≥3 rates were 0%-20%, 10%-33%, 7%, 23%, and 0%-67%, respectively. Conclusion In patients with resectable NSCLC stage, neoadjuvant immunotherapy can improve pathological response rates with acceptable toxicity. Further research is needed to identify patients who may benefit most from this approach, and adequately powered trials to establish clinically meaningful benefits are awaited.

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Section: Resultsmentioning

confidence: 99%

“… 20 , n (%) NR 2/6 (33) Chemotherapy with ICI Range over all studies 27%-86% 9%-63% Rothschild et al. 21 , n (%) 34/55 (62) 10/55 (18) Zhao et al. 11 , n (%) 20/30 (66) 15/30 (50) Forde et al.…”

Section: Resultsmentioning

confidence: 99%

Neoadjuvant immune checkpoint inhibitors in resectable non-small-cell lung cancer: a systematic review

Ulas

Dickhoff²,

Schneiders

et al. 2021

ESMO Open

View full text Add to dashboard Cite

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“…Patients will continue the treatment following surgical resection. The primary endpoint is event-free survival at 12 months, and secondary endpoints include OS, ORR, down-staging, complete resection, recurrence pattern, and toxicity [ 33 ]. In addition, nivolumab is being evaluated in the neoadjuvant setting in early NSCLC.…”

Section: Treatment-naïve Metastatic Nsclcmentioning

confidence: 99%

The next generation of immunotherapy: keeping lung cancer in check

Somasundaram

Burns

2017

J Hematol Oncol

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Lung cancer is the deadliest malignancy with more cancer deaths per year than the next three cancers combined. Despite remarkable advances in targeted therapy, advanced lung cancer patients have not experienced a significant improvement in mortality. Lung cancer has been shown to be immunogenic and responsive to checkpoint blockade therapy. Checkpoint signals such as CTLA-4 and PD-1/PD-L1 dampen T cell activation and allow tumors to escape the adaptive immune response. Response rates in patients with pretreated, advanced NSCLC were much higher and more durable with PD-1 blockade therapy compared to standard-of-care, cytotoxic chemotherapy. Therefore, PD-1 inhibitors such as nivolumab and pembrolizumab were rapidly approved for both squamous and nonsquamous lung cancer in the pretreated population. The advent of these new therapies have revolutionized the treatment of lung cancer; however, the majority of NSCLC patients still do not respond to PD-1/PD-L1 inhibition leaving an unmet need for a large and growing population.Immunotherapy combinations with chemotherapy, radiation therapy, or novel immunomodulatory agents are currently being examined with the hope of achieving higher response rates and improving overall survival rate. Chemotherapy and radiation therapy has been theorized to increase the release of tumor antigen leading to increased responses with immunotherapy. However, cytotoxic chemotherapy and radiation therapy may also destroy actively proliferating T cells. The correct combination and order of therapy is under investigation. The majority of patients who do respond to immunotherapy have a durable response attributed to the effect of adaptive immune system’s memory. Unfortunately, some patients’ tumors do progress afterward and investigation of checkpoint blockade resistance is still nascent.This review will summarize the latest efficacy and safety data for early and advanced NSCLC in both the treatment-naïve and pretreated settings. The emerging role of immunotherapy for the treatment of small cell lung cancer and malignant mesothelioma will also be discussed.

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“…IMpower030 is evaluating the survival and pathological response of atezolizumab or placebo in combination with chemotherapy, planning to enroll 374 patients (102). An ongoing phase II single-arm trial is trialing neoadjuvant combination durvalumab with chemotherapy for the treatment of stage IIIA(N2) NSCLC, for which results, including event-free survival (EFS), are pending (103). Furthermore, AEGEAN is a phase III randomized trial also studying the addition of durvalumab to chemotherapy, but comparing it to chemotherapy alone.…”

Section: Ongoing Trials Of Neoadjuvant Immunotherapy In Lung and Other Cancersmentioning

confidence: 99%

Surgery after neoadjuvant immunotherapy in patients with resectable non-small cell lung cancer

Huynh¹,

Walsh²,

Spicer³

2021

Transl Lung Cancer Res

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Surgery is the standard of care for patients with operable non-small cell lung cancer (NSCLC).However, as a single modality, surgery for early stage or locally advanced NSCLC remains associated with high rates of local and distant recurrence. The addition of neoadjuvant or adjuvant chemotherapy has modestly improved outcomes. While systemic therapy paired with surgery for other malignancies such as breast cancer have resulted in far better outcomes for equivalent stage designations, outcome improvements for operable NSCLC have lagged in part as a result of trials where adjuvant chemotherapy seemed to incur harm for stage IA patients and only modest survival benefit for stage IB-IIIA patients (AJCC 7 th ed.). In recent years, immunotherapy for NSCLC has emerged as a systemic therapy with significant benefit over traditional chemotherapy regimens. These advances with immune checkpoint inhibitors (ICIs) have opened the door to administering peri-operative immunotherapy for operable NSCLC. As a result, a great multitude of studies investigating the use of immunotherapy in combination with surgery for NSCLC as well as several other malignancies have emerged. In this review, we outline the rationale for neoadjuvant immunotherapy in the treatment of operable NSCLC and summarize the available evidence that include preoperative ICI as a single modality or in combination with systemic agents and/or radiotherapy. Further, we summarize how such treatment trajectories open multiple unique windows of opportunity for scientific discovery and potential therapeutic gains for these vulnerable patients.

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SAKK 16/14: Anti-PD-L1 antibody durvalumab (MEDI4736) in addition to neoadjuvant chemotherapy in patients with stage IIIA(N2) non-small cell lung cancer (NSCLC)—A multicenter single-arm phase II trial.

Cited by 6 publications

References 0 publications

Neoadjuvant immune checkpoint inhibitors in resectable non-small-cell lung cancer: a systematic review

Neoadjuvant immune checkpoint inhibitors in resectable non-small-cell lung cancer: a systematic review

The next generation of immunotherapy: keeping lung cancer in check

Surgery after neoadjuvant immunotherapy in patients with resectable non-small cell lung cancer

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