FP03.02 Interim Analysis of Neoadjuvant Chemoradiotherapy and Durvalumab for Potentially Resectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Hong, Min Hee; Ahn, Beung‐Chul; Kim, H.R.; Lim, Sungsu; Lee, S.; Park, S.Y.; Lee, C.Y.; Lee, J.G.; Kim, D.J.; Lee, S.H.; Yoon, Hyun-Ki; Lee, C.G.; Cho, J.; Shim, Hyunbo; Kim, T.; Cho, B.C.

doi:10.1016/j.jtho.2021.01.084

Cited by 18 publications

(20 citation statements)

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“… 27 Regarding the combination of chemoradiotherapy with durvalumab, MPR rate was reported to be 73%. 17 The chemotherapy–ICI group shows higher MPR rates when compared with the monotherapy–ICI group, with rates varying from 27% 24 to 86%. 29 Radiotherapy combined with durvalumab led to MPR in 53% of patients.…”

Section: Resultsmentioning

confidence: 96%

“… 26 II Single-arm cohort study 24 0/21/79 Ipilimumab Two cycles 10 mg/kg IV Safety, feasibility Chemoradiotherapy with ICI Hong et al. 17 I/II Single-arm cohort study 11 0/0/100 Durvalumab Two cycles 1500 mg IV Q4W pCR Radiotherapy with ICI Altorki et al. 28 II Randomized two-arm study 30 37/16/47 Durvalumab Two cycles 1120 mg IV Q3W MPR 30 26/33/40 Durvalumab + SBRT EFS, event-free survival; ICI, immune checkpoint inhibitor; IV, intravenous; MPR, major pathological response; N , number of patients included; ORR, objective response rate; pCR, pathological complete response; PFS, progression-free survival; RECIST, response evaluation criteria in solid tumors; SBRT, stereotactic body radiotherapy.…”

Section: Resultsmentioning

confidence: 99%

“… 26 , n (%) NR 2/13 (15) Chemoradiotherapy with ICI Hong et al. 17 , n (%) 8/11 (73) 3/11 (27) Radiotherapy with ICI Altorki et al. 28 , n (%) Durva Durva + SBRT 2/30 (7) 16/30 (53) 0/30 (0) 8/30 (27) Cam, camrelizumab; Chemo, chemotherapy; Durva, durvalumab; ICI, immune checkpoint inhibitor; Ipi/nivo, ipilimumab/nivolumab; MPR, major pathological response; Nivo, nivolumab; NR, not reported; pCR, pathological complete response; SBRT, stereotactic body radiotherapy.…”

Section: Resultsmentioning

confidence: 99%

“… 20 , 27 Combining chemoradiotherapy with durvalumab led to pCR rate of 27%. 17 The chemotherapy–ICI group reported rates varying from 9% 24 to 63%, 19 with most studies reporting pCR in more than half of the patients achieving MPR. 10 , 11 , 19 , 22 , 23 , 29 When neoadjuvant durvalumab was combined with radiotherapy, 27% of the included patients achieved pCR.…”

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: 96%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

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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“…Several multimodal approaches, in which radiotherapy is added to a combination therapy of ICI and conventional chemotherapy, have been used to improve treatment effects (Table S1) further. Interim analysis of a phase 2 trial exploring a multimodality therapy using durvalumab, PT-DC, and radiotherapy (45 Gy) (NCT03694236) indicated high MPR and pCR rates of 72.7% and 36.4%, respectively, along with a relatively low rate of TRAE of ≥ G3 (7%) [45] (Table 3). We are also conducting a multicentre, prospective, single-arm, phase 2 trial of neoadjuvant concurrent chemo-immuno-radiation therapy (carboplatin plus paclitaxel and durvalumab with radiation therapy 50 Gy) followed by surgical resection and adjuvant immunotherapy for resectable stage IIIA-B (discrete N2) NSCLC (WJOG12119L: SQUAT trial) (Japic-CTI-195069) [46] (Table S1).…”

Section: Clinical Trials For Ici Combination Therapy With Chemotherapy or Chemoradiotherapymentioning

confidence: 99%

Perioperative Therapy for Non-Small Cell Lung Cancer with Immune Checkpoint Inhibitors

Soh

Hamada

Fujino

et al. 2021

Preprint

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The emergence of immune checkpoint inhibitors (ICIs) has dramatically changed the treatment landscape for patients with metastatic non-small cell lung cancer (NSCLC). These achievements inspired investigators and pharmaceutical companies to conduct clinical trials in patients with early-stage NSCLC because both adjuvant and neoadju-vant platinum-based doublet chemotherapies (PT-DCs) showed only a 5% improve-ment in the 5-year overall survival. IMpower010, a phase 3 trial (P3), showed that ad-juvant PT-DC followed by maintenance atezolitumab significantly prolonged dis-ease-free survival than adjuvant PT-DC alone (hazard ratio, 0.79; stage II to IIIA). Since conventional therapies, including chemotherapy and radiotherapy, can promote im-munogenic cell death, which releases tumour antigens from dead tumour cells, ICI combination therapies with conventional therapies are widely proposed. Checkmate 816 trial (P3) indicated a significantly higher pathological complete response rate of neoadjuvant nivolumab/PT-DC combination therapy than neoadjuvant PT-DC alone (odds ratio, 13.9, for stage IB to IIIA). Detection of circulating tumour DNA is highly anticipated for the evaluation of minimal residual disease. Multimodal approaches and new ICI agents are being attempted to improve the efficacy of ICI treatment in phase 2 trials. This review presents the development of perioperative treatment using ICIs in patients with NSCLC while discussing problems and perspectives.

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Neoadjuvant immunotherapy for non–small cell lung cancer: State of the art

Kang

Zhang

Zhong

2021

Cancer Communications

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Lung cancer mortality has decreased over the past decade and can be partly attributed to advances in targeted therapy and immunotherapy. Immune checkpoint inhibitors (ICIs) have rapidly evolved from investigational drugs to standard of care for the treatment of metastatic non‐small cell lung cancer (NSCLC). In particular, antibodies that block inhibitory immune checkpoints, such as programmed cell death protein 1 (PD‐1) and programmed cell death 1 ligand 1 (PD‐L1), have revolutionized the treatment of advanced NSCLC, when administered alone or in combination with chemotherapy. Immunotherapy is associated with higher response rates, improved overall survival (OS), and increased tolerability compared with conventional cytotoxic chemotherapy. These benefits may increase the utility of immunotherapy and its combinational use with chemotherapy in the neoadjuvant treatment of patients with NSCLC. Early findings from various ongoing clinical trials suggest that neoadjuvant ICIs alone or combined with chemotherapy may significantly reduce systemic recurrence and improve long‐term OS or cure rates in resectable NSCLC. Here we further summarize the safety and efficacy of various neoadjuvant treatment regimens including immunotherapy from ongoing clinical trials and elaborate the role of neoadjuvant immunotherapy in patients with resectable NSCLC. In addition, we discuss several unresolved challenges, including the evaluations to assess neoadjuvant immunotherapy response, the role of adjuvant treatment after neoadjuvant immunotherapy, the efficacy of treatment for oncogenic‐addicted tumors, and predictive biomarkers. We also provide our perspective on ways to overcome current obstacles and establish neoadjuvant immunotherapy as a standard of care.

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FP03.02 Interim Analysis of Neoadjuvant Chemoradiotherapy and Durvalumab for Potentially Resectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Cited by 18 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

Perioperative Therapy for Non-Small Cell Lung Cancer with Immune Checkpoint Inhibitors

Neoadjuvant immunotherapy for non–small cell lung cancer: State of the art

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