Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer

Zhao, Ze‐Rui; Yang, Chih Ping; Chen, Si; Yu, Hui; Lin, Yongbin; Lin, Yanwei; Qi, Han; Jin, Jietian; Lian, Sen; Wang, Yizhi; You, Jinqi; Zhai, Wenyu; Long, Hao

doi:10.1080/2162402x.2021.1996000

Cited by 63 publications

(68 citation statements)

References 29 publications

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“…A toripalimab-containing regimen in a neoadjuvant setting yielded a high major pathological response (MPR) rate and caused no treatment-related surgical delays. In a phase 2 study (NeoTPD01/NCT04304248), surgically resectable stage IIIA or T3–4N2 IIIB NSCLC patients received three cycles of neoadjuvant treatment with intravenous toripalimab plus carboplatin, and pemetrexed or nab-paclitaxel ( 50 ). MPR, defined as less than 10% residual tumor remaining at the time of surgery, was achieved in 66.7% (20/30) of patients, and pCR was achieved in 50.0% (15/30) of patients.…”

Section: Efficacy Of Toripalimab In Tumorsmentioning

confidence: 99%

“…MPR, defined as less than 10% residual tumor remaining at the time of surgery, was achieved in 66.7% (20/30) of patients, and pCR was achieved in 50.0% (15/30) of patients. Treatment discontinuation or dose reduction was not observed and there were no treatment-related deaths ( 50 ). In another study, neoadjuvant toripalimab plus chemotherapy led to a lower pCR rate (18.2%) and MPR rate (40.9%), but resulted in an ORR of 75.0% (30/40) and DCR of 95.0% (38/40) ( 51 ).…”

Section: Efficacy Of Toripalimab In Tumorsmentioning

confidence: 99%

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Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China

et al. 2022

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Toripalimab (Tuoyi™) is a selective, recombinant, humanized monoclonal antibody against programmed death protein 1 (PD-1) developed by Shanghai Junshi Bioscience Co., Ltd. Toripalimab is able to bind to PD-1 and block the interaction with its ligands. The binding of toripalimab to PD-1 is mainly attributed to the heavy chain of the former and the FG loop of the latter. Toripalimab received a conditional approval in China for the treatment of melanoma (second-line) in December, 2018. It has also received approvals to treat nasopharyngeal carcinoma (first-line and third-line) and urothelial carcinoma (second-line) in 2021. Additionally, several orphan drug designations were granted to toripalimab by the US Food and Drug Administration. Toripalimab has exhibited primary anti-tumor effects in tumors such as melanoma, lung cancer, digestive tract tumors, hepatobiliary and pancreatic tumors, neuroendocrine neoplasms, nasopharyngeal carcinoma and urothelial carcinoma. It showed a satisfactory anti-tumor effect and long-term survival benefits in Chinese melanoma patients, while the combination of axitinib with toripalimab exhibited an impressive result in metastatic mucosal melanoma. As a checkpoint inhibitor, toripalimab was generally well-tolerated in the enrolled patients. Due to different study populations, comparisons could not be made directly between toripalimab and other drugs in most cases. Nevertheless, the introduction of toripalimab may offer a valuable choice for decision-making in the treatment of tumors in the future.

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Section: Efficacy Of Toripalimab In Tumorsmentioning

confidence: 99%

Section: Efficacy Of Toripalimab In Tumorsmentioning

confidence: 99%

Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China

et al. 2022

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“…Nevertheless, in the neoadjuvant setting, trials have shown contradictory results. PD-L1 expression was significantly associated with MPR rate in NEOSTAR but not in LCMC3, NA_00092076, NADIM, NeoTAP01, and NCT02716038 [ 17 , 19 , 20 , 21 , 22 , 23 ]. Conversely, TMB was associated with MPR in NA_00092076 but not in LCMC3.…”

Section: Discussionmentioning

confidence: 99%

“…In the NeoTAP01 trial, 33 patients with deemed resectable stage III NSCLC were enrolled from a single center in China [ 23 ]. All participants were given three cycles of neoadjuvant treatment of toripalimab, carboplatin, and pemetrexed or nab-paclitaxel.…”

Section: Past Clinical Trials That Included Neoadjuvant With a Combination Of Chemoimmunotherapy In Patients With Resectable Nsclcmentioning

confidence: 99%

Neoadjuvant and Adjuvant Immunotherapy in Early-Stage Non-Small-Cell Lung Cancer, Past, Present, and Future

Szeto

Shalata

Yakobson

et al. 2021

JCM

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Lung cancer is worldwide the most common malignancy. Standard of care treatments for early-stage non-small-cell lung cancer (NSCLC) include surgery and adjuvant chemotherapy. However, these patients continue to have poor prognosis due to systemic or local relapse. Immunotherapy has been considered as a novel approach to improve survival in patients with early-stage NSCLC. Since immune checkpoint inhibitors have transformed the treatment of advanced NSCLC, there is a growing interest in the role of immunotherapy in early-stage NSCLC. In this review, we summarize reported and ongoing clinical trials of immunotherapy in both neoadjuvant and adjuvant settings. We also highlight unaddressed issues in this field of research, such as the predictive markers, the optimal combination therapy, and the need for adjuvant immunotherapy. More studies are needed to optimize the treatment regimen of immunotherapy in patients with early-stage NSCLC.

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“…Furthermore, a phase 2 trial supported the potential value of the neoadjuvant nivolumab with chemotherapy for the treatment of resectable stage IIIA NSCLC ( 8 ). Similarly, a phase 2 trial from China suggested a neoadjuvant chemoimmunotherapy regimen for stage IIIA NSCLC and T3–4N2 IIIB NSCLC ( 9 ). Some other studies that explore the efficiency of the neoadjuvant chemoimmunotherapy on stage IIIA/B NSCLC are ongoing ( 10 ).…”

Section: Introductionmentioning

confidence: 99%

Short-term outcomes of neoadjuvant sintilimab with chemotherapy in stage III non-small cell lung cancer: a case series

Fan¹,

Wang²,

Zhao³

et al. 2022

Transl Cancer Res TCR

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Background: Neoadjuvant chemoimmunotherapy seems to be a promising treatment option for stage III non-small cell lung cancer (NSCLC). Sintilimab, as a programmed death receptor-1 inhibitor, has exhibited a fine performance in treating NSCLC. However, the efficiency of sintilimab combined with chemotherapy for stage IIIA/IIIB NSCLC remains inconclusive. The purpose of this study was to share our experience on sintilimab in neoadjuvant chemoimmunotherapy for stage III NSCLC.Methods: This study retrospectively reviewed patients who received surgical resection following 1-3 cycles of neoadjuvant sintilimab (200 mg) with chemotherapy for stage III NSCLC between June 2020 and March 2022 in our center. Patients characteristics, surgical factors, surgery-related complications 30 days postoperatively, and treatment-related adverse events (TRAEs) before surgery were recorded through reviewing medical record data and telephone follow-up.Results: A total of eight patients were enrolled, including six cases of squamous cell carcinoma and two cases of adenocarcinoma. All of the patients received 1-3 cycles of neoadjuvant therapy. There were no treatment-related surgical delays. All patients underwent lobectomy, among which two underwent sleeve lobectomy and one received bronchoplasty. Five patients underwent open thoracotomy. Fibrosis of the primary tumor and lymph nodes was observed in all the cases. There were no surgery-related complications > grade 2 at 30 days postoperatively. According to the radiographic findings, one patient had stable disease and all of the others achieved a partial response. The median of maximum standardized uptake value change from baseline was a 52.75% reduction (range, 37.2-68.8%). Five patients achieved a major pathological response. R0 resection was achieved in all eight cases. One grade 4 event was observed. Neutropenia was the most common TRAE > grade 2 (3/8). There were no cases of treatment discontinuation or dose reduction due to TRAEs. Conclusions:The current study found that neoadjuvant sintilimab plus chemotherapy bring a high rate of major pathological response and acceptable TRAEs. Even though it increased the difficulties of surgery, there is still no evidence suggesting that it will brings additional surgical death. We believe that neoadjuvant sintilimab plus chemotherapy might be feasible for stage III NSCLC.

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Phase 2 trial of neoadjuvant toripalimab with chemotherapy for resectable stage III non-small-cell lung cancer

Cited by 63 publications

References 29 publications

Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China

Toripalimab: the First Domestic Anti-Tumor PD-1 Antibody in China

Neoadjuvant and Adjuvant Immunotherapy in Early-Stage Non-Small-Cell Lung Cancer, Past, Present, and Future

Short-term outcomes of neoadjuvant sintilimab with chemotherapy in stage III non-small cell lung cancer: a case series

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