1264P Updated analysis of tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment of advanced squamous non-small cell lung cancer (SQ NSCLC)

Wang, J.; Lu, Shun; Hu, Chin-Hwa; Sun, Ying; Yang, Kunyu; Chen, M.; Zhao, Jun; Yang, Guohua; Zhou, Xin; Feng, Guosheng; Pan, Yueyin; Yu, Yan; Zhang, J.; Liang, Li; Lin, Xiao; Wu, Xikun; Cui, Jianli

doi:10.1016/j.annonc.2020.08.1578

Cited by 8 publications

(3 citation statements)

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“…PD-1 inhibitors camrelizumab and sintilimab were approved for non-squamous NSCLC in the first-line setting on June 19th, 2020 and Feb 3rd, 2021 based on CameL study (NCT03134872) [45] , and ORIENT-11 study (NCT03607539) [46] . According to RATIONALE 307 study (NCT03663205), in which the addition of tislelizumab to chemotherapy resulted in an improved PFS than chemotherapy alone for previously untreated squamous NSCLC [47] , tislelizumab was approved on Jan 14th, 2021 by NMPA.…”

Section: Discussionmentioning

confidence: 99%

The changing landscape of anti-lung cancer drug clinical trials in mainland China from 2005 to 2020

Zhong

Tao

Chen

et al. 2021

The Lancet Regional Health - Western Pacific

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Background In recent years, new drug development on lung cancer is in full swing in China. The aim of this study was to overview the changing landscape of anti-lung cancer drug clinical trials in mainland China from 2005 to 2020. Methods We analysed anti-lung cancer drug clinical trials registered on three websites including the China National Medical Products Administration Centre for Drug Evaluation platform, the Chinese Clinical Trial Registry and ClinicalTrials.gov. Findings A total of 1595 anti-lung cancer drug clinical trials from Jan 1st, 2005 to Dec 31st, 2020 were extracted, which included 630 (39•5%) investigator-initiated trials (IITs), 698 (43•8%) domestic industry-sponsored trials (ISTs), and 267 (16•7%) international ISTs. During the past 16 years, the number of anti-lung cancer clinical trials including IITs and domestic ISTs had a remarkable growth, however, the number of international ISTs increased slowly. The number of principal clinical trial units also increased significantly over time. Of the 1595 trials, the largest growth was observed in phase I trials during 2013–2020, with an average annual growth rate of 38•6%. 278 trials were led by principal investigators (PI) from Guangdong, followed by Beijing ( n =273) and Shanghai ( n =257). Among the 965 ISTs, clinical trials involving targeted drugs (588, 60•9%) accounted for the largest proportion, followed by immunotherapeutic drugs (284, 29•4%), cytotoxic drugs (75, 7•8%), and traditional Chinese medicine (18, 1•9%). In terms of targeted drugs, EGFR-TKIs remained the most studied drugs (225/588, 38•27%). As for immunotherapy, 125 out of 284 (44•01%) trials involved PD-1 inhibitors, 60 (21•13%) trials involved PD-L1 inhibitors, and seven (2•46%) trials involved CTLA-4 inhibitors. Interpretation In the past 16 years, the development of anti-lung cancer drug clinical trials has achieved much progress in mainland China. The most progress lied in targeted therapy and immunotherapy. Funding This work was financially supported in part by China National Major Project for New Drug Innovation (2017ZX09304015) and Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences (CIFMS) (2016-I2M-1-001).

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Section: Discussionmentioning

confidence: 99%

The changing landscape of anti-lung cancer drug clinical trials in mainland China from 2005 to 2020

Zhong

Tao

Chen

et al. 2021

The Lancet Regional Health - Western Pacific

View full text Add to dashboard Cite

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“…The RATIONALE307 trial showed that carboplatin plus paclitaxel/nab-paclitaxel combined with tislelizumab signi cantly improved the progression-free survival (PFS) of patients with advanced squamous NSCLC compared with chemotherapy alone. More importantly, no relationships were found between clinical response rates and PFS and PD-L1 expression [12]. In this case, the patient with initially unresectable tumor achieved a pCR and received surgical treatment nally, which implied neoadjuvant chemotheraphy combined with tislelizumab may provide an opportunity of radical resection for such patient.…”

Section: Discussionmentioning

confidence: 80%

Surgical Treatment of Initially Unresectable Locally Advanced Non-small Cell Lung Cancer Following Tislelizumab Plus Chemotherapy: A Case Report

Huang

Dai

Chen

et al. 2021

Preprint

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Background: Radical concurrent chemoradiotherapy is the preferred treatment for patients with stage IIIB non-small cell lung cancer (NSCLC), but the prognosis is poor. The emergence of immune checkpoint inhibitors has changed the treatment strategy for advanced NSCLC, providing new opportunities for therapy. However, neoadjuvant immunotherapy of locally advanced NSCLC is still in the exploratory stage. Case presentation: A 47-year-old male with stage IIIB squamous cell lung cancer with invasion of the pulmonary artery, left superior pulmonary vein (LSPV), and left atrium (LA) at diagnosis. The patient’s lesions were significantly reduced after four cycles of combined treatment with tislelizumab and carboplatin plus nab-paclitaxel, he then underwent successful left pneumonectomy with mediastinal lymph node dissection, and postoperative pathology showed a pathologic complete response (pCR). Conclusions: The findings demonstrated that chemotherapy in combination with immunotherapy can provide an opportunity for radical surgery in some patients with locally advanced NSCLC.

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“…The detail of the search criteria is shown in Table . Eventually, a total of 14 trials 6,8–11,17–25 were included, with 9454 participants enrolled. The detail of the selection process is shown in Figure 1.…”

Section: Resultsmentioning

confidence: 99%

First‐line immune‐based combination therapies for advanced non‐small cell lung cancer: A Bayesian network meta‐analysis

et al. 2021

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Background Immune‐based combination therapies have revolutionized the first‐line treatment for advanced non‐small cell lung cancer (NSCLC). However, for the efficacy and safety, the best treatment option is still uncertain. Methods We conducted a Bayesian network meta‐analysis of randomized controlled trials (RCTs) to evaluate first‐line immune‐based combination therapies for advanced NSCLC. Results Fourteen trials involving 8467 patients were included. For the programmed cell death‐ligand 1 (PD‐L1) expression non‐selective patients, there were no significant differences among all the treatment modes for overall survival (OS), but the ranking profiles indicated that Immunotherapy + Immunotherapy + Chemotherapy (IO + IO + Chemo) was most likely to be the best mode (probability = 68%). Immunotherapy + Immunotherapy + Anti‐angiogenic therapy + Chemotherapy (IO + Anti‐angio + Chemo) was significantly better than most other treatment modes for progression‐free survival (PFS) with better objective response rate (ORR) and more obvious grade ≥3 treatment‐related adverse events (TRAEs). In PD‐L1‐high cohort, IO + Anti‐angio + Chemo seemed to be the best mode for OS, PFS, and ORR according to the ranking profiles. In PD‐L1‐intermediate and PD‐L1‐negative cohort, IO + IO + Chemo was inclined to be ranked first for prolonging OS (probability = 78%; 37%) and IO + Anti‐angio + Chemo was most likely to provide best PFS (probability = 96%; 100%). Conclusion IO + IO + Chemo has great potential to improve the OS regardless of histology type, especially in PD‐L1‐intermediate and PD‐L1‐negative cohort. IO + Anti‐angio + Chemo shows great superiority in improving the short‐term survival accompanied by increasing grade ≥3 TRAEs.

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1264P Updated analysis of tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment of advanced squamous non-small cell lung cancer (SQ NSCLC)

Abstract: Updated analysis of tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment of advanced squamous non-small cell lung cancer (SQ NSCLC

Cited by 8 publications

References 0 publications

The changing landscape of anti-lung cancer drug clinical trials in mainland China from 2005 to 2020

The changing landscape of anti-lung cancer drug clinical trials in mainland China from 2005 to 2020

Surgical Treatment of Initially Unresectable Locally Advanced Non-small Cell Lung Cancer Following Tislelizumab Plus Chemotherapy: A Case Report

First‐line immune‐based combination therapies for advanced non‐small cell lung cancer: A Bayesian network meta‐analysis

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