Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study

Wan, Rui; Dong, Xiaorong; Chen, Qun; Yu, Yan; Yang, Shujun; Zhang, Xiaochun; Zhang, Guojun; Pan, Yueyin; Sun, Shuai; Zhou, Chengzhi; Hong, Wei; Zhao, Hui; Yang, Lei; Huang, Lingxia; Wu, Rong; Zang, Aimin; Ma, Rui; Wu, Lin; Lv, Dongqing; Fu, Xue Jun; Han, Jianyong; Li, Wenxin; Duan, Jianchun; Wang, Kai; Jiang, Ou; Chen, Ying-Lan; Guo, Zhongliang; Gao, Hongjun; Wen, Juyi; Wang, Shubin; Zhao, Ermi; Li, Gaofeng; Yue, Lu; Liang, Li; Zeng, Aiping; Wang, Xiaoshan; Zhu, Yubing; Pan, Hongming; Dai, Zong; Feng, Weineng; Zhao, Guofang; Lin, Chuan Chuan; Li, Chong; Li, Na; Bao, Yongzhan; Li, Yinyin; Su, Yanjun; Zhao, Min; Fang, Haohui; Zhu, Yulong; Ding, Lieming; Wang, Yang; Yuan, Xiaobin; Wang, Jie

doi:10.1016/j.eclinm.2021.101187

Cited by 10 publications

(15 citation statements)

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“…eFigure 2 in Supplement 1 shows the process of study screening. Of the 1195 records sourced from the database and manually searched, 49 studies met the inclusion criteria, including 39 RCTs and 10 cohort studies …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Table 1 and eTable 6 in Supplement 1 summarize the characteristics of the 39 RCTs, which included 18 791 patients with cancer . Of those, 37 RCTs were published in journals, 1 was reported in ClinicalTrials.gov, and 1 was reported in an NMPA review . Of the 39 RCTs, 18 studied bevacizumab biosimilars, 12 studied rituximab biosimilars, and 9 studied trastuzumab biosimilars …”

Section: Resultsmentioning

confidence: 99%

“…The median duration for assessing the primary efficacy end points was 18 weeks (IQR, 18-21 weeks) for bevacizumab biosimilars, 23 weeks (IQR, 23-24 weeks) for rituximab biosimilars, and 24 weeks (IQR, 23-24 weeks) for trastuzumab biosimilars. Thirty-four RCTs reported the incidence of antidrug JAMA Network Open | Health Policy antibodies, [32][33][34][35][36][37][38][39][40][41][42][43][45][46][47][48][49][50][51][52][53][54][55][56][58][59][60][62][63][64][66][67][68]70 and 28 reported the incidence of neutralizing antibodies. [32][33][34][35][36][37][38][39][40][41][42][43][47][48][49][50][51][52][53]…”

Section: Rct and Cohort Study Characteristicsmentioning

confidence: 99%

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Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

Luo,

Du,

et al. 2023

JAMA Netw Open

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ImportanceThe high cost of biologics used to treat cancer has been an increasing burden in the world. In China, the recent approval of cancer biosimilar drugs to resolve this problem is promising, but evidence of clinical benefits, price, and uptake for these drugs is still lacking.ObjectivesTo compare characteristics of pivotal clinical trials in China and other countries for biosimilars of bevacizumab, rituximab, and trastuzumab and investigate the efficacy or effectiveness, safety, and immunogenicity outcomes of cancer biosimilars compared with reference drugs by meta-analysis.Data SourcesFor this systematic review and meta-analysis, PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for published studies from database inception to February 1, 2023, using the search topics (cancers) AND (biosimilars).Study SelectionRandomized clinical trials and cohort studies that included patients with cancer were included.Data Extraction and SynthesisTwo authors independently extracted the outcome estimates and characteristics for each study. A random-effects meta-analysis was performed to summarize the relative estimates with 95% CIs. This study was performed following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline.Main Outcomes and MeasuresClinical trial characteristics were collected for biosimilars of bevacizumab, rituximab, and trastuzumab. The relative estimates of efficacy or effectiveness (objective response rate, progression-free survival, and overall survival), safety, and immunogenicity outcomes were analyzed for biosimilars vs reference drugs. The weighted average price and uptake rate were evaluated for biosimilars relative to their reference drugs between 2015 and 2022.ResultsA total of 39 RCTs (involving 18 791 patients) and 10 cohort studies (involving 1998 patients) were included. The biosimilars of bevacizumab (16 RCTs; risk ratio [RR], 0.97; 95% CI, 0.93-1.01; P = .17), rituximab (12 RCTs; RR, 1.03; 95% CI, 0.98-1.08; P = .70), and trastuzumab (9 RCTs: RR, 1.04; 95% CI, 0.97-1.12; P = .29) met equivalence with reference biologics in regard to the objective response rate. The results summarized from cohort studies were consistent with those from RCTs. In 2022, cancer biosimilars were priced at 69% to 90% of the costs for the reference drugs, and their uptake reached 54% to 83% in China.Conclusions and RelevanceThis systematic review and meta-analysis indicated that cancer biosimilars provided comparable clinical benefits at lower prices compared with reference drugs. These findings suggest the potential feasibility of expediting the transition from reference drugs to biosimilars to benefit more patients with cancer.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Rct and Cohort Study Characteristicsmentioning

confidence: 99%

See 2 more Smart Citations

Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

Luo,

Du,

et al. 2023

JAMA Netw Open

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“…The addition of bevacizumab to consolidation therapy improves response rates, PFS, and OS in LA‐NS‐NSCLC. Therefore, there has been a surge of interest in studying this therapy in patients with earlier stages of the disease 11,12 . In the pilot trial SWOG S0533, the median PFS was 38 months (95% CI: 23–46 months) in low‐risk NSCLC patients.…”

Section: Introductionmentioning

confidence: 99%

A pilot trial of consolidation bevacizumab after hypo‐fractionated concurrent chemoradiotherapy in patients with unresectable locally advanced non‐squamous non‐small‐cell lung cancer

et al. 2023

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PurposeTo determine the feasibility of incorporating bevacizumab consolidation into hypo‐fractionated concurrent chemoradiotherapy (hypo‐CCRT) for patients with unresectable locally advanced non‐squamous non‐small‐cell lung cancer (LA‐NS‐NSCLC).Patients and MethodsEligible patients were treated with hypo‐RT (40Gy in 10 fractions) followed by hypo‐boost (24‐28Gy in 6–7 fractions), along with concurrent weekly chemotherapy. Patients who completed the hypo‐CCRT without experiencing ≥G2 toxicities received consolidation bevacizumab every 3 weeks for up to 1 year, until disease progression or unacceptable treatment‐related toxicities.The primary endpoint was the risk of G4 or higher hemorrhage. Secondary endpoints included progression‐free survival (PFS), overall survival (OS), locoregional failure‐free survival (LRFS), distant metastasis‐free survival (DMFS), and objective response rate (ORR). All time‐to‐event endpoints (OS, PFS, LRFS, and DMFS) were measured from the start of radiotherapy.ResultsBetween December 2017 and July 2020, a total of 27 patients were included in the analysis, with a median follow‐up duration of 28.0 months. One patient (3.7%) developed G5 hemorrhage during bevacizumab consolidation. Additionally, seven patients (25.9%) had G3 cough and three patients (11.1%) experienced G3 pneumonitis. The ORR for the entire cohort was 92.6%. The median OS was 37.0 months (95% confidence interval, 8.9–65.1 months), the median PFS was 16.0 months (95% confidence interval, 14.0–18.0 months), the median LRFS was not reached, and the median DMFS was 18.0 months.ConclusionsThis pilot study met its goal of demonstrating the tolerability of consolidation bevacizumab after hypo‐CCRT. Further investigation of antiangiogenic and immunotherapy combinations in LA‐NSCLC is warranted, while the potential for grade 3 respiratory toxicities should be taken into consideration.

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Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis

Kwon

Son

et al. 2023

BioDrugs

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Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study

Cited by 10 publications

References 28 publications

Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China

A pilot trial of consolidation bevacizumab after hypo‐fractionated concurrent chemoradiotherapy in patients with unresectable locally advanced non‐squamous non‐small‐cell lung cancer

Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis

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