內容目錄
In February 2022, “Lung Cancer Translational Research” published a study evaluating the combination of PD-1 inhibitor nivolumab and recombinant human endostatin in previously treated patients with advanced disease. A study report on safety and efficacy in non-small cell lung cancer (NSCLC).
Immune checkpoint inhibitors (ICIs) play an important role in the treatment of advanced NSCLC. Two phase III trials demonstrated that nivolumab improved overall survival (OS) compared with docetaxel and demonstrated a favorable safety profile in previously treated patients with advanced NSCLC.
Trade name: Opdivo (Opdivo, O medicine)
Generic name : Nivolumab (nivolumab)
Manufacturer: BMS (Bristol-Myers Squibb)
First approval in the U.S. : Dec 2014
First Approved in China: August 2018
Approved Indications:Small cell lung cancer, non-small cell lung cancer (China), liver cancer, kidney cancer, head and neck squamous cell carcinoma (China), colorectal cancer, melanoma, Hodgkin lymphoma, urothelial cancer, gastric cancer (China) )
Strengths:40 mg/4 mL, 100 mg/10 mL, 240 mg/24 mL
Recommended dose for lung cancer:
strong>240mg every 2 weeks or 480mg every 4 weeks, intravenously for 30 minutes.
Storage conditions: 2°C-8°C refrigerated storage
A series of preclinical studies suggest that ICIs and antiangiogenic therapy may have Synergistic antitumor effect. Antiangiogenic therapy not only normalizes the tumor vasculature but also optimizes the tumor’s immune microenvironment. Similar to the promising results of preclinical studies, numerous clinical trials have demonstrated an encouraging clinical benefit and favorable safety profile of the combination of ICIs and antiangiogenic drugs in patients with advanced NSCLC.
Recombinant human endostatin can down-regulate the expression of vascular endothelial growth factors (VEGFs) and inhibit other important targets, such as matrix metalloproteinase (MMP), hypoxia-inducible factor 1 alpha (HIF-1α) , basic fibroblast growth factor (bFGF) (13, 14). Therefore, recombinant human endostatin, as a multi-targeted angiogenesis inhibitor, is comparable to other anti-angiogenic drugs such as monoclonal antibodies (mAbs) and tyrosine kinase inhibitors (TKIs). , has its own advantages.
Clinical Data
A total of 37 patients were screened for eligibility between April 23, 2019 and January 30, 2021. Finally, a total of 34 advanced NSCLC patients without targeted driver mutations received nivolumab combined with recombinant human endostatin. Eligible patients received nivolumab (3 mg/kg, IV infusion, day 1) every 2 weeks and recombinant human endostatin (210 mg, continuous IV infusion over 168 hours) every 4 weeks.
All patients had previously received chemotherapy with or without anti-angiogenic drugs, but none had received immunotherapy. Among these patients, the median age was 60 years, 26.5% had an ECOG score of 2, and 50.0% were current or former smokers. Histological types included: adenocarcinoma in 22 cases (64.7%), squamous cell carcinoma in 8 cases (23.5%), and lymphoepithelioma-like carcinoma in 4 cases. 29.4% of patients had metastases in more than two organs, of which 9 (26.5%) had liver metastases and 8 (23.5%) had brain metastases. 32.4% of patients had received >2 systemic therapy in the past, and 47.1% had received antiangiogenic therapy in the past.
The primary endpoint of the study was objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DOR), clinical benefit response rate (CBR), progression-free survival (PFS), overall survival (OS) and safety .
Among all patients (n=34) with a median follow-up of 12.2 months, 14 (41.2%) patients achieved partial response (PR) and 8 (23.5%) patients had stable disease (SD), 12 patients (35.5%) had disease progression (PD); the objective response rate (ORR) was 41.2%, and the disease control rate (DCR) was 64.7%;< /strong>The clinical benefit response rate (CBR) was 44.1%, and the median duration of response (DOR) was 6.9 months.
In the efficacy evaluable population (n=31), 14 (45.2%) patients achieved PR, 8 (25.8%) patients achieved SD, and 9 (29%) patients developed PD ; ORR was 45.2%, DCR was 71%; CBR was 48.4%, median DOR was 6.9 months.
Overall, median progression-free survival (mPFS) was 6.8 months and median overall survival (mOS) was 17.1 months, the 12-month OS rate was 64.4%.
Adverse Reactions
Among all enrolled patients, 18 (52.9%) experienced at least one treatment-related adverse reaction, including 4 (11.8%) Grade 3 adverse reactions.
The most common adverse reactions included: hypothyroidism (20.6%), arrhythmia (14.7%), immune related Pneumonia (8.8%), proteinuria (8.8%), hepatic dysfunction (5.9%), and elevated serum creatinine (5.9%).
Grade 3 adverse reactions included: immune-related pneumonitis (5.9%), atrial fibrillation (2.9%), and catheter-related infection< /strong> (2.9%). Treatment was discontinued in 3 patients due to immune-related pneumonia or catheter-related infection, and treatment was delayed in 1 patient due to atrial fibrillation.
Conclusion
This study is the first to evaluate the effect of nivolumab combined with recombinant human endostatin in previously treated patients with advanced NSCLC. Given its favorable efficacy and safety profile, the combination represents a promising treatment option in this patient population.
[Important Note] All article information is for reference only, specific treatment Follow the doctor’s advice!
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