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β-glucan combined with Envafolimab and Endostar as immune rechallenge for metastatic non-small cell lung cancer
Qian Geng1,2, Yingying Lu2, Dongqing Li1,2
1Changzhou Medical Center, Nanjing Medical University, Changzhou, 213003, China.
Background:
Immune checkpoint inhibitor rechallenge has emerged as a prominent study area in non-small cell lung cancer (NSCLC). β-glucan was reported to reverse resistance to anti-PD-1/PD-L1 inhibitors by regulating the tumor microenvironment. In this self-initiated clinical trial (ChiCTR2100054796), NSCLC participants who have previously failed anti-PD-1 therapy received β-glucan (500 mg, bid, d1-21), Envafolimab (300 mg, d1) and Endostar (210 mg, civ72h) every 3 weeks until disease progression or unacceptable toxicity. The clinical efficacy and adverse events were observed, while serum samples were collected for proteomic analysis.
Results:
Twenty Three patients were enrolled from January 2022 to March 2023 (median age, 65 years; male, n = 18 [78.3%]; squamous NSCLC, n = 9 [39.1%]; mutant type, n = 13 [56.5%]). The overall response rate (ORR) was 21.7% and disease control rate (DCR) was 73.9%. Median progression-free survival (mPFS) and median overall survival (mOS) was 4.3 months [95% CI: 2.0-6.6] and 9.8 months [95% CI: 7.2-12.4], respectively. The mPFS between PD-L1 positive and negative subgroup has significant difference (6.3 months vs. 2.3 months, p = 0.002). Treatment-related adverse events (TRAEs) occurred in 52.2% of patients. The most common TRAEs were hypothyroidism (26.1%) and fatigue (26.1%). 2 (8.7%) grade 3 adverse events were reported. No adverse reaction related deaths have been observed. Proteomic analysis revealed that the levels of CASP-8, ARG1, MMP12, CD28 and CXCL5 correlated with resistance to the treatment while the levels of CD40-L and EGF related to the favorable response.
Conclusion:
β-glucan combined with Envafolimab and Endostar has considerable efficacy and safety for immune rechallenge in metastatic NSCLC patients who failed of anti-PD-1 treatment previously, especially for PD-L1 positive patients.
Insights
This study shows that combining β-glucan with Envafolimab and Endostar is effective for non-small cell lung cancer (NSCLC) patients who previously failed anti-PD-1 therapy. The treatment demonstrated considerable efficacy and safety, particularly in PD-L1 positive patients.
Area of Science:
- Oncology
- Immunotherapy
- Pharmacology
Background:
- Immune checkpoint inhibitor (ICI) rechallenge is a key strategy for non-small cell lung cancer (NSCLC).
- β-glucan has shown potential in overcoming resistance to anti-PD-1/PD-L1 therapies by modulating the tumor microenvironment.
- Previous anti-PD-1 therapy failure necessitates novel treatment approaches for advanced NSCLC.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of a combination therapy involving β-glucan, Envafolimab, and Endostar.
- To assess the impact of this regimen as an immune rechallenge strategy in metastatic NSCLC patients.
- To explore potential proteomic biomarkers associated with treatment response and resistance.
Main Methods:
- A self-initiated clinical trial (ChiCTR2100054796) enrolled 23 NSCLC patients previously treated with anti-PD-1 therapy.
- Patients received a combination of β-glucan, Envafolimab, and Endostar every three weeks until disease progression or toxicity.
- Serum samples were collected for proteomic analysis to identify response-related proteins.
Main Results:
- The overall response rate (ORR) was 21.7% and the disease control rate (DCR) was 73.9%.
- Median progression-free survival (mPFS) was 4.3 months and median overall survival (mOS) was 9.8 months.
- A significant difference in mPFS was observed between PD-L1 positive (6.3 months) and negative (2.3 months) subgroups (p=0.002).
- Common treatment-related adverse events included hypothyroidism and fatigue; no treatment-related deaths occurred.
Conclusions:
- The combination of β-glucan, Envafolimab, and Endostar demonstrates considerable efficacy and safety for immune rechallenge in metastatic NSCLC patients.
- This regimen is particularly beneficial for patients with PD-L1 positive tumors who have previously failed anti-PD-1 treatment.
- Proteomic analysis identified potential biomarkers (e.g., CASP-8, ARG1, CD40-L, EGF) correlating with treatment outcomes.
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