An open label, safety study of Asian patients with advanced non-small-cell lung cancer receiving second-line nivolumab monotherapy (CheckMate 870)

Abstract

Background: Nivolumab has been approved in China as second-line treatment for advanced non-small-cell lung cancer (NSCLC) via weight-based infusion, based on the CheckMate 078 study. We investigated the safety and efficacy of 240 mg flat-dose nivolumab in patients with advanced NSCLC, including those with hepatitis B virus (HBV) and epidermal growth factor receptor ( EGFR) mutation/ALK receptor tyrosine kinase ( ALK) translocation due to high prevalence in China. Methods: CheckMate 870 was a single-arm, open-label, phase IIIb trial in Asian (primarily Chinese) patients with previously treated advanced NSCLC. Patients received flat-dose nivolumab 240 mg every 2 weeks (Q2W) for up to 2 years. The primary endpoint was the incidence and severity of treatment-related select adverse events (TRsAEs) in non-HBV patients; secondary and exploratory endpoints included severity of high-grade TRsAEs in HBV-infected patients, and safety, efficacy and patient-reported outcomes (PROs) in the whole population. Results: Out of 404 patients enrolled, 400 received treatment. Median (standard deviation) age was 60.5 (8.68) years and the majority were male (78.5%). At a median follow-up of 37.6 months, no Grade 5 TRsAEs were reported, and the frequency of Grade 3–4 TRsAEs was low (0.0–5.9%) in non-HBV and HBV NSCLC patients. Median overall survival (OS) and progression-free survival (PFS) in all treated patients were 14.7 (12.3–18.1) and 3.6 (2.3–3.8) months, respectively. Median OS was 14.2 (12.3–18.1) and 22.3 (10.0–NA) months for non-HBV and HBV-infected patients, 19.3 (11.2–31.7) and 13.7 (11.5–18.1) months for EGFR-positive and wild-type subgroups, and 19.3 (12.9–23.5) and 13.3 (10.9–17.7) months for those with programmed death-ligand 1 (PD-L1) expression ⩾1% and <1%, respectively. No notable changes from baseline were observed in PROs throughout the study. Conclusion: Nivolumab 240 mg infusion Q2W was well tolerated, efficacious, and maintained health status and quality of life in Asian patients with previously treated advanced NSCLC regardless of HBV, EGFR, or PD-L1 status.

Hepatic cavernous hemangioma developed in non-small cell lung cancer patients after receiving Camrelizumab treatment: two case reports

“…They work by specifically blocking signals such as PD-1, PD-L1, and CTLA-4, thereby enhancing the body's ability to recognize and kill tumor cells. Multiple clinical studies, including KEYNOTE, IMpower, and CheckMate trials, have confirmed the anti-tumor effects of PD-1 inhibitors in various solid tumors, particularly when correlated with PD-L1 expression and tumor mutational burden (TMB) (5)(6)(7)(8). The National Comprehensive Cancer Network (NCCN) guidelines have upgraded PD-1 inhibitors to category 1A recommendation for second-line treatment in locally advanced or metastatic nonsquamous non-small cell lung cancer patients who have not received prior PD-1/PD-L1 inhibitors (9,10).…”

Prediction performance comparison of biomarkers for response to immune checkpoint inhibitors in advanced non‐small cell lung cancer

“…In part 1, following rigorous selection steps, 36 articles 10 , 11 , 12 , 19 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 were filtered from a total of 7698 manuscripts for data extraction (Figure S1 ). Finally, 59 individual biomarker results were processed, including PD‐L1 IHC ( n = 20), tTMB ( n = 10), bTMB ( n = 5), GEP ( n = 4), driver gene mutation ( EGFR , n = 6 and KRAS , n = 7) and combined marker ( n = 7, PD‐L1 + tTMB/bTMB/GEP).…”

Immunotherapy for advanced non-small cell lung cancer with negative programmed death-ligand 1 expression: a literature review

“…Therefore, patients with PD-L1-negative lung squamous cell carcinoma could be treated with nivolumab in second-line therapy, while patients with nonsquamous cell carcinoma should also be considered to be treated with nivolumab in second-line therapy. The CheckMate-078 ( 23 ) and CheckMate-870 ( 24 ) studies both suggest that nivolumab should also be attempted in second- and third-line therapy for patients with advanced NSCLC with negative PD-L1 expression in the Chinese population. The value of camrelizumab in second-line therapy in patients with negative PD-L1 expression remains to be considered.…”

“…In addition, the results of the Asian analysis showed that nivolumab had a definite OS benefit compared with docetaxel in both the PD-L1-positive and PD-L1-negative patients. Furthermore, the CheckMate-870 study (NCT03195491) ( 24 ) evaluated the efficacy and safety of nivolumab in a real-world setting in China. The minimum follow-up time of 35.4 months was reported at the European Congress on Lung Cancer (ELCC) in 2022.…”