Batra Ullas, Sharma Mansi, Miller Alexis Andrew, Chufal Kundan Singh, Ahmad Irfan, Dewan Abhinav, Chowdhary Sabeena, Amrith B P, Sachdeva Rashi, Batra Vanshika, Umesh Preetha, Bhatia Kratika, Nathany Shrinidhi, Mehta Anurag, Filho Paulo Nunes, Tolba Khaled, Chico Isagani M, Boixader Laura Vidal, Cantini Luca, Saini Kamal S
Department of Medical Oncology, Rajiv Gandhi Cancer Institute & Research Centre, Delhi, India.
Department of Radiation Oncology, Illawarra Cancer Care Centre, New South Wales, Australia.
Immunotherapy. 2025 Aug;17(11):791-800. doi: 10.1080/1750743X.2025.2548754. Epub 2025 Sep 5.
Pembrolizumab is a standard first-line therapy for advanced/metastatic non-small cell lung cancer (a/mNSCLC) lacking actionable mutations. Data from lower-middle-income countries (LMICs) remain scarce.
From January 2019 to June 2024, we prospectively analyzed 78 a/mNSCLC patients receiving pembrolizumab-based first-line therapy. Endpoints included overall survival (OS), progression-free survival (PFS), disease control rate (DCR), and conditional survival probabilities.
With a median follow-up of 27 months, median OS was 21 months (95% CI: 12.2-30.8) and median PFS 6.3 months (95% CI: 5.5-10.1). At first response evaluation (2 months), partial response was seen in 47.4% (37/78), stable disease in 16.7% (13/78). Next-generation sequencing (85% tested) revealed non-actionable mutations in 70%; notably, 4 of 6 long-term survivors harbored KRAS mutations. PD-L1 TPS ≥ 50% significantly lowered progression and mortality risk. Age, performance status (ECOG), and disease response significantly influenced the OS. The conditional survival probability for an additional 6 months after surviving the first 6 months was 78.1% (90% in patients with controlled disease).
Real-world LMIC data demonstrated comparable effectiveness of pembrolizumab-based therapy in a/mNSCLC despite a higher proportion of adverse prognostic factors. More studies in diverse clinical settings are needed to provide a reliable estimate of benefit.
帕博利珠单抗是缺乏可操作突变的晚期/转移性非小细胞肺癌（a/mNSCLC）的标准一线治疗药物。来自中低收入国家（LMICs）的数据仍然稀缺。
从2019年1月至2024年6月，我们前瞻性分析了78例接受以帕博利珠单抗为基础的一线治疗的a/mNSCLC患者。终点包括总生存期（OS）、无进展生存期（PFS）、疾病控制率（DCR）和条件生存概率。
中位随访27个月，中位OS为21个月（95%CI：12.2 - 30.8），中位PFS为6.3个月（95%CI：5.5 - 10.1）。在首次疗效评估（2个月）时，47.4%（37/78）的患者出现部分缓解，16.7%（13/78）的患者病情稳定。二代测序（85%的患者进行了检测）显示70%的患者存在不可操作的突变；值得注意的是，6例长期存活者中有4例携带KRAS突变。PD-L1 TPS≥50%显著降低了疾病进展和死亡风险。年龄、体能状态（ECOG）和疾病反应对OS有显著影响。在前6个月存活后再存活6个月的条件生存概率为78.1%（疾病得到控制的患者中为90%）。
中低收入国家的真实世界数据表明，尽管不良预后因素比例较高，但以帕博利珠单抗为基础的治疗在a/mNSCLC中具有相当的疗效。需要在不同临床环境中进行更多研究，以提供可靠的获益估计。
