Bolte Fabian J, Dougherty Sean C, Danos Abigail O, Lynch Alia C, Shvorak Yaroslav, Statler Sarah, Gentzler Ryan D, Hall Richard D
Division of Hematology/Oncology, Department of Medicine, University of Virginia Cancer Center, Charlottesville, VA.
Department of Pharmacy, University of Virginia Health System, Charlottesville, VA.
Clin Lung Cancer. 2025 Mar 26. doi: 10.1016/j.cllc.2025.03.006.
Tarlatamab, a bispecific T-cell engager, has shown promising results in previously treated small cell lung cancer (SCLC) patients in the DeLLphi-300 and DeLLphi-301 trials. However, reports on outcomes in more diverse, real-world patient populations are limited.
We retrospectively evaluated safety and efficacy outcomes of all patients who were treated with tarlatamab at the University of Virginia between May and October 2024.
Our analysis included 21 patients with SCLC and 1 patient with DLL-3 positive atypical carcinoid. The median age of patients was 66 years (range, 41-80 years), with 59.1% being females. Most patients (85.7%) had extensive stage SCLC at diagnosis. Brain metastases were present in 9 (40.9%) patients and liver metastasis in 14 (63.8%) patients. A total of 18 (81.8%) patients would not have met the DeLLphi-301 inclusion and exclusion criteria. Cytokine release syndrome (CRS) occurred in 16 (72.7%) patients; the median time of onset was 15.8 hours (9.1-18.8) after tarlatamab infusion. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 9 (40.9%) patients, with higher rates and grades observed in patients with untreated brain metastases. The median time of onset was 14.8 h ([IQR] 7.7-22.1) after tarlatamab infusion. After a median follow-up of 6.7 months, the overall response rate (ORR) was 42.9% in SCLC patients.
Tarlatamab is a promising treatment option for heavily pretreated small cell lung cancer patients. We observed higher rates of CRS and ICANS during the first treatment cycle suggesting that real-world safety outcomes may differ from clinical trial data.
双特异性T细胞衔接器tarlatamab在DeLLphi - 300和DeLLphi - 301试验中,已在先前接受过治疗的小细胞肺癌(SCLC)患者中显示出有前景的结果。然而,关于更多样化的真实世界患者群体的结局报告有限。
我们回顾性评估了2024年5月至10月在弗吉尼亚大学接受tarlatamab治疗的所有患者的安全性和疗效结局。
我们的分析纳入了21例SCLC患者和1例DLL - 3阳性非典型类癌患者。患者的中位年龄为66岁(范围41 - 80岁),女性占59.1%。大多数患者(85.7%)在诊断时患有广泛期SCLC。9例(40.9%)患者存在脑转移,14例(63.8%)患者存在肝转移。共有18例(81.8%)患者不符合DeLLphi - 301的纳入和排除标准。16例(72.7%)患者发生细胞因子释放综合征(CRS);中位发病时间为tarlatamab输注后15.8小时(9.1 - 18.8)。9例(40.9%)患者发生免疫效应细胞相关神经毒性综合征(ICANS),未治疗脑转移的患者中观察到更高的发生率和分级。中位发病时间为tarlatamab输注后14.8小时([IQR] 7.7 - 22.1)。中位随访6.7个月后,SCLC患者的总缓解率(ORR)为42.9%。
Tarlatamab是 heavily pretreated小细胞肺癌患者的一种有前景的治疗选择。我们在第一个治疗周期中观察到CRS和ICANS的发生率较高,这表明真实世界的安全性结局可能与临床试验数据不同。