Johnson & Johnson's Mid-Stage Lung Cancer Trial Reveals Fewer Infusion-Related Reactions
Johnson & Johnson's Mid-Stage Lung Cancer Trial Reveals Fewer Infusion-Related Reactions
Tuesday, Johnson & Johnson (NYSE:JNJ) announced results from the open-label Phase 2 SKIPPirr study, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related reactions (IRRs) with intravenous (IV) Rybrevant (amivantamab-vmjw) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
周二，强生及强生（NYSE:JNJ）宣布了开放标签二期SKIPPirr研究的结果，该研究评估了额外的预防性策略，以减少晚期非小细胞肺癌（NSCLC）患者使用静脉注射创项西妥单抗（amivantamab-vmjw）时的输液相关反应（IRR）的发生率，这些患者具有表皮生长因子受体（EGFR）外显子19缺失（ex19del）或L858R替代突变。
Data were presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC).
数据在国际肺癌研究协会（IASLC）2024年世界肺癌大会（WCLC）上进行了演讲报告。
The 40-patient study showed that prophylaxis with 8-mg dexamethasone taken for two days before the first infusion met the primary endpoint of incidence of IRRs at Cycle 1 Day 1 (C1D1), with an all-grades IRR rate for IV Rybrevant of 22.5%.
这项40名患者的研究显示，在第一个输注前的两天服用8毫克地塞米松，符合第一周期第一天（C1D1）的IRR发生率的主要终点，IV Rybrevant的全部等级IRR率为22.5％。
This represents a three-fold reduction in the incidence of IRRs compared to standard management of IRRs with IV Rybrevant, where historical data has observed an all-grades incidence rate of 67.4%.
与通过IV Rybrevant使用标准IRR管理相比，这代表IRR发生率的三倍降低，其中历史数据观察到全等级发生率为67.4％。
All IRRs were mild or moderate (Grade 1 or 2), with no patients requiring hospitalization due to IRRs. No Grade 3 or higher IRR events were reported.
所有IRR均为轻度或中度（1级或2级），没有患者因IRR而需要住院。没有报告发生3级或更高级的IRR事件。
Over the last weekend, Johnson & Johnson presented longer follow-up data from the landmark Phase 3 MARIPOSA study which showed first-line treatment with Rybrevant combined with Lazcluze (lazertinib) provided consistent benefit across long-term outcomes compared to osimertinib monotherapy in adult NSCLC patients with EGFR exon 19 deletions or L858R substitution mutations.
上个周末，强生及强生发布了地标性第三期MARIPOSA研究的更长期随访数据，该研究显示与奥西替尼单药治疗相比，Rybrevant联合Lazcluze（lazertinib）的一线治疗在长期临床结果上提供了一致的益处，用于EGFR外显子19缺失或L858R替代突变的成年NSCLC患者。
The data show a strong and improving overall survival (OS) trend favoring Rybrevant plus Lazcluze at approximately three years of follow-up.
数据显示，在近三年的随访中，有利于Rybrevant加Lazcluze的总体生存（OS）趋势强劲且持续改善。
- 61% of patients receiving Rybrevant plus Lazcluze were alive compared to 53% of those treated with osimertinib (Median OS not estimable vs 37.3 months).
- 接受Rybrevant加Lazcluze治疗的患者中有61％幸存，而接受奥西替尼治疗的患者中有53％幸存（中位OS无法估算vs37.3个月）。
Overall survival will continue to be assessed with longer term follow-up as a key secondary endpoint.
随着更长时间的随访，总体生存率将继续进行评估，并作为主要的次要终点评估。
Results further showed Rybrevant plus Lazcluze demonstrated a trend toward improved central nervous system disease control compared to osimertinib at three years.
结果进一步显示，与奥妥昔单抗相比，雷沙替尼与拉替伦联合使用在三年的中枢神经系统疾病控制方面表现出趋势性改善。
- Intracranial PFS was double for Rybrevant plus Lazcluzeversus osimertinib (38% vs. 18%, respectively).
- 雷沙替尼与拉替伦与奥妥昔單抗相比，颅内PFS翻倍（分别为38% vs. 18%）。
More patients remained on treatment with the Rybrevant plus Lazcluze combination compared to osimertinib (40% vs. 29%).
与奥妥昔單抗相比，更多患者选择继续接受雷沙替尼与拉替伦联合用药（40% vs. 29%）。
Additionally, more patients receiving Rybrevant plus Lazcluze at the three-year follow-up had not started a subsequent therapy versus osimertinib (45% vs. 32%).
此外，在三年的随访中，接受雷沙替尼与拉替伦联合用药的患者中，更多的患者尚未开始下一线治疗，与使用奥妥昔單抗的患者相比（45% vs. 32%）。
Progression-free survival after the first subsequent therapy was 57% for Rybrevant plus Lazcluze combination compared to 49% for osimertinib.
在第一次后继治疗后的无进展生存率，雷沙替尼与拉替伦联合用药组为57%，奥妥昔單抗组为49%。
In August 2024, the FDA approved Rybrevant plus Lazcluze following a Priority Review as a first-line therapy for patients with EGFR-mutated NSCLC based on the favorable efficacy and safety profile demonstrated in this study.
2024年8月，基于这项研究中所展示的良好疗效和安全性，FDA通过优先审查批准了雷沙替尼与拉替伦用作EGFR突变非小细胞肺癌的一线治疗方案。
Price Action: JNJ stock is up 0.09% at $167.53 during the premarket session at last check Wednesday.
股价走势：截至星期三最后一次查看，周三盘前交易中，强生股票上涨0.09%，报167.53美元。
- AT&T CEO John Stankey Flags Normalizing Wireless Trends And Strong Fiber Growth: Details.
- AT&T首席执行官约翰·斯坦基指出无线趋势正在正常化并且光纤增长强劲：详情请见。
Photo: Shutterstock
Photo: shutterstock