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.
週二，強生及強生（NYSE:JNJ）宣佈了開放標籤二期SKIPPirr研究的結果，該研究評估了額外的預防性策略，以減少晚期非小細胞肺癌（NSCLC）患者使用靜脈注射創項西妥單抗（amivantamab-vmjw）時的輸液相關反應（IRR）的發生率，這些患者具有表皮生長因子受體（EGFR）外顯子19缺失（ex19del）或L858R替代突變。
Data were presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC).
數據在國際肺癌研究協會（IASLC）2024年世界肺癌大會（WCLC）上進行了演講報告。
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%.
這項40名患者的研究顯示，在第一個輸注前的兩天服用8毫克地塞米松，符合第一週期第一天（C1D1）的IRR發生率的主要終點，IV Rybrevant的全部等級IRR率爲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%.
與通過IV Rybrevant使用標準IRR管理相比，這代表IRR發生率的三倍降低，其中歷史數據觀察到全等級發生率爲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均爲輕度或中度（1級或2級），沒有患者因IRR而需要住院。沒有報告發生3級或更高級的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.
上個週末，強生及強生髮布了地標性第三期MARIPOSA研究的更長期隨訪數據，該研究顯示與奧西替尼單藥治療相比，Rybrevant聯合Lazcluze（lazertinib）的一線治療在長期臨床結果上提供了一致的益處，用於EGFR外顯子19缺失或L858R替代突變的成年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.
數據顯示，在近三年的隨訪中，有利於Rybrevant加Lazcluze的總體生存（OS）趨勢強勁且持續改善。
- 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治療的患者中有61％倖存，而接受奧西替尼治療的患者中有53％倖存（中位OS無法估算vs37.3個月）。
Overall survival will continue to be assessed with longer term follow-up as a key secondary endpoint.
隨着更長時間的隨訪，總體生存率將繼續進行評估，並作爲主要的次要終點評估。
Results further showed Rybrevant plus Lazcluze demonstrated a trend toward improved central nervous system disease control compared to osimertinib at three years.
結果進一步顯示，與奧妥昔單抗相比，雷沙替尼與拉替倫聯合使用在三年的中樞神經系統疾病控制方面表現出趨勢性改善。
- Intracranial PFS was double for Rybrevant plus Lazcluzeversus osimertinib (38% vs. 18%, respectively).
- 雷沙替尼與拉替倫與奧妥昔單抗相比，顱內PFS翻倍（分別爲38% vs. 18%）。
More patients remained on treatment with the Rybrevant plus Lazcluze combination compared to osimertinib (40% vs. 29%).
與奧妥昔單抗相比，更多患者選擇繼續接受雷沙替尼與拉替倫聯合用藥（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，在三年的隨訪中，接受雷沙替尼與拉替倫聯合用藥的患者中，更多的患者尚未開始下一線治療，與使用奧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.
在第一次後繼治療後的無進展生存率，雷沙替尼與拉替倫聯合用藥組爲57%，奧妥昔單抗組爲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，基於這項研究中所展示的良好療效和安全性，FDA通過優先審查批准了雷沙替尼與拉替倫用作EGFR突變非小細胞肺癌的一線治療方案。
Price Action: JNJ stock is up 0.09% at $167.53 during the premarket session at last check Wednesday.
股價走勢：截至星期三最後一次查看，週三盤前交易中，強生股票上漲0.09%，報167.53美元。
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Photo: Shutterstock
Photo: shutterstock