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（紐約證券交易所代碼：JNJ）公佈了開放標籤的2期SkipPirr研究的結果，該研究評估了其他預防策略，以降低表皮生長因子受體（EGFR）晚期非小細胞肺癌（NSCLC）患者靜脈注射（IV）Rybrevant（amivantamab-vmjw）患者發生輸液相關反應（IRR）的發生率外顯子 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).
數據已在國際肺癌研究協會（IASLC）2024年世界肺癌大會（WCLC）上公佈。
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名患者的研究表明，在第一次輸液前兩天服用8毫克地塞米松的預防達到週期第一天（C1D1）的IRR發生率的主要終點，靜脈注射的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%.
這意味着與IV Rybrevant的標準IRR管理相比，IRR的發病率減少了三倍，IV Rybrevant的歷史數據顯示，所有年級的發病率爲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。未報告三級或更高的 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.
上週末，強生公佈了具有里程碑意義的MARIPOSA三期研究的更長隨訪數據，該研究顯示，與奧美替尼單一療法相比，在表皮生長因子19缺失或 L858R 替代突變的成年非小細胞肺癌患者中，與奧美替尼單一療法相比，Rybrevant聯合Lazcluze（lazertinib）的一線治療在長期療效方面具有持續的益處。
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，在大約三年的隨訪中，總體存活率（OS）呈強勁且不斷改善的趨勢，有利於Rybrevant和Lazcluze。
- 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％還活着，而接受奧美替尼治療的患者中，這一比例爲53％（與37.3個月相比，操作系統中位數不可估計）。
Overall survival will continue to be assessed with longer term follow-up as a key secondary endpoint.
將繼續評估總體存活率，將長期隨訪作爲關鍵的次要終點。
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，與奧美替尼相比，三年後Rybrevant加Lazcluze顯示出改善中樞神經系統疾病控制的趨勢。
- Intracranial PFS was double for Rybrevant plus Lazcluzeversus osimertinib (38% vs. 18%, respectively).
- Rybrevant加上Lazcluzeversus osimertinib的顱內PFS翻了一番（分別爲38％和18％）。
More patients remained on treatment with the Rybrevant plus Lazcluze combination compared to osimertinib (40% vs. 29%).
與奧西替尼相比，仍在接受Rybrevant加Lazcluze組合治療的患者更多（40％對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，與奧美替尼相比，在爲期三年的隨訪中接受Rybrevant加Lazcluze治療的患者更多沒有開始後續治療（45％對32％）。
Progression-free survival after the first subsequent therapy was 57% for Rybrevant plus Lazcluze combination compared to 49% for osimertinib.
Rybrevant加Lazcluze組合在首次後續治療後的無進展存活率爲57％，而奧西替尼的無進展存活率爲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，美國食品藥品管理局根據該研究顯示的良好療效和安全性，批准了Rybrevant和Lazcluze作爲表皮生長因子突變非小細胞肺癌患者的一線療法。
Price Action: JNJ stock is up 0.09% at $167.53 during the premarket session at last check Wednesday.
價格走勢：在週三最後一次盤前交易中，JNJ股價上漲0.09％，至167.53美元。
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照片：Shutterstock
譯文內容由第三人軟體翻譯。