Friday, the FDA approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.
The FDA approval was based on the pivotal AEGEAN trial results published in The New England Journal of Medicine in October 2023.
Also Read: AstraZeneca's Blockbuster Cancer Drug Imfinzi Flunks As Follow-Up In Type Of Early-Stage Lung Cancer, But Hits Primary Goal In Phase 3 Bladder Cancer Study.
Results from a planned interim analysis of event-free survival (EFS) showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events, or death versus chemotherapy alone in patients treated with the Imfinzi-based regimen before and after surgery (32% data maturity; EFS hazard ratio of 0.68.
In a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone.
Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings.
Imfinzi has also been approved in the UK, Switzerland, and Taiwan (China) in this setting based on the AEGEAN results.
Regulatory applications are also currently under review in the EU, China, and several other countries in this indication.
Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase 3 trial.
Thursday, the FDA accepted and granted Priority Review for a supplemental marketing application seeking approval for Imfinzi limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024.
The application is based on data from the ADRIATIC Phase 3 trial.
In the trial, Imfinzi reduced the risk of death by 27% compared to placebo (based on an overall survival [OS] hazard ratio [HR] of 0.73).
The estimated median OS was 55.9 months for Imfinzi versus 33.4 months for placebo.
An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% on placebo.
Imfinzi also reduced the risk of disease progression or death by 24% (based on progression-free survival [PFS] HR of 0.76) versus placebo. Median PFS was 16.6 months for Imfinzi versus 9.2 months for placebo.
An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% on placebo.
Price Action: AZN stock is up 0.33% at $85.18 during the premarket session at the last check on Friday.
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FDA批准阿斯利康(AstraZeneca Plc,NASDAQ:AZNy)的Imfinzi(durvalumab)联合化疗用于无表皮生长因子受体突变或间变性淋巴瘤患者的可切除早期非小细胞肺癌(NSCLC)治疗。
在这种方案中,患者在手术前接受Imfinzi与新辅助化疗治疗,手术后作为辅助单药治疗。
FDA批准是基于关键的AEGEAN试验结果,《新英格兰医学杂志》于2023年10月公布。
阅读更多:阿斯利康(AstraZeneca)的震撼癌症药物Imfinzi在早期非小细胞肺癌的后续随访中失败,但在第III期膀胱癌研究中达到了主要目标。
事件发生自由生存的计划中间分析结果显示,在接受Imfinzi联合化疗治疗的患者(手术前后治疗)中,复发、进展事件或死亡的风险比单独化疗降低了32%,具有统计学意义和临床意义(32%数据成熟度; EFS风险比为0.68)。
在病理学完全反应(pCR)的最终分析中,先用Imfinzi联合新辅助化学疗法治疗然后再手术的治疗可使pCR率达到17.2%,而单独新辅助化学疗法的患者仅有4.3%。
Imfinzi耐受性良好,在新辅助和辅助设置中未观察到任何新的安全信号。
在AEGEAN试验结果的基础上,Imfinzi也已在英国、瑞士和台湾(中国)的此种设置中获批准。
监管机构也正在审查该适应症在欧盟、中国和其他几个国家的申请。
Imfinzi是在PACIFIC第III期试验的基础上获得批准的唯一的免疫治疗药物,也是在无法手术切除的III期NSCLC患者中,在化疗放疗基础上治疗的全球标准。
FDA同意并为补充营销申请授予Imfinzi在铂类联合放化疗后其小细胞肺癌疾病未进展的患者中的有限期的审查优先权。
处方药用户费法案日期,它是FDA决策的行动日期,预计在2024年第四季度进行。
申请基于ADRIATIC第III期试验数据。
在这项试验中,Imfinzi与安慰剂相比,死亡风险降低了27%(基于总生存[OS]风险比[HR]为0.73)。
Imfinzi的估计中位总生存时间为55.9个月,而安慰剂为33.4个月。
接受Imfinzi治疗的患者中,约有57%在三年后仍然存活,而安慰剂组为48%。
Imfinzi还可以比安慰剂显著降低疾病进展或死亡的风险(基于进展无瘤生存[PFS] HR为0.76)。Imfinzi的中位无进展生存期为16.6个月,而安慰剂为9.2个月。
接受Imfinzi治疗的患者中,约有46%在两年后没有经历疾病进展,而安慰剂组为34%。
股价行动:在周五最新一次查看时,AZN股票上涨0.33%,报85.18美元的盘前交易时段。
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