Friday, Legend Biotech Corporation LEGN and Johnson & Johnson JNJ announced late-breaking three-year follow-up data from the Phase 3 CARTITUDE-4 study.

周五，Legend Biotech Corporation LEGN和Johnson＆Johnson JNJ宣布了第三阶段CARTITUDE-4研究的最新三年随访数据。

Data shows that a single infusion of Carvykti (ciltacabtagene autoleucel) significantly extended overall survival (OS) for relapsed or lenalidomide-refractory multiple myeloma patients who have received at least one prior line of therapy.

数据显示，单次输注Carvykti（ciltacabtagene autoleucel）可显着延长接受至少一种先前治疗方案的复发或来那度胺难治性多发性骨髓瘤患者的总生存期（OS）。

The company says Carvykti is now the first and only cell therapy to improve OS versus standard therapies for patients with lenalidomide-refractory multiple myeloma as early as the second line.

该公司表示，Carvykti是目前第一种也是唯一一种改善OS的细胞疗法，而来那度胺难治性多发性骨髓瘤患者的标准疗法早在二线治疗时就已经出现。

These results were presented at the 2024 International Myeloma Society Annual Meeting.

这些结果在2024年国际骨髓瘤学会年会上发表。

The Phase 3 CARTITUDE-4 study evaluated Carvykti compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.

3期CARTITUDE-4研究评估了Carvykti与标准疗法pomalidomide，硼替佐米和地塞米松（PVd）或daratumumab，pomalidomide和地塞米松（DPd）相比，用于治疗一种先前的治疗方案后复发或来那度胺难治性多发性骨髓瘤。

At a median follow-up of almost three years (34 months), median OS was not reached for patients in the Carvykti arm.

。

At 30-month follow-up, OS rates were 76% in the Carvykti arm and 64% for patients treated with standard therapies.

在30个月的随访中，Carvykti组的OS率为76%，标准治疗组为64%。

In patients randomized to the Carvykti arm, Carvykti reduced the risk of death by 45% compared to standard therapies, demonstrating clinically meaningful responses for patients as early as after the first relapse.

在随机分配到Carvykti组的患者中，与标准疗法相比，Carvykti将死亡风险降低了45%，这表明早在首次复发后患者就有临床意义的反应。

Median progression-free survival (PFS) was not reached in the Carvykti arm and 11.79 months in patients treated with standard therapies, demonstrating sustained deep and durable responses.

Carvykti组未达到中位无进展生存期（PFS），接受标准治疗的患者未达到11.79个月，表明持续的深度和持久反应。

Patients in the Carvykti arm had a 77% complete response or better and an 85% overall response rate.

Carvykti组患者的完全缓解率为77%或更好，总体缓解率为85%。

Patients in the Carvykti arm had 62% minimal residual disease (MRD)negativity at 10-5 and 57% MRD negativity at 10-6, compared to patients treated with standard therapies (18.5%, 9%), respectively.

与使用标准疗法治疗的患者（18.5%，9%）相比，Carvykti组患者在10-5时具有62%的最小残留病（MRD）阴性，在10-6时具有57%的MRD阴性。

The Median duration of response was not reached in the Carvykti arm, but it was 18.69 months for patients treated with standard therapies.

Carvykti组未达到中位反应持续时间，但接受标准治疗的患者为18.69个月。

Median time to symptom worsening was not reached with Carvykti and 34.33 months with patients treated with standard therapies.

Carvykti未达到症状恶化的中位时间，标准治疗患者未达到34.33个月。

William Blair views this data as a positive step for the company, reinforcing the case for Carvykti’s use in second-line treatment.

威廉·布莱尔（WilliamBlair）将此数据视为该公司迈出的积极一步，强化了Carvykti用于二线治疗的理由。

The analyst writes that the near-term revenue and stock performance will largely depend on the availability of commercial manufacturing slots. William Blair’s outlook remains that Legend’s valuation fairly reflects the approval of Carvykti in second-line-plus treatment, its anticipated peak revenue, and the current progress of its other pipeline programs..

这位分析师写道，近期收入和股票表现将在很大程度上取决于商业制造业的可用性。威廉·布莱尔（WilliamBlair）的观点仍然是，Legend的估值公平地反映了Carvykti在二线治疗方面的批准，其预期的最高收入以及其他管道项目的当前进展。。

Price Action: LEGN stock is up 2.29% at $50.40 during the premarket session at last check Monday.

价格走势：LEGN股价在周一最后一次检查的上市前交易中上涨2.29%，至50.40美元。

Illustration of Phrama lab worker created with MidJourney

用MidTourney创建的Phrama lab worker的插图

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