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Johnson & Johnson/ Legend Biotech Partnered Blood Cancer Drug Extends Overall Survival, Support Use In Previously Treated Patients

Johnson & Johnson/ Legend Biotech Partnered Blood Cancer Drug Extends Overall Survival, Support Use In Previously Treated Patients

強生公司與傳奇生物合作的血癌藥物延長整體生存期,支持在先前治療過的患者中使用
Benzinga ·  09/30 09:47

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

週五,傳奇生物技術公司(納斯達克股票代碼:LEGN)和強生公司(紐約證券交易所代碼:JNJ)公佈了第三期 CARTITUDE-4 研究的最新三年隨訪數據。

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.

數據顯示,單次輸注Carvykti(ciltacabtagene autoleucel)可顯著延長先前接受過至少一種治療的復發或來那度胺難治性多發性骨髓瘤患者的總存活率(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.

該公司表示,對於來那度胺難治性多發性骨髓瘤患者,Carvykti現在是第一種也是唯一一種早在第二線就改善操作系統與標準療法相比的細胞療法。

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

這些結果已在2024年國際骨髓瘤協會年會上公佈。

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.

CARTITUDE-4 第 3 期研究評估了 Carvykti 與波馬度胺、硼替佐米和地塞米松 (PvD) 或達拉妥單抗、泊馬度胺和地塞米松 (dpD) 在前一線治療後復發或來那度胺難治性多發性骨髓瘤的標準療法的比較。

  • 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.
  • 在將近三年(34個月)的中位隨訪中,Carvykti組患者的操作系統中位數未達到中位數。
  • 在30個月的隨訪中,Carvykti組的操作系統發病率爲76%,接受標準療法治療的患者的操作系統發病率爲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.

在隨機分配到Carvykti組的患者中,與標準療法相比,Carvykti將死亡風險降低了45%,這表明患者早在首次復發後就具有臨床意義的反應。

  • 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.
  • Patients in the Carvykti arm had a 77% complete response or better and an 85% overall response rate.
  • 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.
  • The Median duration of response was not reached in the Carvykti arm, but it was 18.69 months for patients treated with standard therapies.
  • Median time to symptom worsening was not reached with Carvykti and 34.33 months with patients treated with standard therapies.
  • Carvykti組未達到中位無進展存活率(PFS),接受標準療法治療的患者未達到11.79個月,表現出持續的深度和持久反應。
  • Carvykti組患者的完全反應爲77%或更好,總體反應率爲85%。
  • 與接受標準療法治療的患者(18.5%,9%)相比,Carvykti組的患者在10-5時的最小殘留疾病(MRD)陰性率爲62%,在10-6時MRD陰性爲57%。
  • Carvykti組未達到中位緩解持續時間,但接受標準療法治療的患者爲18.69個月。
  • Carvykti未達到症狀惡化的平均時間,接受標準療法治療的患者達到34.33個月。

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·布萊爾認爲這些數據是該公司邁出的積極一步,進一步證明了Carvykti用於二線治療的理由。

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.

這位分析師寫道,短期收入和股票表現將在很大程度上取決於商業製造業的可用性。威廉·布萊爾的展望仍然是,Legend的估值公平地反映了Carvykti在二線以上待遇方面的認可、其預期的峯值收入以及其他管道項目的當前進展。

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

價格走勢:週一最後一次盤前交易中,LEGN股價上漲2.29%,至50.40美元。

Illustration of Phrama lab worker created with MidJourney

使用 MidJourney 創作的 Phrama 實驗室工作人員的插圖

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