A historic day for solid tumor oncology.
China has approved satri-cel (CLDN18.2 CAR-T) for advanced gastric/GEJ cancer, making it the first CAR-T therapy ever approved for a solid tumor. For years, CAR-T has transformed hematologic malignancies while solid tumors remained left in the dust.
📊 CT041-ST-01 (3L+ CLDN18.2+ gastric/GEJ cancer) in the Lancet
• Median PFS: 3.25 vs 1.77 months (HR 0.37)
• Median OS: 7.9 vs 5.5 months (HR 0.69)
• 18-month OS: 20% vs 10%
• Demonstrated superiority over physician’s choice therapy in a heavily pretreated population.
The absolute numbers are not dramatic, but that isn’t the point.
This is the first regulatory approval of a CAR-T for a solid tumor.
Also notable: this happened in China, not the United States.
As China continues to accelerate development of cell therapies, ADCs, and other oncology platforms, it is increasingly becoming the site of first-in-class innovation.
Satri-cel may ultimately be remembered less for the 2.4-month OS gain and more for what it represents:
The beginning of the solid tumor CAR-T era.
@Onco_Nexus@OncoAlert@TheGutOncLab
https://t.co/gon4I3udIR
先週のテクリスタマブに続き、MM(多発性骨髄腫)で二重特異性抗体の画期的な試験結果。こちらはタルケタマブ。1ライン以上の治療を受けた再発MM患者で、2種類のレジメン(Tal-DP、Tal-D)対DPdで24ヶ月PFSで81.3%、77.6% vs. 51.2%、と圧勝。MMの治療の進展速度は本当に凄い。
https://t.co/59sGIHCnud