2月2023： The Food and Drug Administration (FDA) has approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for people with hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer that has spread to other parts of the body and can not be removed. These people have also had at least two other systemic therapies in a metastatic setting.
TROPiCS-02 (NCT03901339) was a multicenter, open label, randomized study that looked at how well a CDK 4/6 inhibitor, endocrine therapy, and a taxane worked in 543 women with HR-positive, HER2-negative breast cancer that had spread or could not be removed. The patients’ disease got worse after receiving any of these treatments. At least two previous chemotherapies were administered to patients with metastatic disease (one of which could be in the neoadjuvant or adjuvant setting if recurrence occurred within 12 months).
患者は、1日サイクルの1日目と271日目に、単剤化学療法（n = 10）またはサシツズマブ ゴビテカン-ジイ（1 mg/kg）の静脈内注入を受ける群にランダムに割り当てられました（8：21）。 無作為化の前に、研究者は次の選択肢の 22 つから単剤化学療法レジメンを選択しました: カペシタビン (n=63)、ビノレルビン (n=56)、ゲムシタビン (n=130)、またはエリブリン (n=2)。 転移性疾患に対する以前の化学療法レジメン（3対4～6）、内臓転移（はいまたはいいえ）、および少なくともXNUMXか月間にわたる転移環境における内分泌療法はすべて、無作為化の層別化（はいまたはいいえ）に使用されました。 患者は、許容できない副作用が現れるまで治療を受けました。
Progression-free survival (PFS), as defined by a blinded independent central review in accordance with RECIST v1.1, served as the primary efficacy outcome measure. Overall survival was a crucial secondary efficacy outcome metric (OS). The median PFS for the sacituzumab govitecan-hziy arm was 5.5 months (95% CI: 4.2, 7.0) and for the single agent chemotherapy arm was 4 months (95% CI: 3.1, 4.4) (hazard ratio [HR] of 0.661 [95% CI: 0.529, 0.826]; p-value=0.0003). For those getting sacituzumab govitecan-hziy, the median OS was 14.4 months (95% CI: 13.0, 15.7), whereas for those receiving single agent chemotherapy, it was 11.2 months (95% CI: 10.1, 12.7) (HR of 0.789 [95% CI: 0.646, 0.964]; p-value=0.0200).
白血球数の減少 (88%)、好中球数の減少 (83%)、ヘモグロビンの減少 (73%)、リンパ球数の減少 (65%)、下痢 (62%)、疲労 (60%)、吐き気 (59%)、脱毛症TROPiCS-48 でサシツズマブ ゴビテカン-hziy で治療された患者で最も頻繁に見られた有害事象 (37%) は、グルコースの増加 (34%)、便秘 (32%)、およびアルブミンの減少 (25%) でした。
On Days 1 and 8 of a 21-day therapy cycle, 10 mg/kg of sacituzumab govitecan-hziy should be infused intravenously once a week until the disease gets worse or the side effects become too much to handle, whichever comes first.
Project Orbis, an initiative of the FDA Oncology Center of Excellence, was used to carry out this review. Using the infrastructure that Project Orbis provides, international partners can submit and review oncology medications simultaneously. FDA worked together on this review with the Therapeutic Goods Administration (TGA) of Australia, Health Canada, and Swissmedic. At the other regulatory organizations, the application reviews are still proceeding.
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