Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The...

Area of Science:

• Oncology
• Translational Research
• Clinical Trials

Background:

• Metastatic non-small cell lung cancer (mNSCLC) after standard therapies presents a therapeutic challenge.
• Previous treatments for mNSCLC include platinum-based chemotherapy, anti-PD-(L)1 agents, and targeted therapies for actionable genomic alterations (AGAs).

Purpose of the Study:

• To evaluate the efficacy and safety of sacituzumab govitecan (SG) compared to docetaxel in patients with mNSCLC.
• The study focused on patients whose disease progressed despite platinum-based chemotherapy, anti-PD-(L)1 therapy, and targeted treatment for AGAs.

Main Methods:

• The EVOKE-01 study was an open-label, phase III trial with patients randomized 1:1 to receive either SG or docetaxel.
• Stratification factors included histology, response to prior anti-PD-(L)1 therapy, and prior AGA treatment.
• The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), objective response rate, and safety.

Main Results:

• The primary endpoint of overall survival was not statistically met; however, a numerical OS improvement was observed with SG (median 11.1 months) versus docetaxel (median 9.8 months).
• A significant overall survival benefit was observed in the subgroup of patients with mNSCLC unresponsive to their last anti-PD-(L)1-containing regimen, with a 3.5-month median OS increase favoring SG.
• Sacituzumab govitecan demonstrated a more favorable safety profile, with fewer treatment-related adverse events leading to discontinuation compared to docetaxel.

Conclusions:

• While not statistically significant, sacituzumab govitecan showed a numerical improvement in overall survival across histologies in heavily pretreated mNSCLC.
• A clinically meaningful overall survival benefit was observed in patients with mNSCLC who were nonresponsive to their last anti-PD-(L)1-containing regimen.
• Sacituzumab govitecan was better tolerated than docetaxel, consistent with its known safety profile and presenting no new safety concerns.