EVOKE-01 Trial

Background

Phase 3 RCT (EVOKE-01); N≈486 advanced NSCLC previously treated with platinum chemotherapy and immunotherapy, comparing the TROP2 ADC sacituzumab govitecan vs docetaxel.

Interventions and follow up

Arm A: Sacituzumab govitecan 10 mg/kg IV days 1 and 8 of q3w cycle
Arm B: Docetaxel 75 mg/m² IV q3w
Primary endpoint: overall survival
mFollow up: ~15mo

Results

mOS: 11.1mo vs 9.8mo, HR 0.84, 95%CI 0.69-1.02, P=.05; missed significance
mPFS: ~4.1mo vs 3.9mo, HR ~0.92, P NR
ORR: 13.7% vs 18.1%

Adverse events

Overall: grade 3-4 treatment-related AEs ~30% vs 40%, favoring sacituzumab
Hematologic: less febrile neutropenia with the ADC
Dermatologic: less alopecia with the ADC

Conclusions

Sacituzumab govitecan showed a numerical OS trend over docetaxel in pretreated NSCLC with a more favorable safety profile, but narrowly missed the OS endpoint.

Key Limitations

Negative for primary OS endpoint; ORR lower than docetaxel; docetaxel control arm did not include ramucirumab; PFS benefit marginal.

Clinical Context

Formally a negative trial; did not change practice for post-chemo-ICI NSCLC. Subgroup signal (non-responders to prior ICI) hypothesis-generating; sacituzumab govitecan not approved in NSCLC on this basis.

References