Sacituzumab Govitecan + Pembrolizumab in 1L Metastatic Non–Small Cell Lung Cancer: Preliminary Results of the EVOKE-02 Study

Sandip P. Patel, MD, reviews data from the preliminary results of the EVOKE-02 study investigating sacituzumab govitecan plus pembrolizumab in first-line metastatic non–small cell lung cancer.

Background

  • PD-(L)1 inhibitor-based regimens have been established as the standard-of-care 1L treatment for mNSCLC,1,2 and novel combination therapies are needed to further improve outcomes
  • Sacituzumab govitecan is a Trop-2–directed ADC approved in the United States for the treatment of
    2L+ mTNBC and pretreated HR+/HER2– mBC, and received accelerated approval for 2L mUC3
  • Sacituzumab govitecan has previously demonstrated clinical activity and manageable safety in heavily pretreated patients with mNSCLC4
  • EVOKE-02 (NCT05186974) is an ongoing, multicohort phase 2 study of sacituzumab govitecan + pembrolizumab ± platinum agent in patients with untreated 1L mNSCLC
  • Here, we report preliminary results of patients treated with sacituzumab govitecan + pembrolizumab in Cohorts A and B from the EVOKE-02 study

Methods

  • The preliminary efficacy data reported in this presentation are results by investigator assessment.
  • Only patients enrolled ≥ 13 weeks prior to the data cutoff date (16 June 2023) were included in the efficacy analysis.
  • All patients who received ≥ 1 dose of study treatment were included in the safety analysis.

Results

  • At data cutoff (16 June 2023), median (range) follow-up for Cohorts A and B was 5.0 (1.7-12.0) and 5.8 (1.0-12.2) months, respectively
  • Across both cohorts, the most common reason for discontinuation of sacituzumab govitecan was progressive disease
  • The most common any-grade TEAEs were diarrhea (54%), anemia (48%), and asthenia (38%)
  • Immune-mediated TEAEs were consistent with the known safety profile of pembrolizumab.

Conclusions

  • SG + Pembro demonstrated encouraging antitumor activity in patients with 1L mNSCLC across PD-L1 subgroups.
    • ORR was 69% and DCR was 86% in Cohort A
    • ORR was 44% and DCR was 78% in Cohort B
    • Median DOR was not reached, and DOR rate at 6 months was 88% in both cohorts.
  • The safety profile of SG + Pembro was manageable and consistent with the known safety of each agent.
    • The most common any-grade TEAEs were diarrhea, anemia, and asthenia
    • TEAEs leading to treatment discontinuation were low (18%)
  • These preliminary results warrant further investigation of SG + Pembro for the 1L treatment of mNSCLC
    • The ongoing, open-label, global, randomized, phase 3 EVOKE-03 study (NCT05609968) is evaluating SG + Pembro versus Pembro monotherapy in patients with untreated 1L mNSCLC with PD-L1 TPS ≥ 50%

Cho BC, Cobo Dols M, Reyes Cabanillas R, et al. Sacituzumab Govitecan + Pembrolizumab in 1L Metastatic Non–Small Cell Lung Cancer: Preliminary Results of the EVOKE-02 Study. Abstract presented at: World Conference on Lung Cancer, September 9-12, 2023.