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

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.