Trodelvy® (sacituzumab govitecan-hziy)

Combination With Pembrolizumab for 1L Treatment in Patients With mNSCLC

This document is in response to your request for information regarding the use of Trodelvy® (sacituzumab govitecan-hziy [SG]) in combination with pembrolizumab (pembro) for first-line (1L) treatment in patients with metastatic non-small cell lung cancer (mNSCLC).

Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.

Trodelvy is not indicated for use in patients with mNSCLC. The full indication, important safety information, and boxed warnings for neutropenia and diarrhea are available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

Summary

EVOKE-02 Study: SG + Pembro for 1L Treatment

EVOKE-02 is an ongoing, phase 2, multi-cohort study evaluating the efficacy and safety of SG in combination with pembro ± PLT agent in the 1L treatment of adult patients with advanced or mNSCLC without AGAs.1

Preliminary analyses of patients treated with SG + pembro in Cohort A (PD-L1 TPS ≥50%; n=30) and Cohort B (PD‑L1 TPS <50%; n=33) showed the following1,2:

• In Cohort A, ORR was 69% (95% CI: 49–85%; Sq, 72.7%; Nsq, 66.7%) and DCR was 86% (95% CI: 68–96%; Sq, 81.8%; Nsq, 88.9%).
• In Cohort B, ORR was 44% (95% CI: 26–62%; Sq, 53.8%; Nsq, 36.8%) and DCR was 78% (95% CI: 60–91%; Sq, 84.6%; Nsq, 73.7%).
• The most common any-grade TEAEs were diarrhea (54%), anemia (48%), asthenia (38%), and alopecia (37%). Immune-mediated TEAEs that occurred in ≥5% of patients were pneumonitis (8%) and hyperthyroidism (5%).

In an analysis with extended follow-up for Cohort A (PD-L1 TPS ≥50%; n=30)3:

• Overall ORR was 66.7% (95% CI: 47.2–82.7%) and was consistent in patients with both Sq and Nsq histology.

• Median PFS was 13.1 months (95% CI: 5.5‍–NR).
• The most common any-grade TEAEs were diarrhea (56.7%), alopecia, anemia, and asthenia (each, 50%), and the most common immune-mediated TEAE was pneumonitis (16.7%).

An exploratory analysis with a later data cutoff date evaluated Trop-2 expression and no patient subgroup was identified that had a greater treatment benefit (eg, ORR or PFS) with SG + pembro.4

EVOKE-02 Study: SG + Pembro for 1L Treatment

Study Design and Demographics

EVOKE-02 is an ongoing, open-label, multicenter, multicohort, phase 2 study (NCT05186974) evaluating the efficacy and safety of SG in combination with pembro ± PLT agent (eg, carboplatin) in the 1L treatment of adult patients with advanced or mNSCLC without AGAs (Figure 1).1

Figure 1. EVOKE-02: Study Design5,6

Abbreviations: NSCLC=non-small cell lung cancer; RECIST=Response Evaluation Criteria in Solid Tumors.

Select baseline characteristics and exposure are shown in Table 1.1,2

Table 1. EVOKE-02 (Cohorts A and B):
Select Baseline Demographics and Disease Characteristics1,2

aPatients received a median (range) of 6 (1–17+) cycles of SG and pembro.

Preliminary Results: Cohort A and Cohort B

Efficacy

The median (range) follow-up durations for Cohorts A and B were 5 (1.7–12) and 5.8 (1–‍12.2) months, respectively. Efficacy results were reported for 61 patients enrolled for ≥13 weeks (Table 2)1 and reported according to PD-L1 TPS subgroup in Cohort B (Table 3). In patients who achieved a confirmed PR, the mean (standard deviation) time to response was 1.8 (0.82) months in Cohort A and 1.7 (0.6) months in Cohort B.7

Table 2. EVOKE-02 (Cohorts A and B): Efficacy by Investigator Assessment1,2

aPatients without tumor assessment: Cohort A, n=1 (Nsq); Cohort B, n=5 (Sq, n=2; Nsq, n=3).

bEvaluated in patients with a confirmed CR or PR; based on Kaplan-Meier estimates.

Table 3. EVOKE-02: Cohort B PD-L1 TPS Subgroup Analysis7

aFive patients did not have tumor assessment for PD-L1.

Safety1

TEAEs reported in the safety-evaluable population (patients who received ≥1 dose of study treatment; N=63) are shown in Table 4 and Table 5. Any-grade TEAEs were reported in all patients, with 90% related to study treatment.

Table 4. EVOKE-02 (Cohort A and B): Summary of TEAEs1

aCauses of death: malignant lung neoplasm, respiratory tract infection, sepsis, and sudden death (each, n=1). The case of sepsis that led to death was deemed related to study treatment.

Table 5. EVOKE-02 (Cohort A and B): Any-Grade TEAEs Reported in ≥15% of Patients and Immune-Mediated TEAEs (N=63)1

aGrade 3 pneumonitis (n=2) was the highest grade TEAE observed to date.

Extended Follow-Up: Cohort A (PD-L1 TPS ≥50%)3

Efficacy

In this analysis, the median (range) follow-up was 11.3 (8.4–17.5) months, and median (range) durations of exposure to SG and pembro were 7.43 (0.03–16.69) months and 7.18 (0.03–16.69) months, respectively. Efficacy by IRC is shown in Table 6.

Table 6. EVOKE-02 Cohort A Extended Follow-Up: Efficacy3

Safety

Any-grade TEAEs were reported in all patients, with 96.7% related to study treatment. TEAEs are shown in Table 7 and Table 8.

Table 7. EVOKE-02 Cohort A Extended Follow-Up: Summary of TEAEs3

aThe 1 treatment-related death was due to neutropenic sepsis.

Table 8. EVOKE-02 Cohort A Extended Follow-Up:
Any-Grade (≥30%), Grade 3 (≥5%), and Immune-Mediated TEAEs (n=30)3

aThere were no reports of nephritis.

Subanalysis: Efficacy by Trop-2 Expression4

An exploratory analysis with a later data cutoff date evaluated efficacy outcomes according to Trop-2 expression. Trop-2 membrane expression on archival tumor tissue was assessed with immunohistochemistry and expressed as an H-score of 0 to 300. Trop-2 expression was assessed for association with ORR and PFS. Clinical outcomes were evaluated in 184 patients with evaluable archival tissue. With a median Trop-2 H‑score of 178, outcomes were assessed in H-score groups of <178 and ≥178. To boost the numbers for subgroup analyses, Trop-2 subgroups from Cohorts A + B + C + D were combined to correlate with evaluated efficacy outcomes.

In patients who received SG + pembro, there was no correlation between Trop-2 expression and best percentage change in tumor size (Spearman correlation coefficient ρ=-0.013) or BOR. Trop-2 expression ≥ median H-score was not significantly associated with improved PFS or ORR (Table 9).

Table 9. EVOKE-02 Subanalysis of Trop-2 Status: Efficacy4

Ongoing Study: EVOKE-03

A phase 3, open-label, multicenter, randomized study (NCT05609968) is evaluating the efficacy and safety of SG in combination with pembro vs pembro monotherapy as 1L treatment in adults with mNSCLC and PD-L1 TPS ≥50%.

References

1. Cho BC, Dols MC, Reyes Cabanillas R. Sacituzumab govitecan + pembrolizumab in 1L metastatic non-small cell lung cancer: preliminary results of the EVOKE-02 study. [Oral Presentation OA05.04]. Presented at World Conference on Lung Cancer (WCLC); September 9-12; Singapore. 2023.
2. Cappuzzo F, Patel J, Cho BC, et al. Sacituzumab govitecan + pembrolizumab in first-line metastatic non-small cell lung cancer: efficacy results by histology from the EVOKE-02 study [Poster 60P]. Presented at: 2024 European Lung Cancer Congress (ELCC); March 20-23, 2024; Prague, Czech Republic.
3. Patel JD, Cho BC, Dols MC, et al. Sacituzumab govitecan + pembrolizumab in first-line metastatic non-small cell lung cancer with PD-L1 ≥50%: Cohort A of EVOKE-02 [Poster 8592]. Presented at: 2024 American Society of Clinical Oncology (ASCO); May 31-June 4, 2024; Chicago, IL.
4. Patel J, Zavodovskaya M, Chul Cho B, et al. Trop-2 expression and association with efficacy in patients treated with sacituzumab govitecan + pembrolizumab +/- carboplatin in the EVOKE-02 study of non-small cell lung cancer (Poster LB399). Presented at: American Association for Cancer Research (AACR); April 25-30, 2025; Chicago, IL, USA.
5. Cho BC, Dols MC, Reyes Cabanillas R, et al. Sacituzumab govitecan + pembrolizumab in 1L metastatic non-small cell lung cancer: preliminary results of the EVOKE-02 study. [Oral Presentation OA05.04]. Presented at: 2023 World Conference on Lung Cancer (WCLC); September 9-12, 2023; Singapore.
6. ClinicalTrials.gov. Study of sacituzumab govitecan combinations in first-line treatment of participants with advanced or metastatic non-small-cell lung cancer (NSCLC) (EVOKE-02). ClinicalTrials.gov Identifier: NCT05186974. Available at: https://www.clinicaltrials.gov/ct2/show/NCT05186974.
7. Patel J, Cho BC, Dols MC, et al. Sacituzumab govitecan + pembrolizumab in 1L metastatic non–small cell lung cancer: preliminary results of the EVOKE-02 study [Poster PP01.113]. Presented at: 2023 North America Conference on Lung Cancer (NACLC); December 1-3, 2023; Chicago, IL.

Abbreviations

1L=first line
AGA=actionable genomic alteration
BOR=best overall response
CR=complete response
DCR=disease control rate
DOR=duration of response
H-score=histochemical score
IRC=independent review committee
mNSCLC=metastatic non‑small cell lung cancer
NE=not evaluable
NR=not reached
Nsq=nonsquamous
ORR=objective response rate
PD=progressive disease
PD-L1=programmed cell death-1
pembro=pembrolizumab
PFS=progression-free survival
PLT=platinum
PR=partial response
SD=stable disease
SG=sacituzumab govitecan-hziy
Sq=squamous
TEAE=treatment-emergent adverse event
TPS=tumor proportion score
Trop-2=trophoblast cell surface antigen-2
 

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

Follow-Up

For any additional questions, please contact Trodelvy Medical Information at:

☎1‐888-983-4668 or   www.askgileadmedical.com

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