Trodelvy® (sacituzumab govitecan-hziy)

Combination With Pembrolizumab and Chemotherapy for 1L Treatment of 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) and chemotherapy 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 + PC for 1L mNSCLC Treatment

EVOKE-02 is an ongoing, multi-cohort, phase 2 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. Cohorts C (Nsq histology) and D (Sq histology), in which all patients received triplet therapy, are presented here.1

• Following a safety evaluation, the SG dose was reduced from 10 mg/kg to 7.5 mg/kg due to rates of myelosuppression (mainly Grade ≥3 neutropenia).
• In Cohort C (Nsq; n=51), ORR was 45.1% (95% CI: 31.1–59.7) and median PFS was 8.1 (95% CI: 5.2–15) months.
• In Cohort D (Sq; n=41), ORR was 39% (95% CI: 24.2–55.5) and median PFS was 8.3 (95% CI: 4.3–11.2) months.
• Overall, the most common Grade 1 or 2 TEAEs were diarrhea (49.5%), decreased appetite (37.9%), anemia (35.8%), and nausea (35.8%). The most common Grade ≥3 TEAEs were anemia (31.8%), neutropenia (24.2%), and neutrophil count decreased (16.7%).

In an exploratory analysis with a later data cutoff date, Trop-2 expression ≥178 (median H‑score) was associated with a numerically higher PFS and ORR; however, the association was not statistically significant.2

EVOKE-02 Study: SG + PC for 1L mNSCLC Treatment

Study Design and Demographics

EVOKE-02 is an ongoing, open-label, multicenter, multi-cohort, phase 2 study (NCT05186974) evaluating the efficacy and safety of SG in combination with pembro ± PLT agent (eg, carbo) in the 1L treatment of adult patients with advanced or mNSCLC without AGAs (Figure 1). The summary below presents results from Cohorts C (NSq histology) and D (Sq histology), in which all patients received triplet therapy of SG + PC.1 

Figure 1. EVOKE-02: Study Design1,3

Abbreviations: DCR=disease control rate; G-CSF=granulocyte colony-stimulating factor; NSCLC=non-small cell lung cancer.

aDe-escalating dose of SG (10 mg/kg, 7.5 mg/kg, and 5 mg/kg) IV on Days 1 and 8 + pembro 200 mg IV on Day 1 + carbo (AUC 5) IV on Day 1 of a 21-day cycle.

bBased on safety assessment, mandatory long-acting G-CSF was used on Day 9 or short-acting G-CSF once daily for 10 days starting from Day 9 of each cycle.

Note: Patients with brain metastases were eligible to participate if they had stable central nervous system disease for ≥4 weeks prior to enrollment, all neurological symptoms had returned to baseline, and there was no evidence of progression.

The baseline demographics and disease characteristics of patients in Cohorts C and D are shown in Table 1.

Table 1. EVOKE-02 (Cohorts C and D):
Select Baseline Demographics and Disease Characteristics1

aAll patients had a Stage IV diagnosis at screening.

Results: Cohort C and Cohort D

Safety run-in

In Cohorts C and D, 17 and 12 patients, respectively, received SG 10 mg/kg, and 37 and 29 patients received SG 7.5 mg/kg.4 During the safety run-in (SG 10 mg/kg + PC; n=5), the de-escalation criterion (≥2 patients with a predefined DLT) were not met. One DLT of sepsis leading to death was reported. At a planned follow‑up safety evaluation, the SG dose was reduced to 7.5 mg/kg due to rates of myelosuppression (mainly Grade ≥3 neutropenia), which was reported in 19 of the 29 patients (65.5%) who received SG 10 mg/kg. The RP2D of SG was 7.5 mg/kg combined with pembro 200 mg and carbo AUC 5.1

Efficacy1

Overall, the median (range) duration of exposure was 6.08 (0.03–19.29) months for SG, 5.55 (0.03–19.06) months for pembro, and 2.17 (0.03–3.48) months for carbo, with a median (range) number of treatment cycles of 8 (1–28), 8 (1–28), and 4 (1–4), respectively. The median (range) durations of follow-up were 14.5 (12.2–22.3) and 14.2 (11–23) months for Cohorts C and D, respectively. At data cutoff, 40.7% of patients in Cohort C and 43.9% of patients in Cohort D remained in the study. Efficacy results overall and by PD-L1 expression for patients receiving SG 7.5 mg/kg or 10 mg/kg + PC are shown in Table 2 and Table 3, respectively. Regardless of SG dose, most patients in both cohorts had a reduction in best percentage change from baseline in total sum of target lesion diameter.

Table 2. EVOKE-02 (Cohorts C and D): Efficacy by IRC1

aIncludes patients whose histology was not assessed.

bCohort C, n=23; Cohort D, n=16.

Note: Three patients in Cohort C did not have measurable disease per IRC at baseline and were not included in the efficacy analysis.

A PD-L1 TPS ≥50% was associated with the greatest treatment benefit by ORR (Table 3).

Table 3. EVOKE-02 (Cohorts C and D): Efficacy by PD-L1 Expression1

aAssessment per RECIST v1.1

Safety1

All patients in both cohorts reported any-grade TEAEs. Grade ≥3 TEAEs occurred in 93.1% of the SG 10 mg/kg + PC group and in 86.4% of the SG 7.5 mg/kg + PC group. The most common Grade ≥3 TEAEs were anemia (31.8%), neutropenia (24.2%), and neutrophil count decreased (16.7%). Immune-mediated AEs that occurred in ≥1 patient included hypothyroidism (7.6%), hyperthyroidism (4.5%), pneumonitis (4.5%), and rash (3%). A safety summary of TEAEs is reported in Table 4, and a summary of TEAEs seen in ≥25% of patients is shown in Table 5.

Table 4. EVOKE-02 (Cohorts C and D): Summary of TEAEs by Dose Received1

aIncluded sepsis (n=3) and abdominal infection, bacterial sepsis, febrile neutropenia, gastroenteritis, pneumococcal sepsis, and pneumonia (each, n=1).

Note: Safety was assessed in all patients who received ≥1 dose of study drug. AEs were coded using Medical Dictionary for Regulatory Activities v27.0.

Table 5. EVOKE-02 (Cohorts C and D): TEAEs in ≥20% of All Patients Who Received Any SG Dose1

Note: TEAEs were defined as any AE that began on or after the date of the first dose of study drug through 30 days after the last dose of study drug.

Subanalysis: Efficacy by Trop-2 Expression2

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 + PC, there was no correlation between Trop-2 expression and best percentage change in tumor size (Spearman correlation coefficient ρ=-0.01) or best overall response. Trop-2 expression ≥ median H-score resulted in numerically higher but not statistically significant PFS and ORR (Table 6).

Table 6. EVOKE-02 Subanalysis: Efficacy by Trop-2 of Trop-2 Expression2

References

1. Gray JE, Neal JW, Patel JD, et al. First-line sacituzumab govitecan plus pembrolizumab and carboplatin in metastatic non-small cell lung cancer: nonsquamous and squamous cohorts of the EVOKE-02 study (manuscript). Clinical Cancer Research. 2026.

2. 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). Paper presented at: American Association for Cancer Research (AACR); April 25-30, 2025, 2025; Chicago, IL, USA.

3. 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. 

4. Gray JE, Neal JW, Patel JD, et al. First-line sacituzumab govitecan plus pembrolizumab and carboplatin in metastatic non-small cell lung cancer: nonsquamous and squamous cohorts of the EVOKE-02 study [Supplement]. Clinical Cancer Research. 2026.

Abbreviations

1L=first-line
AE=adverse event
AGA=actionable genomic alteration
AUC=area under the concentration-time curve
carbo=carboplatin
DLT=dose-limiting toxicity
DOR=duration of response
ECOG PS=Eastern Cooperative Oncology Group Performance Status
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
PC=pembrolizumab + carboplatin
PD=progressive disease
PD-L1=programmed cell death-ligand 1
pembro=pembrolizumab
PFS=progression-free survival
PLT=platinum
PR=partial response
RECIST=Response Evaluation Criteria in Solid Tumors
RP2D=recommended phase 2 dose
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

Adverse Event Reporting

Please report all adverse events to:

Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
 www.gilead.com/utility/contact/report-an-adverse-event

FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or   www.accessdata.fda.gov/scripts/medwatch

Data Privacy

The Medical Information service at Gilead Sciences may collect, store, and use your personal information to provide a response to your medical request. We may share your information with other Gilead Sciences colleagues to ensure that your request is addressed appropriately. If you report an adverse event or concern about the quality of a Gilead or Kite product, we will need to use the information you have given us in order to meet our regulatory requirements in relation to the safety of our medicines.

It may be necessary for us to share your information with Gilead’s affiliates, business partners, service providers, and regulatory authorities located in countries other than your own. Gilead Sciences has implemented measures to protect the personal information you provide. Please see the Gilead Privacy Statement (www.gilead.com/privacy-statements) for more information about how Gilead handles your personal information and your rights. If you have any further questions about the use of your personal information, please contact gilead.privacy@gilead.com.

TRODELVY, GILEAD, and the GILEAD logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
© 2026 Gilead Sciences, Inc