Trodelvy® (sacituzumab govitecan-hziy)

Combination With Pembrolizumab for First-Line Treatment of Patients with mNSCLC

This document is in response to your request for information regarding Trodelvy® (sacituzumab govitecan-hziy [SG]) and its use in combination with pembrolizumab for first-line (1L) treatment of 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: First-Line Treatment

EVOKE-02 is an ongoing, phase 2, multi-cohort study evaluating the efficacy and safety of SG in combination with pembrolizumab ± PLT agent in the 1L treatment of adult patients with advanced or mNSCLC without actionable genomic alterations. This document summarizes data from Cohorts A and B.1

Preliminary analyses of patients treated with SG + pembrolizumab 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%) and immune-mediated TEAEs that occurred in ≥5% of patients were pneumonitis (8%) and hyperthyroidism (5%).

In an analysis with longer 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 (all 50%), and the most common immune-mediated TEAE was pneumonitis (16.7%).

EVOKE-02 Study: First-Line 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 pembrolizumab ± PLT agent (carboplatin), in the 1L treatment of adult patients with advanced or mNSCLC without actionable genomic alterations (Figure 1). This document summarizes data from Cohorts A and B.1

Figure 1. EVOKE-02 Study Design (Cohorts A and B)1,4

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

Table 1. EVOKE-02: Select Baseline Characteristics and Exposure1,2

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

Preliminary Efficacy: Cohort A and Cohort B

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

Table 2. EVOKE-02: 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 Analysis5

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

Preliminary Safety: Cohort A and Cohort B1

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

Table 4. EVOKE-02: TEAEs Summary1

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

Table 5. EVOKE-02: Grade 1 to 2/Grade ≥3 (≥15%) and Immune-Mediated TEAEs (N=63)1

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

Longer Follow-up Efficacy: Cohort A (PD-L1 TPS ≥50%)3

In this analysis the median (range) follow-up was 11.3 (8.4–17.5) months and median (range) duration of exposure to SG and pembrolizumab 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 Longer Follow-up: Efficacy3

Longer Follow-up Safety: Cohort A (PD-L1 TPS ≥50%)3

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

Table 7. EVOKE-02 Cohort A Longer Follow-up: TEAEs Summary3

a1 treatment-related death due to neutropenic sepsis.

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

aNo reports of nephritis.

Ongoing Study: EVOKE-03

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

References

1. 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.
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. 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. Accessed 8 August 2024.
5. 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
BOR=best overall response

CR=complete response
DCR=disease control rate
DOR=duration of response
IRC=independent review committee
mNSCLC=metastatic non-small cell lung cancer
NR=not reached
Nsq=nonsquamous
ORR=objective response rate
PD=progressive disease
PD-(L)1=programmed cell death-(ligand)1
PFS=progression-free survival
PLT=platinum
PR=partial response
SD=stable disease
SG=sacituzumab govitecan
Sq=squamous
TEAE=treatment-emergent adverse event
TPS=tumor proportion score

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

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