Trodelvy® (sacituzumab govitecan-hziy)
Reports of ILD and Pneumonitis with Monotherapy
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Trodelvy® (sacituzumab govitecan-hziy)
Monotherapy: Reports of ILD/Pneumonitis
This document is in response to your request for information regarding Trodelvy® (sacituzumab govitecan-hziy [SG]) and interstitial lung disease (ILD)/pneumonitis. Information summarized in this document includes data from phase 2 and 3 clinical studies of SG monotherapy (10 mg/kg IV on Days 1 and 8 of a 21-day treatment cycle) and reported cases of ILD/pneumonitis.
Gilead continually assesses safety data from all sources for unidentified drug reactions and updates the product label information accordingly to reflect the safety profile of Trodelvy®. Because case reports of potential adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. For this reason, Gilead does not provide information from post‑marketing spontaneous reports. Due to the limitations in the interpretation of case reports, single case reports found in the literature are not included in this summary.
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
Relevant Product Labeling1
SG can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms include pneumonitis.
Reports of ILD/Pneumonitis With SG Monotherapy
In the phase 3 ASCENT study in second line or later (2L+) metastatic triple negative breast cancer (mTNBC; overall safety population [OSP], n=482), 1 patient (0.4%) in the SG arm developed Grade 3 pneumonitis in the context of multiple confounding factors. The patient had a history of lung metastases and radiation-related fibrosis. The pneumonitis event occurred 14 days after the last dose of SG, and it resolved 7 weeks later.2,3
In the phase 2 TROPHY-U-01 study in metastatic urothelial cancer (mUC), 1 patient in Cohort 1 (OSP, n=113) developed a Grade 2 treatment‑related severe adverse event (SAE) of ILD that resolved after SG was discontinued.4,5
In the phase 1/2 IMMU-132-01 study in metastatic epithelial cancers (OSP, n=495), 1 patient developed Grade 2 radiation pneumonitis that resolved with delay of the next SG dose and treatment with steroids.6
Reports of ILD/Pneumonitis With SG Monotherapy
ASCENT Study in 2L+ mTNBC
The OSP included 482 patients (SG: 258; chemotherapy treatment of physician’s choice [TPC]: 224; [median age, 54 years]) who received ≥1 dose of study treatment. Patients in the SG treatment arm received a median (range) of 7 (1–33) treatment cycles over a median (range) of 4.4 (0.03–22.9) months.2,3
One patient (0.4%) in the SG arm developed Grade 3 pneumonitis.2 The patient was a 52‑year‑old female with a past medical history of mTNBC with lung metastases, pneumothorax, left bronchial stenosis secondary to prior radiation, tumor-related left lung collapse, radiation‑related fibrosis of the lung, and morbid obesity. Grade 3 pneumonitis occurred 14 days after her last dose of SG, approximately 7 months after the start of the study. CT scan findings included increased size of the known right upper lobe mass and new upper and lower lobe patchy ground glass opacities (probable infectious/inflammatory in the upper lung and hypo‑ventilatory in the lower lung). The event was considered possibly related to SG by investigator assessment. SG was permanently discontinued; the patient was treated with antibiotics and IV steroids. Pneumonitis resolved 7 weeks after onset without sequelae.2,3
TROPHY-U-01 Study in mUC
An ongoing, global, open-label, multi-cohort, phase 2 study of SG in patients with unresectable locally advanced, or mUC.5
Cohort 1
The OSP included 113 patients with mUC that progressed on platinum-based chemotherapy and checkpoint inhibitors who were treated with SG 10 mg/kg. The median age was 66 years, and 66% of patients had visceral disease. Patients received a median of 6 treatment cycles, over a median (range) of 3.7 (0–20) months.5
One patient developed Grade 2 ILD 19 days after enrolment.4,5 The patient was a 76‑year‑old female with a past medical history of ischemic cardiomyopathy.5 She discontinued avelumab 2 months prior to participation in the study.4,5 The ILD was considered to be a treatment-related SAE that resulted in an interruption of SG therapy. SG was discontinued after Cycle 1 Day 8 due to progressive disease. The ILD resolved on Day 26.4
IMMU-132-01 Study in Metastatic Epithelial Cancers
During the dose-escalation phase of this study, SG was administered on Days 1 and 8 of a 21‑day cycle at doses of 8 (n=81), 10 (n=402), 12 (n=9), or 18 (n=3) mg/kg.6
The OSP included 495 patients (median age, 61 years) who received ≥1 dose of SG. Patients received a median (range) of 6 (1–73) SG treatment cycles, over a median (range) of 3.7 (0–55.2) months.6
One patient who received 8 mg/kg of SG developed Grade 2 radiation pneumonitis.4,6 The patient’s medical history included mTNBC treated with palliative radiation therapy. The next dose of SG was delayed, the patient was hospitalized, and steroids were administered. The pneumonitis resolved, and the patient subsequently resumed treatment with SG.6
References
4. Gilead Sciences Inc. Data on File.
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
https://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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