HEALTH CANADA APPROVES TRODELVY® (SACITUZUMAB GOVITECAN) IN PRE-TREATED HR+/HER2- METASTATIC BREAST CANCER Français
-- TRODELVY has Now Improved Survival in both Pre-Treated HR+/HER2- Metastatic Breast Cancer and in Second-Line Metastatic Triple-Negative Breast Cancer --
MISSISSAUGA, ON, July 20, 2023 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has issued a Notice of Compliance for TRODELVY® (sacituzumab govitecan) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. This decision is based on statistically significant and clinically meaningful progression-free survival and overall survival data from the Phase 3 TROPiCS-02 study.
"HR+/HER2- metastatic breast cancer patients have limited treatment options, and the market authorization of TRODELVY is a step in the right direction in providing an additional therapy for Canadian patients," said Dr. Karen A. Gelmon, a Professor of Medicine at the University of British Columbia and a Medical Oncologist at BC Cancer. "Nearly all patients with HR+/HER2- advanced breast cancer will eventually develop resistance to endocrine-based therapies and once they have progressed, their primary treatment option is single-agent chemotherapy. At this point, it is common for persons to receive multiple lines of chemotherapy regimens, with decreasing responses with each new treatment. TRODELVY in this indication with its efficacy is welcome news to patients and to the oncology community."
"Though many are living longer than before, when living with uncurable breast cancer, you always want to know what the next treatment will be if you need it. And for the metastatic breast cancer community, they hope that next treatment will be one that helps them live better and longer than the prognosis offered with palliative chemotherapy. We need to make sure newer, more effective treatments are available to Canadians now, when people need them" said MJ DeCoteau, Founder and Executive Director at Rethink Breast Cancer.
The market authorization is supported by results from the Phase 3 TROPiCS-02 study, in which TRODELVY demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months versus comparator single-agent chemotherapy (treatment of physician's choice; TPC) (median OS: 14.4 months vs. 11.2 months; [HR]=0.789; 95% CI: 0.646, 0.964; p=0.0200). TRODELVY also demonstrated a 34% reduction in risk of disease progression or death (median PFS: 5.5 versus 4.0 months; HR: 0.661; 95% CI: 0.529, 0.826; p=0.0003). Three times as many people treated with TRODELVY were progression free at one year versus those treated with chemotherapy (21% versus 7%). This was an exploratory analysis as formal statistical testing was not conducted.
"We are pleased that TRODELVY now has the potential to bring new hope for people living with pre-treated HR+/HER2- metastatic breast cancer, building on the critical role TRODELVY is already playing for people with metastatic triple-negative breast cancer," said Christophe Griolet, Vice President and General Manager, Gilead Sciences Canada, Inc. "On behalf of Gilead, we thank the physicians, patients and their families and caregivers for placing their trust in our clinical trial, and in ultimately helping to provide new and innovative treatments to Canadians."
Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer is the most common type of breast cancer and accounts for approximately 70% of all new cases. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 34%. As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. In this setting, it is common to receive multiple lines of chemotherapy regimens over the course of treatment, and the prognosis remains poor.
The TROPiCS-02 study is a global, multicenter, open-label, Phase 3 study, randomized 1:1 to evaluate TRODELVY versus physicians' choice of chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) in 543 patients with HR+/HER2- metastatic breast cancer who were previously treated with endocrine therapy, CDK4/6 inhibitor and two to four lines of chemotherapy for metastatic disease. The primary endpoint is progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) for participants treated with TRODELVY compared to those treated with chemotherapy. Secondary endpoints include overall survival, overall response rate, clinical benefit rate and duration of response, as well as assessment of safety and tolerability and quality of life measures. In the study, HER2 negativity was defined per American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) criteria as immunohistochemistry (IHC) score of 0, IHC 1+ or IHC 2+ with a negative in-situ hybridization (ISH) test. More information about TROPiCS-02 is available at https://clinicaltrials.gov/ct2/show/NCT03901339.
TRODELVY (sacituzumab govitecan) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. TRODELVY is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment.
TRODELVY is approved in more than 40 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
TRODELVY is also being developed for potential investigational use in TNBC, and HR+/HER2-, as well as a range of tumor types where Trop-2 is highly expressed, including metastatic urothelial cancer (mUC), metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.
Important Safety Information:
Most serious warnings and precautions
- Severe or life- threatening neutropenia may occur. Fatal infections in the setting of neutropenia have been observed in clinical trials with TRODELVY. Withhold TRODELVY for neutropenic fever or absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Complete blood counts should be monitored prior to initiation of TRODELVY and prior to each dose, and as clinically indicated. Based on the severity of neutropenia, TRODELVY may require dose interruption or reduction. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
- Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence >25%) reported in patients receiving TRODELVY were: neutropenia (70.5%), diarrhea (61.9%), nausea (58.6%), alopecia (47.8%), fatigue (39.2%), anemia (36.6%), and constipation (34.7%). The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (4.9%), febrile neutropenia (4.1%), neutropenia (3.0%), abdominal pain (2.2%), neutropenic colitis (1.9%), vomiting (1.9%), pneumonia (1.5%), colitis (1.5%), acute kidney injury (1.1%), pyrexia, urinary tract infection, and sepsis (each 1.1%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.
For all important safety information for TRODELVY, including contraindications, warnings and precautions, adverse reactions and drug interactions, please see the Canadian Product Monograph at www.gilead.ca.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving TRODELVY; uncertainties relating to regulatory applications for TRODELVY and related filing and approval timelines, including the risk that the European Commission may not approve the pending marketing authorization application for TRODELVY in HR+/HER2- metastatic breast cancer, and pending or potential applications for the treatment of metastatic TNBC, mUC, HR+/HER2- breast cancer, NSCLC, SCLC, head and neck cancer, endometrial cancer and other cancers, in the currently anticipated timelines or at all; Gilead's ability to receive regulatory approvals for such indications in a timely manner or at all, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of TRODELVY for such indications and as a result, TRODELVY may never be commercialized for these indications; the risk that physicians may not see the benefits of prescribing TRODELVY for treatment of HR+/HER2- metastatic breast cancer; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
Prescribing Information for TRODELVY including BOXED WARNING, is available at www.gilead.ca
TRODELVY, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company's website at www.gilead.ca, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
SOURCE Gilead Sciences Canada
MEDIA CONTACT: Andrew Forgione, [email protected]
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