FOSTER CITY, CA, USA I May 31, 2024 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC). The TROPiCS-04 study evaluated Trodelvy® (sacituzumab govitecan-hziy; SG) vs. single-agent chemotherapy (treatment of physicians’ choice, TPC) in patients with mUC who have previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy.
The study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population. A numerical improvement in OS favoring Trodelvy was observed, and trends in improvement for select pre-specified subgroups and secondary endpoints of progression-free survival (PFS) and overall response rate (ORR) were also shown. The pre-specified subgroup analyses were not alpha-controlled for formal statistical testing. These data will be presented at an upcoming medical meeting.
In the overall study population, there was a higher number of deaths due to adverse events with Trodelvy compared to TPC, which were primarily observed early in treatment and related to neutropenic complications, including infection. Gilead will further investigate these data, and is working to reiterate to treating physicians the importance of granulocyte-colony stimulating factor (G-CSF) use for the prevention of neutropenic complications. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia; please see below for Important Safety Information.
There are no changes to the known safety profile of Trodelvy for the approved breast cancer indications or other investigational uses. To date, the Trodelvy safety profile is generally well-tolerated and consistent with use in over 40,000 patients across Trodelvy’s approved indications and in clinical trials.
Gilead is continuing to analyze the data and will discuss the results and next steps with the FDA. In the U.S., Trodelvy has an accelerated approval indication for patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and anti-PD-(L)1 therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, including the TROPiCS-04 study.
Metastatic UC is an aggressive disease which most commonly affects older patients with concurrent medical morbidities and additional changes related to the aging process. Despite recent advances, survival rates remain poor with only 8% of patients living beyond five years after diagnosis. These results may in part reflect the difficulty of treating patients with mUC who have previously received platinum-containing chemotherapy and checkpoint inhibitor therapy. There is an urgent need for new treatment options to help improve long-term outcomes.
Gilead would like to thank the patients, families, investigators, and advocates who contributed to this important research. We remain committed to advancing care to address the unmet needs for the bladder cancer community.
Trodelvy is the first approved Trop-2-directed antibody-drug conjugate (ADC), which has demonstrated meaningful survival advantages in two different types of metastatic breast cancers. There are more than 20 ongoing clinical trials for Trodelvy.
Please see below for the approved U.S. Indication and additional Important Safety Information.
About Metastatic Urothelial Cancer
Bladder cancer is one of the most common cancers worldwide, with more than 1.6 million people living with the disease and urothelial cancer (UC) accounting for 90% of these cases. Metastatic bladder cancer is an aggressive disease and survival rates remain poor, with only 8% of patients living beyond five years after diagnosis. Despite recent advances, less than 20% of patients with metastatic bladder cancer go on to receive second-line therapy. There is an urgent need for new treatment options for patients with mUC who have progressed on available therapies to help improve long-term outcomes.
About the TROPiCS-04 Study
The TROPiCS-04 study is an open-label, global, multi-center, randomized Phase 3 study that evaluated Trodelvy vs. single-agent chemotherapy (treatment of physicians’ choice, TPC) in patients with locally advanced or mUC who received platinum-containing chemotherapy and checkpoint inhibitor therapy. The study enrolled 711 patients randomized 1:1 to receive either Trodelvy or one of three TPC chemotherapeutic standard of care (SOC) options: paclitaxel, docetaxel, or vinflunine. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR) and duration of objective tumor response (DoR) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and blinded independent central review (BICR). Further study details are available on clinicaltrials.gov (NCT04527991).
About Trodelvy
Trodelvy® (sacituzumab govitecan-hziy) 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, bladder and lung 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 through a bystander effect.
Trodelvy is approved in almost 50 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 also has multiple global approvals for certain patients with pre-treated HR+/HER2- metastatic breast cancer, including in Australia, Brazil, Canada, the European Union, Israel, United Arab Emirates and the United States. In the U.S., Trodelvy has an accelerated approval for treatment of certain patients with second-line or later metastatic urothelial cancer; see below for full indication statements.
Trodelvy is being explored for potential investigational use in other TNBC, HR+/HER2- and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including metastatic non-small cell lung cancer (NSCLC), head and neck cancer, gynecological cancer, and gastrointestinal cancers.
U.S. Indications for Trodelvy
In the United States, Trodelvy is indicated for the treatment of adult patients with:
- Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
- 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.
- Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Please see full Prescribing Information, including BOXED WARNING.
About Gilead Sciences
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.
SOURCE: Gilead Sciences
Post Views: 1,455
FOSTER CITY, CA, USA I May 31, 2024 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC). The TROPiCS-04 study evaluated Trodelvy® (sacituzumab govitecan-hziy; SG) vs. single-agent chemotherapy (treatment of physicians’ choice, TPC) in patients with mUC who have previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy.
The study did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population. A numerical improvement in OS favoring Trodelvy was observed, and trends in improvement for select pre-specified subgroups and secondary endpoints of progression-free survival (PFS) and overall response rate (ORR) were also shown. The pre-specified subgroup analyses were not alpha-controlled for formal statistical testing. These data will be presented at an upcoming medical meeting.
In the overall study population, there was a higher number of deaths due to adverse events with Trodelvy compared to TPC, which were primarily observed early in treatment and related to neutropenic complications, including infection. Gilead will further investigate these data, and is working to reiterate to treating physicians the importance of granulocyte-colony stimulating factor (G-CSF) use for the prevention of neutropenic complications. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia; please see below for Important Safety Information.
There are no changes to the known safety profile of Trodelvy for the approved breast cancer indications or other investigational uses. To date, the Trodelvy safety profile is generally well-tolerated and consistent with use in over 40,000 patients across Trodelvy’s approved indications and in clinical trials.
Gilead is continuing to analyze the data and will discuss the results and next steps with the FDA. In the U.S., Trodelvy has an accelerated approval indication for patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and anti-PD-(L)1 therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, including the TROPiCS-04 study.
Metastatic UC is an aggressive disease which most commonly affects older patients with concurrent medical morbidities and additional changes related to the aging process. Despite recent advances, survival rates remain poor with only 8% of patients living beyond five years after diagnosis. These results may in part reflect the difficulty of treating patients with mUC who have previously received platinum-containing chemotherapy and checkpoint inhibitor therapy. There is an urgent need for new treatment options to help improve long-term outcomes.
Gilead would like to thank the patients, families, investigators, and advocates who contributed to this important research. We remain committed to advancing care to address the unmet needs for the bladder cancer community.
Trodelvy is the first approved Trop-2-directed antibody-drug conjugate (ADC), which has demonstrated meaningful survival advantages in two different types of metastatic breast cancers. There are more than 20 ongoing clinical trials for Trodelvy.
Please see below for the approved U.S. Indication and additional Important Safety Information.
About Metastatic Urothelial Cancer
Bladder cancer is one of the most common cancers worldwide, with more than 1.6 million people living with the disease and urothelial cancer (UC) accounting for 90% of these cases. Metastatic bladder cancer is an aggressive disease and survival rates remain poor, with only 8% of patients living beyond five years after diagnosis. Despite recent advances, less than 20% of patients with metastatic bladder cancer go on to receive second-line therapy. There is an urgent need for new treatment options for patients with mUC who have progressed on available therapies to help improve long-term outcomes.
About the TROPiCS-04 Study
The TROPiCS-04 study is an open-label, global, multi-center, randomized Phase 3 study that evaluated Trodelvy vs. single-agent chemotherapy (treatment of physicians’ choice, TPC) in patients with locally advanced or mUC who received platinum-containing chemotherapy and checkpoint inhibitor therapy. The study enrolled 711 patients randomized 1:1 to receive either Trodelvy or one of three TPC chemotherapeutic standard of care (SOC) options: paclitaxel, docetaxel, or vinflunine. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR) and duration of objective tumor response (DoR) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and blinded independent central review (BICR). Further study details are available on clinicaltrials.gov (NCT04527991).
About Trodelvy
Trodelvy® (sacituzumab govitecan-hziy) 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, bladder and lung 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 through a bystander effect.
Trodelvy is approved in almost 50 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 also has multiple global approvals for certain patients with pre-treated HR+/HER2- metastatic breast cancer, including in Australia, Brazil, Canada, the European Union, Israel, United Arab Emirates and the United States. In the U.S., Trodelvy has an accelerated approval for treatment of certain patients with second-line or later metastatic urothelial cancer; see below for full indication statements.
Trodelvy is being explored for potential investigational use in other TNBC, HR+/HER2- and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including metastatic non-small cell lung cancer (NSCLC), head and neck cancer, gynecological cancer, and gastrointestinal cancers.
U.S. Indications for Trodelvy
In the United States, Trodelvy is indicated for the treatment of adult patients with:
- Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
- 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.
- Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Please see full Prescribing Information, including BOXED WARNING.
About Gilead Sciences
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.
SOURCE: Gilead Sciences
Post Views: 1,455
