FOSTER CITY, CA, USA I January 22, 2024 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC). EVOKE-01 is evaluating Trodelvy® (sacituzumab govitecan-hziy; SG) vs. docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy.
A numerical improvement in OS favoring SG was observed in the study, including in patients with both squamous and non-squamous histology. The safety profile for Trodelvy was consistent with prior studies. Trodelvy was generally well tolerated, and no new safety signals were identified in this patient population.
A more than three-month difference in median OS favoring SG was observed in a sub-group of patients non-responsive to last prior anti-PD-(L)1 therapy, representing over 60% of the trial population. This analysis was pre-specified in the protocol, but not alpha-controlled for formal statistical testing. This magnitude of difference was not observed in the sub-group of patients with response to last prior anti-PD-(L)1 therapy. Gilead intends to explore potential pathways to further understand the role SG may have in these patients given the high unmet medical need.
Gilead plans to discuss results from this trial with regulators. The data will be presented at an upcoming medical meeting.
“The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Treating metastatic NSCLC that has progressed on or after platinum-based chemotherapy presents significant challenges and the need for safe and effective treatments remains urgent. We will work to further identify the metastatic NSCLC patient populations that may benefit from Trodelvy.”
Gilead’s clinical development program in metastatic NSCLC is broad and includes multiple ongoing registrational Phase 3 studies and several ongoing Phase 2 studies. Based on strong preliminary efficacy and safety data from the Phase 2 EVOKE-02 study of Trodelvy in combination with pembrolizumab, presented at the World Conference on Lung Cancer 2023, Gilead remains confident in its ongoing Phase 3 EVOKE-03 study in 1L metastatic PD-L1 high NSCLC. The EVOKE-03 study is currently enrolling. In addition, Gilead has a broad clinical development program in lung cancer with domvanalimab, the first Fc-silent investigational anti-TIGIT antibody.
Despite recent advances with multiple immunotherapy treatment options for first-line metastatic NSCLC, most people’s cancer will eventually progress. Only about 35-55% of patients respond to immunotherapy-based combinations in the frontline setting, and after progression there are limited treatment options available, particularly for those who did not have a response to immunotherapy. Developing novel options for patients who have progressed on platinum-based chemotherapy and checkpoint inhibitor therapy is a challenge with limited treatment advancements made for these patients.
Gilead would like to thank the patients, families, investigators, and advocates who contributed to this important research.
Trodelvy is the first approved Trop-2-directed antibody-drug conjugate (ADC) that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers and improved clinical outcomes for certain people with 2L metastatic urothelial cancer.
Trodelvy has not been approved by any regulatory agency for the treatment of metastatic NSCLC. Its safety and efficacy have not been established for this indication. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for the approved U.S. Indication and additional Important Safety Information.
About Metastatic Non-Small Cell Lung Cancer
Worldwide, more than two million people were diagnosed with lung cancer in 2020. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for up to 85% of diagnoses. About half of NSCLC cases are diagnosed at the metastatic stage (57%), when treatment is especially difficult. Even in patients whose disease is caught early, half will eventually progress to the metastatic stage within five years. Newly diagnosed patients have several treatment options including platinum-based therapy, checkpoint inhibitors and targeted therapies. However, there are limited treatment options once patients with metastatic NSCLC progress on or after platinum-based chemotherapy and checkpoint inhibitors.
About the EVOKE-01 Study
The EVOKE-01 study is a global, multi-center, open-label Phase 3 study randomized 1:1 to evaluate Trodelvy vs. docetaxel in patients with advanced or metastatic NSCLC that has progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. The study enrolled 603 participants. The primary endpoint is overall survival (OS). Key secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and safety. Additional efficacy measures include time to first deterioration in shortness of breath domain as measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) Score and time to first deterioration NSCLC-SAQ Total Score. Further study details are available on clinicaltrials.gov (NCT05089734).
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 is also approved to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer 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 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: 386
FOSTER CITY, CA, USA I January 22, 2024 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC). EVOKE-01 is evaluating Trodelvy® (sacituzumab govitecan-hziy; SG) vs. docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy.
A numerical improvement in OS favoring SG was observed in the study, including in patients with both squamous and non-squamous histology. The safety profile for Trodelvy was consistent with prior studies. Trodelvy was generally well tolerated, and no new safety signals were identified in this patient population.
A more than three-month difference in median OS favoring SG was observed in a sub-group of patients non-responsive to last prior anti-PD-(L)1 therapy, representing over 60% of the trial population. This analysis was pre-specified in the protocol, but not alpha-controlled for formal statistical testing. This magnitude of difference was not observed in the sub-group of patients with response to last prior anti-PD-(L)1 therapy. Gilead intends to explore potential pathways to further understand the role SG may have in these patients given the high unmet medical need.
Gilead plans to discuss results from this trial with regulators. The data will be presented at an upcoming medical meeting.
“The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Treating metastatic NSCLC that has progressed on or after platinum-based chemotherapy presents significant challenges and the need for safe and effective treatments remains urgent. We will work to further identify the metastatic NSCLC patient populations that may benefit from Trodelvy.”
Gilead’s clinical development program in metastatic NSCLC is broad and includes multiple ongoing registrational Phase 3 studies and several ongoing Phase 2 studies. Based on strong preliminary efficacy and safety data from the Phase 2 EVOKE-02 study of Trodelvy in combination with pembrolizumab, presented at the World Conference on Lung Cancer 2023, Gilead remains confident in its ongoing Phase 3 EVOKE-03 study in 1L metastatic PD-L1 high NSCLC. The EVOKE-03 study is currently enrolling. In addition, Gilead has a broad clinical development program in lung cancer with domvanalimab, the first Fc-silent investigational anti-TIGIT antibody.
Despite recent advances with multiple immunotherapy treatment options for first-line metastatic NSCLC, most people’s cancer will eventually progress. Only about 35-55% of patients respond to immunotherapy-based combinations in the frontline setting, and after progression there are limited treatment options available, particularly for those who did not have a response to immunotherapy. Developing novel options for patients who have progressed on platinum-based chemotherapy and checkpoint inhibitor therapy is a challenge with limited treatment advancements made for these patients.
Gilead would like to thank the patients, families, investigators, and advocates who contributed to this important research.
Trodelvy is the first approved Trop-2-directed antibody-drug conjugate (ADC) that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers and improved clinical outcomes for certain people with 2L metastatic urothelial cancer.
Trodelvy has not been approved by any regulatory agency for the treatment of metastatic NSCLC. Its safety and efficacy have not been established for this indication. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for the approved U.S. Indication and additional Important Safety Information.
About Metastatic Non-Small Cell Lung Cancer
Worldwide, more than two million people were diagnosed with lung cancer in 2020. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for up to 85% of diagnoses. About half of NSCLC cases are diagnosed at the metastatic stage (57%), when treatment is especially difficult. Even in patients whose disease is caught early, half will eventually progress to the metastatic stage within five years. Newly diagnosed patients have several treatment options including platinum-based therapy, checkpoint inhibitors and targeted therapies. However, there are limited treatment options once patients with metastatic NSCLC progress on or after platinum-based chemotherapy and checkpoint inhibitors.
About the EVOKE-01 Study
The EVOKE-01 study is a global, multi-center, open-label Phase 3 study randomized 1:1 to evaluate Trodelvy vs. docetaxel in patients with advanced or metastatic NSCLC that has progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy. The study enrolled 603 participants. The primary endpoint is overall survival (OS). Key secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and safety. Additional efficacy measures include time to first deterioration in shortness of breath domain as measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) Score and time to first deterioration NSCLC-SAQ Total Score. Further study details are available on clinicaltrials.gov (NCT05089734).
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 is also approved to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer 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 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: 386
