– Oral Presentation Highlights Trodelvy Efficacy of 13.5 Months Overall Survival in Patients with Platinum-Ineligible Metastatic UC After Checkpoint Inhibitor Therapy –
– Trodelvy Demonstrated 12.8 Months Overall Survival in Patients with Metastatic UC Whose Disease Progressed Rapidly Following Platinum-Based Chemotherapy –
FOSTER CITY, CA, USA I February 17, 2023 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced new and updated positive results from three cohorts of the Phase 2 TROPHY-U-01 study of Trodelvy® (sacituzumab govitecan-hziy) for the treatment of metastatic urothelial cancer (mUC). These data demonstrate that Trodelvy produced both rapid and durable responses for patients across a range of hard-to-treat types of mUC including platinum-ineligible and rapidly progressing, post-platinum mUC. These findings will be featured in both an oral session (abstract #520) and in poster presentations (abstract #518, #526) during the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) Annual Meeting February 16-18.
“The TROPHY-U-01 data show consistent benefit of Trodelvy across multiple types of metastatic urothelial cancer, including the most difficult-to-treat and, often times, frail patients where treatment options are still scarce,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “Trodelvy has the potential to become a cornerstone treatment in metastatic urothelial cancer, and we are excited about the expected results from the ongoing Phase 3 TROPiCS-04 study that may serve to convert our U.S. accelerated approval to full approval for Trodelvy to treat patients with locally advanced or metastatic urothelial cancer following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor.”
Longer-term follow-up across Cohorts 1, 2, and 3 of TROPHY-U-01 provides an increasing body of evidence supporting the potential benefit of treating mUC with Trodelvy across clinically relevant, hard-to-treat patient populations. Results are summarized below:
| Cohort |
Inclusion Criteria |
Key Findings |
|
Cohort 1
n=113
|
Patients with mUC who progressed after platinum-based chemotherapy and checkpoint inhibitor (CPI) therapy
Abstract 526
|
In new long-term follow-up results, Trodelvy continued to demonstrate efficacy:
- 10.9 months median overall survival (OS); (95% CI, 8.9-13.8)
- 28% overall response rate (ORR) (95% CI, 20.2-37.6); 23% partial response (PR) rate and 38% clinical benefit rate (CBR) with 1.6 months median time to response
- 8.2 months median duration of response (DOR) (95% CI, 4.7-13.7, n=32)
- 5.4 months median progression-free survival (PFS); (95% CI, 3.5-6.9)
- 10.5 months median follow-up (range, 0.3-40.9) for treated patients
|
|
Cohort 2
n=38
|
Platinum-ineligible patients with mUC who progressed after CPI therapy
Abstract 520
|
In this primary analysis, Trodelvy demonstrated:
- 13.5 months median OS (95% CI, 7.6-15.6)
- 32% ORR (95% CI, 17.5-48.7); 32% PR and 42% CBR with 1.4 months median time to response
- 5.6 months median DOR (95% CI, 2.8-13.3; n=12)
- 5.6 months median PFS (95% CI, 4.1-8.3)
- 9.3 months median follow-up for treated patients (range, 0.5-30.6; n=38)
|
|
Cohort 3
n=41
|
Patients with rapidly progressing mUC who progressed after platinum-based therapy
Abstract 518
|
In this primary analysis, Trodelvy plus pembrolizumab, demonstrated:
- 12.8 months OS (95% CI, 10.7-NE) at a median follow-up of 12.5 months (range, 0.9-24.6; n=41)
- 41% ORR (95% CI, 26.3-57.9); 22% PR and 46% CBR with 1.4 months median time to response
- 1.1 months median DOR (95% CI, 4.8-NE; n=17).
- 46% CBR (95% CI, 30.7-62.6) with 1.4 months median time to response
- Median PFS was 5.3 months (95% CI, 3.4-10.2)
|
In April 2021, the U.S. FDA granted accelerated approval of Trodelvy for use in adult patients with locally advanced or mUC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. This approval is based on ORR and DOR established in Cohort 1.
Trodelvy has not been approved by any regulatory agency for the treatment of platinum-ineligible patients with mUC who progressed after prior CPI therapy, or in combination with pembrolizumab in patients with mUC who progressed after platinum-based therapy. Its safety and efficacy have not been established for these indications.
Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for additional Important Safety Information.
About Metastatic Urothelial Cancer
Urothelial Cancer (UC) is the most common type of bladder cancer and occurs when the urothelial cells that line the inside of the bladder and other parts of the urinary tract grow unusually or uncontrollably. An estimated 83,000 Americans will be diagnosed with bladder cancer in 20231, and almost 90% of those diagnoses will be UC2. In total, 30% of cases are considered advanced or metastatic disease.3 Despite advancements in treating mUC, long-term survival remains low.
About the TROPHY U-01 Study
The Phase 2 TROPHY-U-01 trial is an ongoing, international, multi-center, open-label, multi-cohort, single-arm study evaluating Trodelvy monotherapy or combination therapy in patients with mUC after progression on a platinum-based regimen and anti-PD-1/PD-L1-based immunotherapy.
Cohort 1 is assessing Trodelvy after progression on platinum-based chemotherapy and checkpoint inhibitor (CPI) therapy. Cohorts 2, 3, 4 and 5 of the study are ongoing. Cohort 2 is assessing Trodelvy monotherapy in platinum-ineligible patients after progression on anti-PD-1/PD-L1-based immunotherapy. Cohort 3 is assessing Trodelvy in patients with rapidly progressing, mUC who progressed after platinum-based therapy. Cohorts 4 and 5 are assessing Trodelvy combination therapy in patients with treatment naive mUC, with those in Cohort 4 receiving cisplatin and those in Cohort 5 receiving cisplatin and avelumab, respectively, in addition to Trodelvy.
More information about TROPHY is available at https://clinicaltrials.gov/ct2/show/NCT03547973.
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 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 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 approved in the U.S. to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer and has an accelerated approval for treatment of certain patients with second-line metastatic urothelial cancer; see below for full indication statements.
Trodelvy is also being developed for potential investigational use in other TNBC, HR+/HER2- and mUC populations, as well as a range of tumor types where Trop-2 is highly expressed, including metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.
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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
1 Key Statistics for Bladder Cancer. The American Cancer Society. https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html. Last accessed February 6, 2023.
2 Bladder Cancer: An Introduction. The American Society of Clinical Oncology. https://www.cancer.net/cancer-types/bladder-cancer/introduction. Last accessed February 6, 2023.
3 Bladder Cancer Statistics. The American Society of Clinical Oncology. https://www.cancer.net/cancer-types/bladder-cancer/statistics. Last accessed February 6, 2023.
SOURCE: Gilead Sciences
Post Views: 255
– Oral Presentation Highlights Trodelvy Efficacy of 13.5 Months Overall Survival in Patients with Platinum-Ineligible Metastatic UC After Checkpoint Inhibitor Therapy –
– Trodelvy Demonstrated 12.8 Months Overall Survival in Patients with Metastatic UC Whose Disease Progressed Rapidly Following Platinum-Based Chemotherapy –
FOSTER CITY, CA, USA I February 17, 2023 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced new and updated positive results from three cohorts of the Phase 2 TROPHY-U-01 study of Trodelvy® (sacituzumab govitecan-hziy) for the treatment of metastatic urothelial cancer (mUC). These data demonstrate that Trodelvy produced both rapid and durable responses for patients across a range of hard-to-treat types of mUC including platinum-ineligible and rapidly progressing, post-platinum mUC. These findings will be featured in both an oral session (abstract #520) and in poster presentations (abstract #518, #526) during the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) Annual Meeting February 16-18.
“The TROPHY-U-01 data show consistent benefit of Trodelvy across multiple types of metastatic urothelial cancer, including the most difficult-to-treat and, often times, frail patients where treatment options are still scarce,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “Trodelvy has the potential to become a cornerstone treatment in metastatic urothelial cancer, and we are excited about the expected results from the ongoing Phase 3 TROPiCS-04 study that may serve to convert our U.S. accelerated approval to full approval for Trodelvy to treat patients with locally advanced or metastatic urothelial cancer following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor.”
Longer-term follow-up across Cohorts 1, 2, and 3 of TROPHY-U-01 provides an increasing body of evidence supporting the potential benefit of treating mUC with Trodelvy across clinically relevant, hard-to-treat patient populations. Results are summarized below:
| Cohort |
Inclusion Criteria |
Key Findings |
|
Cohort 1
n=113
|
Patients with mUC who progressed after platinum-based chemotherapy and checkpoint inhibitor (CPI) therapy
Abstract 526
|
In new long-term follow-up results, Trodelvy continued to demonstrate efficacy:
- 10.9 months median overall survival (OS); (95% CI, 8.9-13.8)
- 28% overall response rate (ORR) (95% CI, 20.2-37.6); 23% partial response (PR) rate and 38% clinical benefit rate (CBR) with 1.6 months median time to response
- 8.2 months median duration of response (DOR) (95% CI, 4.7-13.7, n=32)
- 5.4 months median progression-free survival (PFS); (95% CI, 3.5-6.9)
- 10.5 months median follow-up (range, 0.3-40.9) for treated patients
|
|
Cohort 2
n=38
|
Platinum-ineligible patients with mUC who progressed after CPI therapy
Abstract 520
|
In this primary analysis, Trodelvy demonstrated:
- 13.5 months median OS (95% CI, 7.6-15.6)
- 32% ORR (95% CI, 17.5-48.7); 32% PR and 42% CBR with 1.4 months median time to response
- 5.6 months median DOR (95% CI, 2.8-13.3; n=12)
- 5.6 months median PFS (95% CI, 4.1-8.3)
- 9.3 months median follow-up for treated patients (range, 0.5-30.6; n=38)
|
|
Cohort 3
n=41
|
Patients with rapidly progressing mUC who progressed after platinum-based therapy
Abstract 518
|
In this primary analysis, Trodelvy plus pembrolizumab, demonstrated:
- 12.8 months OS (95% CI, 10.7-NE) at a median follow-up of 12.5 months (range, 0.9-24.6; n=41)
- 41% ORR (95% CI, 26.3-57.9); 22% PR and 46% CBR with 1.4 months median time to response
- 1.1 months median DOR (95% CI, 4.8-NE; n=17).
- 46% CBR (95% CI, 30.7-62.6) with 1.4 months median time to response
- Median PFS was 5.3 months (95% CI, 3.4-10.2)
|
In April 2021, the U.S. FDA granted accelerated approval of Trodelvy for use in adult patients with locally advanced or mUC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. This approval is based on ORR and DOR established in Cohort 1.
Trodelvy has not been approved by any regulatory agency for the treatment of platinum-ineligible patients with mUC who progressed after prior CPI therapy, or in combination with pembrolizumab in patients with mUC who progressed after platinum-based therapy. Its safety and efficacy have not been established for these indications.
Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for additional Important Safety Information.
About Metastatic Urothelial Cancer
Urothelial Cancer (UC) is the most common type of bladder cancer and occurs when the urothelial cells that line the inside of the bladder and other parts of the urinary tract grow unusually or uncontrollably. An estimated 83,000 Americans will be diagnosed with bladder cancer in 20231, and almost 90% of those diagnoses will be UC2. In total, 30% of cases are considered advanced or metastatic disease.3 Despite advancements in treating mUC, long-term survival remains low.
About the TROPHY U-01 Study
The Phase 2 TROPHY-U-01 trial is an ongoing, international, multi-center, open-label, multi-cohort, single-arm study evaluating Trodelvy monotherapy or combination therapy in patients with mUC after progression on a platinum-based regimen and anti-PD-1/PD-L1-based immunotherapy.
Cohort 1 is assessing Trodelvy after progression on platinum-based chemotherapy and checkpoint inhibitor (CPI) therapy. Cohorts 2, 3, 4 and 5 of the study are ongoing. Cohort 2 is assessing Trodelvy monotherapy in platinum-ineligible patients after progression on anti-PD-1/PD-L1-based immunotherapy. Cohort 3 is assessing Trodelvy in patients with rapidly progressing, mUC who progressed after platinum-based therapy. Cohorts 4 and 5 are assessing Trodelvy combination therapy in patients with treatment naive mUC, with those in Cohort 4 receiving cisplatin and those in Cohort 5 receiving cisplatin and avelumab, respectively, in addition to Trodelvy.
More information about TROPHY is available at https://clinicaltrials.gov/ct2/show/NCT03547973.
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 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 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 approved in the U.S. to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer and has an accelerated approval for treatment of certain patients with second-line metastatic urothelial cancer; see below for full indication statements.
Trodelvy is also being developed for potential investigational use in other TNBC, HR+/HER2- and mUC populations, as well as a range of tumor types where Trop-2 is highly expressed, including metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.
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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
1 Key Statistics for Bladder Cancer. The American Cancer Society. https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html. Last accessed February 6, 2023.
2 Bladder Cancer: An Introduction. The American Society of Clinical Oncology. https://www.cancer.net/cancer-types/bladder-cancer/introduction. Last accessed February 6, 2023.
3 Bladder Cancer Statistics. The American Society of Clinical Oncology. https://www.cancer.net/cancer-types/bladder-cancer/statistics. Last accessed February 6, 2023.
SOURCE: Gilead Sciences
Post Views: 255
