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GILEAD SCIENCES, INC.

(GILD)
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Gilead Sciences, Inc. - New Data for Trodelvy Demonstrate Clinical Efficacy Across Trop-2 Expression Levels in HR+/HER2- Metastatic Breast Cancer

12/07/2022 | 09:55am EST

Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from a post-hoc analysis from the Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy; SG) versus comparator chemotherapy (physicians' choice of chemotherapy, TPC) in patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and at least two chemotherapies.

In the analysis, Trodelvy improved progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared with TPC across Trop-2 expression levels. Details of the late-breaking abstract will be presented today at the 2022 San Antonio Breast Cancer Symposium (SABCS, Abstract GS1-11).

Sacituzumab govitecan improved both progression-free survival and overall survival in pre-treated HR+/HER2- metastatic breast cancer in the Phase 3 TROPiCS-02 study compared to standard chemotherapy options. This post-hoc analysis demonstrates that the level of Trop-2 expression on an individual's tumor did not impact sacituzumab govitecan efficacy,' said Dr. Hope Rugo, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, U.S. 'These data can give us confidence in the potential benefit of sacituzumab govitecan for patients with endocrine-resistant metastatic breast cancer who have progressed on available chemotherapies, across Trop-2 expression levels.'

Trop-2, a protein found on the surface of cancer cells, is involved in several cellular processes regulating cancer growth and invasion. It is highly expressed in most human solid tumors, including more than 90% of breast cancers. In the TROPiCS-02 study, Trop-2 expression was measured by immunohistochemistry and expressed as a histochemical score (H-score; range, 0-300). Efficacy outcomes were assessed across H-score groups, including those with very low Trop-2 expression. Across each H-score subgroup, Trodelvy demonstrated improved PFS, OS and ORR compared to TPC, which is consistent with the PFS, OS and ORR in the TROPiCS-02 intention-to-treat population.

The prognosis for patients with pre-treated HR+/HER2- metastatic breast cancer who have developed resistance to endocrine-based therapies has been poor, and these TROPiCS-02 study results demonstrate clinical efficacy with Trodelvy, across Trop-2 expression levels,' said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. 'Our ambition is to continue our impact beyond our current approval in second-line metastatic TNBC, and we look forward to advancing discussions with the U.S. FDA and global health authorities to help bring Trodelvy to more people living with metastatic breast cancer.'

The safety profile for Trodelvy in TROPiCS-02 was consistent with prior studies, with no new safety signals identified in this population.

Detailed statistically significant and clinically meaningful PFS and OS results from the Phase 3 TROPiCS-02 study were presented at ASCO 2022 and ESMO 2022, respectively. Based on these data, the U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for Trodelvy in adult patients with unresectable locally advanced or metastatic HR+/HER2- (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. The Prescription Drug User Fee Act (PDUFA) target action date is currently set for February 2023.

Trodelvy has not been approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer. 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; pleasesee below for additional Important Safety Information.

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. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

Trodelvy is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including HR+/HER2- metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

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.

Forward-Looking Statements

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 with respect to FDA approval of the sBLA for Trodelvy for treatment of HR+/HER2- metastatic breast cancer, and pending or potential applications for the treatment of metastatic TNBC, HR+/HER2- metastatic breast cancer, metastatic UC, metastatic NSCLC, metastatic SCLC, head and neck cancer, and endometrial cancer, 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 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.

Contact:

Email: public_affairs@gilead.com

(C) 2022 Electronic News Publishing, source ENP Newswire

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Financials (USD)
Sales 2022 26 518 M - -
Net income 2022 4 383 M - -
Net Debt 2022 16 339 M - -
P/E ratio 2022 24,2x
Yield 2022 3,48%
Capitalization 105 B 105 B -
EV / Sales 2022 4,59x
EV / Sales 2023 4,64x
Nbr of Employees 14 400
Free-Float 99,9%
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Daniel P. O'Day Chairman & Chief Executive Officer
Andrew D. Dickinson Chief Financial Officer
Merdad V. Parsey Chief Medical Officer
Flavius Martin Executive Vice President-Research
Kevin E. Lofton Lead Independent Director
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