SACITUZUMAB GOVITECAN RECEIVES POSITIVE CHMP OPINION AS 2L TREATMENT FOR ADULT PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER

SACITUZUMAB  GOVITECAN  RECEIVES  POSITIVE  CHMP  OPINION  AS  2L  TREATMENT  FOR  ADULT  PATIENTS  WITH  METASTATIC  TRIPLE-NEGATIVE  BREAST  CANCER

-- Recommendation is Based on the Phase 3 ASCENT Study Showing that Sacituzumab Govitecan Significantly Improved Overall Survival in 2L vs. Physician’s Choice of Chemotherapy in Metastatic Triple-Negative Breast Cancer --

-- Sacituzumab Govitecan Could Offer a New Treatment Option for an Aggressive Type of Metastatic Breast Cancer if Approved --

Foster City, Calif., October 15, 2021 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for sacituzumab govitecan as monotherapy indicated for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease.¹ The final European Commission decision on the Marketing Authorization Application for sacituzumab govitecan is anticipated later in 2021.

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers.² It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women.3^,4 The five-year survival rate for this sub-type is 12%, compared with 28% for other breast cancer types, and these poor outcomes are often coupled with a significant decrease in quality of life, especially in relapsed/refractory disease.5^,6,7 Sacituzumab govitecan is a first-in-class Trop-2 directed antibody-drug conjugate.¹ Trop-2 is a protein located on the surface of cells and is overexpressed in TNBC and many other tumors.⁸

“Effective treatment options are extremely limited for patients with metastatic TNBC, especially once they progress. We are encouraged by this CHMP positive opinion for sacituzumab govitecan, as we are now one step closer to bringing this much needed treatment option to patients across Europe,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We look forward to the final decision by the EMA and the potential for sacituzumab govitecan to become a new standard of care for use as a second-line option.”

The positive opinion is supported by results from the Phase 3 ASCENT study, where sacituzumab govitecan showed a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death and improved median progression -free survival (PFS) to 4.8 months from 1.7 months seen with physician’s choice of chemotherapy alone among all randomized patients, which included those with and without brain metastases (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001).⁹ Sacituzumab govitecan also reduced the risk of death by 49% and improved median overall survival to 11.8 months vs. 6.9 months with physician’s choice of chemotherapy (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001). ⁹ The most common Grade 3 or higher adverse reactions were neutropenia (49.5%), leukopenia (12.0%), diarrhea (10.7%), anemia (10.1%), febrile neutropenia (6.6%), fatigue (5.2%), hypophosphatemia (5.2%), nausea (4.1%) and vomiting (3.0%).⁹ The sacituzumab govitecan U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea.

Sacituzumab govitecan (under the trade name Trodelvy^®) is approved in Australia, Canada, Great Britain, Switzerland, and the United States in metastatic TNBC, and review is also underway in Singapore and China through Everest Medicines.

About the ASCENT Study

The ASCENT study is a global, open-label, randomized Phase 3 study that enrolled more than 500 patients across 230 study locations. The study evaluated the efficacy and safety of sacituzumab govitecan compared with a single-agent chemotherapy of the physician’s choice in patients with unresectable, locally advanced or metastatic TNBC who had received at least two prior systemic treatments. Patients were randomly allocated to receive either sacituzumab govitecan or a chemotherapy chosen by the patient’s treating physician. The primary endpoint was progression-free survival (PFS, as determined by blinded independent central review) in patients without brain metastases. Secondary endpoints included: PFS for full study population or intention-to-treat (ITT) population, overall survival in both the ITT population and in the subgroup without brain metastasis, independently determined objective response rate, duration of response, time to onset of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), quality of life and safety. More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.  

About Triple-Negative Breast Cancer (TNBC)

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers.² TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women.^3,4 TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2).⁵ Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types.⁵ TNBC has a higher chance of recurrence and metastases than other breast cancer types.⁵ The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower.¹⁰ Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.^5,6

About Sacituzumab Govitecan

Sacituzumab govitecan is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Beyond the approvals of sacituzumab govitecan in the United States, it is also approved for metastatic TNBC in Australia, Canada, Great Britain and Switzerland for adults with metastatic TNBC. Sacituzumab govitecan is also under multiple regulatory reviews worldwide, including the EU, as well as in Singapore and China through our partner Everest Medicines. Sacituzumab govitecan continues to be developed for potential use in other TNBC and metastatic UC populations and is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

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, including those involving sacituzumab govitecan; the possibility of unfavorable results from ongoing or additional trials, including those involving sacituzumab govitecan; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including additional regulatory approvals of sacituzumab govitecan for the treatment of metastatic TNBC, metastatic breast cancer, metastatic UC, metastatic non-small cell lung cancer and other solid tumors, and the risk that any such approvals may be subject to significant limitations on use; 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 June 30, 2021, 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. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are 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.