Gilead Sciences (NASDAQ:GILD), Inc. GILD recently announced that the phase IIb study, EVER-132-001, of sacituzumab govitecan met its primary endpoint of overall response rate (ORR) in metastatic triple-negative breast cancer (TNBC).
The study is sponsored by Everest Medicines and is being conducted in China.
EVER-132-001 is a single-arm, multi-center phase IIb registrational study evaluating sacituzumab govitecan in 80 patients enrolled in China for the treatment of adults with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one for metastatic disease. Data from the study showed an ORR of 38.8% as evaluated by an Independent Review Committee. The safety profile of sacituzumab govitecan was similar to that reported in prior studies, and no new safety signals were identified.
Sacituzumab govitecan is already marketed as Trodelvy in the United States for TNBC. It is also approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Please note that, in May 2021, the Center for Drug Evaluation of the China National Medical Products Administration granted priority review to the biologics license application (BLA) for sacituzumab govitecan for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Gilead has a collaboration agreement with Everest Medicines for the development and commercialization of sacituzumab govitecan in Asia. A tentative approval will increase the growth potential of the drug.
Earlier, the Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion on the Marketing Authorization Application (MAA) for sacituzumab govitecan. The MAA is seeking approval of the candidate as a monotherapy indicated for adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease.
Gilead’s stock has gained 15.5% this year against the industry's decline of 14.2%.
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The decline in its HCV business has forced Gilead to diversify into the oncology space, which promises potential despite stiff competition.
HIIV therapy, Biktarvy, continues to drive growth despite the ongoing impact of the pandemic. However, the loss of exclusivity of Truvada and Atripla has affected the HIV franchise’s performance.
Moreover, competition is stiff in the HIV market as well from the likes of GlaxoSmithKline (NYSE:GSK) GSK among others.
Glaxo reported an 8% growth in its HIV franchise in the third quarter, driven by its new HIV products Dovato, Juluca, Rukobia, and Cabenuva,
To further strengthen its HIV franchise, Gilead has collaborated with a subsidiary of Merck MRK to develop and commercialize long-acting, investigational treatment combinations of Gilead’s lenacapavir and Merck’s islatravir in HIV.
Gilead and Merck have recently initiated a phase II study evaluating an oral weekly combination of lenacapavir and islatravir in people who are living with HIV who are virologically suppressed on an antiretroviral therapy.
Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Sarepta Therapeutics (NASDAQ:SRPT) SRPT which sports a Zacks Rank #1 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Sarepta’s loss estimates have narrowed to $4.99 from $7.27 for 2021 in the last 30 days and to $3.61 from $4.88 for 2022. The company reported a narrower loss in the third quarter. Concurrently, Sarepta also upped its revenue guidance.
(We are reissuing this article to correct a mistake. The original article, issued on Novermber 11, 2021, should no longer be relied upon.)
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