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Gilead (GILD) Reports Positive Data From Urothelial Cancer Study

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Gilead Sciences, Inc. (GILD - Free Report) announced new and updated positive results from three cohorts of the mid-stage TROPHY-U-01 study of Trodelvy (sacituzumab govitecan-hziy) for the treatment of metastatic urothelial cancer (mUC).

The TROPHY-U-01 study 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 did not respond to 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.

Data showed treatment with 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. Trodelvy demonstrated 12.8 months of overall survival in patients with metastatic UC whose disease progressed rapidly following platinum-based chemotherapy.

In April 2021, the FDA granted accelerated approval to 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.

Management stated that the expected results from the ongoing phase III TROPiCS-04 study may serve to convert the accelerated approval to full approval for Trodelvy in the United States for the treatment of patients with locally advanced or mUC following a platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor.

Trodelvy is approved in multiple countries 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. It is also approved in the United States to treat certain patients with pre-treated HR+/HER2- metastatic breast cancer.

The drug is 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.

Gilead’s stock has gained 38.8% in the past year against the industry's decline of 7.5%.

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The company recently reported better-than-expected fourth-quarter results, driven by continued solid demand for its HIV portfolio with further share growth for flagship HIV therapy Biktarvy and oncology revenues driven by the cell therapy franchise and Trodelvy. Cell therapy franchises comprise Yescarta and Tecartus.

Trodelvy sales increased 79% to $680 million in 2022 compared to 2021, reflecting the continued adoption of metastatic TNBC in the United States and Europe.

Gilead is looking to diversify its viral business into the lucrative oncology space. Competition is stiff for the HIV business from the likes of GSK plc (GSK - Free Report) , among others. Strong patient demand for the new HIV medicines (Dovato, Cabenuva, Juluca, Rukobia and Apretude) boosted GSK’s HIV franchise in 2022.

Zacks Rank and Key Picks

Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector include Dynavax Technologies (DVAX - Free Report) and Kala Pharmaceuticals (KALA - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, earnings estimates for Dynavax for 2022 have increased by 11 cents to $1.95. Dynavax surpassed estimates in two of the trailing four quarters and missed in the other two, with the average surprise being 73.15%.

Over the past 90 days, earnings estimates for KALA for 2022 have increased by 26 cents. KALA topped earnings estimates in two of the last four quarters and missed in the other two, with a four-quarter earnings surprise of 2.39% on average.


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