Gilead's (GILD) Trodelvy Late-Line Breast Cancer Study Meets Goal
Gilead Sciences GILD announced results from the phase IIITROPiCS-02 study, which evaluated its oncology drug, Trodelvy, in patients with late-line HR+/HER2- metastatic breast cancer.
The TROPiCS-02 study evaluated the drug in comparison to the physician’s choice of chemotherapy in two equal groups of patients having HR+/HER2- metastatic breast cancer who were already treated with prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.
The study achieved its primary endpoint of progression free survival (PFS) with statistical significance. But GILD did not disclose the exact numerical data, which would indicate the extent of statistical significance achieved by the drug.
However, Gilead reported that the primary endpoint results were consistent with the phase I/II IMMU-132-01 study, which evaluated Trodelvy in participants with HR+/HER2- metastatic breast cancer. The IMMU-132-01 study achieved a median PFS of 5.5 months. Per management, the TROPiCS-02 study achieved the target of 30% reduction in risk of disease progression or death.
The study also showed a trend toward improvement in overall survival (OS), a key secondary endpoint. However, per management, the numerical improvement in OS was not statistically significant at the first interim analysis. A final data on the OS endpoint is expected in 2024. Gilead will continue to follow-up with patients for overall survival.
GILD intends to provide detailed data on the study at a future medical conference.
In the year so far, shares of Gilead have fallen 17% compared with the industry’s 19.3% decline.
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Per management estimates, HR+/HER2- breast cancer accounts for nearly 70% of all breast cancer cases. Gileadaims to cater Trodelvy to a patient population who were heavily pre-treated and developed resistance to endocrine therapies and chemotherapy.
We remind investors that Trodelvy is already approved by the FDA for treating second-line metastatic triple-negative breast cancer (TNBC) in adult patients. The drug is also approved by the FDA under accelerated pathway for second-line metastatic urothelial cancer (UC) in adults. Trodelvy was added to GILD’s portfolio after it acquired the oncology company Immunomedics for approximately $21 billion in 2020.
Apart from the breast cancer indication, Gilead is evaluating Trodelvy across multiple other cancer indications including non-small cell lung cancer and bladder cancer.
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Zacks Rank & Stocks to Consider
Gilead Sciences currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the overall healthcare sector are Adaptimmune Therapeutics ADAP, BioDelivery Sciences BDSI and Vertex Pharmaceuticals VRTX, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Adaptimmune Therapeutics’ loss per share estimates for 2022 have narrowed from 99 cents to 91 cents in the past 30 days. Earnings of Adaptimmune Therapeutics beat estimates in three of the last four quarters and missed the mark on a single occasion, the average surprise being 0.9%.
BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 38 cents in the past 30 days. Shares of BDSI have surged 80% year to date.
Earnings of BioDelivery Sciences beat estimates in three of the last four quarters, missing the mark on a single occasion, the average surprise being 33.7%.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 7.3% year to date.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.
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