Gilead said Monday that the drug at the center of its largest-ever acquisition has succeeded in a key clinical trial, though, for some, the company's decision to not disclose specific data raises doubts about how impactful its treatment could be.
The drug, called Trodelvy, was the centerpiece in Gilead's recent $21 billion purchase of Immunomedics, a New Jersey-based biotechnology company. Trodelvy has already been cleared in the U.S. to treat what's known as "triple negative" breast cancer, but Gilead hopes to broaden its reach by securing another approval in a much more common form called HR-positive, HER-2 negative breast cancer.
To do that, Gilead needed positive results from TROPiCS-02, a study which enrolled close to 550 patients with HR-positive, HER-2 negative breast cancer that had spread to other parts of the body even after multiple other treatments. The company is now reporting Trodelvy hit this study's main goal, reducing the risk of death or cancer progression compared to physician's choice of chemotherapy. The study was targeting at least a 30% reduction in risk, Gilead said.
The study also looked at whether treatment with Trodelvy helped patients live longer, and while too early to draw formal conclusions, Gilead said there appears to be a positive trend.
Though the trial was successful, investors seemed confused by the way Gilead announced the findings. The company did not provide any specific data, saying instead that more details would be presented at an upcoming medical meeting. Additionally, it took the unusual step of posting a frequently asked questions, or FAQ, document about the Trodelvy study and results, rather than host a conference call to walk through the data with analysts.
Gilead's share price was down almost 5% at market's open Monday, though it rebounded later in the morning to trade about even with its Friday closing value of $61.86.
In its FAQ document, Gilead addressed issues like whether the results seen so far in TROPiCS-02 are "clinically meaningful," a term doctors and drug developers use to describe the tangible, real-world benefits a new therapy can have outside the confines of a trial. "There is a broad range of views on what is 'clinically meaningful' in this population," Gilead said. "We are evaluating the data and will explore potential pathways with regulatory authorities to bring Trodelvy to this group of patients."
The company also noted how results were consistent with an earlier study of Trodelvy that enrolled some patients with HR-positive, HER-2 negative breast cancer. In that study, the median time between when a patient was treated and when their cancer progressed was five and a half months.
Overall, Gilead said it remains confident in Trodelvy, and these latest results don't change the company's financial guidance or plans for the drug.
Yet, some analysts aren't convinced. Although Trodelvy hit the study's main goal, "the verbose explanations around the results ... without any quantitative detail, is clearly a signal of a benefit that is questionable, compared to chemotherapy," wrote Baird & Co.'s Brian Skorney in a note to clients.
Skorney added that, while not a failure, the initial results announcement "indicates that the opportunity in HR+/HER2- breast cancer is likely to be constrained," because the benefit offered by Trodelvy may not be substantial enough to sway doctors to use it over the cheap generic chemotherapies that the drug was compared against in TROPiCS-02.
For Brian Abrahams, an analyst at RBC Capital Markets, Monday's announcement is a "negative" for investor sentiment towards Gilead. Abrahams also argues that management could face added pressure or questions about how the company deploys its money. Notably, Gilead, hoping to quickly grow its business in cancer research, entered a string of acquisitions and equity deals in 2020, shelling out roughly $27 billion in the process.