Gilead Reports Positive Data From Trodelvy, Keytruda Combo Study
Data from the phase III ASCENT-04/KEYNOTE-D19 showed Trodelvy plus Merck 's MRK blockbuster immuno-oncology drug Keytruda reduced the risk of disease progression or death by 35% compared with Keytruda and chemotherapy in first-line PD-L1+ metastatic triple-negative breast cancer (TNBC).
Gilead and Merck collaborated in 2021 to evaluate Trodelvy in combination with Keytruda in the phase III ASCENT-04/KEYNOTE-D19 study.
Shares of GILD have gained 20% year to date against the industry 's decline of 3.1%.
More on GILD's & MRK's ASCENT-04/KEYNOTE-D19 Study
The ASCENT-04/KEYNOTE-D19 study is a global, open-label, randomized phase III study evaluating the efficacy and safety of Trodelvy in combination with Keytruda compared with the treatment of chemotherapy plus Keytruda in patients with previously untreated, inoperable locally advanced or metastatic TNBC whose tumors express PD-L1.
The study enrolled 443 patients across multiple study sites.
Patients were randomized equally in two arms - to receive either Trodelvy (10 mg/kg intravenously on Days one and eight of a 21-day cycle) plus Keytruda (200 mg intravenously on Day one of a 21-day cycle) or chemotherapy plus Keytruda.
The chemotherapy regimen included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel.
Patients continued treatment until either blinded independent central review (BICR)-verified disease progression or unacceptable toxicity. Importantly, those who progress on chemotherapy can cross over to receive Trodelvy.
The primary endpoint of the study is progression-free survival (PFS) as determined by BICR using RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to onset of response (TTR), patient-reported outcomes (PROs) and safety.
In April 2025, GILD announced that the study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS.
A highly statistically significant and clinically meaningful improvement was observed with Trodelvy plus Keytruda, with a 35% reduction in the risk of disease progression or death in the intent-to-treat population compared to the standard of care Keytruda plus chemotherapy combination.
A numerically higher overall response rate was observed for the Trodelvy plus Keytruda combination. Additionally, a substantially longer DOR was observed with the combination ofTrodelvy plus Keytruda
While data showed encouraging trends in overall survival (OS), it was still immature at the time of PFS primary analysis. OS follow-up remains ongoing and will continue to be monitored as a key secondary endpoint.
The safety profile of Trodelvy plus Keytruda in the ASCENT-04 study was consistent with the known safety profile of both drugs.
GILD Looks to Expand Trodelvy's Label
TNBC is the most aggressive type of breast cancer. In particular, first-line options remain limited for patients with PD-L1–positive metastatic TNBC.
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate.
Trodelvy is currently approved in more than 50 countries for second-line or later mTNBC patients and in several countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.
Last month, Gilead posted positive top-line results from another late-stage study, ASCENT-03, on Trodelvy. Data from this phase III study showed highly statistically significant and clinically meaningful improvement in PFS in patients with first-line metastatic TNBC who are not candidates for checkpoint inhibitors.
This is the second positive phase III study in first-line mTNBC where Trodelvy has demonstrated a clinically meaningful benefit compared with standard of care chemotherapy.
Per GILD, positive data from the ASCENT-03 and ASCENT-04 study demonstrate Trodelvy's potential as the backbone treatment for all patients across first-line mTNBC.
Gilead has additional ongoing phase III studies evaluating Trodelvy across HER2 breast cancer, including the ASCENT-07 pivotal trial in patients with HR+/HER2- mBC who have received endocrine therapy, and the ASCENT-05 pivotal trial in patients with early-stage TNBC (eTNBC). The drug is also being evaluated in additional late-stage studies across a range of tumor types, including lung and gynecologic cancers.
Gilead's oncology portfolio, comprising the Cell Therapy franchise and breast cancer drug Trodelvy, has diversified its overall business. However, the Cell Therapy franchise, comprising Yescarta and Tecartus, is currently under pressure due to competitive headwinds in the United States and Europe that are expected to continue in 2025.
Nonetheless, the potential launch of anito-cel in multiple myeloma and Trodelvy in first-line metastatic TNBC in 2026 will strengthen the company's oncology business.
GILD's Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Novartis NVS and Pfizer PFE, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate Novartis' 2025 earnings per share (EPS) has risen from $8.47 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 20 cents to $9.02 during this timeframe. The stock has risen 18.6% so far this year.
Pfizer's 2025 EPS estimate has risen from $2.97 to $3.06 in the past 60 days, while that for 2026 has gone up from $2.99 to $3.09 over the same timeframe.
Zacks Names #1 Semiconductor Stock
It's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.
With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.
See This Stock Now for Free >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Novartis AG (NVS): Free Stock Analysis Report
Pfizer Inc. (PFE): Free Stock Analysis Report
Merck & Co., Inc. (MRK): Free Stock Analysis Report
Gilead Sciences, Inc. (GILD): Free Stock Analysis Report
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
National Post
11 minutes ago
- National Post
Dana White says UFC fight at the White House is part of Paramount deal
Hours after Paramount and UFC announced a billion-dollar rights deal, Dana White said he had yet to hear from his friend, President Donald Trump, on his thoughts about the fight company's new streaming home. Article content That was fine with White. The UFC CEO was set to travel to Washington on Aug. 28 to meet with Trump and his daughter, Ivanka, to catch up and discuss logistics on the proposed Fourth of July fight card next year at the White House. Article content Article content Trump said last month he wanted to stage a UFC match on the White House grounds with upwards of 20,000 spectators to celebrate 250 years of American independence. Article content 'It's absolutely going to happen,' White told The Associated Press. 'Think about that, the 250th birthday of the United States of America, the UFC will be on the White House south lawn live on CBS.' Article content The idea of cage fights at the White House would have seemed improbable when the Frittata brothers purchased UFC for $2 million in 2001 and put White in charge of the fledging fight promotion. Article content White helped steer the company into a $4 billion sale in 2016 and broadcast rights deals with Fox and ESPN before landing owner TKO Group's richest one yet — a seven-year deal with Paramount starting in 2026 worth an average of $1.1 billion a year, with all cards on its streaming platform Paramount+ and select numbered events also set to simulcast on CBS. Article content ESPN, Amazon and Netflix and other traditional sports broadcast players seemed more in play for UFC rights — White had previously hinted fights could air across different platforms — but Paramount was a serious contender from the start of the negotiating window. Article content The Paramount and UFC deal came just days after Skydance and Paramount officially closed their $8 billion merger — kicking off the reign of a new entertainment giant after a contentious endeavor to get the transaction over the finish line. White said he was impressed with the vision Skydance CEO David Ellison had for the the global MMA leader early in contract talks and how those plans should blossom now that Ellison is chairman and CEO of Paramount. Article content 'When you talk about Paramount, you talk about David Ellison, they're brilliant businessmen, very aggressive, risk takers,' White said. 'They're right up my alley. These are the kind of guys that I like to be in business with.' Article content The $1.1 billion deals marks a notable jump from the roughly $550 million that ESPN paid each year for UFC coverage today. But UFC's new home on Paramount will simplify offerings for fans — with all content set to be available on Paramount+ (which currently costs between $7.99 and $12.99 a month), rather than various pay-per-view fees.
National Post
11 minutes ago
- National Post
Smarsh Named to Inc. 5000 for 18th Consecutive Year
Article content Prestigious annual ranking of the most successful private companies in America spotlights 3-year revenue growth of 114% at Smarsh Article content PORTLAND, Ore. — Smarsh, the global leader in digital communications compliance and intelligence, today announced it has been named to the Inc. 5000 list of the fastest-growing private companies in America for the 18th year in a row. This remarkable achievement underscores nearly two decades of sustained growth, innovation, and customer impact in one of the most essential and rapidly evolving sectors of enterprise technology. Smarsh is one of only two organizations in the history of the Inc. 5000 to receive this recognition 18 times. Article content Where Vision Meets Execution Article content 'Smarsh is honored to be recognized on the Inc. 5000 list for the eighteenth consecutive year,' said Kim Crawford Goodman, Chief Executive Officer of Smarsh. 'This achievement reflects how we've redefined sustainable growth and delivered lasting value for customers in financial services, government and beyond. It also speaks to our relentless pursuit of excellence across every sector we serve. By combining transformative technology with a forward-looking vision, we help our customers stay secure, competitive, and confident—especially as they navigate shifts like the rise of AI. This recognition is a testament to our people, our partners, and the culture of innovation and leadership that drives our continued success.' Article content Smarsh ranked No. 3437 on this year's list, reporting a three-year (2021–2024) revenue growth rate of 114%. The company's momentum is fueled by major innovations in compliance AI, including the industry's first solution for Microsoft Copilot Capture and an Intelligent Agent that applies cutting-edge AI to find risk in communications data efficiently. Smarsh supports a wide range of organizations, from emerging advisory firms to 18 of the top 20 global banks, helping them meet the requirements of the SEC, FINRA, and other regulators around the world. Article content Execution That Delivers Results Article content This recognition comes amid a year of strong momentum for Smarsh, marked by multiple accolades for its innovation, vision and culture. Recent honors include the 2025 Silver Globee Award for 'Best Use of AI in Finance,' a spot on the 2025 AIFINTECH100 list of the world's most innovative AI companies in financial services, and recognition as a 2025 USA TODAY Top Workplace. These accomplishments demonstrate leadership in delivering secure, scalable and future-ready solutions for the world's most regulated industries. Article content 'Making the Inc. 5000 is always a remarkable achievement, but earning a spot this year speaks volumes about a company's tenacity and clarity of vision,' says Mike Hofman, editor-in-chief of Inc. 'These businesses have thrived amid rising costs, shifting global dynamics, and constant change. They didn't just weather the storm—they grew through it, and their stories are a powerful reminder that the entrepreneurial spirit is the engine of the U.S. economy.' Article content About Smarsh Article content Smarsh enables companies to transform oversight into foresight by surfacing business-critical signals in their digital communications. Serving the top banks, insurers, investment firms, and government agencies worldwide, Smarsh delivers cloud-native solutions that help organizations stay compliant, mitigate risk, and unlock the value of their communications data. Learn more at or follow us on LinkedIn. Article content About Inc. Article content Article content Article content Article content
Globe and Mail
11 minutes ago
- Globe and Mail
Can Agnico Eagle's Ultra-Low Leverage Fuel Bigger Growth?
Agnico Eagle Mines LimitedAEM has made further progress in strengthening its balance sheet, underscoring its commitment to financial discipline. The company remains focused on paying down debt using excess cash, with long-term debt reducing by $550 million sequentially to $595 million at the end of the second quarter. It ended the quarter with a significant net cash position of $963 million, driven by the increase in cash position and reduction of debt. AEM's long-term debt-to-capitalization is just around 2.8%, indicating lower financial risks. This sharp deleveraging, which would lead to reduced interest expenses, was driven by strong free cash flow generation. AEM has a robust liquidity position and generates substantial cash flows, which allow it to maintain a strong exploration budget, finance a strong pipeline of growth projects, pay down debt and drive shareholder value. It recorded second-quarter free cash flow of $1,305 million, more than doubling the prior-year quarter figure of $557 million. This was backed by the strength in gold prices and robust operational results. The company's aggressive deleveraging efforts have rendered enhanced financial flexibility, underpinning confidence in its capacity to fund growth and drive shareholder returns without over-reliance on external financing. Agnico Eagle's ultra-low debt profile also offers a competitive edge in addition to bolstering its ability to reinvest in exploration and development projects. Looking across the peer landscape, Kinross Gold Corporation KGC has also taken steps to improve its leverage profile, thanks to strong free cash flow generation. Kinross improved its net debt position to around $100 million at the end of the second quarter from $540 million in the prior quarter. Notably, Kinross' second-quarter free cash flow surged roughly 87% year over year and 74% from the preceding quarter. Newmont CorporationNEM is balancing deleveraging with post-Newcrest acquisition integration and asset streamlining through strategic non-core divestments. Newmont retired $372 million of debt during the second quarter. Newmont ended the second quarter with net debt of $1,422 million, down from $3,221 million at the end of the prior quarter. The Zacks Rundown for AEM Agnico Eagle's shares have rallied 72.9% year to date against the Zacks Mining – Gold industry's rise of 72.6%, driven by an upswing in gold prices. Image Source: Zacks Investment Research From a valuation standpoint, AEM is currently trading at a forward 12-month earnings multiple of 19.55, a roughly 45.2% premium to the industry average of 13.46X. It carries a Value Score of D. Image Source: Zacks Investment Research The Zacks Consensus Estimate for AEM's 2025 and 2026 earnings implies a year-over-year rise of 64.1% and 0.8%, respectively. The EPS estimates for 2025 and 2026 have been trending higher over the past 60 days. Image Source: Zacks Investment Research AEM stock currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here. Research Chief Names "Single Best Pick to Double" From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all. This company targets millennial and Gen Z audiences, generating nearly $1 billion in revenue last quarter alone. A recent pullback makes now an ideal time to jump aboard. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report This article originally published on Zacks Investment Research ( Zacks Investment Research
