Latest news with #Trodelvy
Yahoo
7 hours ago
- Business
- Yahoo
ASCO 2025: Trodelvy and Keytruda to become new standard of care for frontline TNBC
At the American Society of Clinical Oncology (ASCO) Annual Meeting, held 30 May-3 June 2025, primary results were presented from the ASCENT-04/KEYNOTE-D19 study investigating Gilead's Trodelvy, a trophoblast cell surface antigen 2 (TROP 2)-directed antibody-drug conjugate (ADC), in combination with Keytruda (pembrolizumab), versus standard-of-care (SOC) chemotherapy plus pembrolizumab in patients with PD-L1-positive (CPS ≥10) metastatic triple-negative breast cancer (TNBC). The study aimed to determine whether the addition of Trodelvy, currently approved in the third-line setting for TNBC, could enhance the efficacy of Keytruda in the first-line treatment of this aggressive breast cancer subtype. The data demonstrated an improvement in median progression-free survival (PFS), with 11.2 months observed in the ADC-immunotherapy combination arm compared to 7.8 months in the SOC arm, at a median follow-up of 14 months. Notably, patients receiving Trodelvy and Keytruda experienced a 35% reduction in the risk of disease progression (hazard ratio [HR], 0.64). The combination also achieved a higher overall response rate (60% versus 53%) and a longer duration of response (16.5 months versus 9.2 months) compared to SOC. The frequency of treatment-related adverse events (AEs) was comparable between arms; however, only 12% of patients discontinued treatment due to AEs in the Trodelvy-Keytruda arm versus 31% in the SOC arm. These findings support the expectation that Trodelvy combined with Keytruda will become the new SOC in PD-L1-positive TNBC, shifting the frontline treatment paradigm from chemoimmunotherapy to ADC-based immunotherapy - a growing trend across tumour types in the metastatic setting. Gilead is positioning itself as a key player in human epidermal growth factor receptor 2-negative metastatic breast cancer, currently sponsoring several Phase III trials evaluating Trodelvy: as monotherapy for frontline metastatic TNBC patients ineligible for PD-L1-based therapy (ASCENT-03); in combination with Keytruda in early-stage TNBC (ASCENT-05); and in HR-positive patients previously treated with endocrine therapy (ASCENT-07). GlobalData's analyst consensus forecast projects Trodelvy sales to reach $2.2bn by 2030. Gilead will face competition in the frontline PD-L1-ineligible TNBC setting from Daiichi Sankyo's TROP-2-directed ADC, Datroway, currently in Phase III (TROPION-BREAST02), and Bristol Myers Squibb's izalontamab brengitecan, a bispecific EGFRxHER3 ADC entering Phase III in July. Nevertheless, following the positive ASCENT-04 results, Gilead is expected to secure US Food and Drug Administration approval and capture a significant share of the frontline PD-L1-positive TNBC market. "ASCO 2025: Trodelvy and Keytruda to become new standard of care for frontline TNBC" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
10 hours ago
- Business
- Globe and Mail
Gilead Reports Positive Data From Trodelvy, Keytruda Combo Study
Gilead Sciences, Inc. GILD announced positive data on breast cancer drug Trodelvy (sacituzumab govitecan-hziy) from the late-stage ASCENT-04/KEYNOTE-D19 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
Business Insider
a day ago
- Business
- Business Insider
Merck announces data from trial studying KEYTRUDA plus Trodelvy
Merck (MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA plus Trodelvy reduced the risk of disease progression or death by 35% versus KEYTRUDA plus chemotherapy for the first-line treatment of patients with PD-L1+ inoperable locally advanced or metastatic triple-negative breast cancer, TNBC, as determined by an FDA-approved test. KEYTRUDA, when given in combination with Gilead's TROP2 antibody-drug conjugate, ADC, Trodelvy, resulted in a median progression-free survival, PFS, of 11.2 months versus 7.8 months when KEYTRUDA was given in combination with chemotherapy. These data from the pivotal Phase 3 ASCENT-04/KEYNOTE-D19 study will be presented today as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and were selected for the official ASCO Press Program. A higher objective response rate was observed for the KEYTRUDA plus Trodelvy combination, including 13% and 8% with a complete response, respectively, in the KEYTRUDA plus Trodelvy and KEYTRUDA plus chemotherapy arms. Notably, a substantially longer duration of response was observed with KEYTRUDA plus Trodelvy. Encouraging trends in overall survival were also observed, but data are immature at the time of PFS primary analysis. Overall survival follow-up remains ongoing and will continue to be monitored as a key secondary endpoint.
Business Insider
a day ago
- Business
- Business Insider
Gilead announces data on Trodelvy plus Keytruda
Gilead (GILD) Sciences announced Trodelvy plus Keytruda reduced the risk of disease progression or death by 35% versus standard of care Keytruda plus chemotherapy in first-line treatment for patients with PD-L1+ metastatic triple-negative breast cancer, TNBC. Trodelvy when given in combination with Keytruda resulted in a median progression-free survival of 11.2 months vs 7.8 months when Keytruda was given in combination with chemotherapy. These data from the pivotal Phase 3 ASCENT-04/KEYNOTE-D19 study will be presented today as a late-breaking oral presentation at the 2025 ASCO Annual Congress. For the primary endpoint, the median PFS was 11.2 months with Trodelvy plus Keytruda compared to 7.8 months with Keytruda plus chemotherapy, with a median follow-up of 14 months. A highly statistically significant and clinically meaningful improvement was observed with Trodelvy plus Keytruda, showing a 35% reduction in the risk of disease progression or death in the intent to treat population compared to standard of care Keytruda plus chemotherapy combination. The PFS benefit was generally consistent across key prespecified subgroups. A numerically higher overall response rate was observed for the Trodelvy plus Keytruda combination including 13% and 8% with a complete response, respectively, in the Trodelvy plus Keytruda and Keytruda plus chemotherapy arms. Notably, a substantially longer duration of response was observed with Trodelvy plus Keytruda.
New York Post
2 days ago
- Health
- New York Post
Breast cancer risk cut by 35% in new clinical trial
Trodelvy in combination with Merck's blockbuster immunotherapy Keytruda lowered the risk of an aggressive type of breast cancer worsening by 35% when used as an initial treatment, according to results of a large trial presented on Saturday. The data is likely to change how patients are treated following a diagnosis for advanced triple-negative breast cancer, one expert said. After a median follow-up of 14 months, patients treated with Trodelvy, a so-called antibody-drug conjugate, and Keytruda went 11.2 months without their cancer progressing, a measure known as progress-free survival. That compared with PFS of 7.8 months for those given the standard treatment of chemotherapy and Keytruda, researchers said. Advertisement 3 Trodelvy, in combination with Merck's immunotherapy Keytruda, lowered the risk of an aggressive type of breast cancer worsening by 35% when used as an initial treatment, according to new results. REUTERS Patients given the Trodelvy/Keytruda combination responded to the treatment for a median of 16.5 months, compared with 9.2 months for the chemo group, according to full results of the study presented at the American Society of Clinical Oncology scientific meeting in Chicago. The researchers said patients are still being followed to see if the regimen has an impact on overall survival. Gilead previously said the Phase 3 study in 443 patients with advanced triple-negative breast cancer whose tumors express PD-L1 – the protein targeted by drugs like Keytruda – had met its goal. Advertisement The findings suggest that the combination of Trodelvy and Keytruda 'will likely become a new front-line standard of care in this setting,' Dr. Jane Lowe Meisel, co-director of breast oncology at Emory University School of Medicine and a designated ASCO expert, said in a statement. ASCO estimates that about 10% of breast cancers in the United States are triple-negative. 3 Patients given the Trodelvy/Keytruda combination responded to the treatment for a median of 16.5 months, compared with 9.2 months for the chemo group, according to the results. Peakstock – That tends to be more difficult to treat than hormone-sensitive subtypes, because it does not have the common biomarkers used to guide treatment, the tumors are often larger, and the recurrence rate is high. Advertisement The medical group said that about 40% of triple-negative breast cancers are also PD-L1 positive, making them candidates for Keytruda. Antibody-drug conjugates like Trodelvy are designed to deliver an anti-cancer drug more precisely to malignant cells, causing less damage to healthy cells than chemotherapy. 3 Gilead is also conducting several other Trodelvy studies, including a trial of the drug as an initial treatment for triple-negative breast cancer patients who do not express PD-L1. REUTERS Serious side effects for Trodelvy included neutropenia, a condition caused by cancer treatments that lower levels of infection-fighting white blood cells, reported in 43% of patients, and diarrhea in 10%. In the chemotherapy group, the incidence of neutropenia was 45%, while 16% of patients had anemia and 14% had low blood platelet counts. Advertisement Trodelvy is already approved for patients with advanced triple-negative breast cancer who had two or more prior therapies, and for previously treated hormone-receptor-positive, HER2-negative metastatic breast cancer. Gilead is conducting several other Trodelvy studies, including a trial of the drug as an initial treatment for triple-negative breast cancer patients who do not express PD-L1.
