Latest news with #Trodelvy
Reuters
4 days ago
- Business
- Reuters
Gilead posts flat quarterly profit, raises full-year outlook
Aug 7 (Reuters) - Gilead Sciences (GILD.O), opens new tab on Thursday reported flat quarterly earnings on slightly higher revenue and raised its full-year financial outlook due largely to better-than-expected sales of HIV drugs. Adjusted earnings per share were flat from a year earlier at $2.01, and just ahead of the average analysts' estimate of $1.97, as compiled by LSEG. Revenue rose 2% from a year earlier to $7.1 billion, which was in line analysts' expectations. Gilead did not disclose sales of Yeztugo, a twice-yearly HIV prevention drug approved by U.S. regulators in June. CEO Daniel O'Day told Reuters that the company is very happy with the launch so far. "The first scrip was written within hours... the first dose was delivered within days," he said, adding that the company is on track to achieve its stated goal of 75% insurer coverage of the drug within six months and 90% coverage within a year. Total HIV product sales for the quarter rose 7% year-over-year to $5.1 billion. Gilead said its second-quarter cell therapy sales fell 7% to $485 million due to increased competition, while sales of cancer drug Trodelvy rose 14% to $364 million. Sales of Gilead's portfolio of liver disease treatments fell 4% to $795 million, driven mainly by lower sales of hepatitis C drugs. For the full year, Gilead said it now expects adjusted earnings per share of $7.95 to $8.25, up from its previous estimate of $7.70 to $8.10. The company also bumped up its expectations for 2025 product sales to between $28.3 billion and $28.7 billion from a previous range of $28.2 billion to $28.6 billion. Gilead Chief Financial Officer Andrew Dickinson attributed the new outlook to better-than-expected HIV sales and expense discipline. Analysts have forecast full year earnings of $8.01 per share on revenue of $28.7 billion.
Yahoo
6 days ago
- Business
- Yahoo
IDEAYA Biosciences, Inc. Reports Second Quarter 2025 Financial Results and Provides Business Update
Phase 2/3 trial of the darovasertib and crizotinib combination in 1L HLA-A2-negative metastatic uveal melanoma (MUM) on track to report median PFS data by year-end 2025; potential to enable a U.S. accelerated approval filing First-reported median overall survival data in over 40 1L MUM patients from single-arm Phase 2 trial of the darovasertib and crizotinib combination to be provided at a medical conference in 4Q 2025 Phase 2 data from over 90 plaque brachytherapy and enucleation primary uveal melanoma (UM) patients treated with darovasertib in the neoadjuvant setting will be shared as a Proffered Paper Oral Presentation at the European Society of Medical Oncology (ESMO) in 4Q 2025 First-in-human Phase 1 clinical efficacy and safety data from over 70 SCLC patients treated with IDE849 (DLL3 TOP1i ADC) will be provided as an Oral Presentation at the IASLC 2025 World Conference on Lung Cancer on September 7th, 2025 IDEAYA 10-year Anniversary R&D Day will feature multiple clinical data updates, including from over 20 plaque brachytherapy patients in the Phase 2 trial of darovasertib as neoadjuvant therapy for primary UM and from two expansion cohorts in the Phase 1 combination trial of IDE397 and Trodelvy® (sacituzumab govitecan-hziy) in MTAP-deletion urothelial cancer Three IND submissions are on track by year-end 2025, including IDE892 (PRMT5), IDE034 (B7H3/PTK7 bispecific TOP1i ADC) and IDE574 (KAT6/7) ~$992 million of cash, cash equivalents, and marketable securities as of June 30, 2025; anticipated to fund operations into 2029 SOUTH SAN FRANCISCO, Calif., Aug. 5, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology company committed to advancing the discovery, development, and commercialization of transformative precision medicines to address unmet medical needs in cancer, provided a business update and announced financial results for the second quarter ended June 30, 2025. "We look forward to a catalyst rich period with six clinical data updates guided from now to year-end across three clinical stage programs, including two oral presentations that have been accepted at major medical conferences and our targeted top-line randomized median PFS results for the darovasertib and crizotinib combination in 1L HLA-A2 negative MUM to potentially enable our first accelerated approval filing in the U.S. We are also excited to host our 10-year Anniversary R&D Day in New York City on September 8th, where we will present multiple data updates across our potential first-in-class clinical pipeline and highlight our strategic vision and pioneering research in cancer biology and drug discovery," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. Selected Pipeline Developments and Upcoming Milestones Darovasertib Metastatic uveal melanoma (MUM) Median progression-free survival (PFS) data from the Phase 2/3 trial of darovasertib in combination with crizotinib in first line (1L) HLA-A2-negative MUM is on track to be reported by year-end 2025; this data has the potential to enable an accelerated approval filing in the United States. Over 350 patients have been enrolled in the trial as of August 4, 2025, and the company expects to complete full enrollment of approximately 400 patients by year-end. Based on feedback from the U.S. Food and Drug Administration (FDA), IDEAYA plans to submit median overall survival (OS) data from this trial to support full U.S. approval in HLA-A2-negative MUM. Median OS data from a single-arm, Phase 2 trial of darovasertib in combination with crizotinib will be presented at a medical conference in the fourth quarter of 2025. The readout will include data in over 40 patients, including both HLA-A2-negative and HLA-A2-positive patients. IDEAYA continues to enroll HLA-A2-positive patients in this trial to assess the benefit of the darovasertib/crizotinib combination to support a potential real world evidence (RWE) regulatory submission and/or compendia listing. If granted, this has the potential to broaden the use of darovasertib in MUM patients, independent of HLA status. Neoadjuvant therapy for primary uveal melanoma (UM) IDEAYA is also evaluating darovasertib as a monotherapy in the neoadjuvant setting for primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy, and slow disease progression and metastasis. Initial safety and visual benefit data will be reported from the Phase 2 clinical trial from over 20 patients in the plaque brachytherapy-eligible cohort at IDEAYA's R&D Day on September 8th, followed by additional data from over 90 patients in both the enucleation-eligible and plaque brachytherapy-eligible cohorts in a Proffered Paper Oral Presentation at ESMO, taking place from October 17-21, 2025 in Berlin, Germany. Following a successful Type D meeting with the FDA in April 2025, the company initiated a randomized Phase 3 registration-enabling trial of darovasertib in the neoadjuvant setting for primary UM in the third quarter of 2025. The trial, referred to as OptimUM-10, will enroll a total of approximately 520 patients in two cohorts of plaque brachytherapy-eligible and enucleation-eligible patients. IDE397 (MAT2A) IDEAYA is conducting a Phase 1/2 clinical trial pursuant to a clinical study collaboration and supply agreement with Gilead to evaluate IDE397 in combination with Trodelvy® (sacituzumab govitecan-hziy), Gilead's Trop-2 directed ADC, in patients with MTAP-deletion urothelial cancer, or UC, and non-small cell lung cancer, or NSCLC. In April 2025, the companies announced expansion of the IDE397 and Trodelvy® (sacituzumab govitecan-hziy) combination trial in NSCLC. IDEAYA will provide initial Phase 1 safety and efficacy data from two expansion cohorts in the IDE397 and Trodelvy® (sacituzumab govitecan-hziy) combination trial in MTAP-deletion UC patients at the company's R&D Day September 8th, with additional data targeted for a medical conference in the first half of 2026. IDE849 (DLL3 TOP1i ADC) IDEAYA's partner, Hengrui Pharma, is conducting a multi-site, open label Phase 1 clinical trial for IDE849 in China for patients with small-cell lung cancer (SCLC). Hengrui will present clinical safety and efficacy data from over 70 patients in the trial at the International Association for the Study of Lung Cancer ("IASLC") 2025 World Conference on Lung Cancer (WCLC) taking place from September 6-9, 2025 in Barcelona, Spain. The presentation will include data from the dose escalation and multiple expansion doses. In May 2025, IDEAYA initiated a Phase 1 trial in the U.S. in SCLC. Patient dosing in NETs and other DLL3-expressing tumors is targeted by year-end 2025. Other programs IDE161, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is currently in Phase 1 dose optimization to inform future combination studies with IDE849 and other TOP1i-based ADCs where PARG inhibition may synergize with the payload to deepen responses. IDEAYA plans to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025. The company will also share preclinical data in a poster presentation at WCLC providing combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161. IDE275 (GSK959), a potential first-in-class small molecule inhibitor of Werner Helicase, is being developed in collaboration with GlaxoSmithKline (GSK). A Phase 1 dose escalation in patients with MSI-High solid tumors is ongoing. IDE705 (GSK101), a potential first-in-class small molecule inhibitor of DNA Polymerase Theta Helicase, or Pol Theta, is being developed in collaboration with GSK. A Phase 1 clinical trial in combination with niraparib, GSK's small molecule inhibitor of PARP, is ongoing in patients with BRCA-positive or other HRD-positive tumors. Phase 2 expansion in HRD-positive solid tumors would trigger a $10 million milestone payment from GSK. IDEAYA also plans to submit three investigational new drug, or IND, applications before the end of the year: IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-2025; IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, in the fourth quarter of 2025; and IDE574, a potential first-in-class KAT6/7 dual inhibitor, in the fourth quarter of 2025. R&D Day - September 8, 2025 IDEAYA will host an in-person and virtual R&D Day on September 8th, 2025 from 8:00-10:00 AM ET in New York City. The company will present multiple clinical data updates across the pipeline and highlight future growth drivers and upcoming milestones. Speakers will include members of IDEAYA's senior leadership team and key opinion leader(s). Additional agenda details will be provided by the end of August 2025. Registration for this event can be accessed here or at the investors section of the IDEAYA website at Other corporate updates IDEAYA continues efforts to scale the organization in preparation for the potential U.S. launch of darovasertib, including key hires within the commercial, medical affairs and market access functions. Gary Palmer, M.D., joined as Senior Vice President, Medical Affairs, where he will lead the company's medical affairs activities. Gary joined IDEAYA with over 25 years of global leadership experience in medical affairs from biopharmaceutical companies of various sizes and stages, and across multiple therapeutic areas including oncology, pulmonary medicine, immunology and neurology. Most recently Gary was Senior Vice President of Medical Affairs at Pliant Therapeutics, and prior to that he was Senior Vice President of Global Medical Affairs Immunology & Neuroscience at Bristol-Myers Squibb Co (BMS) where he led the Worldwide Immunology, Fibrosis and Neuroscience Medical Affairs team covering a portfolio spanning four globally marketed medications and more than 15 development candidates across the areas of pulmonary fibrosis, dermatology, gastroenterology, rheumatology and neurology. Financial Results for the Quarter Ended June 30, 2025 As of June 30, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $991.9 million, compared to $1.05 billion as of March 31, 2025. The decrease was primarily driven by net cash used in operations. Research and development (R&D) expenses for the three months ended June 30, 2025 totaled $74.2 million compared to $70.9 million for the three months ended March 31, 2025. The increase was primarily due to higher clinical trial expenses to support our clinical pipeline and personnel-related expenses. General and administrative (G&A) expenses for the three months ended June 30, 2025 totaled $14.6 million compared to $13.5 million for the three months ended March 31, 2025. The increase was primarily due to higher personnel-related expenses to support our growth. The net loss for the three months ended June 30, 2025, was $77.5 million compared to the net loss of $72.2 million for the three months ended March 31, 2025. Total stock compensation expense for the three months ended June 30, 2025, was $11.9 million compared to $10.2 million for the same period in 2024. About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. IDEAYA's corporate presentation is available on its website, at its Investor Relations page: Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing and content of clinical program updates, regulatory updates, clinical trial data readouts, including those at medical conferences and IDEAYA's R&D Day; (ii) the potential therapeutic benefits of IDEAYA therapeutics; (iii) the translation of preliminary clinical trial results into future clinical trial results and/or regulatory approval; (iv) timing of development and regulatory milestones; (v) the timing of new IND applications; and (vi) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA BiosciencesJoshua Bleharski, Financial Officer investor@ IDEAYA Biosciences, Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts)Three Months Ended Six Months EndedJune 30, 2025 March 31, 2025 June 30, 2025 June 30, 2024(Unaudited) (Unaudited)Operating expenses: Research and development$ 74,226 $ 70,886 $ 145,112 $ 97,338General and administrative 14,58013,50328,08318,606Total operating expenses 88,80684,389173,195115,944Loss from operations (88,806)(84,389)(173,195)(115,944)Interest income and other income,net 11,31512,21123,52623,600Net loss (77,491)(72,178)(149,669)(92,344)Unrealized (losses) gains onmarketable securities (64)773709(1,978)Comprehensive loss$ (77,555) $ (71,405) $ (148,960) $ (94,322)Net loss per share attributable to common stockholders, basic and diluted$ (0.88) $ (0.82) $ (1.69) $ (1.21)Weighted-average number of shares outstanding, basic and diluted 88,472,19788,356,33588,414,58676,535,607 IDEAYA Biosciences, Balance Sheet Data(in thousands)June 30, December 31,2025 2024(Unaudited)Cash and cash equivalents and short-term and long-term marketable securities$ 991,869 $ 1,082,151Total assets 1,041,2701,124,091Total liabilities 81,61764,944Total liabilities and stockholders' equity$ 1,041,270 $ 1,124,091 View original content to download multimedia: SOURCE IDEAYA Biosciences, Inc. 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CNBC
03-06-2025
- Business
- CNBC
Healthy Returns: AstraZeneca, Pfizer, Gilead and other drugmakers release promising cancer drug data at ASCO
I'm back in New York City after spending the last weekend in Chicago for the American Society of Clinical Oncology annual meeting. More than 5,000 research abstracts were presented or published at ASCO by pharmaceutical giants, biotech companies, researchers and oncologists. They included studies on existing drugs, experimental treatments, AI tools and ideas for improving patient care. Here are some data highlights and executive commentary from the larger companies I follow: AstraZeneca wins big (again) – The blockbuster drug Enhertu from AstraZeneca and Japanese drugmaker Daiichi Sankyo stalled the growth of a common type of breast cancer by more than a year in a large late-stage trial when used as an initial treatment. The results could expand the use of the drug and change the way the disease is treated for the first time in a decade. The study evaluated Enhertu in combination with a standard medicine called pertuzumab as a frontline treatment, meaning it was used in patients newly diagnosed with what's known as HER2-positive metastatic breast cancer. Patients who got the Enhertu combination lived for almost 41 months before their disease spread, while a group who received a standard three-drug treatment lived for about 27 months before the cancer advanced. David Fredrickson, executive vice president of AstraZeneca's oncology business, told CNBC that one in three patients who start treatment for this type of cancer are not able to receive a second type of therapy because their health worsened or they died. But the results show that the Enhertu combination could give "another third of patients a chance to potentially have a longer progression-free survival time and to benefit from a more effective frontline therapy than if you wait till a second one." Pfizer impresses in colorectal cancer – The company's pill Braftovi, combined with two other cancer treatments, doubled survival time for patients with an aggressive form of colorectal cancer compared to a standard treatment in a late-stage trial. It's good news for Pfizer, which has submitted the data to the Food and Drug Administration to expand Braftovi's approval label. The three-treatment combination included a standard chemotherapy, an antibody drug called cetuximab and Braftovi, which targets a cancer mutation called BRAF V600E. That combination also cut deaths by 51% and slashed the risk that the cancer would progress by 47% compared to a standard treatment during the trial. Pfizer's Chief Scientific Officer Chris Boshoff told CNBC that 10% to 15% of colorectal cancer patients have that specific mutation, and noted their survival rates are "particularly poor." "We're very proud of [the data] because for the first time, it really shows a true impact on survival for a disease that's very challenging to treat," he said. Gilead and Merck combo's breast cancer win — The popular drug Trodelvy from Gilead 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 in a late-stage trial. Gilead could benefit from higher sales of Trodelvy as it competes with Enhertu. The study examined patients with advanced triple-negative breast cancer whose tumors express PD-L1, the protein targeted by drugs like Keytruda. Around 15% of breast cancer cases are triple negative, making them more aggressive and difficult to treat, according to Gilead. 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. A Merck, Daiichi Sankyo drug disappoints in lung cancer – Merck and Daiichi Sankyo on Thursday said they have withdrawn their U.S. application for an experimental treatment after it failed to prolong the lives of lung cancer patients in a late-stage trial. The drug, patritumab deruxtecan, is one of three so-called antibody drug conjugates that Merck has been working on with Daiichi Sankyo as it races to offset Keytruda's upcoming loss of exclusivity. The medication failed the trial's secondary goal of extending overall survival, which is defined as the length of time patients lived from the start of treatment. Those results, along with subsequent discussions with the FDA, led the companies to withdraw the application. But last year, the drug met the study's main goal of helping delay tumor progression compared to chemotherapy in patients who have been previously treated for non-small cell lung cancer with a mutation in a gene called EGFR. Marjorie Greene, Merck's head of oncology global clinical development, told CNBC that the "totality of the data couldn't support" the drug's application for approval. She called it a disappointment but noted that the company is learning from "what worked and what didn't work" and is still "fully investing" in refining the drug. Merck and Daiichi Sankyo plan on advancing the treatment into a late-stage development for breast cancer. Amgen's positive lung cancer data: The company's drug, Imdelltra, reduced the risk of death by 40% compared to chemotherapy for small cell lung cancer patients whose disease had worsened after an initial round of chemotherapy, according to data from a late-stage trial. Imdelltra also extended median overall survival by more than five months compared to the standard-of-care chemotherapy. Amgen said the trial results are intended to support last year's accelerated approval of Imdelltra by the FDA. BONUS: Bristol Myers Squibb inks deal with BioNTech – Bristol Myers Squibb on Monday said it has agreed to pay up to $11.1 billion to partner with BioNTech and develop its next-generation cancer immunotherapy. The drug could take on Keytruda and new treatments in development by Summit Therapeutics and Pfizer. BioNTech is running late-stage studies on the drug in lung cancer and plans to start a phase three trial in triple-negative breast cancer this year. Feel free to send any tips, suggestions, story ideas and data to Annika at The FDA this week approved the first-ever AI platform for breast cancer prediction from Boston-based Clairity, marking a big milestone for women's health tech and potentially for women's health screening. I profiled Clairity's founder Dr. Connie Lehman three years ago, as part of a story on investment in Femtech. At the time, she told CNBC the accuracy of technology can help reduce over-screening for women who are presumed to be at risk, while helping to identify women who might otherwise not be monitored until they've already developed cancer. "By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere," she said in the company's announcement of the approval. But to save lives, the next big step is to ensure women have access to the breakthrough technology as a preventive screening. The American Medical Association will first need to issue a billing code, which for some AI-driven tools has been slow to come. That code will be crucial to securing insurance coverage. Feel free to send any tips, suggestions, story ideas and data to Bertha at Amazon Pharmacy on Tuesday announced new updates for caregivers and more than 50 million Medicare Part D beneficiaries. Launched in 2020, Amazon Pharmacy was formed out of the company's 2018 acquisition of the online pharmacy PillPack. The offering is now a full-service, digital pharmacy that can help support patients with both one-off and recurring prescriptions. Prime members in cities like Los Angeles and New York City are eligible for same-day medication deliveries. Amazon said that customers with Medicare insurance can now directly access PillPack's services, which means those with two or more prescriptions can have their medications sorted into individual tear-away packets labeled with the date and time. The company said these monthly shipments will reduce the need for patients to keep track of multiple pill bottles and help them stick to their routines, according to a release. Patients interested in accessing pre-sorted medications through PillPack can sign up by logging into Amazon Pharmacy. Amazon Pharmacy also introduced a new way for verified caregivers to help manage medications on behalf of their loved ones. Around one in every five adults in the U.S. are caring for an aging family member, according to AARP. Patients can invite trusted caregivers to help oversee their medications by submitting their phone number. The caregiver will receive a text with a link, have to confirm details about the patient in question, and then can begin managing the patient's medications through their own account. "These updates deliver what our customers have been asking for—simpler medication management for themselves and their loved ones," John Love, vice president of Amazon Pharmacy, said in a statement on Tuesday. Amazon's online pharmacy is a part of the company's multi-year effort to push into the health-care industry. The company acquired primary care provider One Medical for roughly $3.9 billion in July 2022. Read the full announcement here. Feel free to send any tips, suggestions, story ideas and data to Ashley at
Yahoo
02-06-2025
- 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
02-06-2025
- 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
