Latest news with #DaiichiSankyo
Yahoo
2 days ago
- Business
- Yahoo
New Potential Treatment Strategy for Brain Metastases and Leptomeningeal Disease: HER3-DXd Shows Promising Results in the Phase II TUXEDO-3 Study for Patients With Limited Therapeutic Options
The TUXEDO-3 trial is the first study to evaluate the intracranial and extracranial efficacy and safety of a novel anti-cancer drug in patients with breast and lung cancer and active brain metastases, and leptomeningeal disease from solid tumors. These results were presented as an oral presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, with select results simultaneously published in Nature Medicine. MEDSIR's DEMETHER clinical trial was mentioned during abstract discussion due to the relevance of its strategy. CHICAGO, June 04, 2025--(BUSINESS WIRE)--Leading international medical research company, MEDSIR announced today the positive results of the TUXEDO-3 trial at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. This phase II study funded by Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada, evaluates the efficacy and safety of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases and leptomeningeal disease, serious complications associated with advanced stages of the cancer. The study was carried out to evaluate HER3-DXd in patients with metastatic breast cancer (mBC) and advanced non-small cell lung cancer (aNSCLC) with active brain metastases, and patients with leptomeningeal disease from solid tumors. This is an antibody-drug conjugate to target HER3, a protein receptor found on the surface of cancer cells in brain metastases. HER3-DXd is an investigational agent consisting of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC Technology payload causes tumor DNA damage, killing cancer cells within and surrounding the tumor microenvironment The study showed promising results, which were presented today in an oral session. Results from the leptomeningeal cohort have been simultaneously published in the renowned journal Nature Medicine due to its potential benefit in patients with a high unmet medical need. In patients with breast cancer and brain metastases, intracranial responses were observed across all breast cancer subtypes, including luminal, HER2-positive, and triple-negative. A NEW HOPE FOR DIFFICULT-TO-TREAT METASTASES "This study represents a significant advancement in our understanding of how to treat brain metastases and leptomeningeal disease, and we are hopeful that our findings will pave the way for new, effective therapies for these patients," stated Dr. Matthias Preusser, MD, Medical Oncologist and Head of the Clinical Division of Oncology, Medical University of Vienna and Principal Investigator of TUXEDO-3. Dr. Rupert Bartsch, MD, PhD, Consultant Hematology and Medical Oncology, Medical University of Vienna, added: "Brain metastases and leptomeningeal disease represent severe complications in cancer, leading to increased morbidity and mortality, and HER3-DXd could be a promising therapeutic alternative for these patients." Read more about TUXEDO-3 here: SHOWCASING PROMISING COLLABORATIVE TRIALS AT ASCO MEDSIR's trial DEMETHER, an international, phase II trial exploring the maintenance of trastuzumab and pertuzumab following trastuzumab deruxtecan as induction treatment for HER2-positive recurrent metastatic breast cancer patients, was mentioned during today's Discussion of LBA1008. DEMETHER's strategy is to optimize the sequence to increase patients' progression free survival (PFS) while improving their quality of life. The relevance of this mention highlighted the ability of MEDSIR for anticipating patients' needs and designing strategical trials to keep on pushing the barriers of clinical research. MEDSIR active presence at the ASCO Annual Meeting 2025 reinforces its leadership in excellence-driven oncology research and highlights its focus on addressing unmet needs in cancer treatment, with the aim of not leaving any patient left behind. ABOUT MEDSIR For further information: View source version on Contacts Media Sergio Aguilar Eduardo Martín Espallargas
Business Wire
2 days ago
- Business
- Business Wire
New Potential Treatment Strategy for Brain Metastases and Leptomeningeal Disease: HER3-DXd Shows Promising Results in the Phase II TUXEDO-3 Study for Patients With Limited Therapeutic Options
CHICAGO--(BUSINESS WIRE)--Leading international medical research company, MEDSIR announced today the positive results of the TUXEDO-3 trial at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. This phase II study funded by Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada, evaluates the efficacy and safety of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases and leptomeningeal disease, serious complications associated with advanced stages of the cancer. "This study represents a significant advancement in our understanding of how to treat brain metastases and leptomeningeal disease" - Dr. Matthias Preusser. Share The study was carried out to evaluate HER3-DXd in patients with metastatic breast cancer (mBC) and advanced non-small cell lung cancer (aNSCLC) with active brain metastases, and patients with leptomeningeal disease from solid tumors. This is an antibody-drug conjugate to target HER3, a protein receptor found on the surface of cancer cells in brain metastases. HER3-DXd is an investigational agent consisting of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC Technology payload causes tumor DNA damage, killing cancer cells within and surrounding the tumor microenvironment The study showed promising results, which were presented today in an oral session. Results from the leptomeningeal cohort have been simultaneously published in the renowned journal Nature Medicine due to its potential benefit in patients with a high unmet medical need. In patients with breast cancer and brain metastases, intracranial responses were observed across all breast cancer subtypes, including luminal, HER2-positive, and triple-negative. A NEW HOPE FOR DIFFICULT-TO-TREAT METASTASES 'This study represents a significant advancement in our understanding of how to treat brain metastases and leptomeningeal disease, and we are hopeful that our findings will pave the way for new, effective therapies for these patients,' stated Dr. Matthias Preusser, MD, Medical Oncologist and Head of the Clinical Division of Oncology, Medical University of Vienna and Principal Investigator of TUXEDO-3. Dr. Rupert Bartsch, MD, PhD, Consultant Hematology and Medical Oncology, Medical University of Vienna, added: 'Brain metastases and leptomeningeal disease represent severe complications in cancer, leading to increased morbidity and mortality, and HER3-DXd could be a promising therapeutic alternative for these patients.' MEDSIR's trial DEMETHER, an international, phase II trial exploring the maintenance of trastuzumab and pertuzumab following trastuzumab deruxtecan as induction treatment for HER2-positive recurrent metastatic breast cancer patients, was mentioned during today's Discussion of LBA1008. DEMETHER's strategy is to optimize the sequence to increase patients' progression free survival (PFS) while improving their quality of life. The relevance of this mention highlighted the ability of MEDSIR for anticipating patients' needs and designing strategical trials to keep on pushing the barriers of clinical research. MEDSIR active presence at the ASCO Annual Meeting 2025 reinforces its leadership in excellence-driven oncology research and highlights its focus on addressing unmet needs in cancer treatment, with the aim of not leaving any patient left behind.
CNBC
3 days ago
- 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
3 days ago
- Business
- Yahoo
ASCO25: AbbVie flexes ADC Phase I data as NSCLC market opportunity beckons
AbbVie's antibody drug conjugate (ADC) Temab-A (telisotuzumab adizutecan) has demonstrated promising results in a Phase I trial in patients with lung cancer, as the ADC modality continues to take centre stage at this year's American Society of Clinical Oncology (ASCO) meeting. AbbVie's candidate, dubbed internally as ABBV-400, achieved an overall response rate (ORR) of 63% in patients with advanced EGFR (epidermal growth factor receptor)-mutated, non-squamous (NSQ) non-small cell lung cancer (NSCLC). The drug has already demonstrated positive data in patients with wildtype EGFR. Patients enrolled in the trial were those who had progressed after platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKIs). Temab-A was administered every three weeks at one of two dose levels – 2.4 or 3 mg/kg. Immunotherapies currently on market are generally not recommended as first-line treatments for patients with EGFR mutation. Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan), the only ADC approved for NSCLC, previously demonstrated an objective response rate (ORR) of 49%. Enhurtu, however, is approved for HER2-mutant NSCLC, making direct comparisons difficult. AbbVie presented results from its Phase I trial (NCT05029882) at the 2025 ASCO Annual Meeting, taking place from 30 May to 3 June in Chicago, Illinois. The trial is enrolling around 500 adults with NSCLC, gastroesophageal adenocarcinoma, colorectal cancer (CRC) or advanced solid tumours. Data from the 41 patients enrolled demonstrated a median duration of response at 9.8 months and a median progression-free survival of 10.9 months. These figures were irrespective of c-Met expression, a protein found in NSCLC. Temab-A works by targeting c-Met and delivering a topoisomerase 1 inhibitor payload. Treatment emergent adverse events occurred in all patients, the most common being haematologic and gastrointestinal side effects. More serious events, those grade 3 and higher, occurred in 73% of patients. As with other ADCs, interstitial lung disease was observed – Temab-A generated a rate of 7% of this respiratory complication in participants. 'Data demonstrate a manageable safety profile, promising anti-tumour activity … and are supportive of further exploration of this novel ADC in this setting,' AbbVie's senior medical director of clinical development for solid tumours Nivedita Aanur told Pharmaceutical Technology. Nearly 85% of lung cancers are NSCLC, with initial treatment for patients with EGFR mutations including targeted therapy and/or chemotherapy. According to a GlobalData report, the global NSCLC market, valued at $30.7bn in 2021, is set to grow to $45.4bn by 2031. Approved immunotherapies in the market include MSD's Keytruda (pembrolizumab), Bristol Myers Squibb's Opdivo (nivolumab), and Roche's Tecentriq (atezolizumab). Daiichi Sankyo and AstraZeneca's ADC Enhertu won approval in NSCLC in the US and Europe in 2022 and 2023 respectively. Aanur comments: 'In addition to the data showcased at ASCO, it has now shown anti-tumour activity in both wild-type and EGFR-mutant advanced NSCLC, demonstrating its potential in these molecularly diverse populations. With its best-in-class potential, we believe Temab-A may offer meaningful patient impact compared to current standards of treatment.' Temab-A is also in Phase I/II (NCT06772623) development as a first-line treatment for NSCLC without actionable genomic alterations in combination with AbbVie's investigational programmed cell death 1 inhibitor budigalimab. AbbVie is also conducting separate Phase II (NCT06107413) and Phase III studies (NCT06614192) with the drug for CRC indications. AbbVie reported positive Phase II data last year for Teliso-V (telisotuzumab vedotin), also an ADC that targets the c-Met protein but uses a different payload, in EGFR-wildtype NSCLC patients. Other ADC data at ASCO this year include Genmab's rinatabart sesutecan for endometrial cancer treatment, MSD's zilovertamab vedotin for lymphoma, and Merck's precemtabart tocentecan for CRC. "ASCO25: AbbVie flexes ADC Phase I data as NSCLC market opportunity beckons" 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. Sign in to access your portfolio
Yahoo
4 days 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
