Latest news with #TNBC
Vogue
2 days ago
- Health
- Vogue
Everything You Need to Know About the New Breast Cancer Vaccine
In the search for a cure for breast cancer, a major breakthrough has finally come. Biotechnology company Anixa Biosciences, Inc. announced earlier this month that its breast cancer vaccine, which is being designed with the help of the Cleveland Clinic, has completed phase 1 of its clinical testing. It will be moving forward to the next stages of development, and if all goes to plan, doctors may soon be able to stop cancerous tumors from forming. 'The vaccine is designed to mobilize the patient's immune system to find, recognize, and destroy breast cancer cells for primary prevention,' Amit Kumar, Ph.D, CEO of Anixa Biosciences, Inc., tells Vogue. 'If a patient is vaccinated and [their] immune system is trained to destroy the cancer cells when the cancer appears, the vaccinated immune system will destroy the cells before they can grow into a cell tumor.' The vaccine, which comes in a set of three shots given to patients two weeks apart, specifically targets alpha-lactalbumin, a milk protein that is produced during lactation. It is typically not found after lactation in normal breast tissue, but scientists have found that the protein is expressed in about 70% of triple-negative breast cancer (TNBC) cases. The hope, Rima Patel, MD, oncologist and assistant professor in the division of hematology and medical oncology at Mount Sinai, explains, is that the vaccine can train people's immune system to recognize the protein as harmful and attack it before it turns into cancer. 'It is designed to alert the immune system to attack a breast tumor, before it can develop or recur, and prevent it from growing,' says Dr. Patel. 'It has been studied in an early phase 1 clinical trial in 35 women who had a history of early-stage TNBC and are at high risk of recurrence, and in patients without a history of cancer but are at high risk of developing breast cancer due to a genetic predisposition or other factors. The study thus far showed that the vaccine is overall well tolerated and resulted in an immune response in most patients.' Research in mice shows that the vaccine has been successful in activating the immune system against alpha-lactalbumin and preventing breast tumors in these small creatures. While the vaccine shows promise in humans, Dr. Kumar says they have to test larger numbers and with control groups in the next phases to show its efficacy and safety.
Yahoo
2 days ago
- Business
- Yahoo
Compugen to Present AI/ML Driven Predictive Computational Research at Upcoming International Scientific Conferences
HOLON, Israel, June 12, 2025 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced the presentation of AI/ML driven predictive computational research at upcoming international scientific conferences reflecting Compugen's scientific capabilities in understanding complex cancer biology. Poster details: Conference: 2025 Annual Congress of the European Association for Cancer Research, June 16-19 Lisbon, PortugalPoster number: EACR25-3113Title: Prediction of immune evasion and immunotherapy resistance mechanisms associated with distinct TNBC subtypesPresenting author: Amir Toporik, Computational Discovery, CompugenDate of presentation: June 18, 2025 Conference: International Society for Computational Biology and European Conference on Computational Biology- Annual International Conference on Intelligent Systems for Molecular Biology, July 20-24, 2025, Liverpool, UKPoster number: 947Title: Computational prediction of TNBC tumor subtypes from an integrative single cell atlas elucidates immune evasion and immunotherapy resistance mechanismsPresenting author: Itamar Borukhov, Ph.D., Computational Discovery, Compugen Posters will be available in the publications section of Compugen's website, following presentation. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery platform (UnigenTM) to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development: COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Rilvegostomig, a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, is in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. GS-0321 (previously COM503), a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which is in Phase 1 development is licensed to Gilead. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Company contact: Yvonne Naughton, of Investor Relations and Corporate CommunicationsEmail: ir@ +1 (628) 241-0071 View original content: SOURCE Compugen Ltd.
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
Business Insider
02-06-2025
- 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.
Medscape
31-05-2025
- Health
- Medscape
Sacituzumab or Chemo in First-Line TNBC: Which Is Better?
Treatment with pembrolizumab and the antibody-drug conjugate (ADC) sacituzumab govitecan improved progression-free survival (PFS) in patients with PD-L1-positive locally advanced or metastatic triple-negative breast cancer (TNBC) compared with treatment with pembrolizumab and chemotherapy, the results of ASCENT-04/KEYNOTE-D19 showed. Swapping in sacituzumab govitecan for chemotherapy led to a 3.4-month improvement in PFS and an almost twofold longer duration of response, with potentially fewer adverse events and a lower rate of discontinuations. Currently, pembrolizumab with chemotherapy is the standard of care for PD-L1-positive TNBC, but the 3-year survival rate remains low at about 36%. These findings support sacituzumab govitecan and pembrolizumab as the new standard for previously untreated patients in this setting, said lead investigator Sara Tolaney, MD, MPH, who presented the results at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. Once the new combination with sacituzumab govitecan, which targets the Trop-2 protein on tumor cells, is approved, 'I would recommend it in the first-line setting,' said Tolaney, a breast medical oncologist at the Dana-Farber Cancer Institute, Boston, Massachusetts. 'I think this really does change the game for' PD-L1-positive metastatic TNBC, said study discussant Jane Meisel, MD, a breast medical oncologist at Emory University, Atlanta, Georgia. 'I look forward to seeing this potentially make its way into clinical practice.' The study included 443 women who had either de novo metastatic disease or were at least 6 months away from completing systemic therapy for early-stage disease. Patients had a combined positive PD-L1 score of 10 or higher, and about 40% of TNBC tumors expressed the Trop-2 protein. Half of the patients were randomly assigned to 10 mg/kg sacituzumab govitecan on day 1 and day 8, plus pembrolizumab 200 mg on day 1 of 21-day cycles for a maximum of 35 cycles (n = 221). The other half were randomly assigned to pembrolizumab on the same schedule plus investigators' choice of gemcitabine plus carboplatin or paclitaxel/nab-paclitaxel (n = 222). Approximately 5% of patients had received a prior checkpoint inhibitor for earlier-stage disease; 43% of women in the chemotherapy arm crossed over to sacituzumab govitecan monotherapy after progression. At a median follow-up of 14 months, median PFS was 11.2 months in the sacituzumab govitecan group vs 7.8 months in the chemotherapy group, which translated to a 35% lower risk of cancer progression during follow-up (hazard ratio [HR], 0.65; P = .0009). Tolaney noted that PFS in the ADC group increased with higher Trop-2 expression, but the ADC group also did better than the chemotherapy arm regardless of Trop-2 levels, suggesting that 'you didn't need to preselect patients for use of sacituzumab by Trop-2.' Median duration of response was 16.5 months with sacituzumab govitecan vs 9.2 months with chemotherapy. Although overall survival follow-up is ongoing, the trend favors the ADC group (HR, 0.89). Commenting on the study, Julie Gralow, MD, a breast medical oncologist at the University of Washington, Seattle, noted that sacituzumab govitecan is already indicated as monotherapy in the third or later lines for metastatic disease. The ASCENT-04 results 'will likely move this drug, this regimen, earlier in the metastatic setting' for TNBC, Gralow agreed. On the side effect front, the most common (≥10% of patients) grade 3 and 4 adverse events in the sacituzumab govitecan group were neutropenia (43%) and diarrhea (10%); in the chemotherapy group, the most common adverse events were neutropenia (45%), anemia (16%), and thrombocytopenia (14%). Serious adverse events were numerically more common in the ADC arm (38 vs 31), but there were fewer dose reductions and fewer treatment discontinuations than with chemotherapy. 'The nice thing is that many of us have used both of these agents, sacituzumab and pembrolizumab, quite a bit,' and with no new safety signals, breast oncologists will 'feel comfortable with [the combination] once it makes its way into the clinic,' Meisel said. The work was funded by Gilead Sciences, maker of sacituzumab govitecan. Tolaney disclosed research and travel funding from Gilead and is a Gilead advisor. Gralow and Meisel reported no relevant financial relationships.
