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Latest news with #pembrolizumab

NHS rolls out bladder cancer treatment that can double life expectancy
NHS rolls out bladder cancer treatment that can double life expectancy

Telegraph

time5 hours ago

  • Health
  • Telegraph

NHS rolls out bladder cancer treatment that can double life expectancy

A new treatment for advanced bladder cancer that doubles life expectancy is set for use on the NHS. Experts said it was the most significant advancement in bladder cancer treatment since the 1980s. Patients diagnosed with stage four bladder cancer, which accounts for one in 10 cases, will be offered a combination of an antibody drug called enfortumab, and pembrolizumab, an immunotherapy drug. In trials, patients lived for an average of almost three years compared to 16 months in those who received standard, platinum-based chemotherapy. Experts said there had been real 'unmet need' for patients with advanced cancer, which has spread to other parts of the body, with just 29 per cent of those diagnosed with stage four living for a year. It is estimated that 1,250 people a year could benefit from the treatment. Researchers also measured the amount of time people survived without their disease worsening – also known as progression-free survival – and found that this doubled for those on the new treatment from just six months to more than a year. Almost a third also had a so-called 'complete response' which meant there was no detectable trace of the cancer, compared to 14.5 per cent who received chemotherapy. 'A highly promising and effective new drug' Martyn Hewett, 75, from Stratford, east London, received the combination treatment on a trial at Barts Health NHS Trust after surgery to remove his tumours failed. He said: 'I feel very, very lucky, because if I hadn't been on this trial, I imagine I would be dead by now. Immediately after the operation that failed, I asked the doctor what the prognosis was, and he said, most people in your position live for a year. Now, three and a half years later, here I am. 'I am going to have an extra few years to see my grandson grow up – and maybe even be around to see him get married.' Following approval from the National Institute for Health and Care Excellence (Nice), the treatment combination will be available for NHS patients in England diagnosed with advanced bladder cancer, who would have been eligible for the platinum-containing chemotherapy. The combination of drugs are given via an IV infusion in hospitals or clinics. Helen Knight, the director of medicines evaluation at Nice, said: 'This is a highly promising and effective new drug, with clinical trial results highlighting the tremendous difference it could make to the length and quality of people's lives. 'Advanced bladder cancer is a devastating condition which can have a substantial impact on people's daily lives, often leading to them struggling to work, travel or maintain physical activity.' 'One of the most hopeful advances in decades' Prof Peter Johnson, NHS England's national clinical director for cancer, said: 'This is one of the most hopeful advances in decades for people with bladder cancer who will now be offered a treatment that can almost double their chances of survival, helping thousands to live longer and giving them more precious moments with their loved ones. 'Bladder cancer is often difficult to treat once it has spread, but this new therapy is the first one in years to really help stop the disease in its tracks, and our rollout to NHS patients will make a huge difference to the lives of those affected and their families.' Jeannie Rigby, the chief executive of the charity Action Bladder Cancer UK, said: 'This new drug has the potential to increase how long people have before their cancer gets worse and how long they live compared with the current, limited, treatment choices available.' Around 18,000 people in England are diagnosed with bladder cancer each year.

First new NHS bladder cancer treatment for decades approved
First new NHS bladder cancer treatment for decades approved

The Independent

time6 hours ago

  • Health
  • The Independent

First new NHS bladder cancer treatment for decades approved

A new combination treatment for advanced bladder cancer has been approved for NHS use in England. The treatment, combining enfortumab vedotin and pembrolizumab, marks the first significant advance in care for this condition since the 1980s. Clinical trials showed the new therapy doubles patients' average survival time to 33.8 months, compared to 15.9 months with chemotherapy. Approximately 1,250 people in England each year are estimated to benefit from this treatment, which also improves progression-free survival and complete response rates. Experts and patient advocates have welcomed the approval, highlighting its potential to fundamentally reshape care and significantly improve the lives of those affected.

Treatment that can double bladder cancer survival rates available to 1,000 patients in England
Treatment that can double bladder cancer survival rates available to 1,000 patients in England

The Guardian

time12 hours ago

  • Health
  • The Guardian

Treatment that can double bladder cancer survival rates available to 1,000 patients in England

More than 1,000 patients living with bladder cancer in England will be eligible for a treatment which can double survival rates from the disease. In England, 18,000 people are diagnosed with bladder cancer each year, and only about 10% of people with stage 4 bladder cancer will survive five years or more after they are diagnosed. The treatment, enfortumab vedotin with pembrolizumab, has been approved for use on the NHS from Thursday. About 1,250 patients across the country to be offered the therapy, which has been described by NHS bosses as one of the 'most hopeful advances in decades'. Clinical trials of the drug have shown that people with bladder cancer that has spread (metastasised) live up to twice as long when given the combination antibody treatment when compared with those given normal chemotherapy. One trial also found that almost 30% of patients had no detectable traces of cancer in their body following treatment with enfortumab vedotin and pembrolizumab, compared with only 12.5% with chemotherapy. Prof Peter Johnson, NHS England's national clinical director for cancer, said that the treatment is 'one of the most hopeful advances in decades for people with bladder cancer'. He added: 'Bladder cancer is often difficult to treat once it has spread, but this new therapy is the first one in years to really help stop the disease in its tracks, and our rollout to NHS patients will make a huge difference to the lives of those affected and their families.' The therapy works by enfortumab vedotin directly targeting the cancer cells and killing them, while pembrolizumab, an immunotherapy drug, helps the immune system recognise and fight the remaining cancer cells. Life expectancy for people with bladder cancer which has metastasised is usually only just over a year, but this new therapy increased survival for people with this stage of the disease by more than one year. Jeannie Rigby, the chief executive of Action Bladder Cancer UK, said the charity, 'bladder cancer patients and their families welcome this much-needed, step forward in treatments available for this hard-to-treat cancer. 'This new drug has the potential to increase how long people have before their cancer gets worse and how long they live compared with the current, limited, treatment choices available. It's also of importance that this treatment can mean these patients can experience a better quality of life with less hard to tolerate side effects.'

Leukemia Relapse: PD-1 Inhibition Shows Mixed Results
Leukemia Relapse: PD-1 Inhibition Shows Mixed Results

Medscape

time7 days ago

  • Health
  • Medscape

Leukemia Relapse: PD-1 Inhibition Shows Mixed Results

TOPLINE: Programmed death-1 (PD-1) inhibition with pembrolizumab led to durable remission in 31.3% of patients with early acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) relapse after hematopoietic cell transplantation (HCT). Mixed CD3 chimerism predicted response, but 37.5% developed severe graft-vs-host disease (GVHD). METHODOLOGY: A prospective phase 1B clinical trial enrolled 16 patients with AML (n = 12) and MDS (n = 4) who experienced relapse after HCT, with a median time to relapse of 5.5 months and median pretreatment bone marrow blast percentage of 21.5%. Participants received 200 mg pembrolizumab intravenously every 21 days for up to four cycles (induction), with responding patients eligible for maintenance therapy up to 1 year. Primary objectives included assessment of safety, overall response rate to pembrolizumab with or without subsequent chemotherapy, and rates of GVHD or clinically significant immune-mediated toxicity. Response evaluation occurred through bone marrow examination on day 35 (after cycle 2) and day 77 (after cycle 4), with complete remission defined as bone marrow blasts less than 5% and absence of circulating blasts. TAKEAWAY: The overall response rate was 31.3%, consisting of three complete remissions (18.8%) and two partial remissions (13.5%), with a median response duration of 610 days. Patients with mixed CD3 chimerism showed significantly higher response rates compared to those with full donor chimerism (50% vs 0%; P = .03). Severe (grades 3-4) GVHD developed in 37.5% of patients, with most cases resistant to corticosteroids and contributing to death in 25% of participants. The 1-year overall survival was 37.5% and event-free survival was 31.3%, with AML patients showing 1-year overall survival of 50.0%. IN PRACTICE: 'PD-1 inhibition led to durable remission in on -third of the patients experiencing early relapse after HCT, suggesting that this approach may augment the GVL [graft-vs-leukemia] response. Responses were exclusively observed in the setting of mixed CD3 donor chimerism. Immune toxicities (GVHD) were a barrier to successful treatment outcome,' the authors of the study wrote. 'The results of the study highlight the challenge of attempting to dissect the graft-vs-leukemia effect from immunologic toxicity in patients with HCT,' Roman M. Shapiro and Robert J. Soiffer, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, said in a press release. SOURCE: The study was led by John M. Magenau, Transplantation and Cell Therapy Program, University of Michigan Rogel Cancer Center in Ann Arbor, Michigan. It was published online on August 12 in Blood Advances. LIMITATIONS: According to the authors, the small sample size limited their ability to determine the extent to which pembrolizumab could separate graft-vs-leukemia effects from GVHD. The researchers note that, while some patients achieved response without GVHD, the limited cohort size may have confounded interpretation of significant variables, including response patterns in patients with high blast percentage, very early relapse, monosomal karyotype, or TP53 mutations. DISCLOSURES: Magenau declared receiving support through a National Institutes of Health career development award (K23AI123595) and a Rogel Cancer Center Scholarship. The study was supported by a research grant (54053) from the Investigator-Initiated Studies Program of Merck Sharp & Dohme LLC. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

IO Biotech to Announce Topline Results of Pivotal Phase 3 Trial of Cylembio® in Combination with KEYTRUDA® (pembrolizumab) as a First-Line Treatment for Patients with Advanced Melanoma
IO Biotech to Announce Topline Results of Pivotal Phase 3 Trial of Cylembio® in Combination with KEYTRUDA® (pembrolizumab) as a First-Line Treatment for Patients with Advanced Melanoma

Yahoo

time11-08-2025

  • Business
  • Yahoo

IO Biotech to Announce Topline Results of Pivotal Phase 3 Trial of Cylembio® in Combination with KEYTRUDA® (pembrolizumab) as a First-Line Treatment for Patients with Advanced Melanoma

NEW YORK, Aug. 10, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company, today announced the company will hold a conference call and webcast on Monday, August 11, 2025, at 8:30 AM ET to disclose the topline results of the pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) of its investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine, Cylembio (imsapepimut and etimupepimut, adjuvant) in combination with pembrolizumab vs. pembrolizumab alone as a first-line treatment for unresectable or metastatic (advanced) melanoma. Webcast and Conference Call Information The IO Biotech management team will host a webcast/conference call on Monday, August 11, 2025, at 8:30 a.m. ET to discuss the topline results from the Phase 3 trial of Cylembio. Those who would like to participate may access the live webcast here or register in advance for the teleconference here . A replay of the webcast will be available on the IO Biotech website following the live event. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, Cylembio®, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), has been granted a Breakthrough Therapy Designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit Follow us on our social media channels on LinkedIn and X (@IOBiotech). Contacts: Investors Maryann Cimino, Director of Investor Relations IO Biotech, Inc. 617-710-7305 mci@ Media Julie Funesti 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

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