Latest news with #Afinitor
Mint
28-07-2025
- Business
- Mint
Celcuity's triple cancer drug combo beats AstraZeneca in halting cancer progression, shows study
Celcuity said on Monday its experimental combination treatment delayed the progression of a type of advanced breast cancer, sending the biotech firm's shares surging more than twofold in premarket trading. The drug, gedatolisib, in combination with Pfizer's Ibrance and AstraZeneca's endocrine therapy Faslodex, reduced the risk of disease progression or death by 76%, compared to Faslodex alone in previously treated HR /HER2- advanced breast cancer patients in a late-stage study. HR /HER2- breast cancer accounts for about 70% of all breast cancers. The combination treatment helped patients live for an average of 9.3 months without progression of the disease, compared to about two months with Faslodex. Gedatolisib belongs to a class of drugs called PAM inhibitors, which include Novartis' Afinitor and AstraZeneca's Truqap. The treatment was better tolerated in the late-stage trial than a previous early-stage study, with lower rates of high blood sugar and inflammation in the tissue lining the mouth, Celcuity said, without offering further details. The study also showed that a double combination of gedatolisib and Ibrance reduced the risk of disease progression or death by 67%, compared to Faslodex. This combination increased survival without progression of the disease in patients by 7.4 months on average, compared to about two months with Faslodex. Celcuity plans to report full results from this late-stage study and data from a separate trial in patients whose tumors had alterations in some genes later this year. It expects to apply for U.S. marketing approval in the fourth quarter. Shares of the Minnesota-based firm jumped nearly 114% to $29.4 before the bell.
Yahoo
28-01-2025
- Business
- Yahoo
ITM's radiotherapeutic beats out standard-of-care in Phase III trial
ITM Radiopharma's Phase III trial of its targeted radiotherapeutic for patients with Grade 1 or 2 gastroenteropancreatic neuroendocrine tumours (GEP-NETs) has hit the primary endpoint of prolonging progression-free survival (PFS). The Munich-based company has confirmed that its prospective, randomised, open-label trial of ITM-11 met its primary endpoint demonstrating a statistically significant benefit in PFS when compared to standard-of-care (SOC) Novartis' Afinitor (everolimus). The company plans to submit data from the Phase III trial as part of a future regulatory submission for approval at some stage this year. The Phase III COMPETE trial (NCT03049189) also evaluated secondary endpoints, including objective response rate (ORR), overall survival (OS), and quality of life (QoL) assessments, however, these are yet to be fully analysed. Investigator for the trial, Jaume Capdevila, said: 'With COMPETE, this marks the first time that a targeted radiopharmaceutical therapy has demonstrated improved PFS compared to a targeted molecular therapy, Afinitor, in patients with Grade 1 and 2 gastroenteropancreatic neuroendocrine tumours in a Phase III clinical trial. 'The patients included represent a real-life scenario, and the COMPETE study evaluates the important question of which therapy might be used first to provide greater benefit to patients.' The trial enrolled 309 patients with Grade 1 or 2 inoperable, progressive, somatostatin receptor-positive neuroendocrine tumours. Patients were randomised to receive ITM-11 with a nephroprotective amino acid solution every three months, or Afinitor 10 mg daily for up to 30 months or until the disease progressed. Andrew Cavey, CEO of ITM, added: 'People with GEP-NETs, whose journey from diagnosis to proper treatment can take years, remain in significant need of more robust, data-driven treatment options to maximize outcomes. The successful COMPETE data support ITM-11's potential and we believe marks an important milestone for patients and for ITM.' The news follows after the company aired concerns that whilst the radiotherapeutics space is set to grow, red tape and industry complexities are holding progress in the space back. Meanwhile, Austrian competitor Telix Pharmaceuticals has announced a 55% year-on-year revenue increase in 2024. "ITM's radiotherapeutic beats out standard-of-care in Phase III trial" 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
