Latest news with #RECIST1.1
Business Insider
11 hours ago
- Business
- Business Insider
Hutchmed, Innovent jointly announce NDA acceptance in China
HUTCHMED (HCM) and Innovent Biologics 'jointly announce that the New Drug Application for the combination of fruquintinib and sintilimab for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment with one tyrosine kinase inhibitor has been accepted for review by the China National Medical Products Administration. The NDA is supported by data from FRUSICA-2, a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma. The study has met its primary endpoint of progression free survival, as assessed by blinded independent central review according to RECIST 1.1 criteria. The combination also demonstrated improvements in secondary endpoints including objective response rate and duration of response. The safety profile was tolerable and no new safety signals were observed. Data from FRUSICA-2 will be submitted for presentation at an upcoming scientific conference.'
Business Insider
4 days ago
- Health
- Business Insider
Replimune presents two posters on data updates for RP1 at 2025 ASCO
Replimune (REPL) Group presented two posters highlighting data updates for RP1 at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting taking place May 30-June 3 in Chicago. The poster included an analysis from the IGNYTE clinical trial of RP1 plus nivolumab in the cohort of anti-PD-1 failed melanoma patients. In the trial, the objective response rate was 32.9% using RECIST 1.1. The complete response rate was 15.0% and landmark overall survival rates at 1, 2, and 3 years were 75.3%, 63.3%, and 54.8% respectively. Median OS has not been reached. Patients experienced numerically higher objective response rates after receiving deep injections compared with superficial injections only. Deep responses were observed in injected and non-injected lesions. The ORR by injection type using RECIST 1.1 was 29.8% when only superficial lesions were injected, 42.9% for deep/visceral plus superficial injections injected, and 40.9% when only deep/visceral lesions were injected. There was a greater than or equal to30% reduction in 93.6% of injected lesions and 79.0% of non-injected lesions. Liver and lung injections had a tolerable safety profile. No bleeding events were reported after liver injection. Lung injections were associated with low rates of pneumothorax events, which were typically of low grade and manageable. Overall, these data support the safety and efficacy of deep/visceral injections and demonstrate the development of a robust systemic anti-tumor response following treatment with RP1 plus nivolumab.
Business Wire
25-04-2025
- Business
- Business Wire
Onc.AI Announces Presentation of Breakthrough-Designated AI Model Evaluated in Clinical Trial Data at AACR 2025
CHICAGO--(BUSINESS WIRE)-- a digital health company developing advanced AI-driven clinical management solutions for oncology, today announced that findings from a recent collaboration with global biopharma company GSK using FDA breakthrough-designated Serial CTRS AI model will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. The study externally evaluated Serial CTRS in GSK's GARNET Phase I clinical trial (NCT02715284) Cohort E, that enrolled patients with advanced non-small cell lung cancer (NSCLC) treated with dostarlimab, GSK's anti-PD-1 checkpoint inhibitor. Results, highlighted in a poster presentation during the Predictive Biomarkers 2 session (poster #21, April 27, 2025, 2-5pm), demonstrated that the Serial CTRS biomarker, leveraging routine CT imaging without manual annotations, improved prediction of overall survival (OS) compared to traditional surrogates including RECIST 1.1 response criteria and tumor volume. The analysis was conducted through an independent and blinded retrospective validation study carried out by GSK. In particular, Serial CTRS showed the ability to distinguish patients with intermediate versus high probabilities of 12-month OS (HR: 2.91, 95% CI: 1.16–7.31), outperforming RECIST 1.1 (HR: 1.34, 95% CI: 0.57–3.13) and tumor volume change assessments (HR: 1.00, 95% CI: 0.43–2.34). This enhanced predictive performance supports commitment to establishing Serial CTRS as a new standard for automated, AI-based imaging endpoints in the early assessment of treatment response, seamlessly integrating into standard imaging workflows across diverse therapeutic regimens. Key findings include: Serial CTRS improved discrimination between intermediate and high probabilities of overall survival compared to RECIST 1.1 and tumor volume changes. Serial CTRS remained a significant predictor of overall survival after adjusting for known prognostic factors, such as age, baseline tumor volume, and PD-L1 Tumor Proportion Score (TPS). 'This important milestone for Serial CTRS builds on a recent breakthrough-designation from FDA,' said Akshay Nanduri, CEO of 'The success of this validation study and ongoing continued collaboration with GSK reflects the strength and robustness of model performance. This can only be achieved using advanced Deep Learning combined with methods for harmonizing diverse imaging data and the breadth of our training data. high-quality data on thousands of patients has been sourced from dozens of healthcare systems representing hundreds of clinics across the United States and other international cancer centers, ensuring unparalleled diversity in training, test and validation.' 'As the past head of multiple Phase I clinics at top cancer centers, I believe that innovation with Serial CTRS could transform the pharma clinical development process from Phase I to Phase III studies,' said George R. Simon, MD, FACP, FCCP, Vice President of Oncology at OhioHealth. About is a digital health company developing AI-driven oncology clinical management solutions using advanced Deep Learning applied to routine diagnostic images. The company's platform is applied at the point of care by medical oncologists and is also leveraged by global pharmaceutical leaders to accelerate oncology drug development. is backed by premier institutional investors, including: Sandbox/Blue Venture Fund, Action Potential Venture Capital, MassMutual Alternative Investments, Accomplice, Digitalis, KdT, and Life Extension Ventures. is also supported by the National Cancer Institute SBIR program (1R44CA291456-01A1). For more information, please visit:
