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News
Tam-Peli meets primary endpoint for relapsed small-cell lung cancer in phase III trial
1+ day, 9+ hour ago (401+ words) The Clinical Trial Vanguard Tam-Peli meets primary endpoint for relapsed small-cell lung cancer in phase III trial Topotecan has been the default second-line chemotherapy for relapsed small-cell lung cancer for decades, and its survival benefit in that setting is modest…...
Mitapivat Just Rewrote the Treatment Floor for Transfusion-Dependent Thalassaemia, Here’s What the ENERGIZE-T Data Actually Mean
1+ day, 8+ hour ago (861+ words) The Clinical Trial Vanguard Mitapivat Just Rewrote the Treatment Floor for Transfusion-Dependent Thalassaemia, Here’s What the ENERGIZE-T Data Actually Mean Picture the patient record that has defined thalassaemia care for decades: a transfusion schedule, printed or scrolling across a clinic…...
Iza-bren 2.5 mg/kg dose advances to Phase 3 in EGFR-mutated NSCLC
1+ day, 9+ hour ago (362+ words) clinicaltrialvanguard.com Iza-bren 2.5 mg/kg dose advances to Phase 3 in EGFR-mutated NSCLC Three dose levels entered a randomized expansion cohort; only one came out with a Phase 3 ticket. SystImmune and Bristol Myers Squibb will present at WCLC in Seoul on…...
Tyra Selects 60mg Dose of Dabogratinib in NMIBC Phase 2 Study
4+ day, 9+ hour ago (344+ words) The Clinical Trial Vanguard Tyra Selects 60mg Dose of Dabogratinib in NMIBC Phase 2 Study Sixty milligrams once daily: that is the dose Tyra Biosciences selected from SURF302 after the Phase 2 study returned its first results on September 9, and the choice carries real…...
BridgeBio Shifts BBO-8520 Focus to KRAS Combinations in Second-Line NSCLC
5+ day, 9+ hour ago (322+ words) The Clinical Trial Vanguard BridgeBio Shifts BBO-8520 Focus to KRAS Combinations in Second-Line NSCLC A 63% objective response rate from a Phase 1 monotherapy arm is an unusual number to anchor a strategic pivot on, but that is what BridgeBio Oncology Therapeutics…...
FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models
1+ week, 1+ day ago (383+ words) The Clinical Trial Vanguard FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models Forty percent of Phase III cancer trials explicitly barred patients with an ECOG performance status of 2 or higher, and among trials that allowed those patients, they made…...
Early Termination No Longer Means Failure. It Means the Trial Was Working.
1+ week, 2+ day ago (616+ words) The Clinical Trial Vanguard Early Termination No Longer Means Failure. It Means the Trial Was Working. The CheckMate 057 trial was supposed to run longer. Bristol Myers Squibb had enrolled hundreds of patients with non-small cell lung cancer, randomized them between…...
Inhibrx to Present INBRX-106 Phase 2 Data in Head and Neck Cancer Study
1+ week, 2+ day ago (190+ words) The Clinical Trial Vanguard Inhibrx to Present INBRX-106 Phase 2 Data in Head and Neck Cancer Study Inhibrx Biosciences is releasing Phase 2 primary endpoint data for INBRX-106 on September 8, four days after announcing the webcast, a pace that signals the company…...
Elevar Presents Age-Stratified Camrelizumab-Rivoceranib Data After FDA Rejection
1+ week, 5+ day ago (385+ words) The Clinical Trial Vanguard Elevar Presents Age-Stratified Camrelizumab-Rivoceranib Data After FDA Rejection Two Complete Response Letters from the FDA in roughly two years should have quieted the camrelizumab-rivoceranib story, but Elevar Therapeutics is betting that a granular post hoc cut…...
When a Failed Primary Endpoint Teaches More Than a Win: What CARDIOTTRansform’s Secondary Analysis Reveals About Stratification in Complex Trials
2+ week, 8+ hour ago (838+ words) The Clinical Trial Vanguard When a Failed Primary Endpoint Teaches More Than a Win: What CARDIOTTRansform’s Secondary Analysis Reveals About Stratification in Complex Trials The CARDIOTTRansform investigators already knew their Phase 3 trial had not met its primary endpoint when they…...