BNTX Stock Discussion (BioNTech SE)

BioNTech flags limited breast-cancer benefit and lung toxicity despite trial success

BioNTech ($BNTX) and DualityBio reported that trastuzumab pamirtecan met the primary endpoint in DYNASTY-Breast02, but described its progression-free survival advantage as modest. The global Phase 3 trial randomized 541 patients with hormone receptor-positive, HER2-low metastatic breast cancer who had progressed after endocrine treatment and had not received chemotherapy for metastatic disease. Overall survival results remained immature, and numerical efficacy estimates were not disclosed. Inter

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@tickerstat11 days ago

BioNTech and Gilead plan pivotal breast cancer combination study

BioNTech ($BNTX) and Gilead ($GILD) entered a collaboration and supply agreement to study pumitamig with Trodelvy in advanced triple-negative breast cancer. BioNTech plans to modify its Phase 3 ROSETTA-Breast-01 trial, replacing chemotherapy with Gilead's antibody-drug conjugate for patients with previously untreated, locally advanced or metastatic disease and low or absent PD-L1 expression. The change requires regulatory approval. BioNTech would remain the trial sponsor and lead the study, whil

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@tickerstat1 month ago

BioNTech reports longer survival in exploratory lung-cancer trial stage

BioNTech ($BNTX) and OncoC4 reported updated results for gotistobart in previously treated advanced squamous non-small cell lung cancer. Median overall survival reached 18.5 months versus 10 months with docetaxel in the non-pivotal first stage of the global Phase 3 PRESERVE-003 study. The analysis involved 87 patients and produced a death hazard ratio of 0.56, with a nominal p-value of 0.0295. The companies are continuing the separate pivotal stage, so the findings should not be presented as a c