BioNTech, Gilead to rework Phase 3 breast study

BioNTech is reworking its global Phase 3 ROSETTA Breast-01 breast cancer trial through a new clinical collaboration and supply agreement with Gilead Sciences. Under the revised plan, the study will compare pumitamig in combination with Gilead’s sacituzumab govitecan, marketed as Trodelvy, against Trodelvy alone. The trial is designed for first-line treatment of patients with locally advanced or metastatic triple-negative breast cancer who have low or absent PD-L1 expression. The planned adaptation of the study protocol is subject to regulatory approval and has not yet demonstrated any treatment benefit.

Within this collaboration framework, BioNTech will assume responsibility for and lead the ROSETTA Breast-01 study. Gilead will provide sacituzumab govitecan for use in the combination and control arms. The design positions pumitamig to be judged on the additional effect it may bring when combined with Trodelvy, since the control arm receives Trodelvy alone. This sets up a direct head-to-head comparison between the combination regimen and a standard Trodelvy monotherapy approach in this patient population.

The revised ROSETTA Breast-01 trial centers on patients with locally advanced or metastatic triple-negative breast cancer, a setting where treatment options are limited. Enrollment will focus on individuals whose tumors show low or no PD-L1 expression. In this context, the study seeks to evaluate pumitamig’s potential contribution on top of an existing antibody-drug conjugate therapy. The global nature of the trial is intended to provide data that may be informative across multiple regions if the study proceeds as planned.

The agreement establishes a clinical collaboration and supply structure but does not guarantee that the trial will ultimately be conducted exactly as outlined. Regulatory authorities must first approve the proposed protocol changes to ROSETTA Breast-01. Until such approvals and subsequent execution occur, the plan remains a development blueprint rather than an active, conclusive study. There is currently no evidence from this trial design itself to show a treatment advantage for the combination over Trodelvy alone.

Pumitamig is also being studied in other cancer indications, underscoring its broader role in BioNTech’s oncology pipeline. A Phase 2 study, ROSETTA Lung-107, is evaluating pumitamig in combination with docetaxel in metastatic non-small cell lung cancer. These lung cancer data relate to a different tumor type, treatment regimen and patient group than the planned breast cancer trial with Trodelvy. As a result, findings from the lung cancer program and outcomes from ROSETTA Breast-01 will each need to be interpreted within their own clinical settings.

The separation of indications and combinations means that any future assessment of pumitamig’s profile must consider the distinct contexts of these studies. The breast cancer trial is focused on a combination with sacituzumab govitecan in triple-negative disease, while the lung cancer investigation explores a pairing with docetaxel. The shared involvement of pumitamig does not by itself justify equating the expectations or potential results of the two programs.