BioNTech, Gilead to test drug combination in advanced breast cancer trial
BNTX•BioNTech and Gilead will test BioNTech’s pumitamig with Gilead’s approved Trodelvy in patients with advanced triple-negative breast cancer. BioNTech plans to compare the combination with Trodelvy alone, subject to health regulator approval.
1. Trial design
The late-stage trial will test pumitamig with Trodelvy in patients with locally advanced or metastatic triple-negative breast cancer whose tumors have low or no levels of PD-L1. BioNTech plans to change the study to compare the combination with Trodelvy alone, replacing an earlier plan to compare pumitamig plus chemotherapy with chemotherapy.
2. Companies’ roles
BioNTech will sponsor and lead the trial, while Gilead will supply Trodelvy. The safety and effectiveness of the combination have not been established, and the planned trial changes would require approval from health regulators.
3. Drug context
Pumitamig is being developed by BioNTech and Bristol Myers Squibb. BioNTech says triple-negative breast cancer accounts for about 10% to 15% of breast cancer cases and lacks common treatment targets.
