BioNTech, Gilead to test drug combination in advanced breast cancer trial

Oct 22 (Reuters) – Germany’s BioNTech said on Thursday it had teamed up with Gilead Sciences to test its experimental cancer therapy in combination with the US drugmaker’s approved treatment in patients with a form of advanced breast cancer.

Here are some details:

• The late-stage trial will test BioNTech’s pumitamig with Gilead’s FDA-approved Trodelvy in patients with triple-negative breast cancer

• BioNTech plans to update its late-stage study to compare the combination against treatment with Trodelvy alone, replacing its earlier plan to test pumitamig plus chemotherapy against chemotherapy

• The safety and effectiveness of the combination has not been established, and the planned trial changes would require approval from health regulators, BioNTech said

• Triple-negative breast cancer is an aggressive form of the disease that lacks common treatment targets and accounts for about 10% to 15% of breast cancer cases, according to BioNTech

• The study will include patients with locally advanced or metastatic triple-negative breast cancer whose tumors have low or no levels of PD-L1, a biomarker used to guide treatment

• BioNTech will sponsor and lead the trial, while Gilead will supply Trodelvy

• Pumitamig is being developed by BioNTech and Bristol Myers Squibb and is central to their $11.1 billion collaboratio signed in 2025

• The drug is designed to help the immune system attack cancer cells and limit blood supply to tumors

(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Jonathan Ananda)