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

By Reuters News

- Germany's BioNTech 22UAy.DE said on Thursday it had teamed up with Gilead Sciences GILD.O 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 BMY.N 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

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