Providence Cancer Institute is now enrolling patients in ROSETTA Breast-01, a phase III clinical trial testing an investigational drug called pumitamig, also known as BNT327, for people with triple-negative breast cancer (TNBC) that has returned or spread and whose tumors are PD-L1 negative. The trial is led by David Page, M.D., medical oncologist at Providence Cancer Institute, specializing in breast cancer treatment and research.
Why TNBC is so hard to treat
Triple-negative breast cancer accounts for approximately 10 to15% of invasive breast cancers. It gets its name from the three most common receptors known to fuel breast cancer growth – estrogen (ER), progesterone (PR) and the HER2 receptor— which aren’t present in a TNBC tumor. TNBC also tends to grow and spread faster than other breast cancer types. The five-year survival rate for those with advanced disease is about 15%.
For some patients, immunotherapy added to chemotherapy has improved outcomes. But those drugs have mainly helped patients whose tumors show high levels of a protein called PD-L1. For patients with PD-L1 negative tumors, the standard first-line treatment is chemotherapy alone. Chemotherapy can shrink tumors and slow the disease, but responses often don't last, and the side effects can be debilitating.
Why this trial matters now
ROSETTA Breast-01 is aimed at people with the fewest first-line options. It asks the question: does adding pumitamig to chemotherapy help people with TNBC live longer and keep their cancer from growing for a longer period of time than chemotherapy alone?
How pumitamig works
Pumitamig is a bispecific antibody, a single drug engineered to attach to two targets at once – in this case, PD-L1 and VEGF-A.
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- PD-L1 - Tumors can use this protein to hide from the immune system. Blocking it helps T cells recognize and attack cancer cells.
- VEGF-A - This protein helps tumors grow the blood vessels that feed them.
By hitting both targets, pumitamig may both activate the immune system and reduce tumor blood supply, potentially shrinking tumors and preventing spread of disease. Researchers hope this two-part approach can help people whose cancers are PD-L1 negative and typically don’t response well to current immunotherapy drugs.
Early-phase trials in TNBC and small cell lung cancer (SCLC) have shown encouraging response rates and prevention of disease, including activity in PD-L1–negative tumors where standard immunotherapies failed.
How the study is designed
This is a phase III, randomized, double-blind trial. Participants receive either pumitamig plus chemotherapy or a placebo plus chemotherapy. Neither participants nor their oncologists know which one they receive. All participants receive active chemotherapy.
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- Who it's for: Adults with locally recurrent inoperable or metastatic TNBC (or ER-low, HER2-negative breast cancer) who haven't yet received treatment for advanced disease and whose tumors are PD-L1 negative.
- Chemotherapy options: Nab-paclitaxel or paclitaxel, gemcitabine plus carboplatin or eribulin.
- Main goals: Overall survival and progression-free survival, plus safety.
- Size: About 558 participants worldwide.
- Exclusion: People who have previously received a PD-(L)1/VEGF bispecific antibody.
You’ll find more information about this study here:
Providence Cancer Institute is currently enrolling patients in ROSETTA Breast-01..
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- Call 503-215-1979 to find out more.
- Send an email
Find out about other clinical trials at Providence Cancer Institute.
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