BioNTech SE (NASDAQ:BNTX) and Bristol Myers Squibb & Co. (NYSE:BMY) on Tuesday shared the first interim data from a global randomized Phase 2 trial of pumitamig (BNT327/BMS986545) plus chemotherapy for locally advanced/metastatic triple-negative breast cancer (TNBC) irrespective of PD-L1 expression levels.
The data showed encouraging anti-tumor responses and a manageable safety profile for pumitamig plus chemotherapy in first-line and second-line treatment settings.
The data will be presented at the 2025 San Antonio Breast Cancer Symposium.
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“Triple-negative breast cancer is a highly aggressive disease with a poor prognosis and 5-year survival rate of just 15% in advanced stages. There remains an urgent need for new treatment options – particularly for patients with PD-L1 low or negative tumors (CPS<10), a subgroup for whom the current standard of care is chemotherapy alone and existing PD-(L)1 inhibitors have historically shown limited benefit,” said Peter Schmid, M.D., Ph.D., Lead Investigator and Director of the Breast Cancer Centre at St. Bartholomew’s Hospital, London, UK.
“The anti-tumor efficacy observed in this interim analysis is encouraging and supports the ongoing investigation of pumitamig in the Phase 3 ROSETTA BREAST-01 trial.”
The trial evaluated pumitamig in two dose levels and in combination with four different chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic TNBC.
In Cohort 1, reported in this analysis, patients received pumitamig (15 or 20 mg/kg Q2W) plus nab-paclitaxel until disease progression or unacceptable toxicity.
In Cohort 2, patients received the flat-dose equivalent of 20 mg/kg in combination with three different chemotherapy regimens (Arm 1: paclitaxel; Arm 2: gemcitabine + carboplatin; Arm 3: eribulin).
The interim analysis at the October 1, 2025, data cut-off included 74 patients.
Key Data Highlights
Among 39 efficacy-evaluable first-line and second-line patients, all in Cohort 1, the confirmed objective response rate (cORR) was 61.5%, the unconfirmed objective response rate (uORR) was 71.8%, and the disease control rate (DCR) was 92.3%.
The progression-free survival (PFS) rate at 9 months was 59.3%.
Median PFS, median duration of response (DOR), and median overall survival (OS) were not mature at the time of analysis.
Pumitamig plus chemotherapy demonstrated a manageable safety profile in both Cohorts in combination with all four chemotherapy regimens.
A global randomized Phase 3 trial, ROSETTA-BREAST-01 is evaluating pumitamig plus chemotherapy versus placebo plus chemotherapy in patients with previously untreated locally advanced/metastatic TNBC determined ineligible for PD-(L)1 therapy based on PD-L1 negative disease.
In June, BioNTech and Bristol Myers Squibb entered into a co-development and co-commercialization agreement worth $11 billion.
The pact focuses on BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types.
Price Action: BioNTech shares were down 0.94% at $96.37 at the time of publication on Tuesday, according to Benzinga Pro data. Bristol-Myers Squibb shares were down 2.26% at $50.50.
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