Pumitamig (BNT327/BMS986545) is BioNTech and Bristol Myers Squibb’s PD-L1 × VEGF-A bispecific antibody. In metastatic triple-negative breast cancer (Phase 2 NCT06449222, ESMO Breast 2026), pumitamig plus carboplatin–paclitaxel showed a 76.7% confirmed objective response rate; the Phase 3 ROSETTA Breast-01 trial is enrolling. Investigational; not approved by any regulatory agency. The lung / SCLC program has its own page.
Discover KOL Sentiment on Pumitamig (BNT327) →Design - Phase 2 randomized, open-label pumitamig (BNT327, a PD-L1 x VEGF-A bispecific antibody) +/- chemotherapy, first- and second-line metastatic TNBC (NCT06449222; BioNTech / Bristol Myers Squibb).
Response - Confirmed ORR 76.7% with carboplatin plus paclitaxel; disease control rate 96.7%, with over 90% of responses ongoing at 6 months.
Safety - Manageable safety across chemotherapy regimens: grade >=3 treatment-related adverse events 42.5% (Cohort 1) and 38.2% (Cohort 2); no pumitamig-related deaths; no new bispecific-class safety signals.
Confirmatory trial - ROSETTA Breast-01 Phase 3 (NCT07173751) is enrolling to confirm the strategy.
Regulatory - Investigational; not FDA approved. Presented at ESMO Breast 2026.
Sponsor / drug - BioNTech / Bristol Myers Squibb; pumitamig (BNT327).
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated September 15, 2026.
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Trial slides shared by KOLs at ESMO Breast 2026 (#ESMOBreast26). Click any image to expand. OCR text extracted via AWS Textract.
[Slide 1] 2026 ESMO BREAST CANCER Annual Congress Pumitamig in combination with DB-1305/BNT325 as first-line treatment for patients with advanced or metastatic triple-negative breast cancer: efficacy and safety from a multicenter, open-label, phase 1/2 trial Jian Zhang.¹ Tao Sun,2 Chen Wang.3 Rama Balaraman, David Berz,5 Weimin Xie, Hongxue Wang, Yuping Sun, Haifeng Liu, Min Yan, Ye Guo,10 Zhongwei Jia," Hua Mu," Rong Shi," Xiaodong Sun, 11 Yang Qiu," Ozlem Türeci,¹ 12 Ugur Sahin,12 Sascha Tillmanns, 12 Jenny Furlanetto, 12 Secil Koseoglu, 13 Erika Hamilton Todan Occursity Sharghai Cancer Center, Shanghair, Chena Lisining Cancer - - Laoning China Tage Medical University Cancer - and Hospital, China Date Charge Center Otala 1L MA Nature - - Angeles, CA, Department - - 4. line and list - Fumex having Chena, Cancer Hospital Shandong - Medical man China - response - Chess - Cancer Hospital Heren Cheque "Sharghai - Shanghai, Chena "Duality Subpox Shanghai, China M. Many Germany US - Cambridge MA, "Sargh Careon Research - Nashile THE USA 426RO Content of the presentation a copyright and responsibility of the author Permission - request or ESMO --- [Slide 2] Pumitamig in combination with DB-1305/BNT325 as first-line treatment Abstract #426RO for patients with advanced or metastatic triple-negative breast cancer: efficacy and safety from a multicenter, T-Lymphocyte open-label, phase 1/2 trial BNT325 Pumitaming VEGF neutralization Jim Thang Tao Sun Chen Wang, Rama Balaraman, David Berz, Weimin Xe, TROP2 Hongue wang. Yuping Sun, Hailing LAL Min Yan, Ye Guo, Zhongwel AA, Hua Mu, Rong SN, Gaodong Sun, Yang Qiu, Ozlem Türed, Ugur $ahin, Sascha Tilimanns, Jenny Furlanetto, Sect Koseoglu, Erika Hamiton DNA damage, immunogenic PD-L1 blockade and furner cell death, and PO-L1 VEGF Insufralization byslander fulling checkpoint blockade Results of phase 2 expansion cohort (bispecific and Cancer cell TROP2 directed ADC) Who were the patients? Advanced TNBC 1st line (50% prior chemo in early setting) Mixed PD-L1 + and -, Unselected TROP2 Pumitamig * BNT325 may have synergy: Targeting VEGF- facilitates ADC penetration into the TME, increasing sensitivity to PD-L1 inhibition* Pumitamig BNT325 (N=30) 25 PR BOR, (%) so CR 0 0 PR 23(76.7) SD 6 (20.0) PD 0 Missing* 1 (3.3) Unconfirmed ORR, % (95% CI) 83.3 (65.3, 94.4) Best percentage change from baseline (%) -25 -50 Confirmed ORR, % (95% CI) 76.7 (57.7, 90.1) 1/5 DCR, % (95% CI) 96.7 (82.8, 99.9) DoR, months (95% CI) NE (6.3, NE) -100 Median PFS, months (95% CI) NE (5.8, NE) Median follow-up: 7.7 months
[Slide 1] Primary Outcome Measures 1. Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment Phase 2 [Time Frame: Up to 5 years] 2. Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) Phase 3 [Time Frame: Up to 5 years] 3. Overall Survival (OS) Phase 3 [Time Frame: Up to 5 years]
Highest-engagement tweets about this trial, ranked by KOL discussant count (replies + quote-tweets). Replies in green, quote-tweets in blue. Wall Street, stock-promo, and non-substantive replies excluded.
VEGF/PD-L1 bispecific pumitamig with novel TROP2 ADC in pre-treated TNBC. Remarkable and durable response, 93% stomatitis. Ongoing Rosetta trial with chemo in 1st line setting. Different ADC would be an intriguing combination strategy. High hopes for this Ab!! @OncoAlert https://
+4
| Handle | Name | Sentiment | Tweet (excerpt) | Imp. |
|---|---|---|---|---|
| @hoperugo | Hope Rugo | Neutral | VEGF/PD-L1 bispecific pumitamig with novel TROP2 ADC in pre-treated TNBC. Remarkable and durable response, 93% stomatiti… | 2,599 |
| @cxliu06 | CX Liu | Neutral | $BMY $BNTX elevated OS to primary endpoint for their PD-L1/VEGF Pumitamig in CRC Ph3. Not sure if there is any emerging … | 91 |
Pumitamig (BNT327/BMS986545) is a novel investigational bispecific antibody jointly developed by BioNTech and Bristol Myers Squibb that combines PD-L1 checkpoint inhibition with VEGF-A neutralization in a single molecule — designed to localize anti-VEGF activity within the tumour microenvironment via PD-L1 targeting. BNT325 (DB-1305) is a TROP2-directed antibody-drug conjugate developed by DualityBio and licensed to BioNTech. Together — presented at ESMO Breast 2026 — pumitamig + BNT325 represents the first PD-L1 bispecific + ADC combination in TNBC, with promising 1L locally advanced/metastatic TNBC efficacy regardless of PD-L1 expression.
Pumitamig (BNT327) is an investigational PD-L1 x VEGF-A bispecific antibody - it simultaneously targets the immune checkpoint ligand PD-L1 and the pro-angiogenic factor VEGF-A. It is being developed by BioNTech in collaboration with Bristol Myers Squibb and is being studied with chemotherapy in metastatic triple-negative breast cancer.
In the Phase 2 trial (NCT06449222), pumitamig combined with carboplatin plus paclitaxel produced a confirmed objective response rate of 76.7% and a disease control rate of 96.7%, with more than 90% of responses ongoing at 6 months. Grade 3 or higher treatment-related adverse events were 42.5% and 38.2% across cohorts, with no pumitamig-related deaths.
No. Pumitamig (BNT327) is investigational and not FDA approved. Its Phase 2 metastatic triple-negative breast cancer data support a confirmatory Phase 3 trial, ROSETTA Breast-01 (NCT07173751), which is now enrolling.
No - pumitamig is a PD-L1 x VEGF-A bispecific antibody, not a PD-1 x CTLA-4 bispecific. By blocking PD-L1 it restores anti-tumor immune activity, and by neutralizing VEGF-A it targets tumor angiogenesis, combining immunotherapy and anti-angiogenic mechanisms in a single molecule.
Pumitamig plus chemotherapy showed a manageable safety profile across the chemotherapy regimens tested, with grade 3 or higher treatment-related adverse events of 42.5% in Cohort 1 and 38.2% in Cohort 2, no pumitamig-related deaths, and no new bispecific-class safety signals. Longer-term data from the confirmatory Phase 3 trial are awaited.
Population: Adults with locally advanced or metastatic TNBC, 1L and 2L+ treatment settings, irrespective of PD-L1 expression (CPS<10 and CPS≥10 both eligible) — addressing the immunotherapy-ineligible TNBC unmet need.
Interventions: Pumitamig (BNT327/BMS986545) at 15 or 20 mg/kg IV in combination with chemotherapy (Cohort 1) — earlier in development pumitamig + nab-paclitaxel — or in combination with BNT325 (TROP2 ADC). Q3W dosing schedules.
Endpoints: Primary: ORR (cORR and uORR), DCR. Secondary: PFS, OS, DoR, safety/tolerability across cohorts.
Per @Dr_Oncologista at ESMO Breast 2026: pumitamig + BNT325 in 1L mTNBC delivered cORR 76.7%, DCR 96.7%, with >90% of responses ongoing at 6 months — a 'breakthrough' chemo-free triple-target strategy. Earlier global Phase 2 (SABCS 2025) of pumitamig + chemotherapy in 1L/2L+ TNBC: cORR 61.5%, uORR 71.8%, DCR 92.3% irrespective of PD-L1 expression. Higher doses (20 mg/kg) correlated with higher response. PFS rate at 9 months: 59.3%. Median PFS, DoR, OS not yet mature.
Pumitamig + chemotherapy demonstrated a manageable safety profile across all four chemotherapy regimens. Grade ≥3 TRAEs: 17/40 (42.5%) in Cohort 1 and 13/34 (38.2%) in Cohort 2. No pumitamig-related deaths reported. No new bispecific-class signals beyond expected PD-L1 and anti-VEGF toxicities.
Hope Rugo offered the only substantive named-KOL read on pumitamig + BNT325 in 1L TNBC: “VEGF/PD-L1 bispecific pumitamig with novel TROP2 ADC in pre-treated TNBC. Remarkable and durable response, 93% stomatitis. Ongoing Rosetta trial with chemo in 1st line setting. Different ADC would be an intriguing combination strategy. High hopes for this Ab!!” The OCR-captured abstract #426RO confirmed the headline efficacy figures — “Confirmed ORR, % (95% CI) 76.7 (57.7, 90.1),” “DCR, % (95% CI) 96.7 (82.8, 99.9),” with median PFS “NE (5.8, NE)” at a median follow-up of 7.7 months. Pumitamig coverage in the curated dataset is thin — one named-KOL voice plus the abstract slide. Rugo’s “93% stomatitis” flag and reference to the ongoing ROSETTA Phase 3 are the central open questions her tweet raises.
