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PD-L1 × VEGF-A Bispecific · BioNTech / Bristol Myers Squibb · SCLC / Lung Program

Pumitamig (BNT327) SCLC Program

Pumitamig (BNT327/BMS986545) is BioNTech and Bristol Myers Squibb’s PD-L1 × VEGF-A bispecific antibody in small-cell lung cancer: a Phase 2 trial (NCT06449209) in extensive-stage disease, WCLC 2026 first data with the B7-H3 ADC elfetabart drozuntecan (ORR 70.4%, DCR 93.0% — small cohorts, 3.2-month follow-up) plus first-line mesothelioma long-term outcomes, and the Phase 3 ROSETTA-LUNG-01 trial (NCT06712355) enrolling globally. Investigational; not approved by any regulatory agency.

Phase II · NCT06449209Sponsor: BioNTech SE⚠️ InvestigationalWCLC 2026 first combo data
New Data · WCLC 2026 · Seoul · Sept 12–15

New Readouts — Lung / SCLC Program (WCLC 2026)

Physician posts about this trial captured live during the IASLC 2026 World Conference on Lung Cancer (Seoul, September 12–15). Quotes are verbatim; each card links to the original post. Last updated 2026-09-15.

Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🆙#WCLC26 #LCSM Mini Oral Session 🔥First-Line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-Term PFS and OS 🎙️Dr. Liang Zhang 🔢MO04.09 🎯cORR 51.6%, DCR 93.5% 🎯mPFS 16.6m, mOS 25.8m 🎯No New Safety Signals ☑️NCT05918107 🔗 https://t.co/xJ8uXBQA72 @OncoAlert @Larvol @IASLC

1.7K impressions10 likes2026-08-25
Mustafa Özdoğan, MD
Mustafa Özdoğan, MD@ozdogan_md

A striking early signal from #WCLC26 Pumitamig plus elfetabart drozuntecan achieved a 70.4% response rate and 93.0% disease control in advanced SCLC Promising but based on small cohorts and only 3.2 months of follow up #SCLC #LungCancer #ADC #Immunotherapy https://t.co/aCuutr2E9A

872 impressions2 likes2026-09-12
Mirage News
Mirage News@MirageNewsCom

Pumitamig Plus Elfetabart Shows Promise in Lung Cancer https://t.co/dr7EyV2WlU

75 impressions2 likes2026-09-12
WHNForum
WHNForum@WHNForum

Pumitamig plus ifinatamab deruxtecan shows encouraging early activity in small cell lung cancer https://t.co/Pr4LkKg2xm #CancerInnovations

57 impressions0 likes2026-09-12
Giannis Mountzios
Giannis Mountzios@g_mountzios

#WCLC26 🌟First report of a combination of a #bispecific targeting PDL1 x VEGF (pumitamig) plus a B7-H3.l ( Elfie-D) #ADC in ES-SCLC, producing excellent responses in all lines of treatment and especially 1L with tolerable toxicity profile. Requires longer follow up to evaluate long-term tolerability of ADCs and the contribution of the bispecific component. Challenging to see how this combo will fit into the TCE in 1L era

1.2K impressions21 likes2026-09-15
OsmanKostekMD
OsmanKostekMD@OncologyMarwarD

WCLC 2026 | SCLC Pumitamig + B7-H3 ADC elfe-D shows a striking early signal: • ORR 70.4% overall • 92.3% in 1L • 71% with brain mets • 87.5% after prior DLL3-TCE Very early data with small subgroups—durability will be key. #WCLC26 #SCLC #B7H3 @OncoAlert @BioNTech_Group https://t.co/kYiVPNa2fv

521 impressions3 likes2026-09-15
Kenn Samala
Kenn Samala@KSamalaMD

#ElfeD with #Pumitamig #BNT32401 for mNSCLC #WCLC26 (SCLC focus) https://t.co/kbQO9LBzGR

194 impressions0 likes2026-09-15
Conference Presentations · WCLC 2026

Key Slides — OA14.02 (Schoenfeld, MSK)

Deck photos of the BNT324-01 first readout shared by global KOLs at WCLC 2026. Click any image to expand; OCR transcriptions are vision-verified. Two captures of the efficacy slide print different data cut-off dates (July 1 vs July 7, 2026) — each transcription reports the date exactly as printed on that capture.

Giannis Mountzios
Giannis Mountzios@g_mountzios
OA14.02 deck (4 slides)
3,634 impressions · 48 likes · 2026-09-05
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Pumitamig + Elfe-D OA14.02 title slide - WCLC 2026, presenter A.J. Schoenfeld (MSK)
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BNT324-01 (NCT06892548) study design - Phase 1b/2 pumitamig + elfe-D
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Efficacy in SCLC all treatment lines - ORR 70.4%, DCR 93.0% (N=71), waterfall by dose group
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Baseline demographics and disease characteristics (n=279: NSCLC 201, SCLC 78)
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[Slide 1 - title card] IASLC 2026 World Conference on Lung Cancer, Seoul. Pumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients With Advanced/Metastatic Lung Cancer (NSCLC or SCLC). Presenter A.J. Schoenfeld (Memorial Sloan Kettering Cancer Center), co-authors incl. L. Sun, J. Bennouna, O. Juan-Vidal, E. Felip, O. Tureci, U. Sahin, L. Paz-Ares. --- [Slide 2 - study design] BNT324-01 (NCT06892548): global Phase 1b/2 of pumitamig + elfe-D in advanced lung cancer. Inclusion: unresectable advanced/metastatic SCLC or NSCLC, RECIST v1.1 measurable disease, ECOG PS 0-1, any PD-L1. Exclusion: prior B7H3-targeted therapy. Part 1 dose escalation (Bayesian optimal interval; complete) + backfill: Elfe-D 4.5 or 6 mg/kg Q3W + pumitamig 20 or 30 mg/kg Q3W. Part 2 (ongoing): dose optimization + signal-seeking cohorts incl. 1L nsqNSCLC, 2L+ SCLC (post-chemo +/- IO), 1L ES-SCLC. Primary endpoint: safety incl. DLTs, and ORR. Secondary: DCR, PFS, DOR, OS, PFS rate, TTR, safety. 'We report the first data from this study with a focus on SCLC; efficacy in NSCLC will be reported separately.' --- [Slide 3 - efficacy, SCLC all lines] N=71: CR 1 (1.4), PR 49 (69.0), SD 16 (22.5), PD 3 (4.2), NE/NA 2 (2.8). ORR 70.4% (95% CI 58.4-80.7); DCR 93.0% (84.3-97.7). ORR by smoking: current/former (n=56) 73.2 (59.7-84.2); never (n=15) 60.0 (32.3-83.7). ORR by brain mets: with (n=31) 71.0 (52.0-85.8); without (n=40) 70.0 (53.5-3.4 as printed on slide). ORR unconfirmed; median PFS not yet reached. Data cut-off as printed on this capture: July 7, 2026. --- [Slide 4 - baseline, n=279] NSCLC n=201 / SCLC n=78 across four dose groups. Median age 64.0 (29-87); male 34.1%; ECOG PS 1 74.6%; brain mets at baseline 25.4%; liver mets 23.7%; smoking: never 22.9%, former 63.8%, current 12.9%. Region: Asia 36.2%, Europe 17.2%, North America 7.2%. Data cut-off: July 7, 2026.
OsmanKostekMD
OsmanKostekMD@OncologyMarwarD
OA14.02 deck - efficacy & safety detail (4 slides)
1,167 impressions · 3 likes · 2026-09-15
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BNT324-01 study design (deck page 4)
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Efficacy in SCLC all treatment lines - ORR 70.4%, DCR 93.0% (N=71)
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Efficacy in SCLC by line of therapy - 1L 92.3%, 2L 76.2%, 3L+ 52.4%; prior DLL3-TCE 87.5%
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Safety summary and TRAEs, overall population (n=279) - no DLTs; Gr>=3 TRAEs 26.5%
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[Slide 1 - study design, deck page 4] BNT324-01 (NCT06892548) Phase 1b/2 design; primary endpoint safety incl. DLTs and ORR; 'first data with a focus on SCLC; efficacy in NSCLC will be reported separately.' Data cut-off: July 7, 2026. --- [Slide 2 - efficacy, SCLC all lines] N=71: CR 1 (1.4), PR 49 (69.0), SD 16 (22.5), PD 3 (4.2), NE/NA 2 (2.8); ORR 70.4% (58.4-80.7); DCR 93.0% (84.3-97.7); subgroups by smoking and brain metastases as shown. ORR unconfirmed; median PFS not yet reached. Data cut-off as printed on this capture: July 1, 2026. --- [Slide 3 - efficacy by line] ORR (95% CI): 1L (n=13) 92.3 (64.0-99.8); 2L (n=21) 76.2 (52.8-91.8); 3L+ (n=21) 52.4 (29.8-74.3). 2L+ SCLC (n=58) by dose group: ORR 53.3 / 80.0 / 64.3 / 64.3; DCR 93.3 / 100 / 92.9 / 85.7. ORR prior IO (n=48) 60.4 (45.3-74.2); prior DLL3-TCE (n=8) 87.5 (47.4-99.7). Footnote: line-of-therapy verification ongoing in 16 patients; one dose-group misassignment (recategorized ORR 58.5% n=16 and 73.6% n=41). Data cut-off: July 1, 2026. --- [Slide 4 - safety, n=279] No DLTs during dose escalation. TEAEs any 89.2% / Gr>=3 32.3%; TRAEs any 82.4% / Gr>=3 26.5%. Discontinuations: both drugs 3.9%, Elfe-D 4.7%, pumitamig 6.1%; Elfe-D dose reduction 8.6%. TRAEs >=10% (Gr>=3): nausea 40.9 (1.8), decreased appetite 22.9 (3.6), anemia 21.5 (1.4), fatigue 19.4 (2.9), WBC decreased 18.6 (2.2), neutrophils decreased 17.9 (3.9), vomiting 17.6 (1.1), platelets decreased 10.8 (1.4), hypertension 10.0 (3.2). 85.7% remain on treatment; proteinuria 6.1%; ILD/pneumonitis 8 (2.9%; 5 treatment-related, 3 adjudicating); 2 deaths (0.7%) possibly treatment-related. Median follow-up 2.4 months. Data cut-off: July 7, 2026.
KOL-Made Infographics
Self-authored summary graphics — secondary commentary, not the presented deck
Mustafa Özdoğan infographic - pumitamig plus elfetabart drozuntecan dual attack in SCLC, ORR 70.4%, DCR 93.0%
@ozdogan_md
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Program Background

About the Pumitamig SCLC / Lung Program

Lung / SCLC program

Lung / SCLC program - Phase 2 in extensive-stage SCLC (NCT06449209) reported encouraging global interim antitumor activity (BioNTech/BMS disclosure); the Phase 3 ROSETTA-LUNG-01 trial (NCT06712355) of first-line pumitamig + chemotherapy versus atezolizumab + chemotherapy in untreated ES-SCLC is enrolling globally (BMS press release).

WCLC 2026 firsts - First global data for pumitamig combined with the B7-H3 ADC elfetabart drozuntecan (Elfe-D; Phase 1/2 NCT06892548) in advanced SCLC and NSCLC, and long-term PFS/OS for first-line pumitamig + chemotherapy in unresectable mesothelioma (MO04.09) (BioNTech WCLC 2026 announcement, Aug 20, 2026).

Questions & Answers

Pumitamig SCLC Program FAQ

What is pumitamig (BNT327)?

Pumitamig (BNT327/BMS986545) is an investigational PD-L1 × VEGF-A bispecific antibody developed by BioNTech and Bristol Myers Squibb, in clinical development across tumor types including small-cell lung cancer and triple-negative breast cancer.

What did WCLC 2026 show for pumitamig in SCLC?

First global data for pumitamig combined with the B7-H3 ADC elfetabart drozuntecan (Elfe-D; Phase 1/2 NCT06892548) in advanced SCLC reported a 70.4% response rate and 93.0% disease control — promising but based on small cohorts with only 3.2 months of follow-up. Long-term PFS/OS for first-line pumitamig plus chemotherapy in unresectable mesothelioma (MO04.09) was also presented.

Is pumitamig approved in lung cancer?

No. Pumitamig is investigational and not approved by any regulatory agency. The Phase 3 ROSETTA-LUNG-01 trial (NCT06712355) of first-line pumitamig + chemotherapy versus atezolizumab + chemotherapy in untreated ES-SCLC is enrolling globally.

Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated September 18, 2026.