pumitamig (BNT327) / BioNTech, BMS - LARVOL DELTA

A phase 1/2, randomized, global trial to investigate efficacy and safety of EpCAM × 4-1BB bsAb (BNT314/GEN1059) in combination with pumitamig (BNT327; PD-L1 × VEGF-A bsAb) and chemotherapy in patients with metastatic colorectal cancer (mCRC). (ASCO-GI 2026) - P1/2 | "In Part C (Phase 2), 2L pts are randomized 1:1:1 to receive BNT314 (Q6W) + BNT327 (Q2W) + SoC chemo, bevacizumab (Q2W) + SoC chemo or BNT327 (Q2W) + SoC chemo. Primary endpoints are safety (Part A & B), objective response rate (ORR) (Part B) and progression free survival (Part C) with key secondary endpoint being ORR in Part C. Overall survival is an exploratory endpoint (Parts A & B) and a secondary endpoint in Part C. The trial was initiated in Q3 2025; recruitment is ongoing in the US. Sites are planned in Europe, Asia-Pacific, and Australia."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • PD-L1 • TNFRSF9

BNT326-02: A clinical trial to test if an investigational combination therapy with BNT326 and BNT327 is safe and potentially beneficial for people with advanced non-small cell lung cancer (NSCLC) (clinicaltrialsregister.eu) - P1/2 | N=88 | Not yet recruiting | Sponsor: BioNTech SE

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BNT326-01: A clinical study to test if an investigational treatment called BNT326 is safe and potentially beneficial when used alone or in combination with other investigational treatments such as BNT327, for people with advanced malignant tumors (clinicaltrialsregister.eu) - P1/2 | N=172 | Recruiting | Sponsor: BioNTech SE

Monotherapy • New P1/2 trial • Oncology • Solid Tumor

BNT326-02: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) with pumitamig (PD-L1 _ VEGF-A bsAb) in non-small cell lung cancer (NSCLC) (ELCC 2026) - No abstract available

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB3 • PD-L1 • VEGFA

CA2660003: Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Previously Untreated, Unresectable, or Metastatic Colorectal Cancer. (clinicaltrialsregister.eu) - P2/3 | N=33 | Not yet recruiting | Sponsor: Bristol-Myers Squibb Services Unlimited Company

New P2/3 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF • MSI

BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: BioNTech SE | N=52 ➔ 82

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

CA2660004: Study of Pumitamig in Combination with Chemotherapy Versus Nivolumab innCombination with Chemotherapy in Previously Untreated Advanced or MetastaticnGastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (clinicaltrialsregister.eu) - P2/3 | N=40 | Not yet recruiting | Sponsor: Bristol-Myers Squibb Services Unlimited Company

New P2/3 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

BNT323-03: A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (clinicaltrials.gov) - P1/2 | N=380 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer (clinicaltrials.gov) - P3 | N=144 | Recruiting | Sponsor: BioNTech SE | N=110 ➔ 144

Enrollment change • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer (clinicaltrials.gov) - P3 | N=110 | Recruiting | Sponsor: BioNTech SE | N=69 ➔ 110

Enrollment change • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR

A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) (clinicaltrials.gov) - P1/2 | N=234 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) (clinicaltrials.gov) - P1/2 | N=129 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

BNT327-02: Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy (clinicaltrials.gov) - P2 | N=83 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Pumitamig in combination with DB-1305/BNT325 as first-line (1L) treatment for patients with advanced or metastatic triple-negative breast cancer (a/mTNBC): efficacy and safety from a multicenter, open-label, phase 1/2 trial (ESMO-BC 2026) - No abstract available

Clinical • Combination therapy • Metastases • P1/2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

BNT324-01: A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=52 | Recruiting | Sponsor: BioNTech SE | N=26 ➔ 52

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Global Phase 2 Randomized Trial of BNT327 (Pumitamig; PD-L1 x VEGF-A bsAb) + Chemotherapy for 1L ES-SCLC: Dose Optimization Analysis (IASLC-WCLC 2025) - P2 | "Methods : In this global Phase 2, randomized, open-label,parallel group trial (NCT06449209), patients with treatment-naïve ES-SCLC received pumitamig+etoposide+carboplatin x 4 cycles followed by pumitamigmaintenance (Cohort 1); patients progressing after 1L or 2L treatment received pumitamig+paclitaxel(Cohort 2) or pumitamig+topotecan (Cohort 3). Pumitamig plus etoposide/carboplatin showed encouraging efficacy and acceptable safety in 1L ES-SCLC. This first presentation in a global population of a bispecific antibody targeting checkpoint inhibition and angiogenesis confirms the encouraging data previously reported in the 1L SCLC Chinese study (https://doi.org/10.1016/S1556-0864(25)00494-0).This dose optimization study supports further development of pumitamig in 1L SCLC,currently being evaluated in the ROSETTA Lung-01 Phase 3 trial."

Clinical • P2 data • Cardiovascular • Hypertension • Lung Cancer • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • PD-L1

BNT323-03: A clinical study to find the optimal dose of an investigational treatment called BNT323 when used in combination with another investigational treatment, BNT327, and to test if that combination treatment is safe and beneficial for patients with advanced breast cancer (clinicaltrialsregister.eu) - P1/2 | N=95 | Not yet recruiting | Sponsor: BioNTech SE

New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • HER-2

ROSETTA Lung-01: A Phase 3, Two-Stage Trial of Pumitamig, a PD-L1 _ VEGF-A Bispecific Antibody, Plus Chemotherapy Versus Atezolizumab + Chemotherapy as First-Line Treatment in Patients With Extensive-Stage Small Cell Lung Cancer (ELCC 2026) - No abstract available

Clinical • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BNT327-03: Safety and efficacy of BNT327, an investigational therapy, in combination with chemotherapy for patients with untreated small-cell lung cancer (clinicaltrialsregister.eu) - P2/3 | N=166 | Recruiting | Sponsor: BioNTech SE

New P2/3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

First-Line Pumitamig (PD-L1 _ VEGF-A bsAb) Monotherapy in PD-L1+ Non-Squamous and Squamous Non-Small Cell Lung Cancer: Data From a Phase 1b/2a Trial in China (ELCC 2026) - No abstract available

Clinical • Monotherapy • P1/2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma. (ASCO 2025) - P2 | " After a safety run-in (n=6), this ongoing, multicenter, single-arm phase 2 clinical trial recruited chemo naive pts (pts) aged ≥18 yrs with unresectable malignant mesothelioma (pleural (MPM) or peritoneal (MPeM)) to evaluate BNT327 30 mg/kg Q3W IV combined with 4-6 cycles pemetrexed and platinum, followed by BNT327 maintenance. BNT327 plus chemo as a 1L regimen for mesothelioma showed encouraging efficacy, including in tumors of epithelioid histology. AEs were consistent with those expected for the treatment regimen."

Clinical • P2 data • Anemia • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • Thoracic Cancer

Progression-Free Survival and Overall Survival With Pumitamig (PD-L1 _ VEGF-A bsAb) Plus Chemotherapy in Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer Following Progression With EGFR TKI in China: Phase 2 Study Results (ELCC 2026) - No abstract available

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Phase 2 Study of First-Line Pumitamig (PD-L1 _ VEGF-A bsAb) Plus Chemotherapy for Extensive-Stage Small-Cell Lung Cancer (ES-SCLC): Updated Efficacy and Safety Results (ELCC 2026) - No abstract available

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

BNT324-01: A clinical study to investigate the efficacy and safety of an investigational combination therapy with BNT324 and BNT327 in patients with advanced lung cancer (clinicaltrialsregister.eu) - P1/2 | N=26 | Not yet recruiting | Sponsor: BioNTech SE

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

BNT314-02: A clinical study to test if an investigational treatment called BNT314 when used in combination with another investigational treatment BNT327 and chemotherapy is beneficial and safe for patients with advanced colorectal cancer (clinicaltrialsregister.eu) - P1/2 | N=168 | Recruiting | Sponsor: BioNTech SE

New P1/2 trial • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • MSI