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

ROSETTA GI 204: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) (clinicaltrials.gov) - P2/3 | N=690 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

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 (clinicaltrials.gov) - P1/2 | N=980 | Recruiting | Sponsor: BioNTech SE | N=550 ➔ 980 | Trial completion date: Feb 2030 ➔ Oct 2029 | Trial primary completion date: May 2028 ➔ Feb 2028

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Lung Cancer • Melanoma • Mucosal Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • ALK • BRAF • HER-2

Bristol-Myers Squibb and BioNTech Advance New Phase 3 Lung Cancer Trial With Pumitamig (TipRanks) - "The ROSETTA Lung-201 study is a Phase 3 trial comparing pumitamig with durvalumab in people with unresectable Stage III non-small cell lung cancer (NSCLC) who have already received combined chemotherapy and radiation. The official title describes a randomized, multicenter, open-label design focused on patients whose cancer has not worsened after platinum-based chemoradiation."

Trial status • Non Small Cell Lung Cancer

A phase II safety and efficacy study of PM8002 (anti-PD-L1 x VEGF-A bispecific) combined with paclitaxel as a second-line therapy for small cell lung cancer (SCLC) (ESMO 2023) - "Conclusions PM8002, in combination with paclitaxel, showed encouraging antitumor activity and an acceptable safety profile for patients with advanced SCLC who failed first-line platinum-based chemotherapy. This phase II study is still ongoing and shall include more patients who had previously received immune checkpoint therapy."

Clinical • P2 data • 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

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

Activity of BNT327/PM8002 (PD-L1 x VEGF-A bispecific antibody) in combination with BNT325/DB-1305 (TROP2 ADC) in solid tumors: Early preclinical and clinical evidence to support BNT327 + ADC combinations (AACR 2025) - P1/2 | "Emerging data suggest that IO-ADC combinations may lead to better patient outcomes. Early clinical data showed successful dose escalation allowing enrollment to NSCLC, TNBC, ovarian, and cervical cancer expansion cohorts, with updated clinical data planned to be presented. Further evaluation is ongoing of BNT327 with ADCs against HER2 (BNT323/DB-1303), B7H3 (BNT324/DB-1311) and HER3 (BNT326/YL202), with a focus on tumors where early monotherapy efficacy has been observed with these ADCs."

Combination therapy • IO biomarker • Preclinical • Breast Cancer • Cervical Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • B2M • CD276 • ERBB3 • HER-2

A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) (clinicaltrials.gov) - P3 | N=750 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

Monotherapy • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

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

A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) (clinicaltrials.gov) - P3 | N=850 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

Monotherapy • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Clinical Trial Testing the Safety of BNT327 (an Investigational Drug) and How Well it Works in Patients With Recurrent Glioblastoma (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: BioNTech SE | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

A phase Ib/II study to assess the safety and efficacy of PM8002/BNT327 in combination with nab-paclitaxel for first-line treatment of locally advanced or metastatic triple-negative breast cancer (ESMO 2024) - P1/2 | "PM8002 combined with nab-paclitaxel showed encouraging antitumor activity and acceptable safety as first-line therapy for locally advanced and metastatic TNBC. This Phase II study is still ongoing, and a phase III study has been approved to be conducted in China based on these results."

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

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

A global phase 2/3, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC). (ASCO 2025) - P2/3 | "In the Phase 3 part, pts will be randomized 1:1 to receive BNT327 at the selected dose (based on the Phase 2 part) plus chemo (carboplatin + pemetrexed for Substudy A, carboplatin + paclitaxel for Substudy B) or pembrolizumab 200 mg plus chemo Q3W IV, followed by Q3W IV maintenance BNT327 or pembrolizumab (both with maintenance pemetrexed for Substudy A). Secondary endpoints include duration of response, disease control rate (Phase 2), PFS per investigator, ORR, landmark PFS and OS, patient reported outcomes and occurrence of AEs, and rates of dose interruption, reduction and discontinuation due to TEAEs (Phase 3); with efficacy endpoints per RECIST 1.1; safety per CTCAE v5.0. The trial is enrolling."

Clinical • Combination therapy • IO biomarker • P2/3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

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

Interim Overall Survival of Patients with Locally Advanced or Metastatic Triple-Negative Breast Cancer treated wtih First Line PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study. (SABCS 2024) - P1/2, P2, P3 | "In pts with LA/mTNBC, first-line therapy with PM8002/BNT327 combined with nab-paclitaxel showed clinically meaningful survival outcomes and antitumor activity regardless of PD-L1 status, together with a manageable safety profile. No new safety signals were observed beyond those typically described for anti-PD-1/PD-L1 and anti-VEGF therapies and nab-paclitaxel. A randomized controlled Phase III clinical trial (NCT06419621) of first-line treatment of TNBC in China and a global Phase II trial (NCT06449222) are ongoing in TNBC."

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

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

A phase II safety and efficacy study of PM8002/BNT327 in combination with chemotherapy in patients with EGFR-mutated non-small cell lung cancer (NSCLC) (ESMO 2024) - P2/3 | "The correlation between tumor PD-L1 expression and clinical response was investigated. Patients received PM8002/BNT327 plus carboplatin and pemetrexed Q3W for 4 cycles, followed by maintenance with PM8002/BNT327 and pemetrexed. PM8002/BNT327 in combination with chemotherapy showed encouraging antitumor activity and acceptable tolerability profile in EGFR-mutated NSCLC patients that progressed after EGFR-TKI therapy. The anti-tumor activity of PM8002/BNT327 therapy is positively correlated with tumor PD-L1 expression level."

Clinical • Combination therapy • IO biomarker • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

ROSETTA Lung-02: A Global Phase 2/3, Randomized, Open-Label Trial of Pumitamig, a PD-L1 × VEGF-A Bispecific Antibody, in Combination With Chemotherapy in Patients (pts) With First-Line Non-Small Cell Lung Cancer (ELCC 2026) - No abstract available

Clinical • Combination therapy • P2/3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pumitamig: “Pumitamig showed favourable efficacy in global phase 2 trials”; Small cell lung cancer/Triple negative breast cancer (BioNTech, 44th Annual J.P. Morgan Healthcare Conference)

P2 data • Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Triple Negative Breast Cancer

Pumitamig: “Pumitamig showed favourable efficacy in global phase 2 trials”; Small cell lung cancer/Triple negative breast cancer (BioNTech, 44th Annual J.P. Morgan Healthcare Conference)

P2 data • Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Triple Negative Breast Cancer

Pumitamig: Data readout from ROSETTA HNSCC-205 trial for 1L HNSCC in 2030 or later (44th Annual J.P. Morgan Healthcare Conference, BioNTech)

Clinical data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Pumitamig: Data readout from ROSETTA HNSCC-205 trial for 1L HNSCC in 2030 or later (44th Annual J.P. Morgan Healthcare Conference, BioNTech)

Clinical data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck