pumitamig (BNT327) / BioNTech, BMS - LARVOL DELTA

A global phase 2, open-label trial of pumitamig (PD-L1 × VEGF-A bsAb) + docetaxel post-chemoimmunotherapy in mNSCLC: First data from ROSETTA Lung-107 (ESMO 2026) - P2 | "Conclusions Pumitamig + docetaxel showed encouraging antitumor activity with a manageable safety profile in patients with mNSCLC post-CIT. These data support further development of pumitamig in this setting and will inform pivotal study design."

Clinical • Late-breaking abstract • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) + pumitamig (PD-L1 x VEGF-A bsAb) in patients with advanced solid tumors: First results from a global phase 2 trial (ESMO 2026) - P2 | "Clinical trial identification NCT06953089. Encouraging antitumor activity was observed in pts with multiple tumor types, including those that had received prior immunotherapy or bevacizumab. Further investigation is warranted."

ADC • Clinical • Metastases • P2 data • Cervical Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD276 • PD-L1 • VEGFA

BioNTech and Bristol Myers Squibb Report Encouraging Global Phase 2 Data for Pumitamig in Advanced NSCLC After Progression on Immunotherapy Plus Chemotherapy (GlobeNewswire) - "The data were presented today in a late-breaking rapid oral presentation (abstract #LBA76) at the European Society for Medical Oncology ('ESMO') Congress 2026....Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapy. An early median progression-free survival of 6.9 months was observed. Significant unmet need remains for patients who have progressed on an immunotherapy-containing regimen, with the average progression-free survival below 4 months for standard of care docetaxel."

Late-breaking abstract • P2 data • Non Small Cell Lung Cancer

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 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

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

ROSETTA CRC-203: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=990 | Recruiting | Sponsor: Bristol-Myers Squibb

Trial initiation date • Colorectal Cancer • Oncology • Solid Tumor

ROSETTA CRC-203: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=990 | Recruiting | Sponsor: Bristol-Myers Squibb | N=346 ➔ 990

Enrollment change • Trial initiation date • Colorectal Cancer • Oncology • Solid Tumor

ROSETTA CRC-203: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=346 | Recruiting | Sponsor: Bristol-Myers Squibb

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

ROSETTA CRC-203: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=990 | Recruiting | Sponsor: Bristol-Myers Squibb | N=288 ➔ 990

Enrollment change • Trial initiation date • Colorectal Cancer • Oncology • Solid Tumor

ROSETTA CRC-203: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=288 | Recruiting | Sponsor: Bristol-Myers Squibb

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

ROSETTA CRC-203: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=990 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

ROSETTA CRC-203: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=990 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P2/3 trial • Colorectal Cancer • Oncology • 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=198 | Recruiting | Sponsor: Bristol-Myers Squibb | N=129 ➔ 198

Enrollment change • Hepatocellular Cancer • Oncology • 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 | N=47 ➔ 129

Enrollment change • Trial initiation date • Hepatocellular Cancer • Oncology • 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=47 | Recruiting | Sponsor: Bristol-Myers Squibb

New P1/2 trial • Hepatocellular Cancer • Oncology • 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

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 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1/2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

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

A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents 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, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) (clinicaltrials.gov) - P1/2 | N=264 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1/2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) (clinicaltrials.gov) - P1/2 | N=474 | Recruiting | Sponsor: Bristol-Myers Squibb | N=254 ➔ 474

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

PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=404 | Active, not recruiting | Sponsor: Biotheus Inc. | Trial primary completion date: Jan 2027 ➔ May 2027

Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=404 | Active, not recruiting | Sponsor: Biotheus Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=404 | Recruiting | Sponsor: Biotheus Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor