pumitamig (BNT327) / BioNTech, BMS - LARVOL DELTA

Pumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC) (IASLC-WCLC 2026) - P1/2 | "At C3D1, 96% (22/23) evaluable patients had confirmed ctDNA reduction vs baseline, with a ctDNA clearance rate of 39% (9/23). Conclusions : In these first data reporting on a PD(L)1×VEGF bsAb + ADC in lung cancer, pumitamig+elfe-D showed a manageable safety profile with encouraging early efficacy in SCLC, supporting further clinical development."

ADC • Clinical • Late-breaking abstract • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276 • DLL3 • PD-L1 • VEGFA

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) - No abstract available

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

PT2.02. Metastatic NSCLC – Immunotherapy (IASLC-WCLC 2026) - "Additional presentations highlight innovative combination and next-generation approaches, including the PD-1/VEGF/CTLA-4 trispecific antibody HC010, tislelizumab plus SYS6010, the LIBRA platform study, the ROSETTA Lung-202 phase 3 trial of pumitamig versus pembrolizumab, and the ResQ1010 and ResQ201A trials evaluating nogapendekin alfa inbakicept and NAI-based regimens. Together with a randomized non-inferiority trial of denosumab dosing in bone metastases, these presentations offer a comprehensive view of the evolving therapeutic landscape and unmet needs in metastatic NSCLC immunotherapy."

IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • BRAF • CTLA4 • KEAP1 • KRAS • PD-1 • RET • STK11

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

Ph1/2 Trial Of Navlimetostat With Pumitamig In MTAP-Deficient Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=17 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2026 ➔ Jul 2026

Enrollment open • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • MTAP • NTRK • ROS1

ROSETTA Gastric-204: a randomized, phase 2/3 study of first-line (1L) pumitamig + chemotherapy versus nivolumab (NIVO) + chemotherapy in advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC), or esophageal adenocarcinoma (EAC) (ESMO 2026) - No abstract available

Clinical • Metastases • P2/3 data • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A phase 1/2 trial of first-line pumitamig monotherapy or pumitamig plus ipilimumab in advanced or unresectable hepatocellular carcinoma (ROSETTA HCC-206) (ESMO 2026) - No abstract available

Clinical • Metastases • Monotherapy • P1/2 data • Hepatocellular Cancer • Oncology • Solid Tumor

ROSETTA RCC-208: a phase 1/2, open-label, randomized study of pumitamig alone or in combination with ipilimumab or cabozantinib in advanced renal cell carcinoma (RCC) (ESMO 2026) - No abstract available

Clinical • Combination therapy • Metastases • P1/2 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Pumitamig + trastuzumab pamirtecan (T-Pam) in patients (pts) with HR+, HER2-low advanced/metastatic breast cancer (a/mBC): phase 1 results of a phase 1/2, open-label trial (BNT323-03) (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

First results from a phase 2 trial of second-line pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in unresectable neuroendocrine neoplasms (ESMO 2026) - No abstract available

Clinical • P2 data • Endocrine Cancer • Neuroendocrine Neoplasm • 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) - No abstract available

ADC • Clinical • Metastases • P2 data • Oncology • Solid Tumor • CD276 • PD-L1 • VEGFA

Efficacy of pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in patients with SCLC or TNBC with brain metastases: a subgroup analysis of two phase 2 trials (ESMO 2026) - No abstract available

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

Pumitamig + trastuzumab pamirtecan (T-Pam) in patients (pts) with HR+, HER2-low advanced/metastatic breast cancer (a/mBC): phase 1 results of a phase 1/2, open-label trial (BNT323-03) (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Clinical • Metastases • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • 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 I/II trial (ESMO-BC 2026) - P1/2 | "The combination of pumitamig and DB-1305/BNT325 showed encouraging efficacy and manageable safety profile as 1L treatment for patients with a/mTNBC."

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

Phase 2/3 trial of pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy versus bevacizumab plus chemotherapy in previously untreated, unresectable, or metastatic colorectal cancer (ROSETTA CRC-203). (ASCO 2026) - P2/3 | "Abstract 301P; Schmid P, et al...In phase 3, eligible pts will be randomized 1:1 to receive pumitamig at the recommended phase 3 dose + FOLFOX (Q2W)/FOLFIRI (Q2W)/CAPOX (Q3W) or bevacizumab + FOLFOX (Q2W)/FOLFIRI (Q2W)/CAPOX (Q3W), until disease progression or unacceptable toxicity...Recruitment is ongoing. ClinicalTrials.gov ID: NCT07221357."

IO biomarker • Metastases • P2/3 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF • MSI • PD-L1

Phase 2 data from ROSETTA Lung-02, a global randomized phase 2/3 trial of pumitamig (PD-L1 × VEGF-A bsAb) + chemotherapy in 1L NSCLC. (ASCO 2026) - P2/3 | "Pts were randomized 1:1 to 1400 mg (dose level [DL] 1) or 2000 mg (DL2) pumitamig + histology-specific chemotherapy Q3W (NSQ: carboplatin + pemetrexed; SQ: carboplatin + paclitaxel). In these first global data for a PD-(L)1 × VEGF-A bsAb in 1L NSCLC regardless of PD-L1 status, pumitamig + chemotherapy showed encouraging efficacy with a manageable safety profile. Efficacy of the lower dose + chemotherapy was particularly encouraging (ORR 72.7% in NSQ, 81.8% in SQ) and is being evaluated vs pembrolizumab + chemotherapy in the ongoing Phase 3 part of the trial."

Clinical • P2/3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • PD-L1

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-202: A Phase 3 Trial of First-Line Pumitamig Monotherapy vs Pembrolizumab in Locally Advanced/Metastatic NSCLC (IASLC-WCLC 2026) - P3 | "Safety will be monitored throughout the study. An estimated 750 patients will be enrolled."

Clinical • IO biomarker • Metastases • Monotherapy • P3 data • Immunology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non 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."

ADC • Bispecific • Combination therapy • First-in-human • 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

The investigational combination of pumitamig and elfetabart drozuntecan (elfe-D) demonstrated a manageable safety profile and encouraging early antitumor activity in patients with small cell lung cancer (SCLC), according to first clinical data from the ongoing Phase Ib/II BNT324-01 trial presented at the International Association for the Study of Lung Cancer (IASLC) 2026 (Medical Xpress) - "Among 71 efficacy-evaluable patients with SCLC as of July 7, 2026, one patient achieved a complete response, 49 achieved partial responses and 16 had stable disease...The overall objective response rate across all doses was 70.4%, and the disease control rate was 93.0%...Response rates varied by treatment line: 92.3% in first-line SCLC, 77.3% in second-line disease and 52.4% in patients treated in the third line or later."

P1/2 data • Lung Neuroendocrine Carcinoma • Small Cell Lung Cancer

BNT327-01: Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy (clinicaltrials.gov) - P2 | N=110 | Active, not recruiting | Sponsor: BioNTech SE | Trial completion date: May 2028 ➔ Feb 2028

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

Anti-B7-H3 ADCs Take Center Stage against SCLC at WCLC. (PubMed, Cancer Discov) - "Separate phase III trials of the anti-B7-H3 antibody-drug conjugates tambotatug pelitecan and risvutatug rezetecan significantly improved overall survival, progression-free survival, and objective response rates compared with topotecan in patients with relapsed small-cell lung cancer. In a third trial, the combination of the investigational PD-L1 x VEGF-A bispecific antibody pumitamig plus the anti-B7-H3 ADC elfetabart drozuntecan showed encouraging early efficacy in SCLC across lines of therapy and doses. The studies were presented at the 2026 World Congress on Lung Cancer in Seoul, Republic of Korea."

Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

First-Line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-Term PFS and OS (IASLC-WCLC 2026) - "Patients received pumitamig 30 mg/kg every three weeks plus 4-6 cycles pemetrexed/platinum, followed by pumitamig maintenance. Five patients (16.1%) discontinued treatment due to TRAEs, and there were no treatment-related deaths. Conclusions : First-line pumitamig plus chemotherapy was efficacious in patients with malignant mesothelioma (MPM and MPeM), with particularly encouraging long-term survival outcomes (PFS and OS) regardless of tumor type and histology and without any new safety signals, suggesting that further development of pumitamig in malignant mesothelioma is warranted."

Clinical • Dermatitis • Immunology • Interstitial Lung Disease • Malignant Pleural Mesothelioma • Mesothelioma • Pulmonary Disease • Respiratory Diseases • Solid Tumor • PD-L1

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