Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2026

Symbiotic-Lung-01: a phase 3 trial of a PD-1/VEGF bispecific antibody, PF-08634404, vs pembrolizumab in combination with platinum-based chemotherapy in first-line for locally advanced or metastatic non-small cell lung cancer (145933)

Malinda Itchins 1 , David Planchard 2 , Martin Reck 3 , Rachel Roberts-Thomson 4 , Vishal Navani 5 , Caicun Zhou 6 , Akito Hata 7 , Yasushi Goto 8 , Noelia Vilarino 9 , Enriqueta Felip 10 , Luis Paz-Ares 11 , James Chih-Hsin Yang 12 , Jhanelle E Gray 13 , Smitha Menon 14 , Matthew Mirsky 15 , Kevin Kim 16 , Matteo Setti 17 , Melissa Johnson 18
  1. Medical Oncology, Royal North Shore Hospital, Sydney, Australia
  2. Medical Oncology, Thoracic Group, Gustave Roussy, Villejuif, France
  3. Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungenClinic, Grosshansdorf, Germany
  4. The Queen Elizabeth Hospital, Central Adelaide Local Health Network, Adelaide, Australia
  5. Arthur Child Cancer Centre & University of Calgary, Calgary, AB, Canada
  6. Shanghai East Hospital, Tongji University, Shanghai, China
  7. Thoracic Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan
  8. National Cancer Center Hospital, Tokyo, Japan
  9. Catalan Institute of Oncology, Barcelona, Spain
  10. Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain
  11. Medical Oncology, Hospital 12 de Octubre, Madrid, Spain
  12. National Taiwan University Hospital, Taipei, Taiwan
  13. Moffitt Cancer Center Tampa, Tampa, FL, United States
  14. Hematology and Oncology, University of Washington School of Medicine, Seattle, WA, United States
  15. Hematology and Oncology, Case Western Reserve University, University Hospitals Seidman Cancer Center, Cleveland, OH, United States
  16. Pfizer, New York, NY, United States
  17. Pfizer, Milan, Italy
  18. Sarah Cannon Research Institute, Nashville, TN, United States

Background: PF-08634404, a fully human immunoglobulin G4 bispecific antibody simultaneously targeting PD-1 and VEGF, have shown promising efficacy and manageable safety with PF-08634404 10 mg/kg Q3W as monotherapy (confirmed objective response rate [cORR] of 67.6%) and with platinum-based chemotherapy (cORR of 75.0% in squamous and 58.6% in non-squamous) in first-line non-small cell lung cancer (NSCLC) in phase 2 studies. 

Trial design: Symbiotic-Lung-01 is a global, double-blind, randomized phase 3 trial (NCT07222566) in adults with previously untreated, pathologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC regardless of PD-L1 expression. Patients must have measurable disease per RECIST 1.1, ECOG performance status of 0 or 1, and life expectancy of ≥3 months. Patients with known active brain metastases, active hepatitis B, or whose tumors have actionable genomic alterations with approved first-line therapies are excluded.  

The study has 2 parallel parts based on tumor histology. In part 1, approximately 640 patients with squamous NSCLC will be randomized 1:1 to receive either PF-08634404 or pembrolizumab intravenously plus carboplatin and investigator’s choice of paclitaxel or nab-paclitaxel for 4 cycles followed by maintenance therapy with PF-08634404 or pembrolizumab for up to 35 cycles. In part 2, approximately 770 patients with nonsquamous NSCLC will be randomized 1:1 to receive either PF-08634404 or pembrolizumab plus carboplatin and pemetrexed for 4 cycles followed by maintenance therapy with PF-08634404 or pembrolizumab plus pemetrexed for up to 35 cycles, after which pemetrexed may continue. Randomization is stratified by PD-L1 expression, brain metastases, and region. 

Dual primary endpoints are overall survival and progression-free survival by blinded independent central review (BICR) per RECIST 1.1. The key secondary endpoint is confirmed objective response rate by BICR. Other secondary endpoints include additional measures of efficacy, safety, quality of life, pharmacokinetics, and biomarkers. All endpoints will be assessed in each part. Enrollment has begun.