Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2026

 Symbiotic-Lung-10: a phase 2 trial of PD-1/VEGF bispecific antibody, PF-08634404, as monotherapy or in combination for non-small cell lung cancer  (146035)

Surein Arulananda 1 , Tina Cascone 2 , Heather Wakelee 3 , Lei Deng 4 , Rafael Perez Casellas 5 , Srilata Gundala 6 , Luis Paz-Ares 7 , Aakash Desai 8 , Mariano Provencio Pulla 9 , Yi-Long Wu 10 , Jin-Yuan Shih 11 , Rachel Roberts-Thomson 12 , Chao-Hua Chiu 13 , Alexandre Martinez Marti 14 , Federico Cappuzzo 15 , Yu-Chung Huang 16 , Ricky Philipossian 16 , Rong Rong 16 , Patrick Forde 17
  1. Monash Health, Clayton, VIC, Australia
  2. MD Anderson Cancer Center, Houston, TX, United States
  3. Stanford Cancer Center, Palo Alto, CA, United States
  4. University of Washington/Fred Hutchinson Cancer Center, Seattle, WA, United States
  5. Pan American Center for Oncology Trials, LLC, Manati, Puerto Rico, United States
  6. Hope and Healing Clinical Research, Hinsdale, IL, United States
  7. Medical Oncology, Hospital 12 de Octubre, Madrid, Spain
  8. O'Neal Comprehensive Cancer Center, University of Alabama Birmingham, Birmingham, AL, United States
  9. Hospital Universitario Puerta de Hierro, Madrid, Spain
  10. Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangdong, China
  11. National Taiwan University Hospital, Taipei, Taiwan
  12. The Queen Elizabeth Hospital, Central Adelaide Local Health Network, Adelaide, Australia
  13. Taipei Medical University Hospital, Taipei, Taiwan
  14. Vall d'Hebron University Hospital, Barcelona, Spain
  15. National Cancer Institute Regina Elena, Rome, Italy
  16. Pfizer, New York, NY, United States
  17. Trinity College Dublin, Dublin, Ireland

Background: PF-08634404 is a fully human IgG4 bispecific antibody simultaneously targeting PD-1 and VEGF. Ph2 studies have shown promising efficacy and manageable safety with PF-08634404 as a monotherapy and in combination with chemotherapy in locally advanced (LA)/metastatic NSCLC. This study will evaluate PF-08634404 as monotherapy or in combination with chemotherapy in early-stage resectable and unresectable NSCLC. 

Trial design: Symbiotic-Lung-10 is a multicenter, open-label, multi-arm Ph2 trial (NCT07489066) in adults with squamous and non-squamous NSCLC without actionable genomic alterations and independent of PD-L1 expression. Approximately 120 patients will be enrolled into 3 independent parts, each with different treatment settings and simultaneous enrollment (approximately 40 in each part). 

Part A will enroll patients with treatment-naïve, early-stage or LA, resectable stage II or IIIA/B NSCLC who are candidates for neoadjuvant therapy followed by surgery. Patients will receive neoadjuvant PF-08634404+platinum-doublet chemotherapy (carboplatin+paclitaxel for squamous or carboplatin+pemetrexed for non-squamous) for 3 cycles, with an optional fourth cycle for patients deriving clinical benefit. Patients who remain candidates for surgery will undergo surgery within 5-8 weeks after the last dose of neoadjuvant PF-08634404. Primary endpoints are safety, surgical feasibility, and pathologic complete response (pCR) rate by central pathology review.  

Part B will enroll patients with completely resected, early-stage or LA, stage II or IIIA/B NSCLC who received standard-of-care neoadjuvant chemoimmunotherapy, did not achieve pCR, and are candidates for adjuvant treatment. Patients will receive PF-08634404 monotherapy for up to 18 cycles/1yr, whichever comes first. The primary endpoint is safety.  

Part C will enroll patients with LA, unresectable stage III NSCLC who did not have progressive disease per RECIST 1.1 after definitive platinum-based concurrent chemoradiotherapy and are candidates for consolidation therapy. Patients must not have had prior curative-intent surgery for NSCLC. Patients will receive PF-08634404 monotherapy for up to 18 cycles/1yr, whichever comes first. The primary endpoint is safety.