Oral Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2026

Phase 2 trial of the PD-1/VEGF bispecific antibody, PF-08634404 (SSGJ-707), plus chemotherapy (chemo) in advanced NSCLC: updated results  (146119)

Malinda Itchins 1 , Lin Wu 2 , Haipeng Xu 3 , Yulan Sun 4 , Fangling Ning 5 , Siyuan Huang 6 , Dingzhi Huang 7 , Yan Yu 8 , Feng Ye 9 , Dongqing Lv 10 , Zhidong Pei 11 , Junguo Lu 12 , Tao Xu 13 , Xingxiang Pu 14 , Xiang Li 15 , Ruoyu Wang 15 , Laiyu Liu 16 , Junfang Tang 17 , Anwen Liu 18 , Eeman Shaikh 19 , Jing Lou 20
  1. Medical Oncology, Royal North Shore Hospital, Sydney, Australia
  2. Thoracic Medical Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan, China
  3. Fujian Cancer Hospital, Fuzhou, China
  4. Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China
  5. Binzhou Medical University Hospital, Binzhou, China
  6. The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
  7. Tianjin Medical University Cancer Institute & Hospital, Tianjin, China
  8. Harbin Medical University Cancer Hospital, Harbin, China
  9. The First Affiliated Hospital of Xiamen University, Xiamen, China
  10. Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou, China
  11. Luoyang Central Hospital, Luoyang, China
  12. Nantong Tumor Hospital, Nantong, China
  13. The Affiliated Hospital of Qingdao University, Qingdao, China
  14. Lung & Gastrointestinal Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan, China
  15. Affiliated Zhongshan Hospital of Dalian University, Dalian, China
  16. Respiratory and Critical Care Medicine, Chronic Airways Diseases Laboratory, Nanfang Hospital, Southern Medical University, Guangzhou, China
  17. Beijing Chest Hospital, Capital Medical University, Beijing, China
  18. The Second Affiliated Hospital of Nanchang University, Nanchang, China
  19. Pfizer, New York, NY, United States
  20. Shenyang Sunshine Pharmaceuticals Co., Ltd., Shenyang, China

Background: PF-08634404 (PF’4404) is an IgG4 bispecific simultaneously targeting PD-1/VEGF. Earlier results (NCT06412471) demonstrated encouraging efficacy and manageable safety with PF’4404+platinum-based chemo (PBC) as 1L treatment of NSCLC regardless of PD-L1 expression.  

Methods: This open-label randomized Ph2 trial evaluated PF’4404 or tislelizumab+PBC in 1L NSCLC. In part 1, patients with non-squamous NSCLC were randomized to PF’4404 or tislelizumab+carbo/pemetrexed. In part 2, patients with squamous NSCLC were randomized to different doses of PF’4404+carbo/paclitaxel in cohort A; or PF’4404 or tislelizumab+carbo/paclitaxel or PF’4404+carbo/nab-paclitaxel in cohort B. Primary objectives were safety and antitumor activity. Efficacy results are shown from the recommended Ph3 dose of 10 mg/kg Q3W; safety and ctDNA include all doses evaluated. 

Results: As of Feb 28, 2026, 261 patients were enrolled (122 non-squamous, 139 squamous); 44% had PD-L1 TPS <1%, 36% TPS 1%–49%, and 20% TPS ≥50%. Median f/u exceeded 10.3 months across cohorts. In non-squamous, cORR was 75.0% with PF’4404 vs 44.7% with tislelizumab. In squamous, cORR with PF’4404 was 82.5% (carbo/paclitaxel) and 69.2% (carbo/nab-paclitaxel) vs 67.7% with tislelizumab. PF’4404 responses occurred irrespective of PD-L1 expression. 12-month PFS trends were favorable in PF’4404 vs tislelizumab in non-squamous and squamous NSCLC. Safety of PF’4404+PBC was comparable to that of tislelizumab+PBC. 

In PF’4404-treated patients with ctDNA detected at baseline and paired samples at C3D1 (n=126), 61.9% cleared their ctDNA and had mPFS of 13.8 months vs 9.6 months in patients without ctDNA clearance.  

Conclusions: PF’4404+PBC continues to demonstrate clinically meaningful antitumor activity with cORR of 69%-82% and promising durability as 1L treatment for NSCLC irrespective of histology or PD-L1 expression. Safety was manageable and consistent in both histologies. ctDNA clearance correlated with improved PFS. These findings support ongoing Ph3 evaluation of PF’4404+chemo in Symbiotic-Lung-01 (NCT07222566).