A phase II trial to evaluate the safety and efficacy of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, as a monotherapy in patients with advanced NSCLC.
Lin Wu, Jun Yao, Yulan Sun, Ruoyu Wang, Xiang Li, Bolin Chen, Qian Chu, Qing Bu, Yong Fang, Jun Zhao, Weizhen Huang, Jin Zhou, Qiming Wang, Jie Li, Yongzhong Luo, Yan Yu, Tienan Yi, Jing Lou, Weifeng Song
Abstract
8543 Background: SSGJ-707 is a recombinant humanized bispecific molecule built on IgG4 that targets the human programmed death 1 (PD-1) and vascular endothelial growth factor (VEGF). The increase of SSGJ-707 affinity for PD-1 was 10-fold more than that of Ivonescimab in the presence of VEGF. Here, we report the initial results from a phase II study of SSGJ-707 monotherapy in patients (pts) with advanced NSCLC(SSGJ-707-NSCLC-II-01, NCT06361927). Methods: Pts with treatment naive advanced NSCLC (without actionable genomic alterations and PD-L1 expression≥1%) were enrolled to receive SSGJ-707 monotherapy until disease progression or unacceptable toxicity. Tumor assessments based on RECIST 1.1 were performed every 6 weeks by investigators. Results: As of Jan 10, 2025, 83 NSCLC pts have received SSGJ-707 at dose of 5mg/kg Q3W (n=31), 10mg/kg Q3W (n=34), 20mg/kg Q3W (n=12), 30mg/kg Q3W(n=6). Overall, the median age was 64 years, 83.1% had ECOG PS of 1, 44.6% of pts with squamous cell carcinoma, 66.3% and 33.7% of pts had PD-L1 expression 1%-49% and ≥50%. Among the 76 pts completed at least one efficacy evaluation, ORR and DCR were 29.6% (8/27)/85.2% (23/27), 61.8%(21/34)97.1% (33/34), 54.5% (6/11)/90.9% (10/11) and 25% (1/4)/75% (3/4) at doses of 5mg/kg Q3W, 10mg/kg Q3W, 20mg/kg Q3W and 30 mg/kg Q3W, respectively. SSGJ-707 10mg/kg Q3W demonstrated promising efficacy results in treatment naive advanced NSCLC. Select subgroups are summarized in SSGJ-707 10mg/kg Q3W. The ORR were 54.5% (12/22) and 75%(9/12) in non-squamous and squamous pts respectively. And the ORR were 57% (12/21) and 69%(9/13) in PD-L1 TPS 1%-49% and ≥ 50% pts respectively. 25 pts completed at least two efficacy evaluation in SSGJ-707 10mg/kg Q3W, the ORR was 72% (18/25), DCR was 100% (25/25). For the 83 pts, 65 pts (78.3%) experienced treatment related adverse events (TRAEs), 20 pts (24.1%) experienced grade≥3 TRAEs. The most common TRAEs included hypercholesterolaemia (18.1%,15/83), hypertriglyceridaemia (18.1%,15/83), alanine aminotransferase increased (15.7%,13/83) and aspartate aminotransferase increased (15.7%,13/83). TRAE leading to discontinuation occurred in 6% of pts. Conclusions: SSGJ-707 monotherapy demonstrated promising efficacy results in treatment naive advanced NSCLC with manageable safety profile. Monotherapy and combination trials with chemotherapy for NSCLC are still ongoing. Research Sponsor: 3S BIO.COM. Clinical trial information: NCT06361927 .