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ASCO 2024 . SURUFATINIB ORAL PLUS PD-1/L1 INHIBITORS AS MAINTENANCE THERAPY FOLLOWING FIRST-LINE ( 1L ) PLATINUM-BASED CHEMOTHERAPY COMBINED WITH PD-1/L1 INHIBITORS IN PATIENTS ( Pts ) WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER ( ES-SCLC ) .

Background :

Pts With ES-SCLC Have a Poor Prognosis . PD-1/L1 Inhibitors Combined With CHEMOTHERAPY As 1L Treatment Has Been Demonstrated To Improve The Survival .

 Yet, Pts Are Prone to Progression After CHEMO-IMMUNOTHERAPY Followed By Anti-PD-1/L1 Monotherapy .

 

A Multicenter, single-arm PHASE II Study Was Conducted to Evaluate The Efficacy and Safety of SURUFATINIB (a small-molecule inhibitor of VEGFR 1-3, FGFR1 and CSF-1R) Combined with PD-1/L1 inhibitors in Pts With ES-SCLC as 1L MAINTENANCE THERAPY .

Methods :

Key inclusion criteria were cytologically or Pathologically Confirmed ES-SCLC, ECOG PS 0-1, No Disease Progression after 4-6 cycles PLATINUM-BASED Chemotherapy Combined with PD-1/L1 inhibitors . Enrolled Pts Received SURUFATINIB (250mg, po, QD) plus PD-1/L1 inhibitors (same as that in prior 1L therapy: DURVALUMAB, SINTILIMAB, TORIPALIMAB or SERPLULIMAB ) until disease progression or intolerable toxicity . The primary endpoint is Progression Free Survival (PFS) per RECIST 1.1 by investigator.

Results :

From Sept 2022 to July 2023, 21 pts were enrolled . The Median age was 62 years . 90.5% were male, 85.7% were former and current smokers and 52.4% had ECOG PS of 0, 11 pts completed 6 cycles of PLATINUM-BASED CHEMOTHERAPY Combined with PD-1/L1 inhibitors, and 12 pts Received DURVALUMAB in 1L therapy. As of 20 Nov, 2023, the Median Follow-Up Duration was 9.2 Months . 

Objective Response rate (ORR) was 14.3% and DCR (Disease control rate) was 71.4%. The mPFS of 1L MAINTENANCE THERAPY was 4.0 months (95%CI: 2.0-5.6) .

 The mPFS from 1L Treatment to Disease Progression Was 8.7 months . mOS was not reached, with 3 mo- , 6 mo- and 9 mo- OS rate was 100%, 94.4% and 75.6%, respectively. 21 (100%) pts experienced treatment-emergent adverse events (TEAEs), and 8 (38.1%) pts experienced grade ≥3 TEAEs, most commonly with platelet count decreased , Neutrophil count decreased and Pneumonia . There Was No Treatment-Related Death .

CONCLUSIÓNS :

SURUFATINIB ORAL COMBINADO CON INHIBIDORES PD-1/L1 MOSTRÓ UNA EFICACIA FOMENTADORA Y UN PERFIL DE SEGURIDAD TOLERABLE COMO TERAPIA DE MANTENIMIENTO DE PRIMERA LINEA .

SURUFATINIB ORAL COMBINED WITH PD-1/L1 INHIBITORS SHOWED ENCOURAGING EFFICACY AND TOLERABLE SAFETY PROFILE AS 1L MAINTENANCE THERAPY .

 FURTHER OS FOLLOW-UP IS WARRANTED .

Clinical trial information : NCT05509699 .