*.- TISLELIZUMAB .
*.- SERPLULIMAB .
*.- DURVALUMAB .
*.- ATEZOLIZUMAB .
EL NOMBRE COMERCIAL EN ESPAÑA ES TEVIMBRA ® .
EL LABORATORIO TITULAR ES BEIGENE IRELAND LÍMITED .
EL LABORATORIO COMERCIALIZADOR EN ESPAÑA ES BEIGENE ESPAÑA, S.L. .
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TISLELIZUMAB PLUS SITRAVATINIB OR ANLOTINIB AS MAINTENANCE THERAPY IN EXTENSIVE-STAGE SMALL-CELL LUNG CANCER ( ES-SCLC ) .
INTRODUCTION :
This Report Presents the Efficacy and Safety of Two PHASE II Trials Evaluating MAINTENANCE TISLELIZUMAB (TIS, a PD-1 inhibitor) Plus SITRAVATINIB ( SITRAVATINIB, Trial 1 ) or ANLOTINIB ( ANLOTINIB, Trial 2 ) in ES-SCLC Patients Following INDUCCTION TISLELIZUMAB + CHEMOTHERAPY .
METHODS :
Untreated ES-SCLC Patients Received TIS + Platinum-Based CHEMOTHERAPY Q3W For 4 Cycles ( INDUCCTION ), followed by MAINTENANCE TISLELIZUMAB ( 200 mg ) and SITRAVATINIB ( 70 mg QD; Trial 1 ) Or ANLOTINIB ( 12 mg QD on D1-14; Trial 2 ) in a 21- Day Cycle For up to 2 years ( Including Both The INDUCCTION And MAINTENANCE PHASES ). The Primary Endpoint Was 1-year PFS Rate in MAINTENANCE Analysis Set (MAS). MAS Included Patients Receiving ≥1 Dose MAINTENANCE THERAPY .
Efficacy and Safety in MAS Were Calculated From The Start of MAINTENANCE THERAPY .
RESULTS :
21 Patients Were Enrolled Separately in trial 1 and Trial 2, With Most Patients Had an ECOG PS of 1 ( 95.2% in Each Trial ), and Had More Than 3 Metastatic Sites (90.5% in Trial 1 and 85.7% in Trial 2). 18 Patients Entered MAINTENANCE PHASE in Each Trial .
FROM THE START OF MAINTENANCE THERAPY :
*.- MEDIAN FOLLOW-UP WAS 17.0 MONTH AND 9.5 MONTH .
*.- RESPECTIVE MEDIAN PFS WAS 6.4 mo AND 7.8 MONTH .
*.- MEDIAN OVERALL SURVIVAL ( OS ) WAS 18.3 MONTH AND NOT REACHED, WITH CORRESPONDING 1-YEAR OS RATES OF 61.1% AND 87.8% .
In MAS, 4 Patients in Trial 1 and 3 in Trial 2 Achieved Further Partial Responses, Resulting in a Confirmed ORR of 22.2% and 16.7%, Respectively (Table). In MAS, the most common Grade ≥3 TRAEs Included Hypertension (22.2%) in Trial 1 and Fatigue (5.6%) in Trial 2. No patients Died from TRAEs .
CONCLUSIONS :
TISLELIZUMAB Plus SITRAVATINIB Or ANLOTINIB Yielded Promising Efficacy With Manageable Toxicities As MAINTENANCE THERAPY in ES-SCLC Patients After Induction TISLELIZUMAB + CHEMOTHERAPY This Enhanced MAINTENANCE Strategy Warrants Further Exploration in Larger-Scale Trials .
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