TEVIMBRA ® ( TISLELIZUMAB BY BEIGENE IRELAND ) APROBADO YA EN PRIMERA LÍNEA ... TAMBIÉN QUIERE LA PRIMERA LÍNEA DE MANTENIMIENTO SMALL CELL LUNG CANCER Y ACABA DE PUBLICAR EN MANTENIMIENTO UNA PFS DE 6,4 // 7,8 MESES .///. Y UNA OVERALL SURVIVAL DE 17,3 MESES .///. IMFORTE APORTA UNA PFS DE 5,4 MESES ... Y UNA OVERALL SURVIVAL DE 13,2 MESES .

TISLELIZUMAB YA ESTA APROBADO POR LA EMA PARA EL TRATAMIENTO DE PRIMERA LÍNEA SMALL CELL LUNG CANCER EXTENSIVE-STAGE ... POR LO QUE YA SON CUATRO LOS TRATAMIENTOS CON INMUNOTERAPIA APROBADOS EN EUROPA :

*.- 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 : 

FIRST-LINE INDUCCTION Chemo-Immunotherapy, Followed by MAINTENANCE Immune-Monotherapy, Significantly Improved Survival For ES-SCLC. However, Rapid Disease Progression Frequently Occurs ( mPFS: 4.5-5.8 Months From INDUCCTION THERAPY ) . We Assessed an Enhanced Treatment Strategy by Adding an Anti-Angiogenic Agent to Immune-Monotherapy During MAINTENANCE to Delay Recurrence .

 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 .