IMpower133: Primary PFS, OS, and safety in a Ph1/3 study of 1L atezolizumab + carboplatin + etoposide in extensive-stage SCLC

Similar documents
Efficacy of Pembrolizumab in Patients With Advanced Melanoma With Stable Brain Metastases at Baseline: A Pooled Retrospective Analysis

CheckMate 153: Randomized Results of Continuous vs 1-Year Fixed-Duration Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer

SYNOPSIS Final Abbreviated Clinical Study Report for Study CA ABBREVIATED REPORT

Introduction. These patients benefit less from conventional chemotherapy than patients identified as MMR proficient or microsatellite stable 3-5

CheckMate-142 Study Design

Efficacy of Sonidegib in Patients With Metastatic BCC (mbcc)

Clinical Study Report Synopsis Drug Substance Naloxegol Study Code D3820C00018 Edition Number 1 Date 01 February 2013 EudraCT Number

A review of the patterns of docetaxel use for hormone-resistant prostate cancer at the Princess Margaret Hospital

University of Texas Health Science Center, San Antonio, San Antonio, Texas, USA

The RUTHERFORD-2 trial in heterozygous FH: Results and implications

New Therapies for Lung Cancer Consultant*: Abbvie, Adaptimmune, Agenus,

New Therapies for Lung Cancer

Sponsor / Company: Sanofi Drug substance(s): AVE0005 (aflibercept)

Safety and Tolerability of Subcutaneous Sarilumab and Intravenous Tocilizumab in Patients With RA

Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients With Relapsing and Primary Progressive Multiple Sclerosis

Reference Slide Deck. Abstract 553 Abstract 554 Abstract 560

Original Article. Breast Care 2016;11: DOI: /

Emerging Options for Thromboprophylaxis After Orthopedic Surgery: A Review of Clinical Data

Supplementary Online Content

Presented at the 75 th Annual Meeting of the American Academy of Dermatology, Orlando, FL, March 3-7, 2017 METHODS INTRODUCTION OBJECTIVE

ClinicalTrials.gov Identifier: NCT

The incidence of melanoma, the most serious

Clinical Evidence for Second- and Third-Line Treatment Options in Advanced Non-Small Cell Lung Cancer

Age related differences in prognosis and prognostic factors among patients with epithelial ovarian cancer

Y. Yazici 1, D. Moniz Reed 2, C. Klem 2, L. Rosenblatt 2, G. Wu 2, J.M. Kremer 3

Results. Table 1: Demographic and Baseline Characteristics, Open-Label Safety Population Prior Double-Blind OC/APAP ER (n=77)

Mortality of patients with multiple sclerosis: a cohort study in UK primary care

The potential future of targeted radionuclide therapy: implications for occupational exposure? P. Covens

PNEUMOVAX 23 is recommended by the CDC for all your appropriate adult patients at increased risk for pneumococcal disease 1,2 :

Comparative Safety of Filgrastim versus Sargramostim in Patients Receiving Myelosuppressive Chemotherapy

In the treatment of cardiovascular disease (CVD), national

Community. Profile Big Horn County. Public Health and Safety Division

Breast-Conserving Surgery Under Local Anesthesia in Elderly Patients with Severe Cardiorespiratory Comorbidities: A Hospital-Based Case-Control Study

Lung cancer is the leading cause of cancer death worldwide, EGFR Mutation and Brain Metastasis in Pulmonary Adenocarcinomas

key words: bortezomib, multiple myeloma, retrospective analysis, treatment outcomes, subcutaneous, intravenous

Clinical Study. Oncology 2006;71:32 39 DOI: /

Tumor Vascularity Does Not Predict Response to Yttrium-90 Radioembolization for Hepatic Metastases from Colorectal Cancer

Esophageal carcinoma is the eighth most common cancer

Rheumatoid-susceptible alleles of HLA-DRB 1 are genetically recessive to non-susceptible alleles in the progression of bone destruction in the wrists

Gemmis Injection 38 mg/ml

Optimisation of diets for Atlantic cod (Gadus morhua) broodstock: effect of arachidonic acid on egg & larval quality

Immune-Mediated Adverse Reactions Management Guide

Community. Profile Powell County. Public Health and Safety Division

Start ORKAMBI today. INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION. Sydney Age 4

Abstract. Background. Aim. Patients and Methods. Patients. Study Design

Therapeutic Angiogenesis With Intramuscular NV1FGF Improves Amputation-free Survival in Patients With Critical Limb Ischemia

EVALUATION OF DIFFERENT COPPER SOURCES AS A GROWTH PROMOTER IN SWINE FINISHING DIETS 1

Original Article. T Akter 1, N Islam 2, MA Hoque 3, S Khanam 4, HA khan 5, BK Saha 6. Abstract:

Metformin and breast cancer stage at diagnosis: a population-based study

See 17 for PATIENT COUNSELING INFORMATION. Revised: 09/2017 FULL PRESCRIBING INFORMATION: CONTENTS*

Supplementary Online Content

TR Spitzer 1, CJ Friedman 2, W Bushnell 2, SR Frankel 3, J Raschko 4. Summary:

Goal: Evaluate plant health effects while suppressing dollar spot and brown patch

Increased Relative Mortality in Women With Severe Oxygen-Dependent COPD

Community. Profile Yellowstone County. Public Health and Safety Division

Community. Profile Lewis & Clark County. Public Health and Safety Division

Community. Profile Missoula County. Public Health and Safety Division

Clinical statistics analysis on the characteristics of pneumoconiosis of Chinese miner population

Community. Profile Anaconda- Deer Lodge County. Public Health and Safety Division

Prognostic significance of pretreatment serum levels of albumin, LDH and total bilirubin in patients with nonmetastatic

Multicenter Randomized Phase 2 Clinical Trial of a Recombinant Human Endostatin Adenovirus in Patients with Advanced Head and Neck Carcinoma

Pegylated liposomal doxorubicin in the treatment of AIDS-related Kaposi s sarcoma

Chilblains (pernio, perniosis) are cold-induced, painful or itching

CHEST. Thyroid transcription factor 1 (TTF-1) is an important. Original Research

Analysis of alternatives for insulinizing patients to achieve glycemic control and avoid accompanying risks of hypoglycemia

Longitudinal inspiratory capacity changes in chronic obstructive pulmonary disease

Management of Relapsed/Refractory Follicular Lymphoma

Lung cancer is the most common cause of cancer deaths in

Case Report INTRODUCTION CASE REPORT. pissn eissn X

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 10/2017

The burden of cirrhosis and impact of universal coverage public health care system in Thailand: Nationwide study

Managing treatment-related adverse events associated with egfr tyrosine kinase inhibitors in advanced non-small-cell lung cancer

Managing treatment-related adverse events associated with egfr tyrosine kinase inhibitors in advanced non-small-cell lung cancer

Patient Survival After Surgical Treatment of Rectal Cancer

Olanzapine for the prophylaxis and rescue of chemotherapyinduced nausea and vomiting (CINV): a retrospective study

EFFECTS OF INGREDIENT AND WHOLE DIET IRRADIATION ON NURSERY PIG PERFORMANCE

R Martino 1, P Romero 1, M Subirá 1, M Bellido 1, A Altés 1, A Sureda 1, S Brunet 1, I Badell 2, J Cubells 2 and J Sierra 1

Using Paclobutrazol to Suppress Inflorescence Height of Potted Phalaenopsis Orchids

P (RCC) was first done in the late 1930s and reported in

One of the most important biological mechanisms of

Symptom Management and Supportive Care

C reactive protein: an aid to assessment and

Effects of physical exercise on working memory and prefrontal cortex function in post-stroke patients

A retrospective study on combination therapy with ifosfamide, adriamycin and cisplatin for progressive or recurrent uterine sarcoma

Oral UFT (uracil plus futrafur) for neoadjuvant chemotherapy of gastric cancer

Patient-Controlled Transdermal Fentanyl Versus Intravenous Morphine Pump After Spine Surgery

Natural History and Treatment of Wilms's Tumour : An Analysis of 335 Cases Occurring in England and Wales

Prophylactic effect of neoadjuvant chemotherapy in gastric cancer patients with postoperative complications

Bone Marrow Transplantation (2001) 27, Nature Publishing Group All rights reserved /01 $

27 June Bmnly L. WALTER ET AL.: RESPONSE OF CERVICAL CANCERS TO IRRADIATION

A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation

PRACTICE GUIDELINE SERIES

See 17 for PATIENT COUNSELING INFORMATION. Revised: 02/2011 FULL PRESCRIBING INFORMATION: CONTENTS*

Antiviral Therapy 2015; 20: (doi: /IMP2874)

See 17 for PATIENT COUNSELING INFORMATION and FDAapproved

Metabolic Syndrome and Health-related Quality of Life in Obese Individuals Seeking Weight Reduction

The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters. doi: /ajg.2012.

Impact of Positive Nodal Metastases in Patients with Thymic Carcinoma and Thymic Neuroendocrine Tumors

Transcription:

IMpower133: Primry PFS, OS, nd sfety in Ph1/3 study of 1L tezolizumb + crbopltin + etoposide in extensive-stge SCLC S. V. Liu, 1 A. S. Mnsfield, 2 A. Szczesn, 3 L. Hvel, 4 M. Krzkowski, 5 M. J. Hochmir, 6 F. Huemer, 7 G. Losonczy, 8 M. L. Johnson, 9 M. Nishio, 10 M. Reck, 11 T. Mok, 12 S. Lm, 13 D. S. Shmes, 13 J. Liu, 14 B. Ding, 13 F. Kbbinvr, 13 W. Lin, 13 A. Sndler, 13 L. Horn 15 1 Georgetown University, Wshington DC, USA; 2 Myo Clinic, Rochester, MN, USA; 3 Mzowieckie Centrum Leczeni Chorób Płuc i Gruźlicy, Otwock, Polnd; 4 Thomyerov Nemocnice, Pneumologická Klinik 1.LF UK, Prgue, Czech Republic; 5 Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie w Wrszwie, Wrsw, Polnd; 6 Deprtment of Respirtory nd Criticl Cre Medicine & Ludwig Boltzmnn Institute for COPD & Respirtory Epidemiology Bumgrtner Höhe, Otto-Wgner-Spitl, Vienn, Austri; 7 2 nd Deprtment of Respirtory nd Criticl Cre Medicine & Ludwig Boltzmnn Institute for COPD & Respirtory Epidemiology Bumgrtner Höhe, Otto-Wgner-Spitl, Vienn, Austri; 8 Semmelweis Egyetem ÁOK, Pulmonológii Klinik, Budpest, Hungry; 9 Srh Cnnon Reserch Institute/Tennessee Oncology PLLC, Nshville, TN, USA; 10 The Cncer Institute Hospitl, Jpnese Foundtion for Cncer Reserch, Tokyo, Jpn; 11 LungClinic Grosshnsdorf, Airwy Reserch Center North (ARCN), Germn Center for Lung Reserch, Grosshnsdorf, Germny; 12 Stte Key Lbortory of South Chin, The Chinese University of Hong Kong, Hong Kong, Chin; 13 Genentech, Inc., South Sn Frncisco, CA, USA; 14 F. Hoffmnn-L Roche, Ltd., Shnghi, Chin; 15 Vnderbilt University Medicl Center, Nshville, TN, USA Downlod from http://bit.ly/2cvy9it, IMpower133

IMpower133: Globl Phse 1/3, double-blind, rndomized, plcebo-controlled tril evluted tezolizumb + crbopltin + etoposide in 1L ES-SCLC Only ptients with treted brin metstses were eligible. ECOG PS, Estern Coopertive Oncology Group Performnce Sttus; IV, intrvenous; PCI, prophylctic crnil irrdition; PD, progressive disese; PFS, progression-free survivl; R, rndomized; RECIST, Response Evlution Criteri In Solid Tumors. Downlod from http://bit.ly/2cvy9it, IMpower133, Presented by Stephen V. Liu

Overll survivl Clinicl dt cutoff dte: April 24, 2018, 11 months fter the lst ptient ws enrolled. CI, confidence intervl; HR, hzrd rtio; CP/ET, crbopltin + etoposide. Downlod from http://bit.ly/2cvy9it, IMpower133, Presented by Stephen V. Liu

Investigtor-ssessed progression-free survivl Clinicl dt cutoff dte: April 24, 2018, 11 months fter the lst ptient ws enrolled. CI, confidence intervl; HR, hzrd rtio; CP/ET, crbopltin + etoposide. Downlod from http://bit.ly/2cvy9it, IMpower133, Presented by Stephen V. Liu

Confirmed objective response nd durtion of response Censored. b At clinicl cutoff dte: April 24, 2018. CR, complete response; EFS, event-free survivl; PD, progressive disese; PR, prtil response; SD, stble disese. Downlod from http://bit.ly/2cvy9it, IMpower133, Presented by Stephen V. Liu

Summry IMpower133 is the first study in over 20 yers to show cliniclly meningful improvement in OS over the current stndrd-of-cre in 1L ES-SCLC The ddition of tezolizumb to crbopltin nd etoposide provided significnt improvement in OS nd PFS, compred with crbopltin nd etoposide lone in 1L ES-SCLC mos: 12.3 vs. 10.3 months; HR: 0.70 (p = 0.0069); 12-month OS: 51.7% vs. 38.2% mpfs: 5.2 vs. 4.3 months; HR: 0.77 (p = 0.017); 12-month PFS: 12.6% vs. 5.4% The sfety profile of tezolizumb plus crbopltin nd etoposide ws s expected with no new findings Rtes of hemtologic side effects were similr between tretment groups Administrtion of tezolizumb did not compromise the bility to deliver stndrd crbopltin plus etoposide The incidence nd types of immune-relted AEs were similr to those seen with tezolizumb monotherpy 1 3 These dt suggest tht tezolizumb plus crbopltin nd etoposide is new stndrd of cre for the first-line tretment of ES-SCLC 1. Rittmeyer A, et l. Lncet, 2017. 2. Cortinovis D, et l. Ann Oncol, 2017 (Suppl. 5). 3. Fehrenbcher L, et l. Lncet, 2016. Downlod from http://bit.ly/2cvy9it, IMpower133, Presented by Stephen V. Liu