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Jun 02, 2018  | Breast Cancer
Breast Cancer
The PHEREXA study evaluated trastuzumab+ capecitabine ± pertuzumab in patients with HER2‑positive metastatic breast cancer who received a prior taxane and progressed during or after trastuzumab-based therapy. The primary analysis of independent review facility-assessed progression-free survival (IRF-PFS; the primary endpoint), as well as an interim analysis of overall survival (OS; a secondary endpoint) and safety has been published previously. Here we report the final prespecified analysis of the secondary endpoints of OS, investigator-assessed PFS (INV-PFS), and safety.

Jun 02, 2018  | Breast Cancer
Breast Cancer
There are limited clinical data on the outcomes of patients with breast cancer and central nervous system (CNS) metastases, due to limitations on enrollment criteria in clinical studies. Real-world data may provide complementary evidence to clinical studies regarding the characteristics, treatment, and outcomes of patients with metastatic breast cancer (MBC) and CNS metastases. This retrospective cohort analysis, conducted using Flatiron Health’s database (derived from patient-level electronic health records), describes the incidence of CNS metastases among patients with metastatic breast cancer, and patient characteristics at the time of MBC diagnosis, systemic drug therapy use, and overall survival after CNS metastases in the sub-population of patients with MBC diagnosed with CNS metastases.

Jun 02, 2018  | Breast Cancer
Breast Cancer
The results of the patient-reported HRQoL secondary endpoints in APHINITY, which were defined as symptoms of therapy, patient functioning, and global health status.

Jun 02, 2018  | Genitourinary Cancer
Genitourinary Cancer
This poster presents clinical outcomes in special populations from an expanded access study of atezolizumab in platinum-treated metastatic urothelial carcinoma. Subgroups evaluated include patients with impaired baseline renal function or variant histology. The impacts of such clinical features on efficacy and safety outcomes are described. ▼Atezolizumab: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Please see safety reporting on the contact us page via the site menu

Jun 02, 2018  | Genitourinary Cancer
Genitourinary Cancer
This poster presents a long-term clinical update from the Phase II IMvigor210 study (atezolizumab in metastatic urothelial carcinoma), both in previously untreated cisplatin-ineligible patients (cohort 1) and in previously platinum-treated patients (cohort 2). Similarities and differences with respect to prior analyses are presented (e.g., updates in mOS, mDOR). Subgroup analyses and characterization of outcomes in elderly Cohort 1 patients are also reported. ▼Atezolizumab: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Please see safety reporting on the contact us page via the site menu

Jun 06, 2018  | Lung Cancer
Lung Cancer
At the primary analysis (data cut-off, 9 February 2017) alectinib showed superior investigator-assessed PFS vs crizotinib in patients with untreated ALK+ NSCLC.  The safety profile of alectinib also compared favourably with crizotinib. This publication presents updated efficacy and safety data (cut-off 1 Dec 2017, with a median follow up time of 27.8 months). ▼Alectinib: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Please see safety reporting on the contact us page via the site menu.

Jun 03, 2018  | Lung Cancer
Lung Cancer
Alectinib, a highly selective inhibitor of ALK tyrosine kinase, has demonstrated systemic and central nervous system activity in ALK+ NSCLC. Two single-arm, open-label phase II studies (NP28673; global [NCT01801111] and NP28761; North American [NCT01871805]) have previously demonstrated robust overall survival (OS) in crizotinib-resistant ALK+ NSCLC (Yang et al, J Thorac Oncol 2017). We report final pooled phase II OS and safety data after a longer duration of follow-up. ▼Alectinib: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Please see safety reporting on the contact us page via the site menu.

Jun 03, 2018  | Lung Cancer
Lung Cancer
The patient-reported outcomes from the randomised, Phase III IMpower150 study investigating the combination of atezolizumab + chemotherapy ± bevacizumab versus chemotherapy + bevacizumab in 1L nonsquamous NSCLC are reported. IMpower150 has shown statistically significant and clinically meaningful progression-free survival and overall survival benefit for patients with atezolizumab + chemotherapy + bevacizumab versus chemotherapy + bevacizumab. This combination has also demonstrated a manageable safety profile with no new safety risks. The objective of this poster was to determine the relative impact of the addition of atezolizumab to chemotherapy ± bevacizumab on patient-reported health-related quality of life, physical functioning, and treatment-related and lung cancer-related symptom burden in the IMpower150 study. ▼atezolizumab: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Please see safety reporting on the contact us page via the site menu.

Jun 03, 2018  | Lung Cancer
Lung Cancer
The multi-center Phase II study LCMC3 evaluates neoadjuvant and adjuvant PD-L1 inhibition with atezolizumab in patients with resectable non-small cell lung cancer. This poster presents the results of a protocol-specified interim safety analysis. ▼Atezolizumab: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Please see safety reporting on the contact us page via the site menu.

Jun 03, 2018  | Lung Cancer
Lung Cancer
The MORPHEUS platform consists of multiple Phase Ib/II trials designed to identify early signals and establish proof-of-concept clinical data to support the development of CIT combinations in several indications. This TiP poster presents the study design, eligibility criteria and endpoints for the MORPHEUS-Lung study, which will enroll two cohorts of patients with advanced unresectable or metastatic non-small cell lung cancer (NSCLC).

Jun 03, 2018  | Gastrointestinal Cancer
Gastrointestinal Cancer
Hepatocellular carcinoma (HCC) is a lethal disease with limited treatment options. Here we report the results from a Phase Ib study of atezolizumab (anti–PD-L1) + bevacizumab (anti-VEGF) in patients with previously untreated, unresectable or metastatic HCC. The safety and clinical activity data from the ITT population and key patient subgroups will be presented. ▼Atezolizumab : This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Please see safety reporting on the contact us page via the site menu

Jun 03, 2018  | Gastrointestinal Cancer
Gastrointestinal Cancer
The MORPHEUS platform consists of multiple Phase Ib/II trials and aims to identify early signals and establish proof-of-concept clinical data to support the development of cancer immunotherapy combinations in several indications. This Trial in Progress poster presents the study design, eligibility criteria, endpoints and enrollment sites for the MORPHEUS-GC and MORPHEUS-PDAC studies, which will enroll patients with advanced unresectable or metastatic gastric cancer (GC) or metastatic pancreatic ductal adenocarcinoma (PDAC), respectively.

Jun 03, 2018  | Gastrointestinal Cancer
Gastrointestinal Cancer
IMbrave150 is a randomized Phase III study that investigates the effects of atezolizumab (anti–PD-L1) + bevacizumab (anti–VEGF) combination therapy vs sorafenib in first-line hepatocellular carcinoma (HCC). It will enroll patients with locally advanced or metastatic and/or unresectable HCC. This Trial in Progress poster presents study design, eligibility criteria, endpoints and enrollment sites of the study. ▼Atezolizumab: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Please see safety reporting on the contact us page via the site menu.

Jun 04, 2018  | Skin Cancer
Skin Cancer
Resistance to BRAF inhibitor monotherapy in BRAFV600-mutated metastatic melanoma limits PFS benefit and is most commonly the result of the paradoxical reactivation of mitogen-activated protein kinase (MAPK) pathway through MEK. The randomized phase 3 coBRIM trial (GO28141) showed that combining the MEK inhibitor cobimetinib with vemurafenib provided a statistically significant and clinically meaningful improvement in PFS and OS versus vemurafenib therapy alone. Extended follow-up of the phase 3 coBRIM study would provide useful clinical insight regarding the long-term efficacy and safety of cobimetinib plus vemurafenib for patients with BRAFV600-mutated metastatic melanoma. This poster presents the long-term efficacy and safety data from patients enrolled in the coBRIM phase 3 study after 4 years of follow-up (data cutoff date, October 13, 2017) ▼Cobimetinib: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Please see safety reporting on the contact us page via the site menu.

Jun 04, 2018  | Gastrointestinal Cancer
Gastrointestinal Cancer
The phase III JACOB study evaluated the efficacy and safety of intravenous pertuzumab plus trastuzumab and chemotherapy, compared with placebo plus trastuzumab and chemotherapy as a first-line treatment in patients with HER2-positive metastatic gastroesophageal junction cancer or gastric cancer. Pharmacokinetic (PK) samples were collected from all patients who participated in JACOB to assess the PK of pertuzumab, trastuzumab and chemotherapy. Here we report the PK, drug-drug interaction, and exposure-response analyses from the JACOB study.

Jun 04, 2018  | Cervical Cancer
Cervical Cancer
Preliminary results from the open-label single-arm CECILIA study after all patients had been followed for at least 6 months.

Jun 04, 2018  | Haematology
Haematology
This analysis assessed the relationship between end of induction (EOI) MRD and PET responses in the phase III GALLIUM study and the prognostic implication for PFS in previously untreated patients with follicular lymphoma (FL).

Jun 04, 2018  | Haematology
Haematology
POLARIX is a multicentre, randomized, double-blind, placebo-controlled phase III study in patients with previously untreated DLBCL; this trial-in-progress presentation reports the study design and endpoints. Patients will be randomized 1:1 (stratified by IPI score [2 versus 3–5], bulky disease and geographical region) to receive pola 1.8 mg/kg on Day 1 plus R-CHP (standard dosing schedule) plus vincristine placebo for 6 cycles, or R-CHOP (standard dosing schedule) with pola placebo for 6 cycles. The primary endpoint is investigator- assessed PFS using Lugano classification. Secondary endpoints include PET-CT complete response rate at end of treatment assessed by an independent review committee, event-free survival due to efficacy reason, 2-year PFS rate, and OS. Enrolment began November 2015 and patient follow-up will continue for 5 years after end of treatment.

Jun 02, 2018  | Lung Cancer
Lung Cancer
Overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) is an established early efficacy endpoint used in clinical trials. Comparison of real world tumor response (rwTR) and ORR can provide important insights for health professionals, regulators, and researchers.

Jun 02, 2018  | Lung Cancer
Lung Cancer
The NCCN evidence blocks are designed to provide affordability ratings on the overall cost of drug treatments (tx), including medication, administration, supportive care, side-effect management and hospitalization. This study characterized the relationship between real-world costs of aNSCLC tx and NCCN affordability rating.