Real-world clinical outcomes in avelumab-treated patients (pts) in the United States (U.S.) from SPEAR-Merkel: Study informing treatment pathway decisions in Merkel cell carcinoma (MCC).

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 269-269
Author(s):  
Abhijeet Bhanegaonkar ◽  
Frank Xiaoqing Liu ◽  
Ruth Kim ◽  
Marley Boyd ◽  
Nicole Fulcher ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
The United States ◽  
Study Data ◽  
Emergency Department Visits ◽  
Sample Population ◽  
Line Setting

269 Background: MCC is a rare, aggressive disease associated with poor prognosis. Avelumab, a fully human anti–PD-L1 monoclonal antibody, was the first immune checkpoint inhibitor approved by the FDA for the treatment of metastatic MCC (mMCC). In the JAVELIN Merkel 200 trial (Clinical trial information: NCT02155647), avelumab resulted in durable responses and a high objective response rate (ORR) in pts with mMCC. This retrospective descriptive study assessed real-world clinical outcomes in avelumab-treated pts with locally advanced MCC (laMCC) and mMCC in a US community oncology setting. Methods: This study included data on avelumab-treated laMCC and mMCC pts from 1/1/17 to 3/31/19 within The US Oncology Network. Study data were captured through 9/30/19 using structured fields and chart review of iKnowMed electronic healthcare records. Real-world ORR was assessed. Duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were estimated using the Kaplan-Meier method. Results: 33 pts initiated treatment with avelumab (laMCC n = 11; mMCC n = 22) and were followed up for a median of 10.9 months (range, 0.5-27.2 months). Median age was 77 years (range, 44-90+ years), 78.8% of pts were male, and the majority (84.8%) of pts were treated in the first-line setting. During treatment, 27.2% of pts had emergency department visits and 39.4% were hospitalized; 1% and 23.1%, respectively, were treatment related. Clinical outcomes are reported in the table. Conclusions: This is the first study to examine pts with laMCC treated with avelumab in a real-world setting. Although the sample population is small, results suggest the clinical benefits in the real world in pts with mMCC treated with avelumab are consistent with benefits reported in the JAVELIN Merkel 200 trial. [Table: see text]

Real-world clinical outcomes in avelumab-treated patients (pts) in the United States (U.S.) from SPEAR-Merkel –Study informing treatment Pathway dEcisions in Merkel cell cARcinoma (MCC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22029-e22029
Author(s):  
Charles Lance Cowey ◽  
Frank Xiaoqing Liu ◽  
Ruth Kim ◽  
Marley Boyd ◽  
Nicole Fulcher ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Outcomes ◽  
Real World ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
The United States ◽  
Emergency Department Visits ◽  
Sample Population ◽  
Clinical Trial Information

e22029 Background: MCC is a rare, aggressive disease associated with poor prognosis. Avelumab, a fully human anti–PD-L1 monoclonal antibody, was the first immune checkpoint inhibitor approved by the FDA for the treatment of metastatic MCC (mMCC). In the JAVELIN Merkel 200 trial (Clinical trial information: NCT02155647), avelumab resulted in durable responses and a high objective response rate (ORR) in pts with mMCC. This retrospective descriptive study assessed real-world clinical outcomes in avelumab-treated pts with locally advanced MCC (laMCC) and mMCC in a US community oncology setting. Methods: This study included data on avelumab-treated laMCC and mMCC pts from 1/1/17 to 3/31/19 within The US Oncology Network. Study data were captured through 9/30/19 using structured fields and chart review of iKnowMed electronic healthcare records. Real-world ORR was assessed. Duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were estimated using the Kaplan-Meier method. Results: 33 pts initiated treatment with avelumab (laMCC n = 11; mMCC n = 22) and were followed up for a median of 10.9 months (range, 0.5-27.2 months). Median age was 77 years (range, 44-90+ years), 78.8% of pts were male, and the majority (84.8%) of pts were treated in the first-line setting. During treatment, 27.2% of pts had emergency department visits and 39.4% were hospitalized; 1% and 23.1%, respectively, were treatment related. Clinical outcomes are reported in the table. Conclusions: This is the first study to examine pts with laMCC treated with avelumab in a real-world setting. Although the sample population is small, results suggest the clinical benefits in the real world in pts with mMCC treated with avelumab are consistent with benefits reported in the JAVELIN Merkel 200 trial. Clinical trial information: NCT02155647 . [Table: see text]

Continuous infusion of Endostar combined with chemotherapy in patients with advanced or recurrent mucosal melanoma: A real-world cohort study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21517-e21517
Author(s):  
Xin Liu ◽  
Shiyu Jiang ◽  
Xiaowei Zhang ◽  
Feng Jin ◽  
Jun Cao ◽  
...  
Keyword(s):  
Continuous Infusion ◽  
Real World ◽  
Immune Therapy ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Mucosal Melanoma ◽  
Cancer Center ◽  
Lymphocyte To Monocyte Ratio ◽  
Line Setting

e21517 Background: Mucosal melanoma is rare and has distinct clinical and genetic features. Even with advances in targeted and immune therapy, the survival of patients with advanced or recurrent mucosal melanomas remains poor. The standard treatment remains controversial and we conducted this real-world study aimed to test continuous intravenous Endostar infusion plus chemotherapy in patients with advanced or recurrent mucosal melanoma in the first-line setting. Methods: In total, all 43 patients with advanced or recurrent mucosal melanoma treated at Fudan University Shanghai Cancer Center between April 2017 and August 2020 were retrospectively included. Patients received dacarbazine plus cisplatin or temozolomide plus cisplatin regimens per the investigators’ preference. Endostar (105 mg/m2) was administered with continuous infusion for 168 hours (Civ 168h). Results: Of the 43 patients, 72.1% had metastatic disease, and 27.9% had locally advanced disease. The most common primary site was the gastrointestinal tract (51.2%), followed by the sinonasal tract (32.6%) and genitourinary tract (14.0%). The most commonly observed mutation was NRAS (23.1%), followed by BRAF (7.7%) and CKIT (5.1%). An objective response was observed in 12 (30.0%) of the 40 evaluable patients, and disease control was achieved in 31 (77.5%) patients. With a median follow-up of 17.6 months, the median progression-free survival (PFS) and overall survival (OS) were 4.9 and 15.3 months, respectively. Multivariate analysis indicated a high lymphocyte-to-monocyte ratio (LMR) was significantly correlated with favorable PFS (p = 0.012, hazard ratio [HR] 0.28, 95% CI: 0.10-0.76). Additionally, a high LMR (p = 0.023, HR 0.29, 95% CI: 0.10-0.84) and BRAF/KIT/RAS mutation (p = 0.028, HR 0.24, 95% CI: 0.07-0.86) were independently correlated with prolonged OS. Toxicity was manageable overall. Conclusions: Continuous Endostar infusion in combination with chemotherapy was effective and safe for the treatment of advanced or recurrent mucosal melanoma. Additionally, a high LMR was correlated with favorable PFS and OS in this patient population.

scholarly journals Real-world clinical outcomes with first-line avelumab in locally advanced/metastatic Merkel cell carcinoma in the USA: SPEAR-Merkel

2021 ◽  
Author(s):  
Charles Lance Cowey ◽  
Frank X Liu ◽  
Ruth Kim ◽  
Marley Boyd ◽  
Nicole Fulcher ◽  
...  
Keyword(s):  
Cell Carcinoma ◽  
Clinical Outcomes ◽  
Merkel Cell Carcinoma ◽  
Real World ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Response Rates ◽  
Merkel Cell ◽  
First Line ◽  
The Usa

Aim: To assess clinical outcomes in patients with locally advanced (la) or metastatic (m) Merkel cell carcinoma (MCC) initiating first-line (1L) avelumab in a USA community oncology setting. Materials & methods: Adults with laMCC or mMCC initiating 1L avelumab were identified from The US Oncology Network electronic health record database and chart review. Results: Median overall survival and progression-free survival were not reached in laMCC (n = 9) vs 20.2 and 10.0 months in mMCC (n = 19); response rates were similar (66.7% vs 63.2%). Conclusion: This is the first study to show clinical benefit in patients with laMCC receiving 1L avelumab in a US real-world setting. Response rates in patients with mMCC were consistent with pivotal trials.

scholarly journals CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer

2018 ◽  
Vol 36 (28) ◽  
pp. 2836-2844 ◽  
Author(s):  
Yelena Y. Janjigian ◽  
Johanna Bendell ◽  
Emiliano Calvo ◽  
Joseph W. Kim ◽  
Paolo A. Ascierto ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Objective Response ◽  
Locally Advanced ◽  
Survival Rates ◽  
Progression Free Survival ◽  
The United States ◽  
Phase Iii ◽  
Programmed Death Ligand 1 ◽  
Programmed Death ◽  
Esophagogastric Cancer

Purpose Metastatic esophagogastric cancer treatments after failure of second-line chemotherapy are limited. Nivolumab demonstrated superior overall survival (OS) versus placebo in Asian patients with advanced gastric or gastroesophageal junction cancers. We assessed the safety and efficacy of nivolumab and nivolumab plus ipilimumab in Western patients with chemotherapy-refractory esophagogastric cancers. Patients and Methods Patients with locally advanced or metastatic chemotherapy–refractory gastric, esophageal, or gastroesophageal junction cancer from centers in the United States and Europe received nivolumab or nivolumab plus ipilimumab. The primary end point was objective response rate. The association of tumor programmed death-ligand 1 status with response and survival was also evaluated. Results Of 160 treated patients (59 with nivolumab 3 mg/kg, 49 with nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, 52 with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg), 79% had received two or more prior therapies. At the data cutoff, investigator-assessed objective response rates were 12% (95% CI, 5% to 23%), 24% (95% CI, 13% to 39%), and 8% (95% CI, 2% to 19%) in the three groups, respectively. Responses were observed regardless of tumor programmed death-ligand 1 status. With a median follow-up of 28, 24, and 22 months across the three groups, 12-month progression-free survival rates were 8%, 17%, and 10%, respectively; 12-month OS rates were 39%, 35%, and 24%, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 47%, and 27% of patients in the three groups, respectively. Conclusion Nivolumab and nivolumab plus ipilimumab demonstrated clinically meaningful antitumor activity, durable responses, encouraging long-term OS, and a manageable safety profile in patients with chemotherapy-refractory esophagogastric cancer. Phase III studies evaluating nivolumab or nivolumab plus ipilimumab in earlier lines of therapy for esophagogastric cancers are underway.

Continuous Infusion of Endostar Combined with Chemotherapy in Patients with Advanced or Recurrent Mucosal Melanoma: A Real-World Cohort Study

2021 ◽  
Author(s):  
Xiaowei Zhang ◽  
Feng Jin ◽  
Shiyu Jiang ◽  
Jun Cao ◽  
Yanchun Meng ◽  
...  
Keyword(s):  
Continuous Infusion ◽  
Real World ◽  
Immune Therapy ◽  
Objective Response ◽  
Progression Free Survival ◽  
Mucosal Melanoma ◽  
Cancer Center ◽  
Lymphocyte To Monocyte Ratio ◽  
Genetic Features ◽  
Line Setting

Abstract BackgroundMucosal melanoma is rare and has distinct clinical and genetic features. Even with advances in targeted and immune therapy, the survival of patients with advanced or recurrent mucosal melanomas remains poor. The standard treatment remains controversial and we conducted this real-world study aimed to test continuous intravenous Endostar infusion plus chemotherapy in this population in the first-line setting. Methods Overall, 43 patients with advanced or recurrent mucosal melanoma treated at Fudan University Shanghai Cancer Center between April 2017 and August 2020 were retrospectively included. Patients received dacarbazine plus cisplatin or temozolomide plus cisplatin regimens per the investigators’ preference. Endostar (105 mg/m2) was administered with continuous infusion for 168 hours (Civ 168h). ResultsOf the 43 patients, 72.1% had metastatic disease, and the most common primary site was the gastrointestinal tract (51.2%). The most commonly observed mutations were NRAS (23.1%), BRAF (7.7%) and CKIT (5.1%). An objective response was observed in 12 (30.0%) of the 40 evaluable patients, and disease control was achieved in 31 (77.5%) patients. With a median follow-up of 17.6 months, the median progression-free survival (PFS) and overall survival (OS) were 4.9 and 15.3 months, respectively. Additionally, a high lymphocyte-to-monocyte ratio (LMR) (p=0.023, HR 0.29, 95% CI: 0.10-0.84) and BRAF/KIT/RAS mutation (p=0.028, HR 0.24, 95% CI: 0.07-0.86) were independently correlated with prolonged OS. Toxicity was manageable overall. ConclusionContinuous Endostar infusion plus chemotherapy was effective and safe for the treatment of advanced or recurrent mucosal melanoma. A high LMR was correlated with favorable PFS and OS in this patient population.

Trastuzumab deruxtecan (T-DXd; DS-8201) in combination with pembrolizumab in patients with advanced/metastatic breast or non-small cell lung cancer (NSCLC): A phase Ib, multicenter, study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS1100-TPS1100
Author(s):  
Hossein Borghaei ◽  
Benjamin Besse ◽  
Aditya Bardia ◽  
Julien Mazieres ◽  
Sanjay Popat ◽  
...  
Keyword(s):  
Topoisomerase I ◽  
Objective Response ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
The United States ◽  
Antibody Drug Conjugate ◽  
Free Survival ◽  
Phase Ib ◽  
Her2 Breast Cancer

TPS1100 Background: T-DXd is an antibody-drug conjugate composed of an anti-HER2 antibody, cleavable tetrapeptide-based linker, and potent topoisomerase I inhibitor. In a phase II trial in patients (pts) with heavily pretreated, metastatic HER2+ breast cancer (BC), T-DXd had a confirmed objective response rate (cORR) of 60.9% (112/184) and median progression-free survival (PFS) of 16.4 mo (Modi N Engl J Med 2019); these results led to the recent FDA approval for HER2+ unresectable or metastatic BC after ≥ 2 prior anti-HER2 based regimens. For HER2-low BC and HER2-expressing/mutated NSCLC, no HER2-directed therapies have been approved. In a phase I trial of T-DXd in pts with HER2-low BC or HER2-expressing/mutated NSCLC, cORR was 44.2% (19/43) (Modi SABCS 2018), and 55.6% (10/18) (Tsurutani Thorac Oncol 2018), respectively. In preclinical models, T-DXd combined with an anti–PD-1 antibody was more effective than monotherapy with either agent (Iwata Mol Cancer Ther 2018). Here we describe a phase Ib study of T-DXd in combination with pembrolizumab in pts with locally advanced/metastatic HER2-expressing BC or HER2-expressing/mutated NSCLC (DS8201-A-U106; NCT04042701). Methods: This is an open-label, multicenter, nonrandomized, multidose, 2-part study in adult (aged ≥18 y) pts in the United States and Europe. In part 1 (dose escalation), pts received T-DXd 3.2 or 5.4 mg/kg IV q3w and pembrolizumab 200 mg IV q3w to determine the recommended dose for expansion (RDE). The RDE will be given to 4 cohorts (part 2): 2 cohorts with BC (HER2+ [IHC 3+ or IHC 2+/ISH+] with progression on prior T-DM1; and HER2-low [IHC 1+ or IHC2+/ISH-] with progression on prior standard treatments) and 2 cohorts with NSCLC (anti–PD-1, –PD-L1, and -HER2 treatment naive either HER2-expressing [IHC ≥ 1+] or HER2-mutated). Enrollment began in February 2020 with approximately 115 to 133 pts planned to be enrolled at 5 sites for part 1 and expanding to 25 sites for part 2. The primary endpoint in part 1 is dose-limiting toxicities. The part 2 primary efficacy endpoint is cORR by independent central review (ICR) per RECIST 1.1. Additional endpoints include duration of response, disease control rate, and progression-free survival by ICR, overall survival, safety, and pharmacokinetics. Clinical trial information: NCT04042701 .

Real-world clinical outcomes of pazopanib immediately following immunotherapy discontinuation for the treatment of advanced renal cell carcinoma.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 573-573
Author(s):  
Xiting Cao ◽  
Derek Tang ◽  
Barbara Elizabeth Ratto ◽  
Austin Poole ◽  
Shoba Ravichandran ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Clinical Outcomes ◽  
Real World ◽  
Renal Cell ◽  
Retrospective Chart Review ◽  
Progression Free Survival ◽  
Advanced Renal Cell Carcinoma ◽  
Kaplan Meier ◽  
Line Setting

573 Background: In the first-line setting (1L), pazopanib (PAZ) is recommended by NCCN for treatment of advanced renal cell carcinoma (aRCC). In 2018, immuno-oncology (IO) therapy became commonly used 1L treatment option for aRCC. This study reports real-world clinical outcomes of PAZ following IO therapy among aRCC patients (pts) in an evolving treatment landscape. Methods: This retrospective chart review study used medical record data collected by medical oncologists. Included pts were those ≥ 18 at initiation of IO therapy who initiated 2L+ PAZ for clear cell aRCC before November 2017, and had complete medical records from the diagnosis of aRCC to discontinuation of PAZ, death, or the chart extraction date (May 2018), whichever occurred first. Primary outcome was PAZ duration of therapy (DOT). Secondary outcomes were progression-free survival (PFS) and overall survival (OS) since PAZ initiation, reasons for PAZ discontinuation, and adverse events (AEs). Time-to-event outcomes were analyzed by Kaplan-Meier method. Results: 258 eligible pts initiated the IO therapies before PAZ as follows: nivolumab (NIVO) (68%), NIVO+ipilimumab (IPI) (14%), pembrolizumab (12%), and IPI (3%). Ninety-seven (38%), 56 (22%), and 92 (36%) pts were grouped as favorable, intermediate, or poor risk by Heng criteria, respectively. Overall, the median PAZ DOT was 13.4 months (Ms) (95% confidence interval [CI] 10.1-16.0). When stratified by lines of therapy, pts who received PAZ as 2L (n=182) or 3L+ (n=76) had DOT of 13.4 Ms (95% CI 11.1-NR) and 9.6 Ms (95% CI 6.2-NR), respectively. The PFS and OS outcomes are shown in the Table. One hundred-nine (42%) pts reported an AE. The most frequently (>10%) reported AEs were fatigue (29%), diarrhea (14%), decreased appetite (14%), and hypertension (13%). Conclusions: In this real-world study, 2+L PAZ following prior IO therapy was well-tolerated, effective, and non-cross-resistant with IO therapy for aRCC pts. [Table: see text]

Real-world outcomes in patients with locally advanced or metastatic urothelial carcinoma receiving taxane monotherapy following platinum and anti-PD-1/L1 therapy.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 458-458
Author(s):  
Zsolt Hepp ◽  
Sonali Shah ◽  
Katherine Tan ◽  
Shreya Balakrishna
Keyword(s):  
Urothelial Carcinoma ◽  
Clinical Outcomes ◽  
Real World ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Disease Status ◽  
Study Cohort ◽  
Start Date ◽  
Metastatic Urothelial Carcinoma ◽  
Platinum Chemotherapy

458 Background: There are currently limited options for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) following progression on platinum chemotherapy and anti-programmed death 1/death-ligand 1 (PD-1/L1) therapy. Further, limited data are available from clinical trials or real-world studies on outcomes in this population. This retrospective analysis investigated clinical outcomes in patients treated with taxane monotherapy, a commonly used and NCCN guideline-recommended option in this setting. Methods: Patients aged ≥18 years with histologically-confirmed diagnosis of la/mUC on or after 2011, ≥2 clinical visits, and sufficient relevant unstructured data were included from the de-identified nationwide Flatiron Health electronic health record-derived database. The study cohort included patients treated with taxane monotherapy (docetaxel, paclitaxel, or nab-paclitaxel) following anti-PD-1/L1 therapy and who have received prior platinum containing chemotherapy. Baseline characteristics, overall survival (OS), real-world progression-free survival (rwPFS) based on clinician documentation of disease status, and real-world response (rwR) based on clinician-confirmed radiologic assessments were reported. Patients were followed until death, data cutoff, or loss to follow up. Results: Among 276 patients treated following anti-PD-1/L1 therapy and who met all of the inclusion/exclusion criteria, 72 were treated with taxanes and also had documented prior platinum chemotherapy. Patients were mostly male (75%) and Caucasian (74%), with a mean age of 73 years. 65% had > 2 sites of metastasis at index (start date of taxane). Post index, median OS = 7.6 months (95% CI 5.2, 14.4) and median rwPFS = 2.9 months (95% CI, 2.4, 4.0). Among the 50 patients with ≥1 rwR assessment, confirmed rwR = 18% (95% CI: 9%, 32%). Conclusions: In the real-world setting, limited responses to taxanes and short duration of PFS and OS were observed in patients with la/mUC previously treated with a platinum and anti-PD-1/L1 therapy. There is a need for more effective therapies to improve clinical outcomes for this patient population.

428 Interim analysis of Phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma (mBCC) who progressed on or are intolerant to hedgehog inhibitors (HHIs)

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A453-A453
Author(s):  
Karl Lewis ◽  
Ketty Peris ◽  
Aleksandar Sekulic ◽  
Alexander Stratigos ◽  
Lara Dunn ◽  
...  
Keyword(s):  
Cell Carcinoma ◽  
Interim Analysis ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Good Clinical Practice ◽  
Phase 2 ◽  
Curative Surgery ◽  
Pivotal Phase ◽  
Study Protocols

BackgroundHHIs, vismodegib and sonidegib, are approved for treatment of patients with mBCC or locally advanced BCC who are not candidates for surgery or radiation. There is no approved option for patients who progress on or are intolerant to HHIs. Cemiplimab is an anti-programmed cell death-1 monoclonal antibody approved for treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Here we present the prespecified interim analysis of the mBCC cohort from the pivotal Phase 2, non-randomized, multi-center study of cemiplimab in patients with advanced BCC who discontinued HHI therapy due to disease progression, intolerance, or no better than stable disease after 9 months (NCT03132636).MethodsPatients with mBCC (nodal and/or distant) received cemiplimab 350 mg intravenously every 3 weeks; interim analysis included patients with the opportunity to be followed for approximately 57 weeks. The primary endpoint was objective response rate (ORR) per independent central review (ICR). Secondary objectives included assessment of safety and tolerability, estimation of duration of response (DOR), progression-free survival (PFS), and overall survival (OS).ResultsIn this interim efficacy analysis of 28 patients, 82.1% were males and median age was 65.5 years (range 38−90). Six patients had a partial response, per ICR, for an ORR of 21.4% (95% CI, 8.3, 41.0). ORR per investigator assessment was 28.6% (95% CI, 13.2, 48.7). Among responders, observed DOR was 9−23 months. Median time to response per ICR was 3.2 months (range, 2.1−10.5). Median Kaplan–Meier (KM) estimation of PFS was 8.3 months. Median DOR had not been reached and median KM estimation of OS was 25.7 months. All six responses had observed durations of at least 8 months. The disease control rate was 67.9% (95% CI, 47.6, 84.1).The most common treatment emergent adverse events (TEAEs) regardless of attribution were fatigue (50.0%), diarrhea (35.7%), pruritus (25.0%), and constipation (25.0%). Hypertension (n=2) was the only Grade ≥3 TEAE regardless of attribution occurring in ≥2 patients. TEAEs leading to death occurred in one (3.6%) patient who died from staphylococcal pneumonia, considered unrelated to study treatment.ConclusionsThis interim analysis demonstrates that cemiplimab is the first agent to provide clinically meaningful anti-tumor activity, including durable responses, in patients with mBCC after progression or intolerance on HHI therapy.AcknowledgementsEditorial acknowledgment: Medical writing support was provided by Cindi Hoover, PhD of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc. and Sanofi.Ethics ApprovalThe study protocols and all amendments were approved by the institutional review board at each participating study site. The study was conducted in accordance with the principles of the Declaration of Helsinki and with Good Clinical Practice guidelines as defined by the International Conference on Harmonization. All patients provided written informed consent before enrollment.

scholarly journals Efficacy and Safety of Lenvatinib Therapy for Unresectable Hepatocellular Carcinoma in a Real-World Practice in Korea

Liver Cancer ◽  
2021 ◽  
pp. 1-11
Author(s):  
Myung Ji Goh ◽  
Joo Hyun Oh ◽  
Yewan Park ◽  
Jihye Kim ◽  
Wonseok Kang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Prognostic Factors ◽  
Disease Progression ◽  
Real World ◽  
Medical Center ◽  
Objective Response ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Eligibility Criteria ◽  
Unresectable Hepatocellular Carcinoma

<b><i>Background:</i></b> Lenvatinib has been recently approved as a first-line treatment option for patients with unresectable hepatocellular carcinoma (HCC) in Korea. We aimed to study the efficacy and safety of lenvatinib therapy in a real-world practice and to find prognostic factors related to survival and disease progression. <b><i>Methods:</i></b> A hospital-based retrospective study was conducted on 111 consecutive patients who had unresectable HCC and were treated with lenvatinib at Samsung Medical Center from October 2018 to March 2020. Efficacy was determined using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria in 111 patients who completed 1st tumor assessment. Safety was evaluated in 116 HCC patients including 5 patients who discontinued lenvatinib due to adverse events (AEs) before 1st tumor assessment using Common Terminology Criteria for AEs version 5.0. <b><i>Results:</i></b> A total of 111 patients with a median age of 59 years were analyzed during a median follow-up duration of 6.2 (4.4–9.0) months. The Kaplan-Meier estimate of overall survival was 10.5 months, and the median progression-free survival was 6.2 months. Based on mRECIST criteria, the objective response rate was 18.9% and disease control rate was 75.7%. AEs developed in 86/116 (74.1%) patients, and grade ≥3 AEs developed in 16/116 (13.8%) patients. Diarrhea, hand-foot skin rash, abdominal pain, hypertension, and anorexia were identified as the AEs with the highest frequencies of any grade. REFLECT eligibility criteria including tumor extent ≥50% liver occupation or inadequate bone marrow function and occurrence of anorexia were prognostic factors for survival, and occurrence of diarrhea was a favorable factor for disease progression. <b><i>Conclusion:</i></b> Lenvatinib therapy showed a favorable efficacy and safety in a real-world practice. The REFLECT eligibility criteria and specific AEs could be one of the prognostic markers.

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