Tivozanib as first-line treatment of metastatic renal cell carcinoma: A real-world outcome review in North-West of England, United Kingdom.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 638-638 ◽  
Author(s):  
Sam Wong ◽  
Kellati Prasad ◽  
Tom Waddell ◽  
Natalie Charnley ◽  
Helen Wong ◽  
...  
Keyword(s):  
Real World ◽  
Kinase Inhibitor ◽  
P Value ◽  
Risk Category ◽  
First Line ◽  
North West ◽  
Low Incidence ◽  
Line Setting ◽  
Treatment Tolerance

638 Background: Tivozanib is a selective tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor and has been shown to offer PFS and tolerance advantage compared to sorafenib among patients with mRCC. In this retrospective review, we aim to investigate the real world efficacy and tolerance of tivozanib delivered in four cancer hospital in the Northwest of England. Methods: mRCC patients started tivozanib in first line setting were identified and reviewed. Primary outcomes of interest include overall response rate (ORR), survival (OS, PFS where possible) and treatment tolerance. Results: A total of 113 patients were identified between March 2017 and May 2019. Median follow up was 200 days (15-792). 26% were switched from other prior TKI due to intolerance. 28%, 48% and 24% had Favourable (F), Intermediate (I) and Poor(P) IMDC risk category respectively. ORR was 29% (CR 0%, PR29%, SD38%, PD26%, NE 7%). Median PFS (after 53 events) was 9 months (F = NR, I = 7 months, P = 3 months p value < 0.0001) with estimated 6 and 12 months OS of 80% and 67 % respectively. At cut-off, 26/32 with F IMDC risk remaining on treatment c.f. 24/54 (I) and 6/27 (P). Median treatment received was 5 cycles and 65% still on full dose at end of observation. Dose reduction was necessary in 31% while treatment was stopped in 15% due to toxicity. 46% received subsequent therapy post- progression. The commonest adverse events were fatigue (32%, G3 0%), diarrhoea (15%, G3 1.7%), mucositis (15%, G3 < 1%), and anorexia (7%, G3 1.7%). Conclusions: Preliminary findings from this review suggests similar clinical efficacy of tivozanib compared to agents such as pazopanib or sunitinib in real-world setting particularly among patient with Favourable IMDC category however longer follow up is required to fully evaluate this. Treatment is well tolerated with low incidence of severe grade toxicities and may be a good monotherapy option in patient of Favourable IMDC category unsuitable for combination therapies.

Activity of second line axitinib in metastatic renal cell carcinoma (mRCC) patients treated with sunitinib: Results from SAX Italian real world trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16054-e16054
Author(s):  
Sabrina Rossetti ◽  
Francesco Jacopo Romano ◽  
Carmine D'Aniello ◽  
Carla Cavaliere ◽  
Salvatore Pisconti ◽  
...  
Keyword(s):  
Real World ◽  
Medical Records ◽  
Kinase Inhibitor ◽  
Univariate Analysis ◽  
P Value ◽  
World Population ◽  
Second Line ◽  
First Line ◽  
Primary Endpoints ◽  
Significant Difference

e16054 Background: Axitinib, a selective tyrosine kinase inhibitor (TKI), is currently approved for the treatment of mRCC after failure of prior treatment with sunitinib or cytokine, according to AXIS trial results. The best sequence hasn’t been established: both axitinib and everolimus (a mTOR inhibitor) are viable therapeutic options, although recently immunotherapy agents entered this setting. This Italian multi-institutional retrospective analysis evaluated outcomes of Axitinib in exclusive sequence after sunitinib in second line treatment of mRCC Methods: Medical records of 148 patients treated with Axitinib from 21 Italian Oncology Centers were retrospectively assessed: PFS, OS, ORR DCR, and safety profile of axitinib were primary endpoints. Results: Median PFS and OS were 7.14 and 15.5 months, respectively. Overall, axitinib at standard schedule of 5 mg bid, was well tolerated, with no grade 4 toxicity event. Most common adverse events were hypertension (26% of the cases), fatigue (50 %), hypothyroidism (18%). At univariate analysis, when patients were stratified by Heng score, mPFS was 5.8, 7.0 and 9.0 months according to poor, intermediate and favourable risk group, respectively. When stratified by median duration of prior sunitinib therapy (≥ 13,1 mo vs < 13,1 mo), there was a statistically significant difference in PFS with 8.8 vs 6.3 months, respectively. Disease control rate (DCR) to previous sunitinib treatment was associated to longer PFS with axitinib ( 8.0 months vs4.0 months). The sequence sunitinib-axitinib was well tolerated, with a mOS of 41 months. At multivariate analysis, prognostic factors for progression were gender (p-value = 0,006), DCR to axitinib (p < 0,0001) and to previous sunitinib (p = 0,041); DCR to axitinib (p = < 0,0001), nephrectomy (p = 0,002) and Heng score (p = 0,025) independently affected overall survival. Conclusions: The preliminary SAX results in the real world population are consistent with available literature. The study confirms that Axitinib is effective and safe in routine clinical practice, and its efficacy seems to be greater in patients who most benefited from first-line sunitinib.

scholarly journals Real-World Utilization of Midostaurin Among Patients with Systemic Mastocytosis (SM)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5378-5378
Author(s):  
Ajeet Gajra ◽  
Andrew J Klink ◽  
Dhruv Chopra ◽  
Bruce Feinberg
Keyword(s):  
Mast Cells ◽  
Median Duration ◽  
Real World ◽  
Systemic Mastocytosis ◽  
Recommended Dose ◽  
Study Cohort ◽  
Cell Transplant ◽  
First Line ◽  
Line Setting

Introduction: Systemic Mastocytosis (SM) is a rare neoplasm of myeloid origin characterized by an accumulation of abnormal mast cells in the bone marrow, liver, spleen, and skin and has a molecular signature of the KITD816V mutation, detectable in >90% of patients. Clinical findings include cytopenias, liver-function abnormalities, hypoalbuminemia, weight loss, ascites, and osteolytic bone lesions due to infiltration of various organs by the malignant mast cells. The indolent and smoldering subtypes of SM can have a long natural history but aggressive systemic mastocytosis (aSM), SM with associated hematological neoplasm (SMHN), and mast cell leukemia (MCL) subtypes are associated with poor prognosis at a median survival of 3.5 years, 2 years and 6 months respectively. In April 2017, the FDA approved midostaurin, a multitargeted kinase inhibitor for the treatment of adults with aSM, SMHN and MCL at a dose of 100mg twice daily based on achievement of response rate endpoint noted in an open label trial of midostaurin (Gotlib et al, NEJM 2016). Pre-midostaurin, the treatment options for aSM, SMHN and MCL were imatinib, cladribine, interferon or allogeneic stem cell transplant (ASCT). The objective of this retrospective study was to assess the uptake and utilization of midostaurin in patients with aSM, SMHN and MCL. Methods: Patients with at least 1 claim for midostaurin (index date) between April 1, 2017 and October 31, 2018 and who had at least 1 claim with a diagnosis of SM (ICD 10 code C96.2x or C94.3x) in the 6-month pre-index period were identified from Symphony Health's Integrated Dataverse (IDV), a large US claims database containing linked longitudinal prescription, medical, and hospital claims. The IDV contains claims for 280 million active unique patients representing over 73% of specialty prescriptions, 58% of medical claims, and 30% of hospital claims volume in the US. Patients included in the study cohort had a 6-month pre-index period with no claims with a diagnosis of SM, were at least 18 years old at initiation of midostaurin, and no evidence of participation in a clinical trial. Patient characteristics and treatment patterns were summarized using descriptive statistics. Median and 95% confidence interval (CI) for duration of midostaurin were calculated using Kaplan-Meier estimates. Results: Of the 38 patients with SM treated with midostaurin, 33 had a diagnosis of aSM and 5 had a diagnosis of MCL. The majority were female (61%) with a median age of 63 years (range 27-79) at diagnosis; 42% of these patients were 65 years or older (Table). The majority (66%) of patients had commercial insurance, and patients resided in all 4 US regions (34% South, 34% West, 18% Midwest, 11% Northeast). Nearly two-thirds (63%) of midostaurin use was in the first line setting, 32% was given in second line, and 5% was given in third line. Among the 14 patients with therapy prior to midostaurin, cladribine was most common (n=4, 29%), followed by hydroxyurea, interferon alfa-2b, brentuximab vedotin, and others (each n=2, 14%). Over two-thirds (68%) had an average daily dose of 200mg on the first fill, 5% treated at 100mg daily, and 26% with average daily doses <100mg. Two thirds (22 of 33) patients with aSM and 4 of 5 with MCL were prescribed the 200mg/day recommended dose. With a median follow-up of 13.4 months from midostaurin initiation, the median duration of midostaurin 2.4 months (95% CI 1.1-4.6). Conclusions: In this retrospective claims based study, there is evidence of early uptake of midostaurin use in SM. Midostaurin was used in the first line setting in the majority of patients. The median duration of midostaurin treatment was short at 2.4 months especially when compared to a median treatment duration of 11.5 months in the pivotal trial. It is noteworthy that almost a third of patients were started on a lower than recommended dose which may compromise efficacy. The relatively short follow up may be another reason for the observed duration of response. Potential barriers to the appropriate use of midostaurin in SM such as lack of awareness, access, cost or delay in diagnosis due to its rarity will need further exploration. While the current claims-based dataset does not provide us the information, early, accurate diagnosis of SM is essential to timely utilization of midostaurin in the real-world setting. Further research and education may be needed to optimize the use of novel therapeutics in such orphan diseases. Disclosures Gajra: Cardinal Health: Employment. Klink:Cardinal Health: Employment. Chopra:Cardinal Health: Employment. Feinberg:Cardinal Health: Employment.

Axitinib and avelumab (AA) as first-line treatment of metastatic renal cell carcinoma (mRCC): A real-world outcome review in the Northwest of England, United Kingdom.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 294-294
Author(s):  
Jennifer Allison ◽  
Natalie Charnley ◽  
Robert Stevenson ◽  
Tom Waddell ◽  
Manon Rhys Pillai
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Kinase Inhibitor ◽  
Checkpoint Inhibitor ◽  
Risk Scores ◽  
Published Data ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

294 Background: The combination of the immune checkpoint inhibitor avelumab and VEGF-targeted, antiangiogenic tyrosine kinase inhibitor axitinib (AA) has demonstrated superior PFS and ORR compared to sunitinib in patients with mRCC and is an option for first line treatment across all IMDC risk scores. In this retrospective review we report our real world experience of this combination in three cancer centres in the Northwest of England. Methods: Treatment naïve mRCC patients receiving AA through the Early Access to Medicine Scheme at 3 cancer sites in the UK between May 2019 and July 2020 were identified. Primary outcomes of interest include overall response rate (ORR), adverse events (AEs) and preliminary survival observations. Results: A total of 44 patients were identified with a median follow up of 6.9 months (0.8-13.5 mo). Median age was 68 (48-81); 68% were male. The patients’ adult comorbidity evaluation score (ACE-27) was calculated: 0 = 43%, 1 = 30%, 2 = 7% and 3 = 20% . 45%, 48% and 7% of patients had favourable (F), intermediate (I) and poor (P) IMDC risk scores respectively. All had clear cell histology with 16% demonstrating sarcomatoid change. Most patients had undergone a nephrectomy (70%) and 36% had a single organ site of metastatic disease. ORR in the whole cohort was 60% (CR 5%, PR 55%, SD 25%, PD 2%, NE 13 %). Median time to first response was 2.6 months (0.6- 8.2mo). At time of data cut-off, 64% of patients remain on treatment (80% F, 48% I and 67% P). 14% of patients discontinued treatment due to disease progression while 22% stopped due to toxicity. The majority of patients (68%) continued axitinib at the starting dose of 5mg BD. Dose escalation of axitinib was possible in 9% patients while 23% needed a dose reduction due to toxicities. AEs were observed in 36 (82%) patients (G3 36%); the commonest being mucositis 30%; hypertension 23% (G3 11%); fatigue 25%; thyroid dysfunction 18%; diarrhoea 20% (G3 5%); hepatitis 20% (G3 11%). 9% of patients experienced an infusion reaction to avelumab. Overall, 9 (20%) patients received steroids for suspected immune related adverse events (irAEs); 6 (14%) were managed as G3≤ irAEs. 9 (20%) patients required inpatient admission due to AEs; 5 (11%) were associated with irAEs. Of the patients who discontinued AA treatment, 50% received subsequent therapy (12.5%, 75% and 12.5% receiving combination checkpoint inhibitor therapy, other VEFG TKi and TKi/MTOR combination respectively). 4 patients remain on active surveillance with no evidence of progression. Conclusions: Our early experience of AA in this real world setting reports comparable clinical responses to the published data. Treatment is well tolerated, with lower than expected levels of G3 or above AEs which is reassuring in a non-trial selected population. Follow-up is ongoing and updated efficacy and safety outcomes will be presented.

scholarly journals Epithelial Ovarian Cancer: Real-World Outcomes

2021 ◽  
Author(s):  
Thejeswar Nakka ◽  
Prasanth Ganesan ◽  
Luxitaa Goenka ◽  
Biswajit Dubashi ◽  
Smita Kayal ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Real World ◽  
P Value ◽  
Optimal Cytoreduction ◽  
Line Treatment ◽  
First Line ◽  
Factors Affecting ◽  
Primary Surgery ◽  
First Line Treatment

Abstract Introduction Ovarian cancer is the third most common cancer and the second most common cause of death among gynecological cancers in Indian women. Ovarian cancer is heterogeneous, among them, epithelial ovarian cancer (EOC) is the most common. Primary cytoreductive surgery along with six to eight cycles of a combination of platinum and taxanes chemotherapy is the cornerstone of first-line treatment in EOC. This study was done to find clinicopathological factors affecting survival outcomes with first-line therapy in EOC in a real-world setting. Objectives This study was aimed to find factors affecting progression-free survival (PFS) and overall survival (OS) with first-line treatment in EOC. Materials and Methods We conducted a single-center retrospective study. We screened all the patients diagnosed with ovarian cancer from January 2015 till December 2019. We locked data in August 2019. Eligible patients were histologically confirmed EOC who underwent primary cytoreduction or received more than or equal to two cycles of chemotherapy or both. Patients who had received first-line treatment at another hospital were excluded. Results Patients demographics and clinical characteristics: between January 5, 2015 to August 31, 2019, 435 patients with a diagnosis of ovarian malignancy were registered at our center. Among them, 406 (82%) had EOC, 290 (64%) newly diagnosed, and fulfilling eligibility criteria were included in the final analysis. The median age of the cohort was 53 years (range: 21–89 years) and 157 patients (54%) were >50 years of age (the Eastern Oncology Cooperative Group Performance status was ≥ 2 in 124 patients [43%]; median duration of symptoms was 3 months; and stage III/IV: 240 [83%]). Grading of the tumor was available in 240 patients of which 219 (91%) were of high grade. Subtyping was available in 272 patients (94%) of which the serous subtype was the most common constituting 228 patients (79%).Treatment Most patients received chemotherapy (n = 283 [98%]) as the first modality of treatment (neoadjuvant/adjuvant and palliative). As neoadjuvant (NACT) in 130 patients (45%) and as adjuvant following surgery in 81 patients (29%). The most common chemotherapy regimen was a combination of carboplatin and paclitaxel in 256 patients (88%). Among 290 patients 218 (75%) underwent cytoreductive surgery. Among them, optimal cytoreduction was achieved in 108 patients (52%). Optimal cytoreduction rate (OCR) with upfront surgery and after NACT was 44 and 53%, respectively (Chi-square test: 0.86; p = 0.35).Survival The median follow-up of the study was 17 months (range: 10–28 months) and it was 20 months (range: 12–35 months) for patients who were alive. At last, follow-up, 149 patients (51%) had progressed and 109 (38%) died. The estimated median PFS and OS were 19 months (95% CI: 16.1–21.0) and 39 months (95% CI: 29.0–48.8), respectively. On multivariate analysis, primary surgery (HR: 0.1, 95% CI: 0.06–0.21; p-value: <0.001) and early-stage disease (HR: 0.2, 95% CI: 0.1–0.6; p-value 0.04) were associated with superior PFS and primary surgery (HR: 0.1, 95% CI: 0.09–0.2; p-value: <0.001) was associated with superior OS. Conclusion Primary surgery (upfront or interval) was associated with improved survival. Newer agents like bevacizumab, poly-ADP (adenosine diphosphate)-ribose polymerase inhibitors and HIPEC should be incorporated precisely into first line of therapy to improve outcomes.

scholarly journals Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2− metastatic breast cancer in US real-world clinical practice

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Angela DeMichele ◽  
Massimo Cristofanilli ◽  
Adam Brufsky ◽  
Xianchen Liu ◽  
Jack Mardekian ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Clinical Practice ◽  
Real World ◽  
Metastatic Breast ◽  
Routine Clinical Practice ◽  
Survival Outcomes ◽  
First Line ◽  
Line Setting

Abstract Background Findings from randomized clinical trials may have limited generalizability to patients treated in routine clinical practice. This study examined the effectiveness of first-line palbociclib plus letrozole versus letrozole alone on survival outcomes in patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor–negative (HER2−) metastatic breast cancer (MBC) treated in routine clinical practice in the USA. Patients and methods This was a retrospective observational analysis of electronic health records within the Flatiron Health Analytic Database. A total of 1430 patients with ≥ 3 months of follow-up received palbociclib plus letrozole or letrozole alone in the first-line setting between February 3, 2015, and February 28, 2019. Stabilized inverse probability treatment weighting (sIPTW) was used to balance baseline demographic and clinical characteristics. Real-world progression-free survival (rwPFS) and overall survival (OS) were analyzed. Results After sIPTW adjustment, median follow-up was 24.2 months (interquartile range [IQR], 14.2–34.9) in the palbociclib group and 23.3 months (IQR, 12.7–34.3) in those taking letrozole alone. Palbociclib combination treatment was associated with significantly longer median rwPFS compared to letrozole alone (20.0 vs 11.9 months; hazard ratio [HR], 0.58; 95% CI, 0.49–0.69; P < 0.0001). Median OS was not reached in the palbociclib group and was 43.1 months with letrozole alone (HR, 0.66; 95% CI, 0.53–0.82; P = 0.0002). The 2-year OS rate was 78.3% in the palbociclib group and 68.0% with letrozole alone. A propensity score matching analysis showed similar results. Conclusions In this “real-world” population of patients with HR+/HER2− MBC, palbociclib in combination with endocrine therapy was associated with improved survival outcomes compared with patients treated with letrozole alone in the first-line setting. Trial registration Clinicaltrials.gov; NCT04176354

scholarly journals Utility of routinely collected electronic health records data to support effectiveness evaluations in inflammatory bowel disease: a pilot study of tofacitinib

2021 ◽  
Vol 28 (1) ◽  
pp. e100337
Author(s):  
Vivek Ashok Rudrapatna ◽  
Benjamin Scott Glicksberg ◽  
Atul Janardhan Butte
Keyword(s):  
Inflammatory Bowel Disease ◽  
Pilot Study ◽  
Disease Activity ◽  
Real World ◽  
Bowel Disease ◽  
P Value ◽  
Health Records ◽  
Real World Evidence ◽  
Inflammatory Bowel

ObjectivesElectronic health records (EHR) are receiving growing attention from regulators, biopharmaceuticals and payors as a potential source of real-world evidence. However, their suitability for the study of diseases with complex activity measures is unclear. We sought to evaluate the use of EHR data for estimating treatment effectiveness in inflammatory bowel disease (IBD), using tofacitinib as a use case.MethodsRecords from the University of California, San Francisco (6/2012 to 4/2019) were queried to identify tofacitinib-treated IBD patients. Disease activity variables at baseline and follow-up were manually abstracted according to a preregistered protocol. The proportion of patients meeting the endpoints of recent randomised trials in ulcerative colitis (UC) and Crohn’s disease (CD) was assessed.Results86 patients initiated tofacitinib. Baseline characteristics of the real-world and trial cohorts were similar, except for universal failure of tumour necrosis factor inhibitors in the former. 54% (UC) and 62% (CD) of patients had complete capture of disease activity at baseline (month −6 to 0), while only 32% (UC) and 69% (CD) of patients had complete follow-up data (month 2 to 8). Using data imputation, we estimated the proportion achieving the trial primary endpoints as being similar to the published estimates for both UC (16%, p value=0.5) and CD (38%, p-value=0.8).Discussion/ConclusionThis pilot study reproduced trial-based estimates of tofacitinib efficacy despite its use in a different cohort but revealed substantial missingness in routinely collected data. Future work is needed to strengthen EHR data and enable real-world evidence in complex diseases like IBD.

scholarly journals POS0619 MODELLING OF DISEASE ACTIVITY IN PATIENTS WITH INFLAMMATORY ARTHROPATHIES TREATED WITH ETANERCEPT ORIGINATOR OR BIOSIMILAR AS FIRST-LINE BIOLOGIC IN AN AUSTRALIAN REAL-WORLD DATASET

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 547.1-547
Author(s):  
C. Deakin ◽  
G. Littlejohn ◽  
H. Griffiths ◽  
T. Smith ◽  
C. Osullivan ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Data ◽  
Real World ◽  
Rank Test ◽  
P Value ◽  
Continuous Variables ◽  
Linear Quadratic ◽  
First Line ◽  
Modest Improvement ◽  
Over Time

Background:The availability of biosimilars as non-proprietary versions of established biologic disease-modifying anti-rheumatic drugs (bDMARDs) is enabling greater access for patients with rheumatic diseases to effective medications at a lower cost. Since April 2017 both the originator and a biosimilar for etanercept (trade names Enbrel and Brenzys, respectively) have been available for use in Australia.Objectives:[1]To model effectiveness of etanercept originator or biosimilar in reducing Disease Activity Score 28-joint count C reactive protein (DAS28CRP) in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) treated with either drug as first-line bDMARD[2]To describe persistence on etanercept originator or biosimilar as first-line bDMARD in patients with RA, PsA or ASMethods:Clinical data were obtained from the Optimising Patient outcomes in Australian rheumatoLogy (OPAL) dataset, derived from electronic medical records. Eligible patients with RA, PsA or AS who initiated etanercept originator (n=856) or biosimilar (n=477) as first-line bDMARD between 1 April 2017 and 31 December 2020 were identified. Propensity score matching was performed to select patients on originator (n=230) or biosimilar (n=136) with similar characteristics in terms of diagnosis, disease duration, joint count, age, sex and concomitant medications. Data on clinical outcomes were recorded at 3 months after baseline, and then at 6-monthly intervals. Outcomes data that were missing at a recorded visit were imputed.Effectiveness of the originator, relative to the biosimilar, for reducing DAS28CRP over time was modelled in the matched population using linear mixed models with both random intercepts and slopes to allow for individual heterogeneity, and weighting of individuals by inverse probability of treatment weights to ensure comparability between treatment groups. Time was modelled as a combination of linear, quadratic and cubic continuous variables.Persistence on the originator or biosimilar was analysed using survival analysis (log-rank test).Results:Reduction in DAS28CRP was associated with both time and etanercept originator treatment (Table 1). The conditional R-squared for the model was 0.31. The average predicted DAS28CRP at baseline, 3 months, 6 months, 9 months and 12 months were 4.0 and 4.4, 3.1 and 3.4, 2.6 and 2.8, 2.3 and 2.6, and 2.2 and 2.4 for the originator and biosimilar, respectively, indicating a clinically meaningful effect of time for patients on either drug and an additional modest improvement for patients on the originator.Median time to 50% of patients stopping treatment was 25.5 months for the originator and 24.1 months for the biosimilar (p=0.53). An adverse event was the reason for discontinuing treatment in 33 patients (14.5%) on the originator and 18 patients (12.9%) on the biosimilar.Conclusion:Analysis using a large national real-world dataset showed treatment with either the etanercept originator or the biosimilar was associated with a reduction in DAS28CRP over time, with the originator being associated with a further modest reduction in DAS28CRP that was not clinically significant. Persistence on treatment was not different between the two drugs.Table 1.Respondent characteristics.Fixed EffectEstimate95% Confidence Intervalp-valueTime (linear)0.900.89, 0.911.5e-63Time (quadratic)1.011.00, 1.011.3e-33Time (cubic)1.001.00, 1.007.1e-23Originator0.910.86, 0.960.0013Acknowledgements:The authors acknowledge the members of OPAL Rheumatology Ltd and their patients for providing clinical data for this study, and Software4Specialists Pty Ltd for providing the Audit4 platform.Supported in part by a research grant from Investigator-Initiated Studies Program of Merck & Co Inc, Kenilworth, NJ, USA. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck & Co Inc, Kenilworth, NJ, USA.Disclosure of Interests:Claire Deakin: None declared, Geoff Littlejohn Consultant of: Over the last 5 years Geoffrey Littlejohn has received educational grants and consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, Novartis, Pfizer, Janssen, Sandoz, Sanofi and Seqirus., Hedley Griffiths Consultant of: AbbVie, Gilead, Novartis and Lilly., Tegan Smith: None declared, Catherine OSullivan: None declared, Paul Bird Speakers bureau: Eli Lilly, abbvie, pfizer, BMS, UCB, Gilead, Novartis

TIVO-3: Tivozanib in patients with advanced renal cell carcinoma (aRCC) who have progressed after treatment with axitinib.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 278-278
Author(s):  
Brian I. Rini ◽  
Sumanta K. Pal ◽  
Bernard Escudier ◽  
Michael B. Atkins ◽  
Thomas E. Hutson ◽  
...  
Keyword(s):  
Kinase Inhibitor ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Risk Category ◽  
Vegf Receptor ◽  
Free Survival ◽  
Prior Therapy ◽  
Third Line ◽  
Line Setting ◽  
Clinical Trial Information

278 Background: Tivozanib (T) is a potent and highly selective VEGF receptor (R) tyrosine kinase inhibitor in clinical development for RCC. Axitinib is also a potent and selective VEGF-R inhibitor now commonly part of front-line aRCC treatment. The activity of T after axitinib has not been previously defined. The activity of T after prior therapy types including axitinib is of clinical relevance. Methods: The pivotal TIVO-3 study enrolled subjects with mRCC who failed 2 or 3 prior systemic regimens, one of which included a VEGFR TKI, stratified by IMDC risk category and type of prior therapy (two TKIs; TKI plus checkpoint; TKI + other) then randomized in a 1:1 ratio to T or S. The primary objective of the overall trial was to compare progression free survival (PFS) by blinded independent radiological review. Patients with prior axitinib received as monotherapy in the second or third line setting and other predefined subgroups were reviewed for outcome with T. Results: Patients treated with T after prior axitinib had a PFS of 5.5 months and an ORR of 13% compared to 3.7 months and 8% for patients treated with S. Other subgroups are presented in the table below. Clinical trial information: NCT02627963 . Conclusions: Tivozanib improved PFS vs. sorafenib in patients who have progressed after multiple VEGFR-TKIs, including patients with prior second or third line axitinib treatment. These results suggest differential activity from tivozanib and axitinib despite both being potent and selective VEGF-R inhibitors. [Table: see text]

scholarly journals Health Resource Utilization and Costs Associated with the Use of Obinutuzumab-Based Regimens Are Similar to Rituximab-Based Regimens for the First-Line Treatment of Follicular Lymphoma

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4721-4721
Author(s):  
Tu My To ◽  
Keith L. Dawson ◽  
Anthony S Masaquel ◽  
Arpamas Seetasith
Keyword(s):  
Drug Treatment ◽  
Follicular Lymphoma ◽  
Real World ◽  
Specific Drug ◽  
First Line ◽  
Employment Equity ◽  
Total Cost ◽  
Claims Database ◽  
Equity Ownership

Introduction: Obinutuzumab (GA101; G), a fully humanized, glycoengineered, type II anti-CD20 monoclonal antibody, is approved in the US for the first-line (1L) treatment of follicular lymphoma (FL). Despite the superior efficacy of G plus chemotherapy (G-chemo) versus rituximab (R) plus chemotherapy (R-chemo) in patients with previously untreated FL demonstrated in the Phase III, randomized GALLIUM study (NCT01332968; Marcus et al. N Engl J Med 2017), information on healthcare resource use (HRU) and real-world costs with G in previously untreated FL patients is limited. The aim of this retrospective cohort study was to examine HRU and costs for G-based and R-based therapies for the 1L treatment of FL using a US claims database. Methods: The data source for this study was the PharMetrics Plus Commercial Claims database. Adult patients (≥18 years) diagnosed with FL between February 1, 2015 and September 30, 2018 and who began any treatment for FL between February 1, 2016 and September 30, 2018 were included. The first FL treatment date within this selection window was denoted the index date. Patients were required to have ≥12 months of pre-index and ≥3 months of post-index continuous study enrolment, and to have at least one FL diagnosis on or during the 12-month pre-index period. Patients with FL treatment during the 12-month pre-index period were excluded in order to select only previously untreated patients. HRU and cost data during the 1L treatment period were descriptive and categorized by HRU category. Costs are in 2018 US dollars ($) and standardized as per patient per month (PPPM) costs. FL treatment determination was based on National Comprehensive Cancer Network guidelines. Results: A total of 1584 FL patients with ≥3 months follow up were analyzed. Overall, 26 patients received G-chemo (any combination) as their 1L treatment, 208 patients received R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), 391 patients received R-Benda (bendamustine) and 17 patients received R-CVP (cyclophosphamide, vincristine, prednisone); the remaining 942 patients received other regimens (predominantly other R combinations). Data are reported for those patients who received G-chemo, R-CHOP, R-Benda or R-CVP as 1L therapy (n=642; 281 females, 361 males). Baseline patient characteristics were similar for most variables across treatment groups. Mean (standard deviation [SD]) age was 56.9 (9.7) years and all patients had a Charlson Comorbidity Index (CCI) of ≥2 (mean [SD]: 2.9 [1.9]). Mean (SD) patient follow-up was 14.1 (8.0) months and mean (SD) duration of 1L treatment was 7.0 (5.1) months. A summary of all-cause HRU in patients receiving 1L treatment is provided by treatment category (Figure 1A). The proportion of patients with at least one hospitalization was highest with R-CHOP (23.6%). The proportion of patients with at least one emergency room (ER) visit was highest with R-Benda (29.4%). Mean (SD) total all-cause healthcare costs PPPM during 1L treatment were comparable among G-chemo, R-CHOP and R-Benda (Figure 1B) and lowest with R-CVP ($17,874 [$13,465]). Medical costs (mean [SD]) were highest for R-Benda ($27,716 [$19,610] PPPM) and lowest for R-CVP ($17,373 [$12,908] PPPM). G-chemo was associated with the lowest pharmacy costs ($76 [$107] PPPM) (Figure 1B). Mean (SD) total cost of FL drug treatment PPPM was $16,028 ($9,942) for G-chemo, $11,684 ($6,122) for R-CHOP and $12,108 ($8,794) for R-CVP. Mean (SD) total cost of FL drug treatment PPPM was highest with R-Benda ($21,263 [$15,328]). G-specific drug costs PPPM ($9,643 [$6,071]) were similar to R-specific drug costs ($9,992 [$5,234] R-CHOP; $9,083 [$5,859] R-Benda; and $10,702 [$7,717] R-CVP). Conclusions: Our results depict real-world HRU and costs associated with G and commonly used 1L regimens for FL. In this setting, HRU and costs associated with G-chemo were comparable with R-chemo, supporting the use of G-chemo as a treatment option for patients with previously untreated FL. The study findings are limited by the small sample size of the G-chemo patient cohort (n=26) and short follow-up; to address this, an updated analysis incorporating a larger number of patients is planned. Disclosures To: Genentech, Inc.: Employment, Equity Ownership. Dawson:Roche/Genentech: Equity Ownership; Genentech: Employment. Masaquel:Genentech: Employment; Roche: Equity Ownership. Seetasith:Genentech: Employment, Equity Ownership.

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