Envision Pharma Group Research Articles

The evolution of payer management of oncology drugs in the United States between 2017 and 2022.

BACKGROUND: Research conducted in 2017 by Runyan et al concerning the current and future management of oncology drugs in the United States formed the basis for this research. The authors concluded that despite the high cost of oncology drugs, US payers relied on traditional management tools to manage the category, although these tools were ineffective at controlling costs. Innovative tools were not common in 2017. OBJECTIVE: To compare findings from the 2017 research with findings from a 2022 payer survey to understand how payer management of oncology drugs changed over 5 years. The study evaluates changing trends in oncology drug management. METHODS: The survey that informed the publication by Runyan et al in 2017 was reviewed, updated, and completed by 21 pharmacy and medical directors across 18 organizations representing 121.9 million covered lives. Both surveys included questions about management tools being employed in oncology and challenges to managing oncology. They used case studies in non-small cell lung cancer and chronic lymphocytic leukemia. These disease areas were chosen again in 2022 because they were included in the 2017 survey and because of the increase in competition in both categories from 2017 to 2022. The payer sample was designed to match the 2017 sample. The research was fielded from March to May 2022. The results were analyzed in Microsoft Excel; basic statistical analysis was conducted. Payers' responses for each question were weighted by the number of reported covered lives at their organization so that the organization's site was represented. RESULTS: On average, payers rated the management priority of oncology as a 5.3 and the budget impact as a 6.3 on a scale of 1 to 7, where 1 was low and 7 was high. Traditional tools remain dominant in this therapeutic area. However, there has been an increase in use of innovative tools. Pathways of care are trending upward since the initial survey in 2017. The Institute for Clinical and Economic Review (ICER) also influences payers' decision-making in oncology more than it did 5 years ago. Despite these shifts, most payers allow for unrestricted access of targeted therapies in non-small cell lung cancer and chronic lymphocytic leukemia, in line with each drug's US Food and Drug Administration-approved label. CONCLUSIONS: The increased use of pathways of care, shifting financial risk to providers, and the influence of ICER should continue to be monitored. Future research should focus on the role of pathways of care, comprehensive, evidence-based treatment protocols, in influencing prescribing decisions of hematologists and oncologists. DISCLOSURES: The authors work for Envision Pharma Group (formerly Two Labs), a company that provides consulting services to the pharmaceutical and biotech industries. As such, clients in these industries pay Envision Pharma Group for their services. This study was funded independently by Envision Pharma Group.

Omalizumab and quality of life in nasal polyps: A post hoc analysis.

Omalizumab and quality of life in nasal polyps: A post hoc analysis.

Epidemiology and treatment patterns for locally advanced or metastatic urothelial carcinoma: a systematic literature review and gap analysis.

BACKGROUND: Several immuno-oncology (IO) agents targeting programmed death-1 or programmed death-ligand 1 (PD-1/L1) are approved second-line therapy options for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) previously treated with platinum-based chemotherapy or first-line options in patients ineligible for cisplatin whose tumors express PD-L1 or for any platinum-based chemotherapy regardless of PD-L1 expression levels. However, literature on the epidemiology of la/mUC is limited, and real-world treatment patterns are not well established, especially with respect to therapies used following IO. OBJECTIVES: To (a) report the epidemiology of urothelial carcinoma (UC) and la/mUC; (b) identify and summarize the published literature on la/mUC treatment patterns, including IO and post-IO treatment; and (c) identify evidence gaps. METHODS: A systematic literature review was conducted using Cochrane dual-reviewer methodology and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Literature databases and selected congress abstracts (2017-2018) were searched for retrospective studies published January 2013-August 2018 in English reporting epidemiological and treatment data (all lines of therapy) for adult patients with la/mUC. RESULTS: Among 6,584 database references and 1,832 congress abstracts screened, 45 publications (29 manuscripts, 1 poster, 15 abstracts; reporting 37 unique studies) were retained. All studies related to treatment patterns, and the majority were from the United States (n = 17), Japan (n = 8), and the United Kingdom (n = 5). Epidemiological data were not identified among the searches thus online registries were leveraged. Among the identified publications, 21 (20 unique) reported on cisplatin versus non-cisplatin regimens, 14 (8 unique) on IO, and 9 (7 unique) on vinflunine. Cisplatin use varied both within and among countries (ranging from 18.4% in 1 U.S. study to 87.9% in 1 Japanese study). The use of IO was higher in later lines of therapy, ranging from 1.4% to 7.9% as first-line therapy to 57.8% as second-line and 64.4% as third-line therapy. Among studies reporting IO discontinuation rates, 41.4%-71% of patients were reported to discontinue IO across the studies, and the median time to discontinuation ranged from 2.7 to 5.8 months. Only 25%-35.5% of patients received subsequent therapy following IO discontinuation; post-IO treatments varied widely. CONCLUSIONS: Additional published data on the country-specific epidemiology of UC and la/mUC are needed, including rates of progression from early-stage disease to la/mUC. There was large variation in treatment rates, particularly cisplatin use, within and across countries. The few published real-world IO studies reported high levels of discontinuation with only a small percentage of patients receiving subsequent therapy. As IO therapies continue to be granted regulatory approval in countries outside the United States and novel therapies gain approval in the post-IO setting, the treatment paradigm for patients with la/mUC is shifting, and future studies with more recent data will be required. DISCLOSURES: This study was funded by Astellas/Seagen. Hepp is an employee of and owns stock in Seagen. Shah was a contractor for Astellas Pharma at the time of the study and owns stock in Pfizer. Smoyer is an employee and shareholder of Envision Pharma Group, paid consultants to Seagen. Vadagam was an employee of Envision Pharma Group, paid consultants to Seagen, at the time of the study. Parts of these data have been presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2019 Annual Meeting; May 18-22, 2019; New Orleans, LA.

RELAY: Global Ph3 study of erlotinib + ramucirumab or placebo in metastatic NSCLC with EGFR mutation - East Asian subset

Abstract Background Dual blockade of the EGFR and VEGFR pathways in EGFR mutation-positive NSCLC is more effective than EGFR inhibition alone. EGFR mutations occur in 10–20% of Caucasian and 40–60% of East Asian (EA) patients (pts) with NSCLC. In the global phase 3 RELAY study (NCT02411448), ramucirumab + erlotinib (RAM+ERL) significantly improved progression-free survival (PFS) compared with placebo + erlotinib (PL+ERL) in pts with EGFR mutation-positive metastatic NSCLC. Here we report efficacy and safety results for the EA subset. Methods Previously untreated pts with metastatic NSCLC and EGFR exon 19 deletions or an exon 21 substitution mutation (L858R) were randomized (1:1) to receive ERL (150 mg/day) plus RAM (10 mg/kg Q2W) or placebo until disease progression or unacceptable toxicity. PFS (investigator-assessed, primary endpoint), duration of response (DoR), PFS2 (time to second disease progression), overall survival (OS), and safety were assessed. Results Of 449 pts randomized from Jan 2016 to Feb 2018, 336 pts (75%) were from East Asia (Japan: 211; Taiwan: 56; Korea: 54; Hong Kong: 15). In the RAM+ERL (n = 166)/PL+ERL (n = 170) arms in the EA subset, 64.5%/64.1% were female, 63.3%/64.1% were never-smokers, and 50.6%/49.4% had exon 19 deletions. RAM+ERL improved PFS (median: 19.4 [95% CI 15.2–22.0] vs 12.5 [95% CI 11.1–13.9] months; hazard ratio [HR]: 0.636, 95% CI 0.485–0.833, P = 0.0009) and DoR (median: 16.2 [95% CI 13.8–19.8] vs 11.1 [95% CI 9.7–12.5] months; HR: 0.646, 95% CI 0.481–0.868, P = 0.0036) compared with PL+ERL. PFS2 and OS data are immature, with 67.3% and 82.7% of pts censored. Grade ≥3 treatment-emergent adverse events reported in > 5% of pts (RAM+ERL vs PL+ERL) were hypertension (21.3% vs 4.7%), dermatitis acneiform (18.3% vs 8.8%), ALT increased (9.1% vs 9.4%), and diarrhea (5.5% vs 1.2%). Conclusions Consistent with the overall RELAY study population, RAM+ERL improved PFS compared with PL+ERL in the EA subset, with a manageable safety profile. This study was sponsored by Eli Lilly Japan K.K. Medical writing assistance was provided by Justine Southby, PhD, CMPP, and Tania Dickson, PhD, CMPP, of ProScribe – Envision Pharma Group, and was funded by Eli Lilly Japan K.K. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP3).

1299P - Radiographic characteristics and poor prognostic factors of interstitial lung disease (ILD) in nivolumab-treated patients with non-small cell lung cancer (NSCLC)

1299P - Radiographic characteristics and poor prognostic factors of interstitial lung disease (ILD) in nivolumab-treated patients with non-small cell lung cancer (NSCLC)

LBA40 - FIGHT-202: A phase II study of pemigatinib in patients (pts) with previously treated locally advanced or metastatic cholangiocarcinoma (CCA)

LBA40 - FIGHT-202: A phase II study of pemigatinib in patients (pts) with previously treated locally advanced or metastatic cholangiocarcinoma (CCA)

LBA10_PR - ClarIDHy: A global, phase III, randomized, double-blind study of ivosidenib (IVO) vs placebo in patients with advanced cholangiocarcinoma (CC) with an isocitrate dehydrogenase 1 (IDH1) mutation

LBA10_PR - ClarIDHy: A global, phase III, randomized, double-blind study of ivosidenib (IVO) vs placebo in patients with advanced cholangiocarcinoma (CC) with an isocitrate dehydrogenase 1 (IDH1) mutation

720P - Comprehensive genomic profiling and clinical outcomes in patients (pts) with fibroblast growth factor receptor rearrangement-positive (FGFR2+) cholangiocarcinoma (CCA) treated with pemigatinib in the fight-202 trial

BackgroundFight-202 is a phase 2 study (NCT02924376) of pemigatinib (INCB054828), a selective, potent, oral inhibitor of FGFR1, 2, and 3 in pts with advanced CCA. Interim results from the first 47 FGFR2+ CCA pts with ≥8 months (mo) of follow-up demonstrated an objective response rate (ORR) of 40.4%, disease control rate (DCR) of 85%, median progression-free survival (mPFS) of 9.2mo, and median overall survival (mOS) of 15.8mo, based on independent central review. Here we report the frequency of FGFR2 rearrangement partners and co-occurring alterations and their impact on clinical outcomes. MethodsComprehensive genomic profiling was performed in all pts prescreened and/or enrolled in fight-202 using FoundationOne. Clinical data were reported previously. ResultsAmong 118 FGFR2+ pts identified, 54 unique FGFR2 rearrangement partners were observed, of which 74.1% (n=40) were unique to a single patient. BICC1 was the most frequent FGFR2 rearrangement partner (29.7% [n=35]). FGFR2+ pts had fewer genomic alterations (3.36 alterations/pt) than unaltered pts (4.6 alterations/pt). The most frequently co-altered gene, BAP1, was altered in 39.8% (n=47) of FGFR2+ pts. As of the data cutoff date (July 24, 2018), 47 FGFR2+ pts were treated with pemigatinib and followed for ≥8mo. There were no meaningful differences in ORR (42.9% vs 39.4%), mPFS (8.9mo vs 9.6mo), or mOS (not reached [NR] vs 15.8mo) in patients with FGFR2-BICC1 (n=14) versus other FGFR2 rearrangements. Similarly, no meaningful difference in ORR (53.3% vs 34.4%), mPFS (8.9mo vs NR), or mOS (NR vs 15.8mo) was observed in pts with BAP1 loss-of-function mutations (n=15). Among other co-occurring genomic alterations, pts with TP53 alterations (n=5) had no objective responses (0% vs 45.2%) and shorter mPFS (6.2mo vs NR) and mOS (10.5mo vs NR). ConclusionsDespite myriad FGFR2 rearrangement partners identified in the study, an interim analysis did not indicate a difference in ORR, mPFS, or mOS between the most common rearrangement partner (BICC1) and other partner genes. Alterations in TP53, but not BAP1, were associated with decreased clinical benefit. Editorial acknowledgementSimon J. Slater, PhD, CMPP, of Envision Pharma Group (Philadelphia, PA), funded by Incyte Corporation. Legal entity responsible for the studyIncyte Corporation. FundingIncyte Corporation. DisclosureA. Hollebecque: Consulting/Advisory Role, Travel/Accommodation/Expenses, Courses/Trainings: Amgen; Consulting/Advisory Role: Spectrum Pharmaceuticals; Consulting/Advisory Role, Travel/Accommodation/Expenses: Lilly; Consulting/Advisory Role, Travel/Accommodation/Expenses: Debiopharm; Travel/Accommodation/Expenses: Servier; Travel/Accommodation/Expenses: Incyte; Courses/Trainings: Bayer; Courses/Trainings: Eisai; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Janssen Cilag; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Sanofi. I.M. Silverman: Shareholder / Stockholder / Stock options, Full / Part-time employment: ): Incyte Research Institute, Incyte Corporation. S. Owens: Shareholder / Stockholder / Stock options, Full / Part-time employment: ): Incyte Research Institute, Incyte Corporation. L. Féliz: Shareholder / Stockholder / Stock options, Full / Part-time employment: Incyte Corporation. C.F. Lihou: Shareholder / Stockholder / Stock options, Full / Part-time employment: Incyte Corporation. H. Zhen: Shareholder / Stockholder / Stock options, Full / Part-time employment: Incyte Corporation. R.C. Newton: Shareholder / Stockholder / Stock options, Full / Part-time employment: ): Incyte Research Institute, Incyte Corporation. T.C. Burn: Shareholder / Stockholder / Stock options, Full / Part-time employment: ): Incyte Research Institute, Incyte Corporation. D. Melisi: Research Grants (Institution), Advisory/Consultancy Role: Shire; Research Grants (Institution), Advisory/Consultancy Role: Incyte; Research Grants (Institution), Advisory/Consultancy Role: Evotec; Research Grants (Institution): Celgene; Advisory/Consultancy Role: Eli Lilly; Advisory/Consultancy: Baxter. All other authors have declared no conflicts of interest.

1670O - ADP-A2M4 (MAGE-A4) in patients with synovial sarcoma

1670O - ADP-A2M4 (MAGE-A4) in patients with synovial sarcoma

NCCN NewsMore People Living With HIV and Cancer Should Get Appropriate Cancer Treatment, According to New GuidelinesNCCN Engages Envision Pharma Group to Support Their Oncology Research Program Using iEnvision—A New Web-Based Software Platform for Medical ProgramsLeading Cancer Organizations Provide Guidance on Understanding and Managing Immunotherapy Side EffectsNCCN Reaches New Records for Guidelines, Resources, and Programs

NCCN NewsMore People Living With HIV and Cancer Should Get Appropriate Cancer Treatment, According to New GuidelinesNCCN Engages Envision Pharma Group to Support Their Oncology Research Program Using iEnvision—A New Web-Based Software Platform for Medical ProgramsLeading Cancer Organizations Provide Guidance on Understanding and Managing Immunotherapy Side EffectsNCCN Reaches New Records for Guidelines, Resources, and Programs

Race/Ethnicity in Atrial Fibrillation Stroke: Epidemiology and Pharmacotherapy

The authors acknowledge the writing and editorial assistance of Rosemary Perkins of Envision Pharma Group, whose services were funded by Boehringer Ingelheim Pharmaceuticals, Inc. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE), were fully responsible for all content and editorial decisions, and were involved in at all stages of manuscript development. The authors received no compensation related to the development of the manuscript.

SAT0372 Clinical and Imaging Efficacy of Etanercept in Early Non-Radiographic Axial Spondyloarthritis: 48-Week Treatment Data

BackgroundOur previous data show that Etanercept (ETN) has superior clinical and anti-inflammatory efficacy to placebo (PBO) in patients with non-radiographic axial spondyloarthritis (nr-axSpA) and inadequate response to NSAIDs in a...