Comparative-effectiveness of pembrolizumab vs nivolumab for patients with metastatic melanoma

Comparative-effectiveness of pembrolizumab vs nivolumab for patients with metastatic melanoma

abstracts 1346P Comparative-effectiveness of pembrolizumab vs nivolumab for patients with metastatic melanoma J. Moser1, G. Wei2, S. Colonna3, K.F...

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abstracts

1346P

Comparative-effectiveness of pembrolizumab vs nivolumab for patients with metastatic melanoma

J. Moser1, G. Wei2, S. Colonna3, K.F. Grossmann3, S. Patel3, J. Hyngstrom4 Drug Development and Medical Oncology, HonorHealth Research Institute, Scottsdale, AZ, USA, 2Internal Medicine, Division of Epidemiology, University of Utah, Salt Lake City, UT, USA, 3Medical Oncology, Huntsman Cancer Institute, Salt Lake City, UT, USA, 4 Surgery, Huntsman Cancer Institute, Salt Lake City, UT, USA

1

Background: Anti-PD-1 antibodies have changed the treatment landscape for patients with metastatic melanoma. Two of these antibodies, pembrolizumab (P) and nivolumab (N), are currently FDA approved in the frontline setting for these patients. The efficacy of these drugs has not been directly compared; thus we aimed to compare the overall survival for patients with metastatic melanoma treated with either front line P or N in routine clinical practice. Methods: This study included patients with advanced melanoma treated with frontline P or N using the U.S. nationwide Flatiron Health electronic health record (EHR)derived database. Overall survival (OS) from the start of frontline therapy was estimated for each treatment group using Kaplan-Meier curves with a log-rank test. OS comparative-effectiveness was estimated using a propensity score-matched Cox regression model to reduce bias for pairs of P (n ¼ 371) and N treated subjects (n ¼ 371). Propensity scores were generated using age, gender, ECOG, LDH (elevated or not), BRAF (mutated or not), KIT (mutated or not), NRAS (mutated or not), PD-L1 expression (0% or greater), BMI and primary site. Results: From a total of 7650 melanoma patients, 888 had advanced disease treated with frontline P (n ¼ 486) or N (n ¼ 402). 58% of N treated patients received flat 240 mg q2 week dosing and 38% of P treated patients received flat 200 mg q3 week dosing. Median OS for patients treated with P was 22.6 months(m) and was 23.9 m for those treated with N (p ¼ 0.91). In the propensity score matched analysis (n ¼ 742), there was no difference in survival between patients treated with P or N (HR 1.10; 95% CI 0.87-1.39). Conclusions: In our retrospective real world analysis of patients with advanced melanoma, no statistical difference in OS was noted between patients treated with frontline P compared to N. This supports the current practice of choosing either P or N based on patient and provider preference. Legal entity responsible for the study: Huntsman Cancer Institute.

v550 | Melanoma and other skin tumours

Funding: Has not received any funding. Disclosure: K.F. Grossmann: Advisory / Consultancy: Array BioPharma; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Genentech; Advisory / Consultancy: Novartis; Advisory / Consultancy: Castle Biosciences. S. Patel: Research grant / Funding (institution): Merck. All other authors have declared no conflicts of interest.

1347P

Long-term efficacy of combination nivolumab and ipilimumab for first-line treatment of advanced melanoma: A network meta-analysis

P. Mohr1, K. Toor2, S. Goring2, K. Chan2, M. Besada2, H.M. Johnson3, A. Moshyk4, S. Kotapati4 1 Dermatology, Elbekliniken Buxtehude, Buxtehude, Germany, 2Evidence Synthesis and Decision Modeling, Precision Xtract, Vancouver, BC, Canada, 3Worldwide HEOR, BristolMyers Squibb, Uxbridge, UK, 4Worldwide HEOR, Bristol-Myers Squibb, Lawrence, NJ, USA Background: Targeted and checkpoint inhibitor therapies for advanced melanoma have led to major improvements in overall survival (OS). Using long-term evidence, the objective was to estimate the relative efficacy of nivolumab plus ipilimumab (NIVOþIPI) vs. relevant comparators among treatment-naı¨ve patients with advanced, unresectable stage III/IV melanoma. Methods: A systematic literature review of randomized controlled trials (RCTs) of first-line advanced melanoma therapies was conducted in November 2018. Key comparators were immunotherapies (NIVOþIPI; NIVO; pembrolizumab [PEM]), and BRAFþMEK inhibitors (dabrafenib þ trametinib [DABþTRAM]; encorafenib þ binimetinib [ENCþBIN]; vemurafenib þ cobimetinib [VEMþCOB]). Bayesian network meta-analysis (NMA) models were used to estimate comparative OS. The NMAs used models of constant (overall) hazard ratio (HR) over time, and fractional polynomials to estimate time-varying HR, along with 95% credible intervals (CrI). Subgroup analyses and alternate models were explored to evaluate effect modification of immunotherapies by BRAF-mutation status. Results: In total, 12 RCTs formed the network of evidence for OS (maximum followup: 30 to 60 months). For NIVOþIPI vs. each BRAFþMEK inhibitor, the HR decreased steadily over time. The hazard of death was similar by 6 months and lower at 12 months; thereafter, NIVOþIPI was associated with a significantly reduced hazard of death. At 18 months, HRs for NIVOþIPI vs. each BRAFþMEK inhibitor ranged from 0.45 to 0.52; by 42 months (longest duration of observed data for BRAFþMEK inhibitors), HRs were 0.24 to 0.29 (all CrIs < 1). The HR of NIVOþIPI relative to other immunotherapies was less varied over time, yet showed similar or significantly improved OS from 6 months onward. Over the follow-up period, overall HRs (95% CrI) for NIVOþIPI were: 0.73 (0.49, 1.10) vs. DABþTRAM, 0.81 (0.52, 1.26) vs. ENCþBIN, 0.70 (0.45, 1.09) vs. VEMþCOB, 0.83 (0.60, 1.13) vs. PEM, and 0.86 (0.70, 1.05) vs. NIVO. Subgroup analyses and alternate model estimates were broadly consistent with the main findings. Conclusions: NIVOþIPI confers similar or sustained improvements in long-term OS compared with immunotherapies and BRAFþMEK inhibitors. Legal entity responsible for the study: The authors. Funding: Bristol-Myers Squibb. Disclosure: P. Mohr: Honoraria (self), To manually add email to ESMO: To manually add email to ESMO. K. Toor: Full / Part-time employment, KT is an employee of Precision Xtract. Precision Xtract received funding for this project from Bristol-Myers Squibb: Precision Xtract. S. Goring: Advisory / Consultancy, SG acted as a consultant to Precision Xtract. Precision Xtract received funding for this project from Bristol-Myers Squibb: Precision Xtract. K. Chan: Full / Part-time employment, KC is an employee of Precision Xtract. Precision Xtract received funding for this project from Bristol-Myers Squibb: Precision Xtract. M. Besada: Full / Part-time employment, MB is an employee of Precision Xtract. Precision Xtract received funding for this project from Bristol-Myers Squibb: Precision Xtract. H.M. Johnson: Advisory / Consultancy: Bristol-Myers Squibb. A. Moshyk: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. S. Kotapati: Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb.

1348P

Long-term real-world (RW) outcomes in patients with advanced melanoma (MEL) treated with ipilimumab (IPI) and non-IPI therapies: IMAGE study

S. Dalle1, L. Mortier2, P. Corrie3, M. Lotem4, R. Board5, A.M. Arance6, F. Meiss7, P. Terheyden8, R. Gutzmer9, J. Brokaw10, T.K. Le11, S.D. Mathias12, J. Scotto10, J. LordBessen13, A. Moshyk13, S. Kotapati13, M.R. Middleton14 1 Dermatologo-Oncology Unit, Centre Hospitalier Universitaire de Lyon, Lyon, France, 2 Institut National de la Sante´ et de la Recherche Me´dicale, Universite´ de Lille, Lille, France, 3Medical Oncology, Addenbrooke’s Hospital, Cambridge, UK, 4Sharett Institute of Oncology, Hadassah Hebrew University Hospital, Jerusalem, Israel, 5Rosemere Cancer Centre, Royal Preston Hospital, Preston, UK, 6Medical Oncology, Hospital Clınic Barcelona, Barcelona, Spain, 7Medical Center, University of Freiburg, Freiburg, Germany, 8 Dermatology, University of Lu¨beck, Lu¨beck, Schleswig-Holstein, Germany, 9HautTumor-Zentrum Hannover (HTZH), Medizinische Hochschule Hannover, Hannover, Germany, 10GPV & E, Bristol-Myers Squibb, Princeton, NJ, USA, 11CORDS, Bristol-Myers Squibb, Princeton, NJ, USA, 12Executive Level Consultation, Health Outcomes Solutions, Winter Park, FL, USA, 13HEOR, Bristol-Myers Squibb, Princeton, NJ, USA, 14Department of Oncology, Churchill Hospital, Oxford, UK Background: IPI has shown durable overall survival (OS) in patients (pts) with MEL in clinical trials, but robust RW evidence is lacking. We present long-term RW outcomes

Volume 30 | Supplement 5 | October 2019

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Amgen; Honoraria (institution): Novartis; Honoraria (institution): Plexxikon. C. Franklin: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre. R. Gutzmer: Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Johnson & Johnson; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: MerckSerono; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Almirall-Hermal; Honoraria (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: SUN; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre; Advisory / Consultancy: LEO; Advisory / Consultancy: 4SC; Advisory / Consultancy: Incyte; Advisory / Consultancy: Takeda. J.C. Hassel: Honoraria (self), Research grant / Funding (institution): BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self), Advisory / Consultancy: Sanofi; Advisory / Consultancy: Pierre Fabre. C. Weishaupt: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Pierre Fabre; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self): Curevac; Honoraria (self): Leo Pharma; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Takeda. T. Eigentler: Honoraria (self), Research grant / Funding (self): Roche; Honoraria (self), Research grant / Funding (self): MSD; Honoraria (self), Research grant / Funding (self): BMS; Honoraria (self): Pierre Fabre; Honoraria (self), Research grant / Funding (self): Novartis; Honoraria (self): Leo Pharma; Research grant / Funding (self): Curevac; Research grant / Funding (self): IOVANCE. F. Kiecker: Honoraria (self): Amgen; Honoraria (self): BMS; Honoraria (self): MSD; Honoraria (self), Research grant / Funding (self): Novartis; Honoraria (self): Roche; Honoraria (self): Pierre Fabre. C. Owen: Travel / Accommodation / Expenses: MSD. K.C. K€ahler: Honoraria (self), Research grant / Funding (self): MSD; Honoraria (self): BMS; Honoraria (self): Novartis; Honoraria (self), Research grant / Funding (self): Philogen; Honoraria (self): Roche; Honoraria (self): Pierre Fabre. D. Niebel: Honoraria (self): BMS; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: BMS; Travel / Accommodation / Expenses: Celgene; Travel / Accommodation / Expenses: MSD. P. Mohr: Honoraria (self): Amgen; Honoraria (self), Research grant / Funding (self), Research grant / Funding (institution): BMS; Honoraria (self): GSK; Honoraria (self): Novartis; Honoraria (self), Research grant / Funding (self), Research grant / Funding (institution): MSD; Honoraria (self): Merck Serono; Honoraria (self): Pierre Fabre; Honoraria (self): Roche. D. Schadendorf: Honoraria (self), Honoraria (institution), Advisory / Consultancy: Pierre Fabre; Honoraria (self): Amgen; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Leo Pharma; Honoraria (self), Honoraria (institution): Roche; Honoraria (self): MSD; Honoraria (self): Incyte; Honoraria (self), Honoraria (institution): Regeneron; Honoraria (self): 4SC; Honoraria (self): AstraZeneca; Honoraria (self), Honoraria (institution), Research grant / Funding (self): BMS; Honoraria (self), Honoraria (institution): Merck-EMD; Honoraria (self): Pfizer; Honoraria (self), Honoraria (institution): Philogen; Honoraria (self): Array. L. Zimmer: Advisory / Consultancy: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre; Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD. All other authors have declared no conflicts of interest.

Annals of Oncology