Research

Empowering Healthcare with Real-World Evidence

Dive into our repository of groundbreaking research papers, where we merge clinical expertise with data driven insights to revolutionize patient care and treatment strategies.

Group 79
Brittany A. McKelvey, PhD, Elizabeth Garrett-Mayer, PhD, FSCT, Donna R. Rivera, PharmD, MSc, Amy Alabaster, MS, MPH, Hillary S. Andrews, PhD, Elizabeth G. Bond, MPH, Thomas D. Brown, MD, MBA, Amanda Bruno, PhD, MPH, Lauren Damato, ACNP-BC, Janet L. Espirito, PharmD, Laura L. Fernandes, PhD, Eric Hansen, MD, Paul Kluetz, MD, Xinran Ma, MS, Andrea McCracken, MPH, Pallavi S. Mishra-Kalyani, PhD, Yanina Natanzon, PhD, MS, Danielle Potter, PhD, MPH, Nicholas J. Robert, MD, Lawrence Schwartz, MD, Regina Schwind, MS, MHI, Connor Sweetnam, BS, Joseph Wagner, BS, Mark D. Stewart, PhD, and Jeff D. Allen, PhD
Real-world data (RWD) holds promise for ascribing a real-world (rw) outcome to a drug intervention; however, ascertaining rw-response to treatment from RWD can be challenging. Friends of Cancer Research formed a collaboration to assess available data attributes related to rw-response across RWD sources to inform methods for capturing, defining, and evaluating rw-response.
Alexander Spira, Dexter Waters, Tao Ran, Pratyusha Vadagam, Jinghua He, Julie Vanderpoel, Anjali Donnelly, Iris Lin
Amivantamab (AMI), a bispecific antibody targeting EGFR and MET, and mobocertinib (MOBO), an EGFR tyrosine kinase inhibitor, were recently approved for patients with EGFR exon 20 insertion-mutated (ex20ins) advanced Non-Small Cell Lung Cancer (NSCLC) who have progressed on/after platinum-based chemotherapy.
Naomi Dempsey, Muni Rubens, Pooja Prem Advani, Ana Cristina Sandoval-Leon, Lauren Carcas, Manmeet Singh Ahluwalia, and Reshma L. Mahtani
Metaplastic breast cancer (MpBC) is a subtype of breast cancer (BC) that is commonly triple negative (TN) and chemotherapy (CT) resistant. Despite CT resistance, standard of care therapy is administered according to receptor status, regardless of metaplastic histology. Randomized data regarding optimal treatment of this rare histologic subtype are lacking.
Shaji Kumar, Katja C Weisel, Qiufei MaChristian Hampp, Olivier Humblet, Mostafa Shokoohi, Nicolle Bonar, Paul Spin, James Harnett, Wenzhen Ge, Jessica J Jalbert, Rachel E Sobel, Glenn Scott Kroog, Karen Rodriguez-Lorenc, and Sundar Jagannath
Pts with TCE RRMM have poor outcomes and a high unmet need, with no established SOC tx. LINKER-MM1 (NCT03761108) is a single-arm, Phase 1/2 study investigating linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody, in pts with RRMM who were previously treated with a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody, or were triple-class refractory (TCR) to these tx. The aim of this study was to contextualize LINKER-MM1 by comparing outcomes with linvoseltamab vs a real-world (RW) external control arm (ECA).
Ester Rita Alessandrini, Jeverson Moreira, Virginie Simon, Oscar Mallet, Rihab Gamaoun, Romane Péan, Gauvain Hamkoung, Yue Zuo, Théophile Reppelin, Mehdi Kertous, Alexandre Templier, and Nadjat Mounedji
In the last two decades, new therapeutic options have emerged to complement traditional intensive chemotherapy (IC) regimens in the treatment of Acute myeloid leukemia (AML). Hypomethylating agents (HMAs), the B-cell lymphoma 2 (BCL-2) protein inhibitor Venetoclax, and other targeted therapies are examples. Guideline-based treatment decisions are intricate, considering both patient fitness to IC and disease characteristics. AML real-word studies on treatment patterns typically focus on specific subpopulations (e.g., elderly or unfit patients), and few studies analyze broader populations. We analyzed an US electronic health records (EHR) database to describe AML treatment patterns.
Harsh Parmar, Anna Barcellos, Noa Biran, Pooja Phull, David H. Vesole, Andrew J. Belli, Laura L. Fernandes, Eric Hansen, Christina Zettler, Ching-Kun Wang, Stefanie Goran, Courtney Anderson, Kimberley Doucette, Thomas S Gunning, Andrew Ip, and David Samuel DiCapua Siegel
Stem cell transplant (SCT) followed by maintenance therapy (MT) is the standard of care for transplant eligible NDMM pts. Tandem transplantation has been found to have progression free (PFS) and overall survival (OS) benefit particularly for patients with high-risk cytogenetic abnormalities (HRCA). However, this modality remains under-utilized in clinical practice. We report RWO with tandem transplant (TT) in comparison with single SCT followed by MT (STM).
Harsh Parmar, Anna Barcellos, Noa Biran, Pooja Phull, David H. Vesole, Andrew J. Belli, Laura L. Fernandes, Eric Hansen, Christina Zettler, Ching-Kun Wang, Stefanie Goran, Courtney Anderson, Kimberley Doucette, Thomas S Gunning, Andrew Ip, David Samuel DiCapua Siegel
SCT followed by MT is the standard of care for pts with transplant-eligible (TE) NDMM. Five randomized clinical trials (RCTs) comparing lenalidomide MT versus no MT showed improved progression free survival (PFS), but no overall survival (OS) benefit except for one by McCarthy et al. that allowed pt crossover between treatment arms. Use of MT has also been associated with an increased risk of second primary malignancies and an inferior quality of life. We report RWO post SCT with and without MT in TE NDMM.
Merola D, Campbell U, Lenis D, Madsen A, Schneeweiss S, Wang S, Carrigan G, Taylor A, Huang J, Chia VM, Ovbiosa O, Pinheiro S, Pace ND, Bruno A, Stewart M, Khosla S, Zhang Y, Rimawi M, Hendricks-Sturrup R, Locke T, Jiao X, Becnel L, McRoy L, Rabon-Stith K, Eckert JC, Rodriguez-Watson C, Lunacsek O, Harvey R, Greshock J, Sarsour K, Belli A, Wang C, Fernandes L, Chen J, Natanzon Y, Dhopeshwarkar N, Wasserman A, Quinn J, Taylor B, Rider J
As a pilot exercise to assess feasibility of using routine clinical practice data to duplicate randomized control trial (RCT) design, we attempted to emulate the KEYNOTE-189 RCT using real-world data (RWD), and report findings from comparing the results.
Rihab Gamaoun, Pauline Chamard, Soutrik Banerjee, Mehdi Kertous, Prapti A Patel, Nadjat Mounedji, Koji Sasaki, Guillermo Garcia-Manero
This study focuses on comparing the treatment response assessment of frontline IDH1-mutated MDS patientstreated with hypomethylating agents (HMA), specifically exploring the evolution from IWG 2006 to IWG 2023 criteria among the general IDH1 mutated MDS, and the specific group of HR-MDS patients.