Research matters

When you’re focusing on the future of cancer care, it helps to start with a clear and accurate picture of the present.

Breast Cancer
Brittany Avin McKelvey, Elizabeth Garrett-Mayer, Andrew J. Belli, Thomas D. Brown, Jessica Dow, Janet L. Espirito, Paul Kluetz, Xinran Ma, Andrea McCracken, Pallavi Shruti Mishra-Kalyani, Yanina Natanzon, Danielle Potter, Donna Rivera, Hillary Stires, Mark Stewart, Jeff Allen
Friends of Cancer Research formed a multi-stakeholder partnership to assess available data attributes to measure response across RWD sources to inform development of a consistent method for measurement.
Rami S. Komrokji, Leyla Hernandez Donoso, Sejla Hodzic, Henry F Owusu, Kevin Nolan, Claire Nourry, Maria Diez-Campelo
Pts with higher-risk MDS have poor outcomes. To understand current tx patterns/identify unmet needs, the COTA database, using pt-level curated electronic health record (EHR) data from centers across the US, was analyzed.
Luciano J. Costa, Thomas William LeBlanc, Hans Tesch, Pieter Sonneveld, Ryan Kyle, Liliya Sinyavskaya, Patrick Hlavacek, Aster Meche, Jinma Ren, Alex Schepart, Didem Aydin, Marco DiBonaventura
A retrospective cohort study was conducted to indirectly compare the efficacy observed in MM-3 Cohort A (BCMA-naïve; N=123) from the 9-month data cut with two US-based oncology electronic health record databases, Flatiron Health (FH) and COTA, as external controls.
Javier Munoz, Alex Mutebi, Tongsheng Wang, Guihua Zhang, Junhua Yu, Jing He, Anindit Chibber, Rajesh Kamalakar, Monika P. Jun, Kelechi Adejumo, Shibing Yang, Anupama Kalsekar
In large B-cell lymphoma (LBCL) trials, racial and ethnic representation is difficult to determine due to underreporting in some regions, or because some patients may not provide data. Analyses of the distribution of different racial and ethnic categories were conducted across 6 real-world clinical practice databases from the United States (US): SEER-Medicare, COTA, Medicare, Optum Market Clarity, Optum CDM, and ConcertAI RWD.
Yolcar Chamorro, Reshma L. Mahtani, Shanada Monestime, Naomi Dempsey, Mukesh Roy, Muni B. Rubens, Manmeet Singh Ahluwalia, Ana Cristina Sandoval-Leon
A retrospective chart review was performed to include pts with HR+ HER2- MBC with a documented PIK3CA mutation (detected by ctDNA or tissue) treated with alpelisib in combination with fulvestrant at Miami Cancer Institute from 2019-2022. Pts were identified using pharmacy records and the COTA real-world database (RWD).
Sikander Ailawadhi, Ching-Kun Wang, Andrew J. Belli, Catarina Jansson Blixt, Diana Cripps, Stojan Zavisic, Karthik Ramasamy
Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. The single-arm, open-label, Phase 2 HORIZON study (NCT02963493), conducted in Europe and the USA, demonstrated in patients with heavily pre-treated relapsed/refractory multiple myeloma (RRMM), including those with triple-class-refractory and extramedullary disease, that melflufen in combination with dexamethasone showed clinically meaningful efficacy and a manageable safety profile (Richardson PG, et al. J Clin Oncol. 2021;39:757-767). Comparative trials between all regimens/agents are not feasible, and hence, real-world datasets may be valuable to allow the comparison of patient outcomes in single-arm clinical trials with similar patient populations in the real world. The objective of the REAL-world Myeloma (REALM) study was to compare clinical outcomes between patients in the COTA database and those of patients in the HORIZON study in order to compare routine care with melflufen.
Peter Feng Wang, Leah Sansbury, Maral DerSarkissian, Shannon Ferrante, Rachel Bhak, Boris Gorsh, Miriam L. Zichlin, Christopher W. Yee, Natalie Boytsov, Anamika Khanal, Prani Paka, Ahmed Noman, Mei Sheng Duh
Real-world data on treatment patterns and outcomes in patients with RRMM resistant to multiple drug classes are limited.
S. Ou, J. Hong, H. Lin, S. Vincent, E. Churchill, J. Soeda, P. Christopoulos, A. Stenzinger, M. Thomas
The population of EGFR exon 20 insertion (ex20ins) mutations includes a diverse array of insertion variants and represents 5%-10% of EGFR mutations in non–small cell lung cancer (NSCLC). Specific targeted therapies are not available for patients with EGFR ex20ins+ NSCLC, regardless of insertion variant status; however, mobocertinib and amivantamab are currently in development. Identifying patients with EGFR ex20ins is challenging due to the limited coverage of polymerase chain reaction (PCR) assays and relatively recent use of next-generation sequencing (NGS). The detection of insertion variants will become more important as more drugs targeting EGFR exon 20 are being developed. Here we describe the distribution of EGFR ex20ins variants in NSCLC patients in a global clinical trial and real-world data in the United States, Germany, and Japan, and evaluate the ability of PCR versus NGS to identify EGFR ex20ins in NSCLC.
Anna Rachel Minchom, Nicolas Girard, Lyudmila Bazhenova, Sai-Hong Ignatius Ou, Shirish M. Gadgeel, José Trigo, Santiago Viteri, Daniel Backenroth, Archan Bhattacharya, Tracy Li, Parthiv Mahadevia, Joshua Bauml
Amivantamab is an epidermal growth factor receptor (EGFR)-MET bispecific antibody with immune cell-directing activity. Amivantamab has demonstrated efficacy and safety in patients (pts) with EGFR exon 20 insertion (Exon20ins) in the ongoing CHRYSALIS phase 1 study in advanced non-small cell lung cancer (aNSCLC). Because CHRYSALIS is a non-randomized, single arm study, external controls (EC) can add valuable context in interpreting amivantamab’s efficacy and appreciating the unmet needs given real-world therapies. A protocol-driven treatment comparison was conducted of amivantamab vs real-world therapies in pts with Exon20ins aNSCLC who progressed after platinum chemotherapy.

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