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Observational Study
. 2025 Feb;14(3):e70369.
doi: 10.1002/cam4.70369.

Patterns of Treatment and Real-World Outcomes of Patients With Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Receiving Mobocertinib: The EXTRACT Study

Geoffrey Liu  1 , Shi Feng Nyaw  2 , Tony S K Mok  3 , Hubert Curcio  4 , Alexis B Cortot  5 , Tsz Yeung Kam  6 , Renaud Descourt  7 , Yin Kwan Chik  8 , Parneet Cheema  9 , James M Gwinnutt  10 , Eric N Churchill  11 , Justin Nyborn  12 , Eileen Curran  13 , Alexandra Savell  12 , Yu Yin  14 , Katie Chong  15 , Yuka Tanaka-Chambers  16 , Julian Kretz  17 , Jacques Cadranel  18
Affiliations
Observational Study

Patterns of Treatment and Real-World Outcomes of Patients With Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations Receiving Mobocertinib: The EXTRACT Study

Geoffrey Liu et al. Cancer Med. 2025 Feb.

Abstract

Background: Real-world data regarding patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations receiving mobocertinib are limited. This study describes these patients' characteristics and outcomes.

Methods: A chart review was conducted across three countries (Canada, France, and Hong Kong), abstracting data from eligible patients (NCT05207423). The inclusion criteria were: ≥ 18 years old; diagnosis of stage IIIB-IV NSCLC with EGFR ex20ins between January 1, 2017 and November 30, 2021; received mobocertinib. Data on demographics, clinical parameters, treatment patterns, mobocertinib exposure, real-world outcomes, and adverse events (AEs) were collected. Results are also reported by Asian/Non-Asian races.

Results: Overall, 105 patients were enrolled (median [IQR] age at initial diagnosis: 64.0 years [56, 71]; women: 62.9%). The most common first-line of therapy (LoT) was chemotherapy; the most common second LoT was EGFR tyrosine kinase inhibitors. Most patients received mobocertinib during LoT two and three (74.3%); the maximum dose was 160 mg/day for 67.6% of the cohort (mean [SD] daily dose: 130.6 mg [36.68]). The median real-world progression-free survival (PFS) on mobocertinib was 4.76 months (95% CI: 3.98, 6.21). The overall response rate and disease control rate were 20.0% and 48.6%, respectively (median duration of response: 8.34 months [95% CI: 3.61, 9.49]). The median overall survival (OS) was 26.28 months (95% CI: 20.21, 36.44). Asian patients had numerically superior PFS and OS compared with non-Asian patients. Regarding safety analysis, 73 patients (69.5%) experienced any AE. The most common AE was diarrhea (any grade) (52 patients; 49.5%).

Conclusions: These data illustrate the real-world effectiveness of mobocertinib.

Keywords: EGFR exon 20 insertion; mobocertinib; non‐small cell lung cancer; real‐world outcomes.

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Conflict of interest statement

Geoffrey Liu has received honoraria from and served on advisory boards for Takeda, Amgen, AstraZeneca, Roche, Novartis, Merck, Pfizer, Jazz Pharmaceuticals, Bristol Myers Squibb, Anheart, Eli Lilly, EMD Serono, Bayer, and Jansen and has received research grants from Takeda, AstraZeneca, Amgen, Boehringer Ingelheim, Bayer, EMD Serono, and Pfizer. Shi Feng Nyaw reports no conflict of interest. Tony S. K. Mok has acted in a consulting or advisory role for AbbVie, ACEA Pharma, Alpha Biopharma, Amgen, Amoy Diagnostics, AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Blueprint Medicines, CStone Pharmaceuticals, Daiichi Sankyo, Eisai, Fishawack Facilitate, GeneDecode, Gritstone Oncology Inc., Guardant Health, Hengrui Therapeutics, Ignyta Inc., IQVIA, Incyte, Janssen, Lilly, Loxo Oncology, Lunit USA, Merck Serono, Merck Sharp & Dohme, Mirati Therapeutics, MORE Health, Novartis, OrigiMed, Pfizer, Puma Biotechnology, Roche, Sanofi‐Aventis R&D, Takeda, Virtus Medical Group, Yuhan Corp., SFJ Pharmaceuticals, Curio Science, Inivata, Berry Oncology, G1 Therapeutics Inc., Qiming Development (HK) Ltd., Gilead Sciences, Vertex Pharmaceuticals, Covidien LP, Elevation Oncology, and C4 Therapeutics; has been an invited speaker for ACEA Pharma, Alpha Biopharma, Amgen, Amoy Diagnostics, AstraZeneca, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Fishawack Facilitate, GeneDecode, InMed Medical Communication, Janssen, Eli Lilly, Lunit USA, MD Health, Medscape/WebMD, Merck Serono, Merck Sharp & Dohme, Novartis, OrigiMed, PeerVoice, Physicians' Education Resource, P. Permanyer SL, Pfizer, PrIME Oncology, Research to Practice, Roche, Sanofi‐Aventis R&D, Takeda, Touch Medical Media, Daz Group, Lucence Health, Merck Pharmaceuticals HK Ltd., Shanghai BeBirds Translation & Consulting Co., Llangylhul Network Technology Co., and Taiho; has served as a member of the board of directors for Lunit USA, AstraZeneca PLC, Hutchison Chi‐Med, Act Genomics‐Sanomics Group, and Aurora; reports stock ownership for Hutchison Chi‐Med, Act Genomics‐Sanomics Group, and Aurora; and has received funding from Clovis Oncology and Xcovery. Hubert Curcio reports honoraria from and advisory board participation for AstraZeneca, Bristol Myers Squibb, and Takeda and registration fees and accommodation from Sandoz and GlaxoSmithKline. Alexis B. Cortot has been an invited speaker for Pfizer, Amgen, Takeda, Novartis, Roche, AstraZeneca, Merck Sharp & Dohme, Janssen, Bristol Myers Squibb, and Sanofi; acted in a consulting or advisory role for Novartis, AbbVie, Roche, Exeliom, Pfizer, Janssen, Amgen, Takeda, AstraZeneca, and Merck Sharp & Dohme; received research funding of institution from Exeliom; received support for attending meetings from Roche, Merck Sharp & Dohme, Novartis, Pfizer, AstraZeneca, Amgen, and Bristol Myers Squibb; and participated on DMSB for InhaTarget and Merck. Tsz Yeung Kam reports no conflict of interest. Renaud Descourt has served on the advisory boards for AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Pfizer, Sanofi, and Takeda. Yin Kwan Chik reports no conflict of interest. Parneet Cheema has served on the advisory boards for Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Novartis, Roche, Pfizer, Janssen, Merck, Sanofi, and GlaxoSmithKline, and has received honoraria from GlaxoSmithKline, Janssen, Sanofi, Merck, and Amgen. James M. Gwinnutt is an employee of IQVIA. Eric N. Churchill is an employee of Takeda. Justin Nyborn is an employee of Takeda. Eileen Curran reports former employment with Takeda. Alexandra Savell is an employee of Takeda. Yu Yin is an employee of Takeda. Katie Chong is an employee of Takeda. Yuka Tanaka‐Chambers reports former employment with Takeda. Julian Kretz reports former employment with Takeda. Jacques Cadranel has served on advisory boards for Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and Takeda.

Figures

FIGURE 1
FIGURE 1
Sankey plot of the first three LoTs, by regimen category. The Sankey plot illustrates the proportions of patients receiving combinations of each regimen category at each LoT, from LoT 1 to LoT 3, as well as the treatment patterns. Each combination of regimen categories is represented by a unique color, and the nodes (bars) are labeled. The drugs that comprise each regimen category are listed in the Methods section. The LoT is listed at the top of each column and also indicated in square brackets in the node labels. The size of each node in each LoT column is proportional to the number of patients receiving that combination of regimen categories during that LoT. The gray paths between nodes are proportional to the number of patients who changed from one combination of regimen categories to another between LoTs and represent the patient's journey between different regimens. The Sankey plot represents treatment patterns for systemic anticancer therapies. Radiotherapy and surgery are not included. EGFR TKI = epidermal growth factor receptor tyrosine kinase inhibitor; IO agents = immuno‐oncologic agents; LoT = line of therapy.
See this image and copyright information in PMC

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