1MO A phase IIIb study of savolitinib in patients with locally advanced or metastatic NSCLC harboring MET exon 14 mutation Article Swipe
Shun Lü
,
Qisen Guo
,
Nong Yang
,
Yisheng Zhang
,
Jian Fang
,
Diansheng Zhong
,
Liu B
,
Pinhua Pan
,
Dongqing Lv
,
Lin Wu
,
Yanqiu Zhao
,
J. Li
,
Zhongjun Liu
,
Chang Liu
,
Qi Song
,
Songhua Fan
,
Xiaoping Luo
,
Mei Shi
,
Wu‐Chou Su
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1016/j.esmoop.2024.102580
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1016/j.esmoop.2024.102580
Savolitinib is a potent and highly selective oral MET tyrosine-kinase inhibitor, approved in China for the treatment of NSCLC patients (pts) that have progressed following prior systemic therapy or are unable to receive chemotherapy with MET exon 14 mutation (METex14) based on the phase II study (NCT02897479). Here we report the primary analysis results from a phase IIIb confirmatory study (NCT04923945; data cut: Oct 20, 2023; follow-up: treatment-naïve ≥12 months, previously treated ≥6 months). Previously treated (≥2L) or treatment-naive (1L) pts with advanced or metastatic METex14 NSCLC were enrolled. Pts received savolitinib QD at 600 mg (≥50 kg) or 400 mg (<50 kg). The primary endpoint was ORR assessed by BIRC per RECIST 1.1. Secondary endpoints mainly included DCR, DoR, TTR, PFS and OS. For treatment-naïve pts (n=87; median age: 70 yrs; male: 58.6%; ECOG PS of 1: 81.6%; adenocarcinoma: 80.5%; PSC: 8.0%; brain metastasis: 11.5%), as assessed by BIRC, ORR was 62.1%, DCR was 92.0%; mPFS was 13.7 months and mOS was not reached with median follow-up 18.0 and 20.8 months, respectively. For previous treated pts (n=79; median age: 68.8 yrs; male: 57.0%; ECOG PS of 1: 87.3%; adenocarcinoma: 78.5%; PSC: 5.1%; brain metastasis: 26.6%), ORR was 39.2%, DCR was 92.4%; mPFS was 11.0 months and mOS was also immature with median follow-up 11.0 and 12.5 months, respectively (see details in Table). Study drug-related treatment-emergent adverse events of Grade ≥3 occurred in 100 pts (60.2%) from total 166 pts. The most common ones (≥5%) were hepatic function abnormal (16.9%), alanine aminotransferase increased (14.5%), aspartate aminotransferase increased (12.0%), gamma-glutamyltransferase increased (6.0%), and oedema peripheral (6.0%). Table: 1MOBIRC assessedTreatment-naïve n=87Previously treated n=79ORR, % (95% CI)62.1 (51.0, 72.3)39.2 (28.4, 50.9)DCR, % (95% CI)92.0 (84.1, 96.7)92.4 (84.2, 97.2)mDoR, mos (95% CI)12.5 (8.3, 15.2)11.1 (6.6, -)mTTR, mos (95% CI)1.4 (1.4, 1.5)1.6 (1.4, 2.7)mPFS, mos (95% CI)13.7 (8.5, 16.6)11.0 (8.3, 16.6) Open table in a new tab The data showed an encouraging efficacy and a tolerable safety profile of savolitinib in treatment for METex14-mutated NSCLC, offering a new standard treatment option for naïve and treated pts for this population.
Related Topics
Concepts
Exon
Medicine
Mutation
Internal medicine
Oncology
Cancer research
Phase (matter)
non-small cell lung cancer (NSCLC)
Lung cancer
Biology
Gene
Genetics
Chemistry
Organic chemistry
A549 cell
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1016/j.esmoop.2024.102580
- http://www.esmoopen.com/article/S205970292400348X/pdf
- OA Status
- gold
- Cited By
- 3
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4393165829
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4393165829Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1016/j.esmoop.2024.102580Digital Object Identifier
- Title
-
1MO A phase IIIb study of savolitinib in patients with locally advanced or metastatic NSCLC harboring MET exon 14 mutationWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-03-01Full publication date if available
- Authors
-
Shun Lü, Qisen Guo, Nong Yang, Yisheng Zhang, Jian Fang, Diansheng Zhong, Liu B, Pinhua Pan, Dongqing Lv, Lin Wu, Yanqiu Zhao, J. Li, Zhongjun Liu, Chang Liu, Qi Song, Songhua Fan, Xiaoping Luo, Mei Shi, Wu‐Chou SuList of authors in order
- Landing page
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https://doi.org/10.1016/j.esmoop.2024.102580Publisher landing page
- PDF URL
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https://www.esmoopen.com/article/S205970292400348X/pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
-
https://www.esmoopen.com/article/S205970292400348X/pdfDirect OA link when available
- Concepts
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Exon, Medicine, Mutation, Internal medicine, Oncology, Cancer research, Phase (matter), non-small cell lung cancer (NSCLC), Lung cancer, Biology, Gene, Genetics, Chemistry, Organic chemistry, A549 cellTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
3Total citation count in OpenAlex
- Citations by year (recent)
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2025: 1, 2024: 2Per-year citation counts (last 5 years)
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.with | 34, 81, 165, 211 |
| abstract_inverted_index.yrs; | 131, 181 |
| abstract_inverted_index.≥3 | 230 |
| abstract_inverted_index.≥6 | 72 |
| abstract_inverted_index.(1.4, | 295, 297 |
| abstract_inverted_index.(6.6, | 290 |
| abstract_inverted_index.(8.3, | 288, 304 |
| abstract_inverted_index.(8.5, | 302 |
| abstract_inverted_index.(pts) | 20 |
| abstract_inverted_index.16.6) | 305 |
| abstract_inverted_index.2023; | 65 |
| abstract_inverted_index.5.1%; | 192 |
| abstract_inverted_index.8.0%; | 142 |
| abstract_inverted_index.BIRC, | 149 |
| abstract_inverted_index.China | 13 |
| abstract_inverted_index.Grade | 229 |
| abstract_inverted_index.NSCLC | 18, 86 |
| abstract_inverted_index.Study | 223 |
| abstract_inverted_index.based | 40 |
| abstract_inverted_index.brain | 143, 193 |
| abstract_inverted_index.male: | 132, 182 |
| abstract_inverted_index.phase | 43, 56 |
| abstract_inverted_index.prior | 25 |
| abstract_inverted_index.study | 45, 59 |
| abstract_inverted_index.table | 307 |
| abstract_inverted_index.total | 237 |
| abstract_inverted_index.≥12 | 68 |
| abstract_inverted_index.(28.4, | 276 |
| abstract_inverted_index.(51.0, | 274 |
| abstract_inverted_index.(84.1, | 281 |
| abstract_inverted_index.(84.2, | 283 |
| abstract_inverted_index.(n=79; | 177 |
| abstract_inverted_index.(n=87; | 127 |
| abstract_inverted_index.(≥50 | 96 |
| abstract_inverted_index.39.2%, | 198 |
| abstract_inverted_index.57.0%; | 183 |
| abstract_inverted_index.58.6%; | 133 |
| abstract_inverted_index.62.1%, | 152 |
| abstract_inverted_index.78.5%; | 190 |
| abstract_inverted_index.80.5%; | 140 |
| abstract_inverted_index.81.6%; | 138 |
| abstract_inverted_index.87.3%; | 188 |
| abstract_inverted_index.92.0%; | 155 |
| abstract_inverted_index.92.4%; | 201 |
| abstract_inverted_index.CI)1.4 | 294 |
| abstract_inverted_index.NSCLC, | 329 |
| abstract_inverted_index.RECIST | 112 |
| abstract_inverted_index.Table: | 265 |
| abstract_inverted_index.common | 242 |
| abstract_inverted_index.events | 227 |
| abstract_inverted_index.highly | 5 |
| abstract_inverted_index.mainly | 116 |
| abstract_inverted_index.median | 128, 166, 178, 212 |
| abstract_inverted_index.months | 159, 205 |
| abstract_inverted_index.naïve | 337 |
| abstract_inverted_index.oedema | 262 |
| abstract_inverted_index.option | 335 |
| abstract_inverted_index.potent | 3 |
| abstract_inverted_index.report | 49 |
| abstract_inverted_index.safety | 321 |
| abstract_inverted_index.showed | 314 |
| abstract_inverted_index.unable | 30 |
| abstract_inverted_index.(6.0%), | 260 |
| abstract_inverted_index.(6.0%). | 264 |
| abstract_inverted_index.(60.2%) | 235 |
| abstract_inverted_index.(≥2L) | 76 |
| abstract_inverted_index.(≥5%) | 244 |
| abstract_inverted_index.-)mTTR, | 291 |
| abstract_inverted_index.1.5)1.6 | 296 |
| abstract_inverted_index.11.5%), | 145 |
| abstract_inverted_index.1MOBIRC | 266 |
| abstract_inverted_index.26.6%), | 195 |
| abstract_inverted_index.CI)12.5 | 287 |
| abstract_inverted_index.CI)13.7 | 301 |
| abstract_inverted_index.CI)62.1 | 273 |
| abstract_inverted_index.CI)92.0 | 280 |
| abstract_inverted_index.METex14 | 85 |
| abstract_inverted_index.Table). | 222 |
| abstract_inverted_index.adverse | 226 |
| abstract_inverted_index.alanine | 250 |
| abstract_inverted_index.details | 220 |
| abstract_inverted_index.hepatic | 246 |
| abstract_inverted_index.months, | 69, 171, 217 |
| abstract_inverted_index.primary | 51, 104 |
| abstract_inverted_index.profile | 322 |
| abstract_inverted_index.reached | 164 |
| abstract_inverted_index.receive | 32 |
| abstract_inverted_index.results | 53 |
| abstract_inverted_index.therapy | 27 |
| abstract_inverted_index.treated | 71, 75, 175, 269, 339 |
| abstract_inverted_index.(12.0%), | 257 |
| abstract_inverted_index.(14.5%), | 253 |
| abstract_inverted_index.(16.9%), | 249 |
| abstract_inverted_index.abnormal | 248 |
| abstract_inverted_index.advanced | 82 |
| abstract_inverted_index.analysis | 52 |
| abstract_inverted_index.approved | 11 |
| abstract_inverted_index.assessed | 108, 147 |
| abstract_inverted_index.efficacy | 317 |
| abstract_inverted_index.endpoint | 105 |
| abstract_inverted_index.function | 247 |
| abstract_inverted_index.immature | 210 |
| abstract_inverted_index.included | 117 |
| abstract_inverted_index.months). | 73 |
| abstract_inverted_index.mutation | 38 |
| abstract_inverted_index.n=79ORR, | 270 |
| abstract_inverted_index.occurred | 231 |
| abstract_inverted_index.offering | 330 |
| abstract_inverted_index.patients | 19 |
| abstract_inverted_index.previous | 174 |
| abstract_inverted_index.received | 90 |
| abstract_inverted_index.standard | 333 |
| abstract_inverted_index.systemic | 26 |
| abstract_inverted_index.(METex14) | 39 |
| abstract_inverted_index.15.2)11.1 | 289 |
| abstract_inverted_index.16.6)11.0 | 303 |
| abstract_inverted_index.2.7)mPFS, | 298 |
| abstract_inverted_index.50.9)DCR, | 277 |
| abstract_inverted_index.72.3)39.2 | 275 |
| abstract_inverted_index.96.7)92.4 | 282 |
| abstract_inverted_index.Secondary | 114 |
| abstract_inverted_index.aspartate | 254 |
| abstract_inverted_index.endpoints | 115 |
| abstract_inverted_index.enrolled. | 88 |
| abstract_inverted_index.follow-up | 167, 213 |
| abstract_inverted_index.following | 24 |
| abstract_inverted_index.increased | 252, 256, 259 |
| abstract_inverted_index.selective | 6 |
| abstract_inverted_index.tolerable | 320 |
| abstract_inverted_index.treatment | 16, 326, 334 |
| abstract_inverted_index.97.2)mDoR, | 284 |
| abstract_inverted_index.Previously | 74 |
| abstract_inverted_index.follow-up: | 66 |
| abstract_inverted_index.inhibitor, | 10 |
| abstract_inverted_index.metastatic | 84 |
| abstract_inverted_index.peripheral | 263 |
| abstract_inverted_index.previously | 70 |
| abstract_inverted_index.progressed | 23 |
| abstract_inverted_index.Savolitinib | 0 |
| abstract_inverted_index.encouraging | 316 |
| abstract_inverted_index.metastasis: | 144, 194 |
| abstract_inverted_index.population. | 343 |
| abstract_inverted_index.savolitinib | 91, 324 |
| abstract_inverted_index.chemotherapy | 33 |
| abstract_inverted_index.confirmatory | 58 |
| abstract_inverted_index.drug-related | 224 |
| abstract_inverted_index.respectively | 218 |
| abstract_inverted_index.(NCT04923945; | 60 |
| abstract_inverted_index.respectively. | 172 |
| abstract_inverted_index.(NCT02897479). | 46 |
| abstract_inverted_index.n=87Previously | 268 |
| abstract_inverted_index.METex14-mutated | 328 |
| abstract_inverted_index.adenocarcinoma: | 139, 189 |
| abstract_inverted_index.treatment-naive | 78 |
| abstract_inverted_index.tyrosine-kinase | 9 |
| abstract_inverted_index.aminotransferase | 251, 255 |
| abstract_inverted_index.treatment-naïve | 67, 125 |
| abstract_inverted_index.treatment-emergent | 225 |
| abstract_inverted_index.assessedTreatment-naïve | 267 |
| abstract_inverted_index.gamma-glutamyltransferase | 258 |
| cited_by_percentile_year.max | 96 |
| cited_by_percentile_year.min | 91 |
| countries_distinct_count | 1 |
| institutions_distinct_count | 19 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.8299999833106995 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.83837784 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |