Rivoceranib, a VEGFR-2 inhibitor, monotherapy in previously treated patients with advanced or metastatic gastric or gastroesophageal junction cancer (ANGEL study) : an international, randomized, placebo-controlled, phase 3 trial
© 2024. The Author(s)..
BACKGROUND: Rivoceranib is an oral, selective tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2. ANGEL (NCT03042611) was a global, randomized, double-blinded, placebo-controlled, phase 3 study evaluating rivoceranib as 3rd-line or ≥4th-line therapy in patients with advanced/metastatic gastric or gastroesophageal junction (GEJ) cancer.
METHODS: Patients had failed ≥2 lines of chemotherapy and were randomized 2:1 to rivoceranib 700 mg once daily or placebo with best supportive care.
PRIMARY ENDPOINT: overall survival (OS) in the intention-to-treat population. Secondary endpoints: progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) by blinded independent central review (BICR).
RESULTS: In total, 460 patients (rivoceranib n = 308, placebo n = 152) were enrolled. OS was not statistically different for rivoceranib versus placebo (median 5.78 vs. 5.13 months; hazard ratio [HR] 0.93, 95% CI 0.74-1.15; p = 0.4724). PFS by BICR (median 2.83 vs. 1.77 months; HR 0.58, 95% CI 0.47-0.71; p < 0.0001), ORR (6.5% vs. 1.3%; p = 0.0119), and DCR (40.3 vs. 13.2%; p < 0.0001) were improved with rivoceranib versus placebo. In patients receiving ≥4th-line therapy, OS (median 6.34 vs. 4.73 months; p = 0.0192) and PFS by BICR (median 3.52 vs. 1.71 months; p < 0.0001) were improved with rivoceranib versus placebo. The most common grade ≥ 3 treatment-emergent adverse events with rivoceranib were hypertension (17.9%), anemia (10.4%), aspartate aminotransferase increased (9.4%), asthenia (8.5%), and proteinuria (7.5%).
CONCLUSIONS: This study did not meet its primary OS endpoint. Compared to placebo, rivoceranib improved PFS, ORR, and DCR. Rivoceranib also improved OS in a prespecified patient subgroup receiving ≥4th-line therapy.
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2024 |
---|---|
Erschienen: |
2024 |
Enthalten in: |
Zur Gesamtaufnahme - volume:27 |
---|---|
Enthalten in: |
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association - 27(2024), 2 vom: 28. Feb., Seite 375-386 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Kang, Yoon-Koo [VerfasserIn] |
---|
Links: |
---|
Anmerkungen: |
Date Completed 28.02.2024 Date Revised 29.02.2024 published: Print-Electronic Citation Status MEDLINE |
---|
doi: |
10.1007/s10120-023-01455-5 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM367717050 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | NLM367717050 | ||
003 | DE-627 | ||
005 | 20240229234853.0 | ||
007 | cr uuu---uuuuu | ||
008 | 240129s2024 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1007/s10120-023-01455-5 |2 doi | |
028 | 5 | 2 | |a pubmed24n1311.xml |
035 | |a (DE-627)NLM367717050 | ||
035 | |a (NLM)38281295 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Kang, Yoon-Koo |e verfasserin |4 aut | |
245 | 1 | 0 | |a Rivoceranib, a VEGFR-2 inhibitor, monotherapy in previously treated patients with advanced or metastatic gastric or gastroesophageal junction cancer (ANGEL study) |b an international, randomized, placebo-controlled, phase 3 trial |
264 | 1 | |c 2024 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 28.02.2024 | ||
500 | |a Date Revised 29.02.2024 | ||
500 | |a published: Print-Electronic | ||
500 | |a Citation Status MEDLINE | ||
520 | |a © 2024. The Author(s). | ||
520 | |a BACKGROUND: Rivoceranib is an oral, selective tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2. ANGEL (NCT03042611) was a global, randomized, double-blinded, placebo-controlled, phase 3 study evaluating rivoceranib as 3rd-line or ≥4th-line therapy in patients with advanced/metastatic gastric or gastroesophageal junction (GEJ) cancer | ||
520 | |a METHODS: Patients had failed ≥2 lines of chemotherapy and were randomized 2:1 to rivoceranib 700 mg once daily or placebo with best supportive care | ||
520 | |a PRIMARY ENDPOINT: overall survival (OS) in the intention-to-treat population. Secondary endpoints: progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) by blinded independent central review (BICR) | ||
520 | |a RESULTS: In total, 460 patients (rivoceranib n = 308, placebo n = 152) were enrolled. OS was not statistically different for rivoceranib versus placebo (median 5.78 vs. 5.13 months; hazard ratio [HR] 0.93, 95% CI 0.74-1.15; p = 0.4724). PFS by BICR (median 2.83 vs. 1.77 months; HR 0.58, 95% CI 0.47-0.71; p < 0.0001), ORR (6.5% vs. 1.3%; p = 0.0119), and DCR (40.3 vs. 13.2%; p < 0.0001) were improved with rivoceranib versus placebo. In patients receiving ≥4th-line therapy, OS (median 6.34 vs. 4.73 months; p = 0.0192) and PFS by BICR (median 3.52 vs. 1.71 months; p < 0.0001) were improved with rivoceranib versus placebo. The most common grade ≥ 3 treatment-emergent adverse events with rivoceranib were hypertension (17.9%), anemia (10.4%), aspartate aminotransferase increased (9.4%), asthenia (8.5%), and proteinuria (7.5%) | ||
520 | |a CONCLUSIONS: This study did not meet its primary OS endpoint. Compared to placebo, rivoceranib improved PFS, ORR, and DCR. Rivoceranib also improved OS in a prespecified patient subgroup receiving ≥4th-line therapy | ||
650 | 4 | |a Randomized Controlled Trial | |
650 | 4 | |a Clinical Trial, Phase III | |
650 | 4 | |a Journal Article | |
650 | 4 | |a Stomach neoplasms | |
650 | 4 | |a Tyrosine protein kinase inhibitors | |
650 | 4 | |a Vascular endothelial growth factor receptor-2 | |
650 | 7 | |a Vascular Endothelial Growth Factor Receptor-2 |2 NLM | |
650 | 7 | |a EC 2.7.10.1 |2 NLM | |
650 | 7 | |a apatinib |2 NLM | |
650 | 7 | |a 5S371K6132 |2 NLM | |
650 | 7 | |a Vascular Endothelial Growth Factor A |2 NLM | |
650 | 7 | |a Pyridines |2 NLM | |
700 | 1 | |a Ryu, Min-Hee |e verfasserin |4 aut | |
700 | 1 | |a Di Bartolomeo, Maria |e verfasserin |4 aut | |
700 | 1 | |a Chau, Ian |e verfasserin |4 aut | |
700 | 1 | |a Yoon, Harry |e verfasserin |4 aut | |
700 | 1 | |a Kim, Jong Gwang |e verfasserin |4 aut | |
700 | 1 | |a Lee, Keun-Wook |e verfasserin |4 aut | |
700 | 1 | |a Oh, Sang Chul |e verfasserin |4 aut | |
700 | 1 | |a Takashima, Atsuo |e verfasserin |4 aut | |
700 | 1 | |a Kryzhanivska, Anna |e verfasserin |4 aut | |
700 | 1 | |a Chao, Yee |e verfasserin |4 aut | |
700 | 1 | |a Evesque, Ludovic |e verfasserin |4 aut | |
700 | 1 | |a Schenker, Michael |e verfasserin |4 aut | |
700 | 1 | |a McGinn, Arlo |e verfasserin |4 aut | |
700 | 1 | |a Zhao, Yufan |e verfasserin |4 aut | |
700 | 1 | |a Lee, Jennifer |e verfasserin |4 aut | |
700 | 1 | |a Wyrwicz, Lucjan |e verfasserin |4 aut | |
700 | 1 | |a Boku, Narikazu |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association |d 1998 |g 27(2024), 2 vom: 28. Feb., Seite 375-386 |w (DE-627)NLM115990356 |x 1436-3305 |7 nnns |
773 | 1 | 8 | |g volume:27 |g year:2024 |g number:2 |g day:28 |g month:02 |g pages:375-386 |
856 | 4 | 0 | |u http://dx.doi.org/10.1007/s10120-023-01455-5 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 27 |j 2024 |e 2 |b 28 |c 02 |h 375-386 |