Avelumab Plus Axitinib as First-Line Therapy for Advanced Renal Cell Carcinoma : Long-Term Results from the JAVELIN Renal 100 Phase Ib Trial
© The Author(s) 2022. Published by Oxford University Press..
BACKGROUND: Progression-free survival was significantly longer in patients who received avelumab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma (aRCC) in a randomized phase III trial. We report long-term safety and efficacy of avelumab plus axitinib as first-line treatment for patients with aRCC from the JAVELIN Renal 100 phase Ib trial (NCT02493751).
MATERIALS AND METHODS: In this open-label, multicenter, phase Ib study, patients with untreated aRCC received avelumab 10 mg/kg every 2 weeks plus axitinib 5 mg twice daily or with axitinib for 7 days followed by avelumab plus axitinib. Safety and efficacy were assessed in all patients receiving at least one dose of avelumab or axitinib.
RESULTS: Overall, 55 patients were enrolled and treated. Median follow-up was 55.7 months (95% CI, 54.5-58.7). Treatment-related adverse events of any grade or grade ≥3 occurred in 54 (98.2%) and 34 (61.8%) patients, respectively. The confirmed objective response rate was 60.0% (95% CI, 45.9-73.0), including complete response in 10.9% of patients. Median duration of response was 35.9 months (95% CI, 12.7-52.9); the probability of response was 65.8% (95% CI, 46.7-79.4) at 2 years. Median progression-free survival was 8.3 months (95% CI, 5.3-32.0). Median overall survival was not reached (95% CI, 40.8-not estimable); the 5-year overall survival rate was 57.3% (95% CI, 41.2-70.5).
CONCLUSION: Five-year follow-up for combination treatment with avelumab plus axitinib in previously untreated patients with aRCC showed long-term clinical activity with no new safety signals, supporting use of this regimen within its approved indication in clinical practice (Clinicaltrials.gov NCT02493751).
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:28 |
|---|---|
| Enthalten in: |
The oncologist - 28(2023), 4 vom: 06. Apr., Seite 333-340 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Larkin, James [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 10.04.2023 Date Revised 26.04.2023 published: Print ClinicalTrials.gov: NCT02493751 Citation Status MEDLINE |
|---|
| doi: |
10.1093/oncolo/oyac243 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM350875863 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM350875863 | ||
| 003 | DE-627 | ||
| 005 | 20231226045958.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/oncolo/oyac243 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1169.xml |
| 035 | |a (DE-627)NLM350875863 | ||
| 035 | |a (NLM)36576173 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Larkin, James |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Avelumab Plus Axitinib as First-Line Therapy for Advanced Renal Cell Carcinoma |b Long-Term Results from the JAVELIN Renal 100 Phase Ib Trial |
| 264 | 1 | |c 2023 | |
| 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 10.04.2023 | ||
| 500 | |a Date Revised 26.04.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02493751 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2022. Published by Oxford University Press. | ||
| 520 | |a BACKGROUND: Progression-free survival was significantly longer in patients who received avelumab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma (aRCC) in a randomized phase III trial. We report long-term safety and efficacy of avelumab plus axitinib as first-line treatment for patients with aRCC from the JAVELIN Renal 100 phase Ib trial (NCT02493751) | ||
| 520 | |a MATERIALS AND METHODS: In this open-label, multicenter, phase Ib study, patients with untreated aRCC received avelumab 10 mg/kg every 2 weeks plus axitinib 5 mg twice daily or with axitinib for 7 days followed by avelumab plus axitinib. Safety and efficacy were assessed in all patients receiving at least one dose of avelumab or axitinib | ||
| 520 | |a RESULTS: Overall, 55 patients were enrolled and treated. Median follow-up was 55.7 months (95% CI, 54.5-58.7). Treatment-related adverse events of any grade or grade ≥3 occurred in 54 (98.2%) and 34 (61.8%) patients, respectively. The confirmed objective response rate was 60.0% (95% CI, 45.9-73.0), including complete response in 10.9% of patients. Median duration of response was 35.9 months (95% CI, 12.7-52.9); the probability of response was 65.8% (95% CI, 46.7-79.4) at 2 years. Median progression-free survival was 8.3 months (95% CI, 5.3-32.0). Median overall survival was not reached (95% CI, 40.8-not estimable); the 5-year overall survival rate was 57.3% (95% CI, 41.2-70.5) | ||
| 520 | |a CONCLUSION: Five-year follow-up for combination treatment with avelumab plus axitinib in previously untreated patients with aRCC showed long-term clinical activity with no new safety signals, supporting use of this regimen within its approved indication in clinical practice (Clinicaltrials.gov NCT02493751) | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase I | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a clinical trials as topic | |
| 650 | 4 | |a drug therapy | |
| 650 | 4 | |a immunotherapy | |
| 650 | 4 | |a kidney neoplasms | |
| 650 | 7 | |a Axitinib |2 NLM | |
| 650 | 7 | |a C9LVQ0YUXG |2 NLM | |
| 650 | 7 | |a avelumab |2 NLM | |
| 650 | 7 | |a KXG2PJ551I |2 NLM | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 700 | 1 | |a Oya, Mototsugu |e verfasserin |4 aut | |
| 700 | 1 | |a Martignoni, Marcella |e verfasserin |4 aut | |
| 700 | 1 | |a Thistlethwaite, Fiona |e verfasserin |4 aut | |
| 700 | 1 | |a Nathan, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Ornstein, Moshe C |e verfasserin |4 aut | |
| 700 | 1 | |a Powles, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Beckermann, Kathryn E |e verfasserin |4 aut | |
| 700 | 1 | |a Balar, Arjun V |e verfasserin |4 aut | |
| 700 | 1 | |a McDermott, David |e verfasserin |4 aut | |
| 700 | 1 | |a Gupta, Sumati |e verfasserin |4 aut | |
| 700 | 1 | |a Philips, George K |e verfasserin |4 aut | |
| 700 | 1 | |a Gordon, Michael S |e verfasserin |4 aut | |
| 700 | 1 | |a Uemura, Hirotsugu |e verfasserin |4 aut | |
| 700 | 1 | |a Tomita, Yoshihiko |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Jing |e verfasserin |4 aut | |
| 700 | 1 | |a Michelon, Elisabete |e verfasserin |4 aut | |
| 700 | 1 | |a di Pietro, Alessandra |e verfasserin |4 aut | |
| 700 | 1 | |a Choueiri, Toni K |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t The oncologist |d 1998 |g 28(2023), 4 vom: 06. Apr., Seite 333-340 |w (DE-627)NLM095483306 |x 1549-490X |7 nnns |
| 773 | 1 | 8 | |g volume:28 |g year:2023 |g number:4 |g day:06 |g month:04 |g pages:333-340 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1093/oncolo/oyac243 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 28 |j 2023 |e 4 |b 06 |c 04 |h 333-340 | ||