ライフサイエンスコーパス: avelumab

1 sistent with known safety profiles of SG and avelumab.

2 .6% with avelumab + cetuximab and 21.4% with avelumab.

3 compared three versus six cycles followed by avelumab.

4 Treatment consisted of axitinib and avelumab.

5 m patients who received at least one dose of avelumab.

6 s were enrolled and initiated treatment with avelumab.

7 l patients who received at least one dose of avelumab.

8 those expressing PD-L1, after treatment with avelumab.

9 e enrolled and received at least one dose of avelumab.

10 IN Solid Tumor trial) assessed four doses of avelumab (1 mg/kg, 3 mg/kg, 10 mg/kg, and 20 mg/kg), wit

11 Patients received avelumab 10 mg/kg intravenously every 2 weeks and axitin

12 ion after single-agent chemotherapy received avelumab 10 mg/kg intravenously every 2 weeks until huma

13 and unselected for PD-L1 expression received avelumab 10 mg/kg intravenously every 2 weeks.

14 Avelumab 10 mg/kg intravenously was administered every 2

15 Patients received avelumab (10 mg/kg every 2 weeks) and cetuximab (400 mg/

16 :1:1) via interactive response technology to avelumab (10 mg/kg intravenously every 2 weeks), aveluma

17 elumab maintenance group); chemotherapy plus avelumab (10 mg/kg intravenously every 3 weeks) followed

18 nts unselected for PD-L1 expression received avelumab (10 mg/kg, 1 h intravenous infusion) every 2 we

19 Talazoparib, 1 mg, orally, daily, and avelumab, 10 mg/kg, intravenously, every 2 weeks, were a

20 rimental therapy (48 received cetuximab plus avelumab, 26 received trifluridine-tipiracil plus panitu

21 st-line PBC were randomized 2 : 1 to receive avelumab (800 mg every 2 weeks) plus SG (10 mg/kg on day

22 ce A091802 is a randomized phase II trial of avelumab (800 mg IV once every 2 weeks) plus cetuximab (

23 ssessed the safety and antitumor activity of avelumab, a fully human anti-programmed death-ligand 1 (

24 Avelumab, a human Ig-G1 monoclonal antibody targeting PD

25 Avelumab, a human monoclonal anti-PD-L1 antibody, has sh

26 cetuximab significantly improved PFS versus avelumab alone in patients with advanced cSCC.

27 b (500 mg/m(2) IV once every 2 weeks) versus avelumab alone once every 2 weeks for up to 2 years.

28 We report results of avelumab alone or avelumab plus pegylated liposomal doxo

29 patients, with the objective to show whether avelumab alone or avelumab plus PLD is superior to PLD.

30 Neither avelumab plus PLD nor avelumab alone significantly improved progression-free s

31 We assessed treatment with avelumab, an anti-PD-L1 monoclonal antibody, in patients

32 The A-BRAVE trial evaluated the efficacy of avelumab, an anti-programmed death-ligand 1 (PD-L1) anti

33 astatic MCC, who was resistant to first-line avelumab and acquired resistance to ipilimumab/nivolumab

34 Moreover, avelumab and cetuximab enhanced macrophage-mediated phag

35 The 3-year OS estimates for avelumab and control arm were 84.8% (95% CI 79.5% to 88.

36 2.9%) and 19.4% (95% CI, 10.6%-30.2%) in the avelumab and control groups, respectively, and 27.4% (95

37 esults Forty-four patients were treated with avelumab and followed for a median of 16.5 months (inter

38 Avelumab and JQ1 treatments alone or in combination led

39 controlled trial suggest that treatment with avelumab and talazoparib demonstrated a favorable toxic

40 ed with clinical benefit from treatment with avelumab and talazoparib.

41 um therapy and cisplatin-naive) treated with avelumab and to assess antitumour activity of this drug

42 combined a checkpoint inhibitor anti-PD-L1 (Avelumab) and recombinant human interleukin-15 (rhIL-15)

43 pression and its saturation by atezolizumab, avelumab, and durvalumab can be quantified independently

44 argeted monoclonal antibodies (atezolizumab, avelumab, and durvalumab) and a high-affinity PD-L1-bind

45 gagement with anti-PD-L1 mAbs (atezolizumab, avelumab, and durvalumab) that were administered at equi

46 ll grade 3; four patients (12%) discontinued avelumab, and nine patients (26%) underwent axitinib dos

47 ious adverse event related to treatment with avelumab, and one treatment-related death occurred (pneu

48 e phase 3 JAVELIN Ovarian 100 trial compared avelumab (anti-PD-L1 monoclonal antibody) in combination

49 Avelumab (anti-PD-L1) induces NK cell-mediated cytotoxic

50 We aimed to assess if addition of avelumab (anti-PD-L1) to chemoradiotherapy could improve

51 The approval of the anti-PD-L1 antibody avelumab as maintenance therapy for patients without ini

52 ved ramucirumab at 8 mg/kg on days 1 and 15, avelumab at 10 mg/kg on days 1 and 15, and paclitaxel at

53 nment to the two chemotherapy groups without avelumab at the time of randomisation until completion o

54 Avelumab + axitinib provided long-term efficacy benefits

55 ial (NCT02684006), first-line treatment with avelumab + axitinib resulted in significantly longer pro

56 ation was 59.7% (95% CI 55.0% to 64.3%) with avelumab + axitinib versus 32.0% (95% CI 27.7% to 36.5%)

57 tigator-assessed PFS remained prolonged with avelumab + axitinib versus sunitinib [5-year event-free

58 OS analyses favored avelumab + axitinib versus sunitinib but did not reach s

59 gression-free survival (PFS) with first-line avelumab + axitinib versus sunitinib in advanced renal c

60 The median OS with avelumab + axitinib versus sunitinib, respectively, was

61 status was prognostic but not predictive for avelumab benefit in terms of DFS (test for interaction P

62 cancer (JAVELIN Bladder 100; NCT02603432 ), avelumab/best supportive care (BSC) significantly prolon

63 ved 1 or more doses of an ICI (atezolizumab, avelumab, cemiplimab, durvalumab, ipilimumab, nivolumab,

64 All patients received an ICI (atezolizumab, avelumab, cemiplimab, durvalumab, ipilimumab, nivolumab,

65 occurred in 48.3% and 21.5% of patients with avelumab + cetuximab (most common: rash [20.7%], infusio

66 The confirmed ORR was 27.6% with avelumab + cetuximab and 21.4% with avelumab.

67 Cetuximab was given for 1 year in the avelumab + cetuximab arm.

68 Avelumab + cetuximab significantly improved PFS versus a

69 Avelumab + cetuximab significantly improved PFS versus a

70 Crossover at progression to avelumab + cetuximab was allowed.

71 l fibrillation) and one (<1%) patient in the avelumab combination group (due to disease progression).

72 y 3 weeks) followed by avelumab maintenance (avelumab combination group); or chemotherapy followed by

73 enance group, 11.0 months (7.4-14.5) for the avelumab combination group, and 10.2 months (6.7-14.0) f

74 avelumab maintenance group, 63 [19%] in the avelumab combination group, and 53 [16%] in the control

75 avelumab maintenance group, 118 (36%) in the avelumab combination group, and 64 (19%) in the control

76 ndomly assigned (avelumab maintenance n=332, avelumab combination n=331, and control n=335).

77 1.14 (0.83-1.56; one-sided p=0.79) with the avelumab combination regimen, versus control treatment.

78 Together, these data indicate that rhIL-15/avelumab combination therapy could be a useful strategy

79 umab maintenance, 18.1 months (14.8-NE) with avelumab combination treatment, and NE (18.2 months-NE)

80 Avelumab combined with axitinib has promising anti-tumou

81 acy and safety of maintenance treatment with avelumab combined with other antitumor agents versus ave

82 s of platinum-based chemotherapy followed by avelumab continues to be used in some circumstances in a

83 Avelumab could be a new therapeutic option, particularly

84 ollow-up was 25 months, and median number of avelumab cycles was 8 (range, 2-11).

85 %) had hCG normalization after a median of 9 avelumab cycles; none subsequently relapsed.

86 At a median follow-up of 52.1 months, avelumab did not significantly improve DFS in the ITT po

87 d to receive standard second-line therapy or avelumab every 2 weeks until progression, unacceptable t

88 Avelumab exhibited promising activity in MMRD EC regardl

89 (F + P), or fulvestrant plus palbociclib and avelumab (F + P + A).

90 Avelumab first-line maintenance is a recommended treatme

91 ts were eligible and received treatment with avelumab for a median of 12 weeks (IQR 6.0-19.7) and fol

92 ly 17 patients; of 15 patients who initiated avelumab, four exhibited OR (one complete response, thre

93 e PLD group, and 1.9 months (1.8-1.9) in the avelumab group (combination vs PLD: stratified HR 0.78 [

94 PLD group, and 11.8 months (8.9-14.1) in the avelumab group (combination vs PLD: stratified HR 0.89 [

95 deaths occurred in two (1%) patients in the avelumab group (due to general disorders and site condit

96 e patient each in the PLD group (sepsis) and avelumab group (intestinal obstruction).

97 , 697 patients were randomly assigned to the avelumab group (n=350) or the placebo group (n=347).

98 rvival was 14.6 months (IQR 8.5-19.6) in the avelumab group and 14.8 months (11.6-18.8) in the placeb

99 events occurred in 124 (36%) patients in the avelumab group and in 109 (32%) patients in the placebo

100 ed (95% CI 16.9 months-not estimable) in the avelumab group and not reached (23.0 months-not estimabl

101 ents with disease control, 18 (75.7%) in the avelumab group compared with 9 (19.1%) in the control gr

102 ed adverse events of at least grade 3 in the avelumab group than in the chemotherapy group (20 [31.7%

103 neutropenia (57 [16%] of 348 patients in the avelumab group vs 52 [15%] of 344 patients in the placeb

104 tion of 70 Gy [35 fractions during 7 weeks]; avelumab group) or placebo plus chemoradiotherapy (place

105 vs nine [5%] in the PLD group vs none in the avelumab group), rash (11 [6%] vs three [2%] vs none), f

106 9 (11%) in the PLD group, and 14 (7%) in the avelumab group.

107 D group, and 18.2 months (15.8-21.2) for the avelumab group.

108 ith single-agent chemotherapy-resistant GTT, avelumab had a favorable safety profile and cured approx

109 INTERPRETATION: Avelumab has an acceptable toxicity profile up to 20 mg/

110 provide the rationale for therapeutic use of avelumab in metastatic urothelial carcinoma and it has r

111 The activity of avelumab in MMRP/non-POLE-mutated ECs was low.

112 VEGFR inhibitor axitinib and PD-L1 inhibitor avelumab in patients with recurrent/metastatic adenoid c

113 establish the safety and pharmacokinetics of avelumab in patients with solid tumours while assessing

114 Seventy-four percent of patients received avelumab in the 3C arm, versus 56% in the 6C arm.

115 observed, results do not support the use of avelumab in the frontline treatment setting.

116 providing a rationale for further studies of avelumab in this disease setting.

117 phase II study evaluated the PD-L1 inhibitor avelumab in two cohorts of patients with EC: (1) MMRD/PO

118 The TROPHIMMUN trial assessed avelumab in women with chemotherapy-resistant GTT.

119 ligand 1 (PD-L1) by an anti-PD-L1 antibody (avelumab) in combination with recombinant human interleu

120 text of weekly administration of anti-PD-L1 (Avelumab) in SIV-infected RM receiving combination antir

121 ponse technology system) to receive 10 mg/kg avelumab intravenously every 2 weeks plus chemoradiother

122 rm phase 2 trial suggest that cetuximab plus avelumab is an active, well tolerated rechallenge therap

123 cles of chemotherapy followed by maintenance avelumab is associated with better QoL than six cycles.

124 parable to the atezolizumab, durvalumab, and avelumab licensed monoclonal antibodies targeting PD-L1.

125 a week [investigators' choice]) followed by avelumab maintenance (10 mg/kg intravenously every 2 wee

126 /kg intravenously every 3 weeks) followed by avelumab maintenance (avelumab combination group); or ch

127 deaths occurred in one (<1%) patient in the avelumab maintenance group (due to atrial fibrillation)

128 nance (10 mg/kg intravenously every 2 weeks; avelumab maintenance group); chemotherapy plus avelumab

129 QR 7.1-14.9); 11.1 months (7.0-15.3) for the avelumab maintenance group, 11.0 months (7.4-14.5) for t

130 y grade occurred in 92 (28%) patients in the avelumab maintenance group, 118 (36%) in the avelumab co

131 vents were anaemia (69 [21%] patients in the avelumab maintenance group, 63 [19%] in the avelumab com

132 avelumab plus chemoradiotherapy followed by avelumab maintenance in patients with locally advanced s

133 , 2018, 998 patients were randomly assigned (avelumab maintenance n=332, avelumab combination n=331,

134 95% CI 1.05-1.95; one-sided p=0.99) with the avelumab maintenance regimen and 1.14 (0.83-1.56; one-si

135 months (95% CI 13.5-not estimable [NE]) with avelumab maintenance, 18.1 months (14.8-NE) with aveluma

136 in combination with chemotherapy followed by avelumab maintenance, or chemotherapy followed by avelum

137 mab maintenance, or chemotherapy followed by avelumab maintenance, versus chemotherapy alone in patie

138 cetuximab significantly improved PFS versus avelumab (median, 11.1 [7.6-not reached (NR)] v 3.0 mont

139 0 mg/kg on days 1 and 8 of 21-day cycles) or avelumab monotherapy (800 mg every 2 weeks).

140 Patients received infusional avelumab monotherapy 10 mg/kg every 2 weeks until diseas

141 r PFS and overall survival (OS), data in the avelumab monotherapy arm were extended per protocol usin

142 lus SG arm and 10/37 patients (27.0%) in the avelumab monotherapy arm were still receiving study trea

143 S was prolonged with avelumab plus SG versus avelumab monotherapy as maintenance treatment.

144 Median PFS with avelumab plus SG versus avelumab monotherapy was 11.17 versus 3.75 months, respe

145 In patients treated with avelumab plus SG or avelumab monotherapy, any-grade treatment-related advers

146 combined with other antitumor agents versus avelumab monotherapy.

147 lumab plus sacituzumab govitecan (SG) versus avelumab monotherapy.

148 Avelumab (MSB0010718C) is a human IgG1 monoclonal antibo

149 omly assigned (combination n=188; PLD n=190, avelumab n=188).

150 n 7 days previously and followed by 10 mg/kg avelumab or placebo every 2 weeks maintenance therapy fo

151 This was preceded by a single 10 mg/kg avelumab or placebo lead-in dose given 7 days previously

152 n patients who received at least one dose of avelumab or placebo.

153 better PFS and disease control duration with avelumab over standard second-line treatment, with a fav

154 Avelumab patients who crossed over (n = 9) to combinatio

155 edge, the JAVELIN Renal 101 trial, assessing avelumab plus axitinib versus sunitinib in patients with

156 sed clinical trial for renal cell carcinoma (avelumab plus axitinib; HR 1.59 per HLA-A*03 allele, 1.1

157 he recent JAVELIN Bladder 100 phase 3 trial, avelumab plus best supportive care significantly prolong

158 of prolonging progression-free survival with avelumab plus chemoradiotherapy followed by avelumab mai

159 We report results of avelumab alone or avelumab plus pegylated liposomal doxorubicin (PLD) comp

160 umab (10 mg/kg intravenously every 2 weeks), avelumab plus PLD (40 mg/m(2) intravenously every 4 week

161 objective to show whether avelumab alone or avelumab plus PLD is superior to PLD.

162 Neither avelumab plus PLD nor avelumab alone significantly impro

163 We report an interim analysis of avelumab plus sacituzumab govitecan (SG) versus avelumab

164 data cut-off, 38/74 patients (51.4%) in the avelumab plus SG arm and 10/37 patients (27.0%) in the a

165 In patients treated with avelumab plus SG or avelumab monotherapy, any-grade trea

166 after first-line PBC, PFS was prolonged with avelumab plus SG versus avelumab monotherapy as maintena

167 Median PFS with avelumab plus SG versus avelumab monotherapy was 11.17 v

168 In a descriptive analysis, avelumab reduced the hazard of OS events: HR 0.66, 95% C

169 till ongoing, and was well tolerated; hence, avelumab represents a new therapeutic option for advance

170 In avelumab-resistant patients (46.7%), hCG was normalized

171 rash [20.7%], infusion reaction [20.7%]) and avelumab, respectively.

172 INTERPRETATION: Avelumab showed an acceptable safety profile and antitum

173 INTERPRETATION: Avelumab showed antitumour activity in the treatment of

174 whole-transcriptome sequencing revealed that avelumab survival benefit was positively associated with

175 The potential added benefit of avelumab to axitinib in ACC requires further investigati

176 rial (NCT03494322) assessing the addition of avelumab to cetuximab treatment in HNSCC.

177 anageable safety profile was reported in all avelumab-treated patients.

178 se-expansion cohort of that trial, we assess avelumab treatment in a cohort of patients with advanced

179 mal models to assess the efficacy of JQ1 and avelumab treatment on PD-L1 expression and immune cell i

180 echallenge therapy, including cetuximab plus avelumab, trifluridine-tipiracil plus panitumumab, irino

181 = 0.170; 3-year DFS estimates were 66.9% for avelumab versus 60.7%).

182 = 0.172; 3-year DFS estimates were 68.3% for avelumab versus 63.2%], or in stratum B (HR 0.80, 95% CI

183 eo)adjuvant chemotherapy, 1 year of adjuvant avelumab versus observation did not improve DFS.

184 ients with high-risk early TNBC to 1 year of avelumab versus observation, after completion of standar

185 ated 88.85% CI 0.74-1.24], one-sided p=0.21; avelumab vs PLD: 1.14 [0.95-1.58], one-sided p=0.83]).

186 ated 93.1% CI 0.59-1.24], one-sided p=0.030; avelumab vs PLD: 1.68 [1.32-2.60], one-sided p>0.99).

187 The increased PFS seen with the addition of avelumab warrants further investigation in this patient

188 Avelumab was associated with durable responses, most of

189 Avelumab was given as a 1-h intravenous infusion every 2

190 Avelumab was given intravenously at a dose of 10 mg/kg e

191 ollow-up of 33.3 (95% CI, 28.3-34.8) months, avelumab was superior to chemotherapy with or without ta

192 Conclusion Avelumab was well tolerated and associated with durable

193 Combining avelumab with anti-Trop-2 antibody-drug conjugates may b

194 association of treatment with cetuximab plus avelumab with overall survival (OS) may be worthy of inv

195 In this study, the combination of avelumab with paclitaxel plus ramucirumab showed favorab

196 the combination of the anti-PD-L1 inhibitor avelumab with the anti-angiogenesis drug axitinib in pat

197 ious adverse event related to treatment with avelumab, with infusion-related reaction (in four [2%] p