ライフサイエンスコーパス: pembrolizumab

1 , allowing patients to continue therapy with pembrolizumab.

2 ceptional response to the anti-PD-1 antibody pembrolizumab.

3 treatment of NSCLC before the first cycle of pembrolizumab.

4 of 26 patients received at least one dose of pembrolizumab.

5 erved in patients with melanoma treated with pembrolizumab.

6 the humanized anti-PD-1 monoclonal antibody pembrolizumab.

7 eatment with the immune checkpoint inhibitor pembrolizumab.

8 nts were masked to assignment of the dose of pembrolizumab.

9 (42%) developed cutaneous AEs attributed to pembrolizumab.

10 l benefit of immune checkpoint blockade with pembrolizumab.

11 r cells correlated with improved efficacy of pembrolizumab.

12 erapeutic efficacy of the anti-PD-1 antibody pembrolizumab.

13 d 370 patients received at least one dose of pembrolizumab.

14 to confirm and characterise the activity of pembrolizumab.

15 anoma received one of three dose regimens of pembrolizumab.

16 e-effect profile, and antitumour activity of pembrolizumab.

17 ll-cell lung cancer (NSCLC) before receiving pembrolizumab.

18 e enrolled and received their first cycle of pembrolizumab.

19 keratoacanthomas (KAs) in patients receiving pembrolizumab.

20 likelihood to anti-PD-1 therapies, including pembrolizumab.

21 ts demonstrated an immunological response to pembrolizumab.

22 stribution and pharmacokinetics of (89)Zr-Df-pembrolizumab.

23 As of June 20, 2016, 25 patients received pembrolizumab.

24 arepvec followed by combination therapy with pembrolizumab.

25 I 0.45-0.73; p<0.0001) and those assigned to pembrolizumab 10 mg/kg (0.50, 0.39-0.64; p<0.0001) compa

26 Methods Patients were treated with pembrolizumab 10 mg/kg every 2 weeks for up to 24 months

27 Pembrolizumab 10 mg/kg every 2 weeks, 10 mg/kg every 3 w

28 pembrolizumab 2 mg/kg group, 25 (14%) in the pembrolizumab 10 mg/kg group, and 45 (26%) in the chemot

29 Patients received pembrolizumab 10 mg/kg intravenously every 2 weeks.

30 R 0.54, 95% CI 0.38-0.77; p=0.0002) and with pembrolizumab 10 mg/kg than with docetaxel (17.3 months

31 R 0.59, 95% CI 0.44-0.78; p=0.0001) and with pembrolizumab 10 mg/kg than with docetaxel (5.2 months v

32 R] 0.71, 95% CI 0.58-0.88; p=0.0008) and for pembrolizumab 10 mg/kg versus docetaxel (0.61, 0.49-0.75

33 s docetaxel (0.88, 0.74-1.05; p=0.07) or for pembrolizumab 10 mg/kg versus docetaxel (HR 0.79, 95% CI

34 eceive pembrolizumab 2 mg/kg, 181 to receive pembrolizumab 10 mg/kg, and 179 to receive chemotherapy.

35 d to pembrolizumab 2 mg/kg, 346 allocated to pembrolizumab 10 mg/kg, and 343 allocated to docetaxel.

36 with pembrolizumab 2 mg/kg, 4.0 months with pembrolizumab 10 mg/kg, and 4.0 months with docetaxel, w

37 with pembrolizumab 2 mg/kg, 12.7 months with pembrolizumab 10 mg/kg, and 8.5 months with docetaxel.

38 nse system to receive pembrolizumab 2 mg/kg, pembrolizumab 10 mg/kg, or docetaxel 75 mg/m(2) every 3

39 neumonitis (each in two [1%]) in those given pembrolizumab 10 mg/kg; and anaemia (nine [5%]), fatigue

40 Patients received pembrolizumab (10 mg/kg every 2 weeks) for up to 2 years

41 Patients received pembrolizumab, 10 mg/kg every 2 weeks, until disease pro

42 olizumab, 10 mg/kg, every 3 weeks, P = .001; pembrolizumab, 10 mg/kg, every 2 weeks, P = .003; pembro

43 progression-free intervals in all 3 groups (pembrolizumab, 10 mg/kg, every 3 weeks, P = .001; pembro

44 urvival was improved in patients assigned to pembrolizumab 2 mg/kg (HR 0.57, 95% CI 0.45-0.73; p<0.00

45 173 patients received pembrolizumab 2 mg/kg (n=89) or 10 mg/kg (n=84).

46 eeks for four doses, followed by intravenous pembrolizumab 2 mg/kg every 3 weeks for up to 2 years or

47 events occurred in 20 (11%) patients in the pembrolizumab 2 mg/kg group, 25 (14%) in the pembrolizum

48 -free survival was 34% (95% CI 27-41) in the pembrolizumab 2 mg/kg group, 38% (31-45) in the 10 mg/kg

49 n a block size of six to receive intravenous pembrolizumab 2 mg/kg or 10 mg/kg every 3 weeks or inves

50 Patients received intravenous pembrolizumab 2 mg/kg plus intravenous ipilimumab 1 mg/k

51 erall survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 14.9 m

52 -free survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 5.0 mo

53 ocetaxel, with no significant difference for pembrolizumab 2 mg/kg versus docetaxel (0.88, 0.74-1.05;

54 verall survival was significantly longer for pembrolizumab 2 mg/kg versus docetaxel (hazard ratio [HR

55 median overall survival was 10.4 months with pembrolizumab 2 mg/kg, 12.7 months with pembrolizumab 10

56 0 patients were randomly assigned to receive pembrolizumab 2 mg/kg, 181 to receive pembrolizumab 10 m

57 we enrolled 1034 patients: 345 allocated to pembrolizumab 2 mg/kg, 346 allocated to pembrolizumab 10

58 rogression-free survival was 3.9 months with pembrolizumab 2 mg/kg, 4.0 months with pembrolizumab 10

59 interactive voice-response system to receive pembrolizumab 2 mg/kg, pembrolizumab 10 mg/kg, or doceta

60 a (each in two [1%] patients) in those given pembrolizumab 2 mg/kg; hypopituitarism, colitis, diarrho

61 One patient in the pembrolizumab 2 week group and 22 patients in the ipilim

62 Pembrolizumab, 2 mg/kg every 3 weeks, for 4 cycles.

63 olizumab, 10 mg/kg, every 2 weeks, P = .003; pembrolizumab, 2 mg/kg, every 3 weeks, P = .009) compare

64 grated web response system to receive either pembrolizumab 200 mg every 3 weeks (35 cycles) or invest

65 Patients received pembrolizumab 200 mg every 3 weeks.

66 Enrolled patients received intravenous pembrolizumab 200 mg every 3 weeks.

67 ractive voice-response system to 4 cycles of pembrolizumab 200 mg plus carboplatin area under curve 5

68 fractory MM (RRMM) received 28-day cycles of pembrolizumab, 200 mg IV every 2 weeks, pomalidomide 4 m

69 we enrolled 86 patients, 84 of whom received pembrolizumab (42 in each disease cohort) and 80 of whom

70 iated with a higher frequency of response to pembrolizumab; 42 (38%, 95% CI 29-48) of 110 patients wi

71 ing to the following therapeutic regimen for pembrolizumab: 43 received 10 mg/kg every 3 weeks, 24 re

72 ty, tolerability, and antitumour activity of pembrolizumab, a humanised anti-programmed death recepto

73 designed to test the efficacy and safety of pembrolizumab, a humanized PD-1-blocking antibody, at a

74 The response rate was improved with pembrolizumab administered every 2 weeks (33.7%) and eve

75 Among patients with advanced melanoma, pembrolizumab administration was associated with an over

76 nd 89.9% in the 67 patients who discontinued pembrolizumab after CR for observation.

77 n patients who received one or more doses of pembrolizumab (all-patients-as-treated population); acti

78 l patients who received at least one dose of pembrolizumab (all-patients-treated population).

79 We assessed the safety and efficacy of pembrolizumab (an anti-programmed cell death receptor 1

80 ry and radiotherapy underwent treatment with pembrolizumab, an anti-PD-1 antibody, at an academic der

81 We assessed pembrolizumab, an anti-PD-1 antibody, for safety and act

82 e evaluated safety and antitumor activity of pembrolizumab, an anti-PD-1 antibody, in rrPMBCL as part

83 2 study to evaluate the clinical activity of pembrolizumab, an anti-programmed death 1 immune checkpo

84 rm, phase II KEYNOTE-055 study, we evaluated pembrolizumab, an anti-programmed death 1 receptor antib

85 of non-small cell lung cancers treated with pembrolizumab, an antibody targeting programmed cell dea

86 the KEYNOTE-001 (MK-3475) clinical trial of pembrolizumab, an antiprogrammed cell death-1 therapy fo

87 S/QOL score was 6.9 (95% CI 3.3 to 10.6) for pembrolizumab and -0.9 (-4.8 to 3.0) for chemotherapy, f

88 Individual treatment assignment between pembrolizumab and chemotherapy was open label, but inves

89 r treatment with the PD-1-targeting antibody pembrolizumab and identify pharmacodynamic changes in ci

90 ted adverse events led to discontinuation of pembrolizumab and ipilimumab in 22 (14%) patients, inclu

91 n patients who received at least one dose of pembrolizumab and the proportion of patients achieving o

92 olled patients received at least one dose of pembrolizumab and were included in the safety analyses.

93 Seven patients were receiving pembrolizumab, and 3 patients were receiving nivolumab.

94 clinical trials, received at least 1 dose of pembrolizumab, and had at least 1 follow-up visit.

95 Subject Heading terms were used: nivolumab, pembrolizumab, and PD-1 inhibitor.

96 complete remission after discontinuation of pembrolizumab, and the low incidence of relapse after me

97 ived no previous systemic therapy to receive pembrolizumab (anti-PD-1) at a dose of 2 mg per kilogram

98 INTERPRETATION: Pembrolizumab appears to be well tolerated and might con

99 Nivolumab and pembrolizumab are monoclonal antibodies that block the p

100 These findings establish pembrolizumab as a new standard of care for the treatmen

101 These data establish pembrolizumab as a new treatment option for this populat

102 These conclusions further support the use of pembrolizumab as a standard of care for advanced melanom

103 e head and neck, supporting further study of pembrolizumab as anticancer therapy for advanced head an

104 e, 83 years; range 77-91 years), experienced pembrolizumab-associated eruptive KAs.

105 Patients received intravenous pembrolizumab at 10 mg/kg once every 2 weeks for 24 mont

106 on schedule (1:1 final ratio) to intravenous pembrolizumab at 2 mg/kg every 3 weeks or 10 mg/kg every

107 The results suggest that pembrolizumab at a dose of 2 mg/kg or 10 mg/kg every 3 w

108 Patients received pembrolizumab at a dose of either 2 mg/kg of bodyweight

109 We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 w

110 dvanced melanoma in a 1:1:1 ratio to receive pembrolizumab (at a dose of 10 mg per kilogram of body w

111 We assigned 495 patients receiving pembrolizumab (at a dose of either 2 mg or 10 mg per kil

112 Combination of pembrolizumab, carboplatin, and pemetrexed could be an e

113 he phase 3 KEYNOTE-024 trial, treatment with pembrolizumab conferred longer progression-free survival

114 ults of the interim analyses of KEYNOTE-006, pembrolizumab continued to provide superior overall surv

115 ligand 1-positive advanced cervical cancer, pembrolizumab demonstrated antitumor activity and exhibi

116 edictors of CR and patient disposition after pembrolizumab discontinuation after CR.

117 ponses in patients who received at least one pembrolizumab dose and who either had a post-baseline sc

118 We assessed the efficacy and safety of two pembrolizumab doses versus investigator-choice chemother

119 ersus ipilimumab, with no difference between pembrolizumab dosing schedules.

120 and randomly assigned to receive intravenous pembrolizumab every 2 weeks (n=279), intravenous pembrol

121 Patients were given 10 mg/kg intravenous pembrolizumab every 2 weeks until disease progression, u

122 Patients were given 10 mg/kg pembrolizumab every 2 weeks until progression.

123 hazard ratio [HR] 0.68, 95% CI 0.53-0.87 for pembrolizumab every 2 weeks vs ipilimumab; p=0.0009 and

124 2%, respectively (hazard ratio for death for pembrolizumab every 2 weeks, 0.63; 95% CI, 0.47 to 0.83;

125 ogression-free-survival rates were 47.3% for pembrolizumab every 2 weeks, 46.4% for pembrolizumab eve

126 rolizumab every 2 weeks (n=279), intravenous pembrolizumab every 3 weeks (n=277), or intravenous ipil

127 ipilimumab; p=0.0009 and 0.68, 0.53-0.86 for pembrolizumab every 3 weeks vs ipilimumab; p=0.0008).

128 CI, 0.47 to 0.83; P=0.0005; hazard ratio for pembrolizumab every 3 weeks, 0.69; 95% CI, 0.52 to 0.90;

129 % for pembrolizumab every 2 weeks, 46.4% for pembrolizumab every 3 weeks, and 26.5% for ipilimumab (h

130 atients were treated with 200 mg intravenous pembrolizumab every 3 weeks.

131 Conclusion Pembrolizumab exhibited clinically meaningful antitumor

132 Overall, pembrolizumab exhibited selective efficacy in CLL patien

133 regression in response to anti-PD-1 therapy (pembrolizumab) followed by disease progression months to

134 Eligible patients who received pembrolizumab for >/= 6 months and at least two treatmen

135 trexed 500 mg/m(2) every 3 weeks followed by pembrolizumab for 24 months and indefinite pemetrexed ma

136 limumab for one event and later discontinued pembrolizumab for another.

137 We assessed the efficacy of pembrolizumab for patients with previously treated, PD-L

138 f patients with cancer who were treated with pembrolizumab from March 1, 2011, to May 28, 2014.

139 d a potentially acceptable safety profile of pembrolizumab given every 2 weeks to patients with heavi

140 INTERPRETATION: Standard-dose pembrolizumab given in combination with four doses of re

141 nonrandomized phase Ib trial of single-agent pembrolizumab given intravenously at 10 mg/kg every 2 we

142 n overall survival was not reached in either pembrolizumab group and was 16.0 months with ipilimumab

143 eported in five (3%) patients in the 2 mg/kg pembrolizumab group, was the only drug-related grade 3 t

144 s of grade 3 to 5 severity were lower in the pembrolizumab groups (13.3% and 10.1%) than in the ipili

145 tment-related grade 3-4 adverse event in the pembrolizumab groups was fatigue (two [1%] of 178 patien

146 Efficacy was similar in the two pembrolizumab groups.

147 or metastatic PD-L1-positive gastric cancer, pembrolizumab had a manageable toxicity profile and prom

148 Pembrolizumab had an acceptable side-effect profile and

149 tivity was assessed in patients who received pembrolizumab, had measurable disease at baseline, and h

150 tients who had received at least one dose of pembrolizumab, had measurable disease at baseline, and o

151 use of PD-1 inhibitors such as nivolumab and pembrolizumab has a lower incidence of irAEs compared wi

152 patients demonstrate that PD-1 blockade with pembrolizumab has a manageable safety profile and promis

153 ed-dose ipilimumab followed by standard-dose pembrolizumab has a manageable toxicity profile and prov

154 INTERPRETATION: First-line pembrolizumab has antitumour activity and acceptable tol

155 In view of this result, pembrolizumab has become a new treatment option for pati

156 The anti-PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patie

157 -programmed-death-receptor-1 (PD-1) antibody pembrolizumab has shown potent antitumour activity at di

158 antibodies blocking PD-1 ligation, including pembrolizumab, have recently received Food and Drug Admi

159 gs, such as the anti-programmed death-1 drug pembrolizumab, have shown promising results in trials, a

160 INTERPRETATION: Pembrolizumab improves or maintains health-related QOL c

161 esigned to assess the safety and efficacy of pembrolizumab in 20 programmed death ligand 1-positive,

162 al RECIST might underestimate the benefit of pembrolizumab in approximately 15% of patients; modified

163 sessed the activity and safety of first-line pembrolizumab in cisplatin-ineligible patients with loca

164 ty and anti-tumour activity of standard-dose pembrolizumab in combination with reduced-dose ipilimuma

165 In this study, first-line therapy with pembrolizumab in patients with advanced Merkel-cell carc

166 ogrammed cell death 1 (PD-1) inhibition with pembrolizumab in patients with advanced non-small-cell l

167 rammed cell death protein 1 (PD-1) inhibitor pembrolizumab in patients with advanced TNBC.

168 safety and activity of an anti-PD-1 antibody pembrolizumab in patients with locally advanced or metas

169 afety and activity of the anti-PD-1 antibody pembrolizumab in patients with PD-L1-positive recurrent

170 he activity and safety of the PD-1 inhibitor pembrolizumab in patients with untreated brain metastase

171 Pembrolizumab in the first-line setting is being further

172 ollow-up in patients who experienced CR with pembrolizumab in the KEYNOTE-001 study.

173 with advanced melanoma who were treated with pembrolizumab in the phase Ib KEYNOTE-001 study (clinica

174 patients with advanced melanoma treated with pembrolizumab in the phase Ib KEYNOTE-001 study.

175 supporting ongoing phase 2 and 3 studies of pembrolizumab in this population.

176 ody distribution of (89)Zr-deferoxamine (Df)-pembrolizumab in two rodent models (mice and rats).

177 okinetics, biodistribution, and dosimetry of pembrolizumab in vivo, accomplished through radiolabelin

178 kinetics and biodistribution of radiolabeled pembrolizumab in vivo, while providing detailed dosimetr

179 ort the cases of 3 consecutive patients with pembrolizumab-induced eruptive KAs and their management.

180 Pembrolizumab inhibits the programmed cell death 1 (PD-1

181 Pembrolizumab is a humanized monoclonal antibody targeti

182 Pembrolizumab is used in advanced melanoma, advanced non

183 tuximab, checkpoint inhibitors nivolumab and pembrolizumab, lenalidomide, everolimus, or observation

184 plus ipilimumab doses; 64 (42%) remained on pembrolizumab monotherapy.

185 e tumor remission for >2 years on anti-PD-1 (pembrolizumab) monotherapy.

186 2015, 305 patients were randomly assigned to pembrolizumab (n=154) or chemotherapy (n=151).

187 h locally advanced cSCC who was treated with pembrolizumab, nearly complete tumor regression was obse

188 ued ipilimumab only and 14 (9%) discontinued pembrolizumab only because of treatment-related adverse

189 consecutive HL patients treated by anti-PD1 (pembrolizumab or nivolumab) at Gustave Roussy from 2013

190 treated with anti-PD1 monoclonal antibodies (pembrolizumab or nivolumab), 10 (2.9%) developed subacut

191 d with the approved PD1-targeting antibodies pembrolizumab or nivolumab.

192 linicians should use single-agent nivolumab, pembrolizumab, or atezolizumab; if tumor has negative or

193 pants (1:1:1) to one of two dose regimens of pembrolizumab, or one regimen of ipilimumab, using a cen

194 Ipilimumab (CTLA-4) and pembrolizumab (PD-1) are approved by the US Food and Dru

195 We hypothesized that pembrolizumab, PD-1-antibody, can enhance antimyeloma ce

196 ration-approved immune checkpoint inhibitors-pembrolizumab (PEM), nivolumab (NIVO), and ipilumumab (I

197 33 (55%; 95% CI 42-68) of 60 patients in the pembrolizumab plus chemotherapy group achieved an object

198 tween groups (23 [39%] of 59 patients in the pembrolizumab plus chemotherapy group and 16 [26%] of 62

199 e enrolled; 60 were randomly assigned to the pembrolizumab plus chemotherapy group and 63 to the chem

200 One (2%) of 59 patients in the pembrolizumab plus chemotherapy group experienced treatm

201 orse treatment-related adverse events in the pembrolizumab plus chemotherapy group were anaemia (seve

202 110 (72%) of 153 patients received all four pembrolizumab plus ipilimumab doses; 64 (42%) remained o

203 These data suggest that standard-dose pembrolizumab plus reduced-dose ipilimumab might be a to

204 Pembrolizumab, pomalidomide, and low-dose dexamethasone

205 Pembrolizumab prevents PD-1 ligation by both PD-L1 and P

206 The anti-PD-1 antibody pembrolizumab prolonged progression-free survival and ov

207 Pembrolizumab prolongs overall survival and has a favour

208 Purpose Pembrolizumab provides durable antitumor activity in met

209 disease progression, 0.58; P<0.001 for both pembrolizumab regimens versus ipilimumab; 95% confidence

210 rogrammed death ligand 1 (PD-L1) expression, pembrolizumab should be used alone; if the patient has l

211 INTERPRETATION: Pembrolizumab showed anti-tumour activity and acceptable

212 However, pembrolizumab showed encouraging activity in patients wi

213 Pembrolizumab shows activity in brain metastases in pati

214 d on data from different clinical studies of pembrolizumab, starting with a small pilot of 19 melanom

215 Time to deterioration was longer with pembrolizumab than with chemotherapy (median not reached

216 related adverse events were less common with pembrolizumab than with docetaxel (43 [13%] of 339 patie

217 This case series demonstrates that pembrolizumab therapy may also be associated with erupti

218 Pembrolizumab therapy was associated with cutaneous AEs

219 occurrence of vitiligo in patients receiving pembrolizumab therapy.

220 median of 13 months (range, 4-18 months) of pembrolizumab therapy.

221 We assessed whether the addition of pembrolizumab to platinum-doublet chemotherapy improves

222 port study of 3 patients from 2 centers with pembrolizumab-treated cancer who all developed eruptive

223 Fewer pembrolizumab-treated patients had deterioration in the

224 Ps) using RNA from baseline tumor samples of pembrolizumab-treated patients.

225 he study, 17 (25%) developed vitiligo during pembrolizumab treatment and 50 (75%) did not.

226 tients with metastatic melanoma who received pembrolizumab treatment in the context of a phase 1 stud

227 Pembrolizumab treatment induced favorable responses in a

228 sion-free survival and overall survival with pembrolizumab treatment than that seen in patients who d

229 Pembrolizumab treatment was continued without disruption

230 ated with clinical benefit in the context of pembrolizumab treatment.

231 well as disease progression and response to pembrolizumab treatment.

232 that is currently being evaluated in ongoing pembrolizumab trials.

233 btained before and during anti-PD-1 therapy (pembrolizumab) using quantitative immunohistochemistry,

234 ort the prespecified exploratory endpoint of pembrolizumab versus chemotherapy on patient-reported ou

235 ior overall and progression-free survival of pembrolizumab versus ipilimumab in patients with advance

236 Pembrolizumab was administered intravenously at a dose o

237 Conclusions Pembrolizumab was associated with a favorable safety pro

238 Pembrolizumab was discontinued by 91 patients (86.7%), i

239 of concept, the biodistribution of (89)Zr-Df-pembrolizumab was further investigated in a humanized mu

240 Progression-free survival with pembrolizumab was significantly longer in patients who p

241 Overall survival with pembrolizumab was significantly longer in patients who p

242 Pembrolizumab was well tolerated and demonstrated clinic

243 Pembrolizumab was well tolerated, with 10 (17%) of 60 pa

244 Common side effects that were attributed to pembrolizumab were fatigue, pruritus, and decreased appe

245 Patients who received at least one dose of pembrolizumab were included in the safety analysis and p

246 All the patients treated with pembrolizumab who developed vitiligo were alive at the t