Four-year survival follow-up of toripalimab (JS001) as salvage therapy in Chinese melanoma patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21522-e21522
Author(s):  
Bixia Tang ◽  
Zhihong Chi ◽  
Yingbo Chen ◽  
Xiufeng Liu ◽  
Di Wu ◽  
...  
Keyword(s):  
Salvage Therapy ◽  
Advanced Melanoma ◽  
Extension Study ◽  
Unknown Primary ◽  
Term Survival ◽  
Long Term Survival ◽  
Systemic Treatments ◽  
Melanoma Patients

e21522 Background: Toripalimab, a PD-1 monoclonal antibody received conditionally approval in China as a salvage therapy for metastatic melanoma in 2018 based on a phase II trial with confirmed objective response rate of 17.3%. With four-year survival follow-up, here we report long-term survival results and related predictive biomarkers (NCT03013101). Methods: Patients with advanced melanoma who had failed prior systemic treatments were given toripalimab at 3 mg/kg i.v. Q2W until disease progression, intolerable toxicity or 2-year of treatment. Pts were followed for survival every 3 mo after discontinuation of treatment. Pts were transferred to an extension study after 2-year treatment. The Primary endpoint for the extension study was overall survival (OS). Results: 127 pts were enrolled, including50 (39.4%) acral, 22 (17.3%) mucosal, 29 (22.9%) nonacral cutaneous, and 26 (20.5%) unknown primary subtypes. After a median follow-up of 16.5 mo (range, 0.9-48.8), 74 (58%) pts had died. Median duration of response was 25.6 mo (95%CI:12.8-NE). Median OS was 22.0 mo (95%CI: 15.3-32.5). The OS rates for year 1 to 4 were 67.1%, 48.2%, 38.0% and 31.7% respectively. The median OS of complete response (CR)/ partial response (PR) (n = 22), stable disease (SD) (n = 51), progression disease (PD) (n = 54) were not reached, 34.0 mo and 9.7 mo, respectively. The median OS of non-acral cutaneous, unknown primary, acral and mucosal melanoma subtypes were 46.1, 37.3, 16.9 and 10.3 mo, respectively. The median OS of PD-L1+ (n = 26) and PD-L1- (n = 84) patients were 46.1 and 14.4 mo (P = 0.026, HR = 0.45, 95%CI 0.26-0.76). The median OS of TMB high (n = 20), TMB low (n = 78) was 16.0 and 22.3 mo with no statistically significance (P = 0.49, HR = 1.28, 95%CI 0.63-2.58). Conclusions: Salvage treatment with toripalimab leads to long-term survival benefit in advanced melanoma patients, especially for those with non-acral cutaneous and unknown primary subtypes, CR/PR/SD as best response or PD-L1+.

Long-term survival from pembrolizumab (pembro) completion and pembro retreatment: Phase III KEYNOTE-006 in advanced melanoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10013-10013 ◽  
Author(s):  
Georgina V. Long ◽  
Jacob Schachter ◽  
Ana Arance ◽  
Jean-Jacques Grob ◽  
Laurent Mortier ◽  
...  
Keyword(s):  
Clinical Care ◽  
Advanced Melanoma ◽  
Phase Iii ◽  
Term Survival ◽  
Long Term Survival ◽  
Prior Therapy ◽  
Additional Clinical Benefit ◽  
Ecog Ps

10013 Background: 5-year follow-up of the phase 3 KEYNOTE-006 study (NCT01866319) showed pembro improved OS vs ipilimumab (ipi) in patients (pts) with advanced melanoma. 3-y OS rate from pembro completion for pts who completed 2 y of pembro was 93.8%. Results with 8 mo of additional follow-up are presented to inform clinical care. Methods: Eligible pts with ipi-naive advanced melanoma, ≤1 prior therapy for BRAF-mutant disease, and ECOG PS 0 or 1 were randomized to pembro 10 mg/kg Q2W or Q3W for ≤2 y or ipi 3 mg/kg Q3W for 4 doses. Pts discontinuing pembro with CR, PR, or SD after ≥94 weeks were considered pts with 2-y pembro. Pts who stopped pembro with SD, PR or CR could receive ≤12 mo of additional pembro (2nd course) upon disease progression if still eligible. ORR was assessed per immune-related response criteria by investigator review. OS was estimated using the Kaplan-Meier method. Pembro arm data were pooled. Post hoc ITT efficacy analyses are shown. Results: Median follow-up from randomization to data cutoff (Jul 31, 2019) was 66.7 mo in the pembro and 66.9 mo in the ipi arms. OS outcomes are shown in Table. For the 103 pts with 2-y pembro (30 CR, 63 PR, 10 SD), median follow-up from completion was 42.9 mo (95% CI, 39.9-46.3).Median DOR was not reached. 36-mo OS from pembro completion was 100% (95% CI, 100.0-100.0) for pts with CR, 94.8% (95% CI, 84.7-98.3) for pts with PR, and 66.7% (95% CI, 28.2-87.8) for pts with SD. 15 pts received 2nd-course pembro; BOR in 1st course was 6 CR, 6 PR, and 3 SD. Median time from end of 1st course to start of 2ndcourse was 24.5 mo (range, 4.9-41.4). Median follow-up in pts who received 2nd-course pembro was 25.3 mo (range, 3.5-39.4). Median duration of 2nd-course pembro was 8.3 mo (range, 1.4-12.6). BOR on 2ndcourse was 3 CR, 5 PR (ongoing responses, 7 pts), 3 SD (ongoing, 2 pts), and 2 PD (1 death); 2 pts pending. Conclusions: Pembro improves the long-term survival vs ipi in pts with advanced melanoma, with all pts who completed therapy in CR still alive at 5 years. Retreatment with pembro at progression in pts who stopped at SD or better can provide additional clinical benefit in a majority of pts. Clinical trial information: NCT01866319. [Table: see text]

scholarly journals Whole cell melanoma vaccine genetically modified to stem cells like phenotype generates specific immune responses to ALDH1A1 and long-term survival in advanced melanoma patients

2018 ◽  
Vol 7 (11) ◽  
pp. e1509821 ◽  
Author(s):  
Eliza Kwiatkowska-Borowczyk ◽  
Patrycja Czerwińska ◽  
Jacek Mackiewicz ◽  
Katarzyna Gryska ◽  
Urszula Kazimierczak ◽  
...  
Keyword(s):  
Stem Cells ◽  
Immune Responses ◽  
Genetically Modified ◽  
Advanced Melanoma ◽  
Term Survival ◽  
Melanoma Vaccine ◽  
Whole Cell ◽  
Long Term Survival ◽  
Melanoma Patients

Long-term survival of patients (pts) with advanced melanoma treated with ipilimumab with or without dacarbazine

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9038-9038 ◽  
Author(s):  
E. Hersh ◽  
J. Weber ◽  
J. Powderly ◽  
A. Pavlik ◽  
G. Nichol ◽  
...  
Keyword(s):  
Clin Oncol ◽  
Cytotoxic T Lymphocyte ◽  
Human Monoclonal Antibody ◽  
Survival Rates ◽  
Advanced Melanoma ◽  
Open Label ◽  
Term Survival ◽  
Long Term Survival

9038 Background: Ipilimumab is a fully human monoclonal antibody targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4). Here, we report updated survival of pts with advanced melanoma treated with ipilimumab in 2 completed studies. Methods: Seventy-two chemotherapy-naïve pts were randomized to receive 3 mg/kg ipilimumab every 4 weeks (Q4W) × 4 alone or with ≤6 × 5-day courses of DTIC 250 mg/m2/day (ipilimumab, n = 37; ipilimumab + DTIC, n = 35) in the multicenter, open- label Phase II study MDX010–08 (Sep 2002-Aug 2004)(Hersh E et al. J Clin Oncol 26: 2008 (May 20 suppl; abstr 9022)). In the phase I/II dose-ranging study MDX010–15, 23 pts were treated with 10 mg/kg ipilimumab every 3 weeks (Q3W) × 4 (induction) (Jun 2004- Jul 2006) (Urba W et al. J Clin Oncol 26: 2008 (May 20 suppl; abstr 3018)). No maintenance ipilimumab was administered in either study. Long-term survival was determined under a follow-up protocol (MDX010–28) from May 2007-Jan 2008. Results: Long-term data are available for 62 pts for MDX010–08 and 22 pts for MDX010–15. For MDX010–08, the median follow-up was 4.3 years (range, 4.0–4.7 years); it was 2.2 years (range, 2.0–2.4 years) for MDX010–15. Survival rates are reported in the Table . Conclusions: Ipilimumab monotherapy, administered at 3 mg/kg and without maintenance dosing, resulted in survival rates better than those observed with historical controls (Korn EJ et al. J Clin Oncol 26:527–34; 2008). Adding DTIC to ipilimumab did not suppress the effect of ipilimumab (as might have been predicted), but enhanced it still further. Consistent with previously reported response data showing that 10 mg/kg is the recommended dose (study CA184022) (Hamid O et al. J Clin Oncol 26: 2008 (May 20 suppl; abstr 9025)), there was a trend toward better survival with the higher dose (eg, a 2-year survival rate of 36% vs. 22% for 10 mg/kg vs. 3 mg/kg). [Table: see text] [Table: see text]

37% long-term survival of children with ALL relapse by risk-stratified salvage therapy - Results of trial ALL-REZ BFM 87 after 15 years of follow-up

2004 ◽  
Vol 216 (03) ◽  
Author(s):  
H Graf Einsiedel ◽  
R Hartmann ◽  
R Fengler ◽  
K Seeger ◽  
G Henze ◽  
...  
Keyword(s):  
Salvage Therapy ◽  
Term Survival ◽  
Long Term Survival

scholarly journals 1103P Long-term survival of real-world advanced melanoma patients treated with targeted therapy

2020 ◽  
Vol 31 ◽  
pp. S745-S746
Author(s):  
R. Ismail ◽  
A. de Boer ◽  
M. van Dartel ◽  
D. Hilarius ◽  
M. van Zeijl ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Real World ◽  
Advanced Melanoma ◽  
Term Survival ◽  
Long Term Survival ◽  
Melanoma Patients

Effect of ipilimumab treatment on 18-month survival: Update of patients (pts) with advanced melanoma treated with 10 mg/kg ipilimumab in three phase II clinical trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9033-9033
Author(s):  
S. O'Day ◽  
J. Weber ◽  
C. Lebbe ◽  
M. Maio ◽  
H. Pehamberger ◽  
...  
Keyword(s):  
Phase Ii ◽  
Survival Data ◽  
Survival Benefit ◽  
Survival Rates ◽  
Advanced Melanoma ◽  
Controlled Study ◽  
Term Survival ◽  
Long Term Survival

9033 Background: The monoclonal antibody ipilimumab targets cytotoxic T lymphocyte antigen-4. Updated survival data (≤32.5 months follow-up) from 3 Phase II trials of ipilimumab in pts with mostly pretreated advanced melanoma are reported. Methods: Study CA184008 was an open-label, single-arm study of ipilimumab 10 mg/kg. Study CA184022 was a randomized, dose-ranging study of ipilimumab 0.3, 3, or 10 mg/kg. Study CA184007 was a randomized, placebo-controlled study of the effect of budesonide on gastrointestinal immune-related adverse events in pts receiving ipilimumab 10 mg/kg. In all studies, ipilimumab was given every 3 weeks (Q3W) × 4 (induction); eligible pts could continue to receive maintenance ipilimumab Q12W from week 24. Pts continue to be followed-up to determine long-term survival. Results: With a median follow-up ranging from 10.1 to 16.3 months and reaching up to 32.5+ months, pts receiving 10 mg/kg ipilimumab showed durable survival; 12- and 18-month survival rates are presented [ Table ]. The tail of the Kaplan-Meier curve flattened at 18 months, indicating that a substantial proportion of patients continued to survive beyond the updated follow-up period in all three studies. Long-term survivors include pts with disease progression (PD) per modified World Health Organization (mWHO) criteria. Conclusions: Ipilimumab may result in a long-term survival benefit in pts with advanced melanoma, where 18-month survival rates across 3 Phase II studies range from 34.5% to 39.4% for previously treated pts. These results indicate that more than 1/3 of ipilimumab-treated pts with advanced melanoma experience a long-term survival benefit, including some pts characterized as PD by mWHO. The survival data continue to mature, and follow-up is ongoing. [Table: see text] [Table: see text]

Extended survival analysis of ipilimumab for the treatment of advanced malignant melanoma in pretreated patients: Five-year long-term follow-up of the South African expanded access program.

2017 ◽  
Vol 35 (7_suppl) ◽  
pp. 84-84
Author(s):  
Bernardo Leon Rapoport ◽  
Daniel A. Vorobiof ◽  
Lydia Mary Dreosti ◽  
Adam L. Nosworthy ◽  
Georgina Laird McAdam ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Cutaneous Melanoma ◽  
Unknown Primary ◽  
Term Survival ◽  
Long Term Survival ◽  
Expanded Access ◽  
Long Term Follow Up ◽  
Ecog Ps

84 Background: Ipilimumab is a human monoclonal IgG1 antibody against CTLA-4 that has been shown to prolong the overall survival of patients with advanced pretreated melanoma. In 2015, a retrospective, multi-centre, non-interventional analysis was performed on data collected from the ipilimumab expanded access programme in South Africa, with last follow-up date (or death) in December 2014. The current study extends this analysis by follow-up on the long-term survival of pre-treated metastatic patients up to September 2016. Methods: Follow-up questions were sent to participating investigators, who had patients who were still alive (29) or for whom it was not known whether they were still alive (11) following the last ipilimumab infusion. Investigators had to confirm whether patients were still alive, the date of death or last contact, clinical response at last contact, and whether the patient was still responding to ipilimumab. Results: Of the 108 patients, 84 (78%) had cutaneous melanoma and 24 patients (22%) had non-cutaneous melanoma, including uveal, mucosal, and melanoma of unknown primary. Twenty patients previously received two or more lines of treatment for metastatic melanoma. The median age was 59 years (range 27 – 86) and there were 73 (68%) males and 35 (32%) females. Baseline ECOG PS was 0 in 33%, PS 1 in 58% and PS 2 in 6% of patients. The longest follow-up time available was 5.4 years. The median OS was 9.36 months (95% CI 7.48 – 11.84). One-year survival was 39% (95% CI 29% - 48%), 2-year survival was 22% (95% CI 15% - 30%), 3-year survival was 19% (95% CI 12% - 27%), 4- and 5-year survival was 15% (95% CI 8% - 21%). In the group of cutaneous melanoma patients, the 4- and 5-year survival was 17% (95% CI 9% - 25%) while in the non-cutaneous group the 4- and 5-year survival was 6% (95% CI 0% - 16%). Conclusions: Ipilimumab at a dose of 3mg/kg is an effective treatment for patients with pre-treated advanced (unresectable or metastatic) melanoma and is associated with durable remissions and long-term survival.

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