scholarly journals Durable benefit and the potential for long-term survival with immunotherapy in advanced melanoma

2014 ◽  
Vol 40 (9) ◽  
pp. 1056-1064 ◽  
Author(s):  
David McDermott ◽  
Celeste Lebbé ◽  
F. Stephen Hodi ◽  
Michele Maio ◽  
Jeffrey S. Weber ◽  
...  
Keyword(s):  
Advanced Melanoma ◽  
Term Survival ◽  
Long Term Survival

scholarly journals Long-Term Survival of Patients with Advanced Melanoma Treated Second Line with Ipilimumab

2012 ◽  
Vol 23 ◽  
pp. ix370
Author(s):  
D. Lee ◽  
L. Pericleous ◽  
M. Lebmeier ◽  
B. Winn ◽  
A. Batty ◽  
...  
Keyword(s):  
Advanced Melanoma ◽  
Second Line ◽  
Term Survival ◽  
Long Term Survival

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]

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+.

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

scholarly journals Estimating the percentage of patients with advanced melanoma achieving long-term survival with pembrolizumab (Pembro) treatment in KEYNOTE-006

2016 ◽  
Vol 27 ◽  
pp. vi382
Author(s):  
C. Blank ◽  
J. Ma ◽  
J.J. Grob ◽  
J. Larkin ◽  
B. Neyns ◽  
...  
Keyword(s):  
Advanced Melanoma ◽  
Term Survival ◽  
Long Term Survival

Disease control and long-term survival in chemotherapy-naive patients with advanced melanoma treated with ipilimumab (MDX- 010) with or without dacarbazine

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 9022-9022 ◽  
Author(s):  
E. M. Hersh ◽  
J. S. Weber ◽  
J. D. Powderly ◽  
K. Khan ◽  
A. C. Pavlick ◽  
...  
Keyword(s):  
Disease Control ◽  
Advanced Melanoma ◽  
Term Survival ◽  
Long Term Survival

Long-term survival of patients with advanced melanoma who received ipilimumab administered at 10 mg/kg every 3 weeks for 4 doses (induction dosing)

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 3018-3018 ◽  
Author(s):  
W. J. Urba ◽  
J. S. Weber ◽  
S. J. O'Day ◽  
J. D. Powderly ◽  
M. J. Yellin ◽  
...  
Keyword(s):  
Advanced Melanoma ◽  
Term Survival ◽  
Long Term Survival

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]

Sign in / Sign up

Export Citation Format

Share Document