Immunotherapy in the Adjuvant Setting for Melanoma: What You Need to Know

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1 Immunotherapy in the Adjuvant Setting for Melanoma: What You Need to Know Jeffrey Weber, MD, PhD Laura and Isaac Perlmutter Cancer Center NYU Langone Medical Center New York, New York

2 What Is the Current Landscape for Adjuvant Melanoma Therapy? High-dose interferon α-2b was approved by the US FDA in 1996 for resected stages 2c and 3 melanoma, based on a controlled phase III study One-year regimen, 4 weeks of intravenous therapy at 20 MU/m 2 followed by 11 months of SC therapy at 10 MU/m 2 TIW 27% increase in RFS, 2%-3% absolute change in survival In 2015 ipilimumab at 10 mg/kg was approved by the US FDA for resected stage 3 melanoma based on a placebocontrolled phase III study Increase in RFS, HR = 0.75, survival data at ESMO % rate of grades 3-4 iraes observed FDA, Food and Drug Administration; irae, immune-related adverse event; RFS, recurrence-free survival; TIW, three times per week

3 Track Record for Interferon α-2b As Adjuvant Melanoma Therapy Meta Analysis In Mocellin et al, the authors reviewed data on more than 10,499 patients with high-risk melanoma from 18 randomized controlled trials, and performed a metaanalysis. Adjuvant interferon was associated with significantly improved disease-free survival (HR [hazard ratio] = 0.83; 95% CI [confidence interval] 0.78 to 0.87, P value <.00001) and overall survival (HR = 0.91; 95% CI 0.85 to 0.97; P value =.003). Considering that the 5-year overall survival rate for TNM stage II-III cutaneous melanoma is 60%, the number needed to treat (NNT) is 35 participants (95% CI = 21 to 108 participants) in order to prevent 1 death. Mocellin S, et al. Cochrane Database Syst Rev. 2013;18(6):CD

4 Pegylated Interferon As Adjuvant Melanoma Therapy EORTC was an observation-controlled study of pegylated interferon α-2b in 1256 patients with resected stages IIIA-B-C melanoma At 7.6 years median follow-up, 384 recurrences or deaths had occurred with PEG-IFN-α-2b versus 406 in the observation group (HR 0.87, P =.055); 7-year RFS rate was 39.1% versus 34.6%. There was no difference in OS (P =.57). The drug was approved in 2011 by the US FDA. In stage III-N1 ulcerated melanoma, RFS (HR, 0.72, P =.06), DMFS (HR, 0.65, P =.02), and OS (HR, 0.59, P =.006) were prolonged with PEG-IFN-α-2b. PEG-IFN-α-2b was discontinued for toxicity in 37% of patients. These data have stimulated an EORTC trial of PEG-IFN-α-2b in ulcerated stage IIIC melanoma DMFS, distant metastasis free survival; EORTC, European Organisation for Research and Treatment of Cancer; OS, overall survival Eggermont AM, et al. J Clin Oncol. 2012;30(31):

5 Biochemotherapy As Melanoma Adjuvant Therapy In the SWOG S0008 trial, 432 patients were randomly assigned to high-dose interferon or 3 cycles of inpatient biochemotherapy At a median follow-up of 7.2 years, biochemotherapy improved RFS (HR, 0.75; P =.015), with a median RFS of 4.0 years versus 1.9 years for HDI, and a 5-year RFS of 48% versus 39% Median OS was not different (HR, 0.98; P =.55), with a 5-year OS of 56% for both arms The complexity, cost, lack of OS advantage, and toxicity of this treatment have prevented it from becoming widely used in resected melanoma Flaherty LE, et al. J Clin Oncol. 2014;32(33):

6 Relapse-Free Survival and Overall Survival in the S0008 Adjuvant Biochemotherapy Trial Relapse-Free Survival Overall Survival Lawrence LE, et al. J Clin Oncol. 2014;32(33):

7 Ipilimumab As Adjuvant Therapy for Melanoma 75 patients with resected stage IIIc/IV melanoma received ipilimumab every 6 to 8 weeks for 1 year Eligible patients received further maintenance treatments, every 12 weeks, up to 5 years The first 25 patients received 3 mg/kg of ipilimumab, and an additional 50 patients received 10 mg/kg HLA-A*0201+ patients received multipeptide immunizations in combination with ipilimumab Median overall and relapse-free survivals were not reached after a median follow-up of 29.5 months Significant grades iraes were observed in 28 of 75 patients (37%) and were positively associated with longer relapse-free survival Sarnaik AA, et al. Clin Cancer Res. 2011;17(4):

8 Ipilimumab As Adjuvant Therapy for Melanoma Sarnaik AA, et al. Clin Cancer Res. 2011;17(4):

9 Schema: EORTC 18071: Ipilimumab vs Placebo ITT, intention-to-treat. PPT, per-protocol treatment (eligible patients who started the treatment allocated at randomization). *One patient had follow-up for a long period of time and the other five were lost to follow-up. Because of a lack of disease assessment after randomization, recurrence-free survival duration was censored at 1 day. Eggermont AM, et al. Lancet Oncol. 2015;16(5):

10 Forest Plot of Benefit by Subgroup: Ipilimumab vs Placebo Subgroup analyses of recurrence-free survival as assessed by IRC (independent review committee). AJCC, American Joint Committee on Cancer; df, degrees of freedom; LN+, positive lymph nodes; O E, observed expected number of events (recurrence or death) Eggermont AM, et al. Lancet Oncol. 2015;16(5):

11 RFS With Ipilimumab Versus Placebo Kaplan-Meier curves of recurrence-free survival, as assessed by IRC *RFS distributions of the treatment groups compared with a log-rank test at a two-sided alpha level of 05, stratified by stage as indicated at randomization. Type of RFS event: locoregional recurrence (n = 87), distant metastasis or death due to melanoma (n = 138), death due to another cause or unknown cause (n = 9). Type of RFS event: locoregional recurrence (n = 106), distant metastasis or death due to melanoma (n = 186), death due to another cause or unknown cause (n = 2) Eggermont AM, et al. Lancet Oncol. 2015;16(5):

12 Completed Ipilimumab Adjuvant Trials for Melanoma In EORTC 18071, median RFS was 26.1 months with ipilimumab vs 17.1 months with placebo (HR, 0.75; 95% CI, ; P =.0013), leading to FDA approval in 2015 In the ECOG-SWOG 1609 trial, 1500 patients were randomly allocated to receive either the FDA-approved one-year regimen of interferon alpha 2b, or ipilimumab at 3 mg/kg or 10 mg/kg given for 4 doses every 3 weeks, then every 12 weeks for the rest of one year Stage IIIB-C-IV patients resected NED were eligible RFS was the primary endpoint, OS was co-primary Toxicity, tolerability, and quality of life were secondary Activated May 2011, accrual finished August 2014 First results expected mid to late 2017 ECOG, Eastern Cooperative Oncology Group; NED, no evidence of disease; SWOG, (formerly) Southwest Oncology Group

13 Pilot Trial of Adjuvant Nivolumab Therapy for Resected Stage IIIC and IV Melanoma Induction Cohort 1 NIVO (1 mg/kg) IV + peptide vaccine q2 weeks X 12 Cohort 2 NIVO (3 mg/kg) IV + peptide vaccine q2 weeks X 12 Cohort 3 NIVO (10 mg/kg) IV + peptide vaccine q2 weeks X 12 Maintenance NIVO (3 mg/mg) IV q12 weeks X 2 years Gibney G, et al. Clin Cancer Res. 2015;21(4):

14 Pilot Trial of Adjuvant Nivolumab Therapy for Resected Stage IIIC and IV Melanoma Gibney G, et al. Clin Cancer Res. 2015;21(4):

15 Pilot Trial of Adjuvant Nivolumab/Ipilimumab Therapy for Resected Stage IIIC and IV Melanoma Induction Cohort 4 NIVO (1 mg/kg) + IPI (3 mg/kg) IV q3 weeks X 4 Cohort 5 NIVO (3 mg/kg) + IPI (1 mg/kg) IV q3 weeks X 4 Maintenance NIVO (3 mg/mg) IV q2 weeks X 2 years Khushalani NI, et al. J Clin Oncol. 2016;34(suppl): Abstract 9586.

16 Pilot Trial of Adjuvant Nivolumab/Ipilimumab Therapy for Resected Stage IIIC and IV Melanoma Relapse-Free Survival Log rank P = Khushalani NI, et al. J Clin Oncol. 2016;34(suppl): Abstract 9586.

17 Completed Nivolumab Adjuvant Trial for Melanoma In the CheckMate 238 phase III trial, 883 patients were randomly allocated to receive ipilimumab at the FDAapproved dose of 10 mg/kg for 4 doses every 3 weeks, then every 12 weeks for the rest of one year versus nivolumab at 3 mg/kg every 2 weeks for 1 year. Stage III-B-C-IV patients resected NED were eligible Accrual took 6 months in this international trial; last patient registered in October 2015 Primary endpoint was RFS; OS was secondary First data expected in late 2017 or early 2018; there is no planned interim analysis for efficacy NED, no evidence of disease

18 Ongoing Pembrolizumab Adjuvant Trials for Melanoma In the ECOG 1404 phase III trial, 1378 patients will be randomly allocated to receive pembrolizumab at 200 mg flat dose every 3 weeks for 1 year, compared with either IFN alpha 2b at doses used in the standard one year regimen or ipilimumab at 10 mg/kg for 4 doses every 3 weeks, then every 12 weeks for the rest of 1 year The original trial started accrual in November 2015, but the design was amended to include either ipilimumab or interferon in the reference arm due to the recent FDA approval of ipilimumab Stage IIIA-B-C-IV patients resected NED are eligible RFS is the primary endpoint, OS is secondary First results expected late 2018 or early 2019

19 Ongoing Pembrolizumab Adjuvant Trials for Melanoma In the EORTC KEYNOTE-054 phase III trial, 900 patients will be randomly allocated 1:1 to receive pembrolizumab at 200 mg flat dose every 3 weeks for one year versus placebo Resected stage IIIA-B-C patients are eligible Primary endpoints are RFS in all patients and RFS in the PD-L1 population Secondary endpoints are DMFS and OS for the above First patient accrued fall 2015; first data expected late sites are open and accruing in Atlanta DMFS, distant metastasis free survival

20 Completed Targeted Adjuvant Trial for Melanoma In the COMBI-A/D trial, 852 patients were randomly allocated in a blinded fashion 1:1 to receive either dabrafenib at 150 mg PO BID and trametinib 2 mg PO QD at the FDA-approved dose and schedule versus placebo Stage IIIA-B-C resected melanoma patients that are BRAF V600E/K+ are eligible Primary endpoint is RFS, and secondary endpoints are OS, DMFS, and safety Enrollment began early 2013 and has ended First results expected early 2017

21 Conclusions: Adjuvant Therapy for Melanoma The therapeutic index is frankly modest for all currently used adjuvant regimens High-dose interferon offers modest gains in OS and real improvement in RFS for those with resected stage 3 disease, at a cost in generalized fatigue and toxicity Ipilimumab offers possible gains in OS and real gains in RFS but at a cost in immune-related toxicity that occurs in over 1/3 of patients but is reversible with steroids Nivolumab and pembolizumab are less toxic and promising adjuvant therapies; conclusive data are 1-2 years away at the earliest for nivolumab Data from a comparison of IFN with 3 or 10 mg/kg of ipilimumab are eagerly awaited, maybe 1-2 years away

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