Georgina V. Long, MD, PhD, on Melanoma: Distant Metastasis–Free Survival With Adjuvant Pembrolizumab
2022 ASCO Annual Meeting
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, The University of Sydney, discusses phase III findings from the KEYNOTE-716 study. The trial showed that compared with placebo, adjuvant pembrolizumab significantly improved distant metastasis–free survival in patients with resected stage IIB and IIC melanoma. The findings also suggest a continued reduction in the risk of recurrence and a favorable benefit-risk profile (Abstract LBA9500).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
Keynote 716 is a phase three randomized trial of adjuvant pembrolizumab versus placebo in resected stage 2B and 2C melanoma. Historically from retrospective studies, stage 2B and C melanoma has been thought to be not as high risk as it actually is. In fact, many patients recur at 24 months and beyond, and these patients have very poor outcomes. So I'm reporting the distant metastasis free survival from this trial. We've previously reported on the relapse free survival on two previous analyses. And what we see is pembrolizumab significantly improves the distant metastasis free survival compared with placebo with a hazard ratio of 0.64, this represents a 36% reduction in the risk of recurrence, and a P value of 0.0029. This is highly significant. We also see on the 24 month and the 12 month landmark distant metastasis free survival rates, a significant increase compared with placebo of pembrolizumab. What's more in this study when we look at the subgroups, key subgroups, every subgroup favors pembrolizumab compared with placebo for the distant metastasis free survival, including the T subcategories 3B, 4A and 4B, as well as the US geographical region. We also see a sustained improvement in the relapse free survival. So at this analysis, this is the third analysis for the relapse free survival. It was the first for distant metastasis free survival. We see a hazard ratio of 0.64 and continued separation of the Kaplan-Meier curves for the relapse-free survival, meaning that adjuvant pembrolizumab significantly decreases the risk of recurrence for patients with resected stage 2B and 2C melanoma. So what are the next steps? The next steps are that we will continue to follow up with this trial and look at the overall survival benefit. In the design of this trial, we had crossover at recurrence. So patients were initially randomized to placebo versus pembrolizumab. But if they recurred, they were unblinded. If they were on the placebo arm or on the pembrolizumab arm, and they had their last dose of pembrolizumab six months or further prior, they were eligible to cross over to pembrolizumab. So we'll also be watching for the overall survival in the coming years. The take home message is that adjuvant pembrolizumab significantly improves both the relapse free survival and the distant metastasis free survival, and should be considered for patients with resected stage 2B and 2C melanoma.
Related Videos
The ASCO Post Staff
Mairéad G. McNamara, PhD, MBBCh, of The Christie NHS Foundation Trust, discusses phase II findings of the NET-02 trial, which explored an unmet need in the second-line treatment of patients with progressive, poorly differentiated extrapulmonary neuroendocrine carcinoma. In the trial, the combination of liposomal irinotecan, fluorouracil, and folinic acid, but not docetaxel, met the primary endpoint of 6-month progression-free survival rate (Abstract 4005).
The ASCO Post Staff
Ann H. Partridge, MD, MPH, of Dana-Farber Cancer Institute, and Kevin Kalinsky, MD, of Winship Cancer Institute at Emory University, discuss phase II findings from the MAINTAIN trial, which showed a benefit in progression-free survival for patients with hormone receptor–positive/HER2-negative metastatic breast cancer when they switched to endocrine therapy and received ribociclib after disease progression on another CDK4/6 inhibitor (Abstract LBA1004).
The ASCO Post Staff
Robert Hugh Jones, MD, PhD, of Cardiff University and Velindre Hospital, discusses results from an updated analysis of the FAKTION trial, which showed improved overall survival with fulvestrant plus capivasertib in women with metastatic estrogen receptor–positive breast cancer whose disease had relapsed or progressed on an aromatase inhibitor. The benefit may be predominantly in patients with PIK3CA/AKT1/PTEN pathway–altered tumors, a topic researchers continue to study in the phase III CAPItello-291 trial (Abstract 1005).
The ASCO Post Staff
Courtney D. DiNardo, MD, MSCE, of The University of Texas MD Anderson Cancer Center, and Stéphane de Botton, MD, PhD, of Institut Gustave Roussy, discuss phase III findings from the IDHENTIFY trial, which showed that mutational burden and co-mutational profiles differed between patients with relapsed or refractory acute myeloid leukemia that exhibited IDH2-R140 and IDH2-R172 mutations. Enasidenib improved survival outcomes for patients with IDH2-R172 mutations: median overall survival and 1-year survival rates were approximately double those in the conventional care arm (Abstract 7005).
The ASCO Post Staff
Gilberto de Lima Lopes, Jr, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, and Karen L. Reckamp, MD, of Cedars-Sinai Medical Center, discuss phase II findings from substudy S1800A of the Lung-MAP protocol. The data showed that ramucirumab and pembrolizumab improved overall survival compared with the standard of care for patients with advanced non–small cell lung cancer who were previously treated with immunotherapy and platinum-based chemotherapy (Abstract 9004).