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.
The ASCO Post Staff
Apar Kishor Ganti, MD, of the University of Nebraska Medical Center, discusses results from the CALGB 30610 study, which showed a similar clinical benefit for once- and twice-daily radiotherapy administered to patients with limited-stage small cell lung cancer. While both regimens were well tolerated, patients who received radiotherapy once daily had better quality-of-life scores at week 3 and slightly worse scores at week 12. Patients believed the once-daily regimen was more convenient (Abstract 8504).
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Akihiro Ohba, MD, of Japan’s National Cancer Center Hospital, discusses phase II data from the HERB trial on fam-trastuzumab deruxtecan-nxki, which showed activity in patients with HER2-expressing unresectable or recurrent biliary tract cancer (Abstract 4006).
The ASCO Post Staff
Martin McCabe, PhD, of the University of Manchester, discusses a phase III assessment of chemotherapy for patients with recurrent and primary refractory Ewing sarcoma. The trial, called rEECur, is the first study to provide comparative toxicity and survival data for the four most commonly used chemotherapy regimens in this disease. The analysis showed that high-dose ifosfamide is more effective in prolonging survival than topotecan plus cyclophosphamide (Abstract LBA2).
The ASCO Post Staff
Nabil F. Saba, MD, of Winship Cancer Institute of Emory University, discusses new data from a trial of pembrolizumab and cabozantinib in patients with recurrent metastatic head and neck squamous cell carcinoma. The study met its primary endpoint of overall response rate. The regimen was well tolerated and exhibited encouraging clinical activity in this patient population (Abstract 6008).
The ASCO Post Staff
Clifford A. Hudis, MD, of the American Society of Clinical Oncology, and Karen E. Knudsen, PhD, MBA, of the American Cancer Society, discuss their collaboration, pooling their research and education resources to help empower patients with cancer and their families. Within 48 hours, Drs. Hudis and Knudsen were able to gear up a rapid response to the crisis in Ukraine, forming a clinical corps of volunteers to post information online in multiple languages, which helped patients navigate their care in the war-torn region. To date, 300 European cancer organizations have joined their efforts.