REAL-WORLD CLINICAL OUTCOMES AND CORRELATION OF RECURRENCE FREE SURVIVAL (RFS) AND DISTANT METASTASIS FREE SURVIVAL (DMFS) TO OVERALL SURVIVAL (OS) IN RESECTED STAGE IIB/C CUTANEOUS MELANOMA
Author(s)
Wolfram Samlowski, MD1, Yuexin Tang, PhD2, Wenyang Mao, PhD3, Lang Xu, MS4, Ahong Huang, MS5, Ke Meng, PhD2, Dmitri Grebennik, MD6, Sameer Ghate, PhD7.
1University of Nevada, Las Vegas, NV, USA, 2Merck & Co., Inc., Rahway, NJ, USA, 3Tigermed BDM, Newton Upper Falls, MA, USA, 4Tigermed-BDM, Somerset, NJ, USA, 5Tigermed-BDM, Allen, TX, USA, 6Merck & Co. Inc., North Wales, PA, USA, 7Merck & Co. Inc, Rahway, NJ, USA.
1University of Nevada, Las Vegas, NV, USA, 2Merck & Co., Inc., Rahway, NJ, USA, 3Tigermed BDM, Newton Upper Falls, MA, USA, 4Tigermed-BDM, Somerset, NJ, USA, 5Tigermed-BDM, Allen, TX, USA, 6Merck & Co. Inc., North Wales, PA, USA, 7Merck & Co. Inc, Rahway, NJ, USA.
OBJECTIVES: Treatment with anti-PD-1 adjuvant therapies (AT) have demonstrated efficacy in reducing the risk of recurrence in clinical trials. Limited evidence exists on correlations of intermediate endpoints to OS, especially in anti-PD1 AT treated stage IIB/C melanoma. This study assessed real-world (rw) clinical outcomes and the correlation of RFS and DMFS to OS in resected stage IIB/C melanoma in US community setting.
METHODS: Patients with newly diagnosed resected stage IIB/C cutaneous melanoma between Jan 2018 and Aug 2025 (study period) were identified from US Oncology Network. Anti-PD-1 AT group received pembrolizumab or nivolumab within 11 weeks of resection following FDA approvals (n=153). No-AT group did not receive AT during study period (n=262). Kaplan-Meier methods were used to estimate rwRFS, rwDMFS, and rwOS. Kendall τ rank correlation coefficients were calculated to assess correlations of rwRFS and rwDMFS to rwOS.
RESULTS: Overall, the mean age was 67 years, and the median follow-up was 19.1 months (IQR, 10.8-26.9). Compared with patients without AT, those receiving anti-PD-1 AT had greater comorbidity burden (mean CCI: 2.4 and 1.3), but better performance status (0-1 ECOG 54.9% and 41.2%). In the anti-PD-1 AT group, 12-month rwRFS, rwDMFS, and rwOS rates were 91.3%, 92.6%, and 96.3%; in the no-AT group, they were 84.5%, 86.5%, and 91.4%, respectively. Kendall τ correlation coefficients were 0.91 (95%CI: 0.85, 0.97) for rwRFS and rwOS and 0.94 (0.90, 0.98) for rwDMFS and rwOS in the AT-PD-1 AT group, compared with 0.82 (0.76, 0.88) and 0.86 (0.81, 0.92), respectively, in the no-AT group.
CONCLUSIONS: Patients receiving anti-PD1 AT experienced numerically favorable rwRFS, rwDMFS, and rwOS than no-AT in resected stage IIB/C melanoma. The Kendall τ correlations suggest rwRFS and rwDMFS may act as meaningful intermediate endpoints for interpreting long-term outcomes in AT treated stage II melanoma where OS data remains limited.
METHODS: Patients with newly diagnosed resected stage IIB/C cutaneous melanoma between Jan 2018 and Aug 2025 (study period) were identified from US Oncology Network. Anti-PD-1 AT group received pembrolizumab or nivolumab within 11 weeks of resection following FDA approvals (n=153). No-AT group did not receive AT during study period (n=262). Kaplan-Meier methods were used to estimate rwRFS, rwDMFS, and rwOS. Kendall τ rank correlation coefficients were calculated to assess correlations of rwRFS and rwDMFS to rwOS.
RESULTS: Overall, the mean age was 67 years, and the median follow-up was 19.1 months (IQR, 10.8-26.9). Compared with patients without AT, those receiving anti-PD-1 AT had greater comorbidity burden (mean CCI: 2.4 and 1.3), but better performance status (0-1 ECOG 54.9% and 41.2%). In the anti-PD-1 AT group, 12-month rwRFS, rwDMFS, and rwOS rates were 91.3%, 92.6%, and 96.3%; in the no-AT group, they were 84.5%, 86.5%, and 91.4%, respectively. Kendall τ correlation coefficients were 0.91 (95%CI: 0.85, 0.97) for rwRFS and rwOS and 0.94 (0.90, 0.98) for rwDMFS and rwOS in the AT-PD-1 AT group, compared with 0.82 (0.76, 0.88) and 0.86 (0.81, 0.92), respectively, in the no-AT group.
CONCLUSIONS: Patients receiving anti-PD1 AT experienced numerically favorable rwRFS, rwDMFS, and rwOS than no-AT in resected stage IIB/C melanoma. The Kendall τ correlations suggest rwRFS and rwDMFS may act as meaningful intermediate endpoints for interpreting long-term outcomes in AT treated stage II melanoma where OS data remains limited.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO32
Topic
Clinical Outcomes, Health Technology Assessment
Topic Subcategory
Relating Intermediate to Long-term Outcomes
Disease
Oncology