KEY TAKEAWAYS
- The PRESERV MEL aimed to assess the real-world effectiveness, safety, and QoL outcomes in melanoma pts receiving adjuvant NIVO.
- The result concluded that PRESERV MEL aligns with CheckMate 238 with NIVO’s efficacy in melanoma.
Adjuvant nivolumab (NIVO) has garnered approval for patients (pts) afflicted by melanoma featuring lymph node involvement or metastatic disease, provided they have undergone a comprehensive resection.
Herein, Bart Neyns and his research group presented updated results on the PRESERV MEL study. This study was observational and seeks to delineate the efficacy, safety, and impact on the quality of life in pts subjected to adjuvant NIVO within real-world conditions.
The study included pts either prospectively or retrospectively over two years and are currently under observation for five years. The index date corresponds to the initial administration of NIVO. Patients were prescribed NIVO according to the label for 12 months. The study evaluated parameters such as recurrence-free survival (RFS), distant metastasis-free survival (DMFS) – including pts with stage IV at baseline, time to discontinuation (TTD), subsequent treatment, and the occurrence of adverse events (AEs) or treatment-related AEs (TRAEs).
About 152 pts were enrolled in the study, with 125 being prospective and 27 retrospective. The enrollment took place at 15 sites in Belgium and Luxembourg. The median follow-up duration was 25 months. The median TTD was 11.1 months. Treatment was concluded by pts due to treatment completion (56%), AEs (23%), recurrence (15%), patient decisions unrelated to AEs (1%), or other reasons (5%).
The median RFS was 47.2 months, with a 2-year RFS rate of 62%. Median DMFS was not reached, and the 2-year DMFS rate was 72%. The sites of first recurrence in pts with distant recurrence (n = 41; 27%) were distributed among soft tissue (39%), lungs (34%), multiple organs (37%), skin (27%), liver (22%), lymph nodes (22%), bone (15%), brain (7%), intestines (5%), other visceral organs (17%), and other (2%). Subsequent treatment was administered to 51 pts (34%), involving surgery (9%), radiotherapy (8%), and systemic treatment (32% [adjuvant treatment, 10%; unresectable/metastatic treatment, 22%]).
The median time from NIVO discontinuation (D/C) to subsequent treatment was 12.6 months. Grade 3/4 TRAEs occurred in 21 pts (14%). Any AEs led to treatment discontinuation in 35 pts (23%). Late-emergent grade 3/4 TRAEs (100 days to 2 years after treatment) were reported in 3 pts (2%; 2 of 3 pts had prior TRAE occurrence).
The result concluded that the efficacy and safety findings of adjuvant NIVO in pts with surgically treated stage III/IV melanoma in the PRESERV MEL study aligned with the outcomes observed in the CheckMate 238 trial.
This study is sponsored by Bristol-Myers Squibb.
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34
Clinical Trial: https://clinicaltrials.gov/study/NCT03771859
Neyns B et al. “Real-world (RW) effectiveness and safety of adjuvant nivolumab (NIVO) in patients (pts) with melanoma in Belgium and Luxembourg: PRESERV MEL” Presented at ESMO IO 2023. (Abstract: 108P).
