JCO: Does the Double Exemption Federation Improve the Recurrence-Free Survival of Advanced Melanoma?

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1

J Clin Oncol: Navurizumab combined with ipimumab does not improve recurrence-free survival in patients with stage IIIB-D or IV melanoma

▎Clinical Problems:
For high-risk resected melanoma, both navurizumab and ipimuzumab have shown therapeutic benefit
.
However, it is unclear whether the combination of the two drugs improves the patient's recurrence-free (RFS)
compared with navulliumab monotherapy.

A randomized controlled trial from J Clin Oncol showed that navuriumab combined with ipimumumab did not improve RFS
in patients with stage IIIB-D or IV melanoma compared with navurizumab monotherapy.


▎Study protocol: (1) Inclusion criteria:
1833 patients with resected stage IIIB-D or IV melanoma were included;
(2) 916 patients received navurizumab 240 mg every 2 weeks, plus ipimumab 1 mg/kg every 6 weeks; 917 patients received navurizumab 480 mg every 4 weeks; The duration of treatment in both groups ≤ 1 year;
(3) After random assignment, patients are stratified according to the expression and stage of tumor programmed death ligand 1 (PD-L1);
(4) The dual primary endpoint was to randomly assign patients and tumors with RFS
< 1% subgroup with PD-L1 expression levels.
<b112>▎ Main findings:
(1) There was no significant difference in RFS between treatment groups of all randomly assigned patient groups at about 23.
7 months (HR was 0.
92; 95% CI was 0.
77-1.
09; P=0.
269); There was no significant difference in RFS between patients with PD-L1 expression <1% (HR 0.
91; 95% CI 0.
73-1.
14);<b114> (2) at 24 months, the RFS rate was 64.
6% in the combination group and 63.
2% in the navulucumab monotherapy group;
(3) Grade 3 or 4 adverse events related to treatment occurred in 32.
6% of patients in the combination group, and 12.
8% in the navulucumab monotherapy group;
(4) 0.
4% of patients in the combination group had treatment-related deaths, and there were no treatment-related deaths
in the navuriumab monotherapy group.

▎ Outlook:
The efficacy of navullizumab in this study is consistent with the results of previous studies and similar to the current eighth edition of the American Cancer Council specification, which reaffirms that navurizumab should be used as an adjuvant treatment for
melanoma.

References:[1] https://ascopubs.
org/doi/full/10.
1200/JCO.
22.
00533
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