麻豆果冻传媒影音

In this exclusive MedPage Today video, Ahmad Tarhini, MD, PhD, of Moffitt Cancer Center in Tampa, Florida, gives an overview on some of the key melanoma data presented at the recent American Society of Clinical Oncology (ASCO) meeting.

Following is a transcript of his remarks:

We're excited about emerging data in the neoadjuvant setting in melanoma. We have the NADINA study, which is scheduled for presentation tomorrow by Christian Blank at the plenary session. This is a study that is randomizing patients with macroscopic local-regionally advanced disease into the neoadjuvant combination of ipilimumab [Yervoy] and nivolumab [Opdivo] followed by surgery and adjuvant nivolumab, or surgery upfront followed by adjuvant nivolumab. This is an exciting study. Being at a plenary, my prediction is it's going to be a positive study. It would have a major impact on clinical practice in this setting in melanoma.

Now this builds upon the S1801 SWOG study, which tested neoadjuvant pembrolizumab [Keytruda] versus surgery and adjuvant pembrolizumab. So it's exciting that we're moving the field forward now with combinations.

Now, the other neoadjuvant study, which was presented yesterday at the oral melanoma session was the daromun phase III study (PIVOTAL), which tested the combination of the antibody cytokine fusion of L19 interleukin-2 and L19 TNF [tumor necrosis factor]. This is given injectable into the tumor weekly for four doses, followed by surgery as compared to surgery upfront. This was a positive study. It's a pivotal study for this regimen, and the study met the primary endpoint of recurrence-free survival. [It] was also positive in terms of distant metastasis-free survival. Toxicities were manageable and no, let's say, systemic immune-mediated adverse events related to the regimen itself. This is exciting as well, and I think it'll move this field forward.

Now other exciting developments were the triplet combinations presented yesterday at the oral session as well was the by Paolo Ascierto, which tested the triplet of ipilimumab 1 mg/kg given once every 8 weeks in combination with relatlimab [Opdualag]-nivolumab given every 4 weeks for two doses. This was a phase II study, about 46 patients. The response rate was 59%. The complete response rate was 17%.

But importantly, what we observed is that on long-term follow-up, at 4 years, 72% of patients were alive on the study and 52% of patients had no evidence of disease recurrence. So recurrence-free survival was 52%. So this is exciting data. The toxicity profile appears manageable as well, not worse than [ipilimumab 3 mg/kg plus nivolumab 1 mg/kg], for example.

Now in terms of sequencing of immunotherapy and targeted therapy for BRAF-mutant melanoma, the study presented by Caroline Robert yesterday at the oral session as well showed interesting data. There was no significant differences in terms of progression-free survival between upfront ipilimumab-nivolumab, or an induction phase with encorafenib [Braftovi]-binimetinib [Mektovi] for 3 months, followed by ipilimumab-nivolumab. But suggested that for patients who have high LDH [lactate dehydrogenase], more than two times the upper limit of normal, and with liver metastasis, that these patients may benefit from the induction [encorafenib-binimetinib], followed by ipilimumab-nivolumab.

Comment