Sunday May 31, 2015; 1:00 PM–4:00 PM

Plenary Session

LBA1 Efficacy and safety results from a phase III trial of nivolumab (NIVO) alone or combined with ipilimumab (IPI) versus IPI alone in treatment-naive patients (pts) with advanced melanoma (MEL) (CheckMate 067). Authors: JD Wolchok, V Chiarion-Sileni, R Gonzalez, et al

Take-Home Message

• The paradigm for treating advanced melanoma has changed for the better in recent years. This plenary presentation should add some clarity in terms of initial treatment for metastatic melanoma.

Saturday May 30, 2015; 1:15 PM–4:15 PM

Oral Abstract Session

9001 Long term follow up of survival in a randomized trial of wide or narrow excision margins in high risk primary melanoma. Authors: AJ Hayes, L Maynard, RA'Hern, et al

Take-Home Message

• A total of 900 patients with primary cutaneous melanoma ≥2 mm in Breslow thickness were randomized to a 1-cm excision (n = 453) or 3-cm (n = 447) excision. After a median of 8.8 years' follow-up, 494 patients died; 359 of the deaths were melanoma-related. The rate of melanoma-related death was 24% higher in those who received a 1-cm excision vs those who received a 3-cm excision.
• This randomized trial of patients with melanomas ≥2 mm in depth has demonstrated an improvement in melanoma-specific mortality in addition to locoregional relapse with 3-cm excisions compared with 1-cm excisions and may very well lead to the recommendation of even wider margins for such patients.

LBA9002 Survival of SLNB-positive melanoma patients with and without complete lymph node dissection: A multicenter, randomized DECOG trial. Authors: U Leiter, R Stadler, C Mauch, et al

Take-Home Message

• I am looking forward to this presentation. Results could lead to a change in the standard of care and possibly improved quality of life for these patients.

9003. Surveillance imaging with FDG-PET in the follow-up of melanoma patients at high risk of relapse. Authors: JH Lewin, A Sanelli, I Walpole, et al

Take-Home Message

• In this study, 86 Australian patients with stage III melanoma were followed with serial FDG-PET scans, and 25 recurrences were found. The majority of the patients were asymptomatic, and 9 were able to undergo potentially curative surgery.
• Although not yet a part of guidelines, this imaging modality should be considered in selected patients and may someday be a standard of care.

9004 Clinical response, progression-free survival (PFS), and safety in patients (pts) with advanced melanoma (MEL) receiving nivolumab (NIVO) combined with ipilimumab (IPI) vs IPI monotherapy in CheckMate 069 study. Authors: FS Hodi, MA Postow, JA Chesney, et al

Take-Home Message

• In the CheckMate 069 trial, 142 patients with metastatic or unresectable melanoma were randomized 2:1 to receive ipilimumab plus nivolumab or ipilimumab monotherapy. Both objective response rate (60% vs 11%; P < .0001) and progression-free survival (8.9 months vs 4.7 months; P = .0012) significantly improved with the addition of nivolumab compared with ipilimumab monotherapy. While the safety profile was manageable, 51% of patients receiving ipilimumab plus nivolumab reported grade 3/4 drug-related adverse events compared with 20% of those receiving ipilimumab alone.
• This is another important presentation in the saga of PD-1 inhibition, which may potentially change the standard of initial care for advanced melanoma. The combination led to a higher response rate and improvement in progression-free survival.

9005 Long-term efficacy of pembrolizumab (pembro; MK-3475) in a pooled analysis of 655 patients (pts) with advanced melanoma (MEL) enrolled in KEYNOTE-001. Authors: A Daud, A Ribas, C Robert, et al

Take-Home Message

• In 342 ipilimumab-treated (IPI-T) and 313 ipilimumab-naïve (IPI-N) patients with metastatic melanoma, after receiving PD-1 inhibitor pembrolizumab, ORR was 34% (29% of IPI-T patients and 38% of IPI-N patients); CR rate was 6%. The 6-month progression-free survival (PFS) rate was 44% (41% in IPI-T patients and 47% in IPI-N patients), and the 12-month PFS rate was 34% (32% in IPI-T patients and 36% in IPI-N patients). Overall survival at 1 year was 67% (63% in IPI-T patients and 71% in IPI-N patients), and at 2 years was 50% (46% in IPI-T patients and 53% in IPI-N patients). Grade 3/4 treatment-related adverse events were reported in 14% of patients.
• This PD-1 inhibitor was demonstrated to have robust and durable activity in patients with previous ipilimumab exposure and in previously untreated patients, with manageable toxicity.