Long-Term Survival Benefit for Patients With Melanoma Demonstrated With Immunotherapy

Immunotherapy continues to offer strong results in patients with advanced melanoma, according to data presented at the European Society for Medical Oncology (ESMO) 2024.¹

Results of a phase 3 trial of immunotherapy with an anti–programmed death (PD)-1–based therapy showed continued long-term survival benefit in patients with advanced melanoma. After a follow-up period of at least 10 years, the median overall survival was about 6 years in 945 patients who were assigned to combination immunotherapy with nivolumab (Opdivo; Bristol Myers Squibb) plus ipilimumab (Yervoy; Bristol Myers Squibb) in the CheckMate 067 trial. Very few of the patients showing good initial response to anti-PD-1-based immunotherapy, with no disease progression for at least 3 years, had died of melanoma at 10 years (10-year melanoma- specific survival rate 96%).

“The results from this trial do confirm the potential for cure with immunotherapy in patients with advanced melanoma,” said Dr Marco Donia, associate professor of clinical oncology at the National Center for Cancer Immune Therapy of Denmark, Copenhagen University Hospital Herlev, Denmark, who was not a study author but commented in a press release.² He added: “For patients who show no disease progression beyond 3 years, these longer-term results demonstrate that most of them never progress. The melanoma-specific survival is very high in this group of patients.”

“Importantly, the long-term survival benefit with immunotherapy is also seen in routine clinical practice, outside clinical trials,” Donia continued. “Immunotherapy has transformed advanced melanoma from something that was previously a deadly disease with a median survival of less than 1 year to what we see today, with half of patients surviving for many years.” He considered this raises practical questions about how best to follow up with these patients, including whether they need long-term check-ups. “It also supports their right ‘to be forgotten’ as former cancer patients after 5 years of being cancer-free following the end of treatment, so they don’t suffer discrimination compared to the general population when seeking financial credit.”

In other results presented at ESMO 2024, researchers discussed follow-up data from KEYNOTE-006, which was an open-label, randomized, phase 3 study comparing the efficacy and safety of pembrolizumab (Keytruda; Merck) versus ipilimumab in participants with advanced melanoma.

The primary end points for KEYNOTE-006 were progression-free survival and overall survival overall survival (OS). At the conclusion of the study, participants were eligible to transition to the KEYNOTE-587 extension study for long-term follow-up. The primary end point for KEYNOTE-587 is OS. Results presented at ESMO included an analysis of the efficacy and safety outcomes for 211 former KEYNOTE-006 participants who transitioned to KEYNOTE-587 (pembrolizumab, n=159; ipilimumab, n=52) after 10 years of follow-up and an analysis of additional antitumor activity in patients who received a second course of pembrolizumab.

Findings from this long-term follow-up showed that the median OS was 32.7 months (95% confidence interval, 24.5-41.6) for pembrolizumab versus 15.9 months for ipilimumab. The 10-year OS rate was 34% for KEYTRUDA versus 23.6% for ipilimumab.³

References

1. Larkin J, Chiarion Sileni V, Gadudy Marqueste C, et al. 10-y survival outcomes from the phase 3 CheckMate 067 trial of nivolumab plus ipilimumab in advanced melanoma. ESMO Congress 2024. September 13-17, 2024. Barcelona, Spain, & online; abstract LBA43.
2. ESMO. Studies show immunotherapy improves long-term survival in growing number of cancers. Press release. September 15, 2024. Accessed September 24, 2024. https://www.esmo.org/newsroom/press-and-media-hub/esmo-media-releases/studies-show-immunotherapy-improves-long-term-survival-in-growing-number-of-cancers
3. Robert C, Carlino MS, McNeil C, et al. Pembrolizumab vs ipilimumab in advanced melanoma: 10-year follow-up of the phase 3 KEYNOTE-006 study. ESMO Congress 2024 September 13-17, 2024. Barcelona, Spain, & online; abstract LBA44.