Advanced stage melanoma, survival improves thanks to therapies: here’s what, the study

Bristol Myers Squibb announced 10-year follow-up data from CheckMate-067, a randomized, double-blind, Phase 3 clinical study showing a sustained and sustained improvement in survival with first-line therapy with nivolumab plus ipilimumab and nivolumab monotherapycompared with ipilimumab alone in patients with previously untreated advanced or metastatic melanoma. At a minimum follow-up of 10 years, the median overall survival (OS) was 71.9 months with nivolumab plus ipilimumab, the longest median OS reported from a phase 3 study in advanced melanoma, 36.9 months with nivolumab, and 19.9 months with ipilimumab. These data were presented at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, ​​and simultaneously published in ‘The New England Journal of Medicine’.

Among all patients randomized in the study, 64% who received the combination, 50% who received nivolumab, and 33% who received ipilimumab had not received subsequent systemic therapy at 10 years of follow-up, a statement said. “These data continue to demonstrate the significant and durable clinical benefit of nivolumab in combination with ipilimumab, with survival curves remaining consistent for several years,” said James Larkin, Consultant Medical Oncologist, Department of Medical Oncology, The Royal Marsden. “In particular, 43% of patients treated with nivolumab and ipilimumab are alive at 10 years, and many patients have not required subsequent therapy.” Furthermore, at 10-year follow-up, the nivolumab plus ipilimumab combination showed melanoma-specific survival rates of 52% (median not reached) compared to 44% (median 49.4 months) and 23% (median 21.9 months) in patients treated with nivolumab alone and ipilimumab alone, respectively.

“Just 10 years ago, a diagnosis of advanced melanoma meant a mere few months to live. The dual immunotherapy combination of nivolumab and ipilimumab has dramatically changed the outlook for many patients,” said Dana Walker, vice president, global program lead, melanoma and gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “Our goal was and is to redefine the survival expectations of patients with melanoma; these data demonstrate our commitment to that goal and continue to give us confidence.”

Durable and sustained clinical benefit – the note details – was observed with nivolumab and ipilimumab or with nivolumab alone in relevant subgroups, including patients with Braf mutation and wild-type tumors. In patients with tumors with Braf mutation, the 10-year OS rate was 52% in patients treated with nivolumab plus ipilimumab, 37% with nivolumab alone, and 25% with ipilimumab alone. In patients with Braf wild-type tumors, the 10-year OS rate was 39% in patients who received nivolumab plus ipilimumab, 37% with nivolumab alone, and 17% with ipilimumab alone. At 10-year follow-up, the objective response rate (ORR) was higher in the two groups with nivolumab, in combination with ipilimumab and alone, equal to 58.3% and 44.9%, respectively, compared to the ipilimumab group, equal to 19%. The median duration of response (DOR) was not reached in those who received nivolumab and ipilimumab, while the median DOR was 103.2 months in patients treated with nivolumab and 19.2 months in those treated with ipilimumab.

The safety profile of nivolumab plus ipilimumab is consistent with previous results – the note highlights – with no new safety signals, and no treatment-related deaths were detected after the three previous analyses. Grade 3/4 treatment-related adverse events were reported in 62.6% of patients in the combination group, 24.6% in the nivolumab group, and 29.6% in the ipilimumab group. Bristol Myers Squibb thanks the patients and investigators who participated in the CheckMate -067 clinical study.

Melanoma is a type of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) in the skin. Metastatic melanoma is the most deadly form of the disease and occurs when the cancer spreads beyond the surface of the skin to other organs. The incidence of melanoma has increased steadily over the past 30 years. Globally, the WHO estimates that by 2035, the incidence of melanoma will reach 424,102, with 94,308 related deaths. In the United States, there will be an estimated 100,640 new diagnoses of melanoma in 2024, and approximately 8,290 related deaths. Most melanoma is curable when treated in the early stages; however, survival rates decrease as the disease progresses.