Dr. Vincent Ma mentioned the newest and notable therapy updates for sufferers with high-risk and superior melanoma.
Though the 2025 ASCO Annual Assembly didn’t generate practice-changing throughout the realm of melanoma care, the assembly highlighted practice-affirming knowledge, in line with Dr. Vincent Ma, a college member within the Division of Hematology, Medical Oncology and Palliative Care on the College of Wisconsin.
“[Based on] the findings of the [RELATIVITY-098] research, the usual of care nonetheless stays that for sufferers after resection of stage 2, stage 3, or stage 4 melanoma, anti-PD-1 monotherapy ought to nonetheless be the usual of care, slightly than a two-drug immunotherapy routine,” Ma mentioned when discussing this analysis in an interview with CURE, reaffirming the present standard-of-care for sufferers with this illness.
Within the interview, he mentioned a number of the most therapy updates for sufferers with high-risk and superior melanoma.
Ma can be an assistant professor throughout the Division of Medication and is a college affiliate of the Division of Dermatology, all on the College of Wisconsin, Faculty of Medication and Public Well being.
CURE: What have been a number of the most notable therapy updates for sufferers with melanoma that have been shared on the 2025 ASCO Annual Assembly?
Ma: At ASCO this 12 months, there have been a number of attention-grabbing updates relating to the administration of advanced-stage melanoma, in addition to research investigating whether or not there’s a position for therapy after full surgical resection of melanoma. General, [the meeting] was extra affirming of scientific apply slightly than presenting practice-changing knowledge for melanoma.
One of many attention-grabbing research introduced this 12 months was the DANTE trial. This was a part 3 research analyzing whether or not two years of immunotherapy — the present commonplace minimal — is more practical than one 12 months for sufferers with advanced-stage melanoma.
To supply some background, the present commonplace for treating advanced-stage melanoma includes a minimal of two years of immunotherapy as a result of that is how these medication have been studied in large-scale scientific trials. Nevertheless, each suppliers and sufferers typically surprise if two years of therapy is really essential. Two years of remedy generally is a vital burden for sufferers, who should take break day from work each three to 4 weeks for therapy. There is no clear organic or scientific rationale for a two-year length; some sufferers reply to therapy after just a few doses, and the results of immunotherapy may even persist after therapy stops. This was the idea for the DANTE trial: to find out if two years of therapy is really wanted, or if one 12 months of remedy could possibly be ample.
The research was primarily carried out in the UK, with an preliminary aim of enrolling 1,200 sufferers. Sadly, the research needed to shut after a number of years, accruing solely 166 sufferers in whole. Due to this fact, the research was thought of underpowered, which means it did not attain the goal variety of sufferers wanted to statistically show if one 12 months versus two years yielded the identical or higher outcomes. The research’s aim was to show that one 12 months was non-inferior to 2 years.
What the research did discover was that, general, one 12 months of therapy was not statistically inferior to 2 years of remedy when it comes to progression-free survival. This means that we may probably scale back therapy to at least one 12 months as a substitute of two. Nevertheless, as a result of research being underpowered, the investigators concluded that the usual of care ought to stay a minimal of two years of immunotherapy for sufferers with advanced-stage melanoma.
One essential query the research didn’t totally reply is the general survival outcomes between two years versus one 12 months, and this stays an unanswered query. Nonetheless, different research are presently underway which can be exploring the position of giving much less remedy primarily based on how sufferers reply to therapy. Due to this fact, that is neither the primary nor the final time we’ll hear a couple of research investigating the right length of immunotherapy for sufferers with advanced-stage melanoma.
What have been a number of the updates in adjuvant therapy for sufferers with stage 3 or 4 melanoma, significantly from the RELATIVITY research?
Completely. At ASCO this 12 months, investigators introduced knowledge from the RELATIVITY-098 trial. This explicit research aimed to have a look at the position of giving Opdivo (nivolumab) plus Opdualag (relatlimab) within the adjuvant setting, particularly after surgical resection of stage 3 or 4 melanoma.
To present you a bit background on treating melanoma after surgical procedure, the present commonplace of look after resected high-risk stage 2 or stage 3 melanoma presents two principal choices. Sufferers can obtain anti-PD-1 remedy, like Opdivo or Keytruda (pembrolizumab), after surgical procedure. Alternatively, if a affected person has a BRAF V600 mutation, they’ll use BRAF/MEK focused remedy. Whereas these FDA-approved medication have been proven to cut back recurrence, which is great, not all sufferers profit from adjuvant anti-PD-1 or BRAF/MEK focused remedy. So, researchers are exploring new methods to assist stop recurrence.
What are a number of the current efforts to discover new adjuvant therapy methods for sufferers with stage 3 or 4 melanoma?
[Because] researchers are exploring new methods to assist stop recurrence, we requested: the place can we search for drug alternatives to cut back recurrence? We presently have FDA approval for Opdivo plus Opdualag for unresectable stage 3 and 4 melanoma. This was FDA authorised again in 2022 and has been proven to enhance response charges, progression-free survival, and general survival in sufferers with superior stage melanoma.
The investigators of the RELATIVITY-098 trial wished to see if we may use Opdivo plus Opdualag within the adjuvant setting, after surgical resection of stage 3 and 4 melanoma. This was a part 3 research the place they checked out half of the sufferers who acquired Opdivo plus Opdualag after surgical procedure, and the opposite half of sufferers acquired Opdivo by itself, which is the usual of care arm.
What they discovered within the research was that there was really no distinction when it comes to recurrence-free survival between the 2 arms. This was a little bit of a shock as a result of we all know there’s efficacy and profit to utilizing Opdivo plus Opdualag within the unresectable setting. Nevertheless, we did not actually see the good thing about two medication versus one drug on this explicit part 3 trial. The investigators and researchers tried to interrupt it all the way down to see if there was a specific group of sufferers which may profit from two medication versus one, however they did not discover a particular subgroup.
From the findings of this general research, the usual of care nonetheless stays that for sufferers after resection of stage 2, stage 3, or stage 4 melanoma, anti-PD-1 monotherapy ought to nonetheless be the usual of care, slightly than a two-drug immunotherapy routine.
Transcript has been edited for readability and conciseness
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