FIRST-LINE CLINICAL TRIALS
Uptake for the Opdualag combination is
O
likely to be swift, owing to its convincing efficacy data so far and its positive side-effect profile, experts also say. Yet there are still questions, particularly as to where Opdualag would fit into the treatment spectrum, since there is still clinical value to available front-line melanoma therapies. These options are Bristol Myers Squibb’s (BMS’s) own combination of anti-CTLA-4 antibody Yervoy (ipilimumab) plus the anti-PD-1 antibody Opdivo (nivolumab), and Opdivo alone. On 18 March, BMS’s Opdualag secured
approval by the US Food and Drug Administration for use in adult and paediatric patients 12 years of age or older with unresectable or metastatic melanoma. Approval by the European Medicines Agency is also likely, even if the regulatory body is more interested in overall survival (OS) data, which Opdualag needs more of. Opdualag, which is a combination of LAG-3- blocking antibody relatlimab + Opdivo, was heralded as a step forward in the checkpoint inhibitor space as relatlimab’s mechanism may open the door to a new approach.
Melanoma clinical trials need to reflect Opdualag data It is no longer feasible to have monotherapy as a head-to-head comparator due to availability of the two combinations, says Opdualag investigator Dr Paolo Ascierto, melanoma unit director at the National Tumour Institute, Fondazione G Pascale in Naples. All forthcoming data will be compared to Opdualag results by the melanoma community, adds Opdualag investigator Dr Dirk Schadendorf, department of dermatology director at the University Hospital Essen, Germany. There are patients receiving anti-PD1/PD-L1
monotherapy in the adjuvant setting, which also argues the case for a combination as an active comparator arm in first-line trials, Ascierto says. These trials will have to separate patients who received an anti-PD1/PD-L1 in the adjuvant setting and those who have not, he adds.
Monotherapy comparator still in melanoma clinical trials? It could be argued that a single-agent active comparator can still be used in future first-line trials, notes Dr Ahmad Tarhini, cutaneous clinical and translational research director at the Moffitt Cancer Center, Florida. Monotherapy approaches are still efficacious in certain patients as well as having better safety profiles than combination approaches, he says. Yet there would be the need to single out these specific patients who should get monotherapy in the first place, he adds. It is not so clear which patients would benefit
more from a monotherapy, says Dr Ryan Joseph Sullivan, medicine associate professor, Harvard Medical School. Perhaps biomarkers can help find these patients, he notes.
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