Fianlimab/cemiplimab for melanoma (HARMONY)

Resolution Criteria Trial: NCT06246916 Selected endpoint key: 7fcce255d6869494e1fe9f4999c2f807de5b44084b6273b98c874d096ae2a022 Selected endpoint: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR) Endpoint type: ORR Protocol outcome group: primary Endpoint description: Not provided by ClinicalTrials.gov. Endpoint timeframe: Up to 72 months ClinicalTrials.gov population: Adult participants with unresectable advanced or metastatic melanoma Market population: Adult participants with unresectable advanced or metastatic melanoma Analysis set: Not specified in the enumerated protocol outcome Comparison: Fianlimab plus cemiplimab versus relatlimab plus nivolumab Success direction: superiority Success rule: At the protocol-specified time frame of up to 72 months, objective response rate per RECIST version 1.1 based on blinded independent central review must be higher with fianlimab plus cemiplimab than with relatlimab plus nivolumab, and the prespecified statistical superiority criterion must be met in the protocol-specified analysis set. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT06246916?tab=researcher#outcome-measures:~:text=Objective%20response%20rate%20(ORR)%20per%20Response%20Evaluation%20Criteria%20in%20Solid%20Tumors%20(RECIST)%20version%201.1%20based%20on%20blinded%20independent%20central%20review%20(BICR) YES 1. The exact selected endpoint (Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)) satisfies the approved success rule in the specified population, analysis set, comparison, and timepoint. 2. The result is supported by a qualifying source in the approved evidence hierarchy. NO 1. The exact selected endpoint (Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2027-12-31 at 23:59:59 UTC. NO DECISION / ADMIN REVIEW 1. Available evidence is contradictory, incomplete, pooled, interim, subgroup-only, or does not match the approved population, analysis set, comparison, and timepoint. Resolution deadline: 2027-12-31T23:59:59Z Deadline evidence: Admin-selected market resolution deadline: 2027-12-31. The ClinicalTrials.gov record retrieved on 2026-10-06 lists estimated primary completion on 2027-03-22 for this exact head-to-head study. The later December 31 cutoff allows time for analysis and disclosure. This is an administrative contract cutoff, not a sponsor-promised readout date; disclosure timing remains uncertain and the approved no-disclosure-by-deadline rule applies. Deadline evidence source: https://clinicaltrials.gov/study/NCT06246916 Evidence precedence 1. ClinicalTrials.gov posted results 2. Sponsor regulatory filing or official release 3. Peer-reviewed publication or official conference abstract Only the selected endpoint in the specified population, analysis set, comparison, and timeframe can resolve YES. Overall positive messaging, another endpoint, interim results, pooled analyses, or an unmatched subgroup cannot resolve YES.