KEY TAKEAWAYS
- The phase I/II clinical trial studied the long-term follow-up data and a sub-group evaluation of metastatic melanoma pts treated with IDO/PD-L1 targeting peptide vaccine and nivolumab.
- The study highlighted that the IDO/PD-L1 vaccine and nivolumab combination are effective and safe for metastatic melanoma patients, including those with unfavorable baseline characteristics.
The study enrolled 30 patients (pts), all of whom received a maximum of 15 IDO/PD-L1-targeting peptide vaccines, administered 6 doses every 2 weeks, followed by 9 doses every 4 weeks. Nivolumab was given at a dosage of 3 mg/kg every 2 weeks, with a maximum duration of two years. The study assessed the long-term clinical effectiveness, toxicity, and survival outcomes.
As of the data cutoff date, January 5th, 2023, the complete response rate (CRR) stood at 50%, while the overall response rate (ORR) reached 80%. The median progression-free survival (mPFS) was 25.5 months, with a minimum follow-up period of 29.8 months. Median overall survival (mOS) was not reached. A subgroup analysis revealed that pts with unfavorable baseline characteristics, such as those with M1c stage, elevated LDH levels, and negative PD-L1 status, achieved favorable and enduring responses. Immune-related adverse events were similar to those seen in pts receiving anti-PD1 monotherapy. No additional toxicity was observed in pts with unfavorable baseline characteristics.
These follow-up data confirmed the long-lasting activity of the IDO/PD-L1 vaccine and nivolumab combination in metastatic melanoma pts who had not received prior anti-PD-1 therapy. This approach achieved unprecedented CRR and ORR rates of 50% and 80%, respectively. Importantly, patients with less favorable baseline characteristics also demonstrated remarkable response rates.
Source: https://eado2023.com/wp-content/uploads/2023/04/Abstract-Band_EADO2023_Stand-21-04-2023-kl.pdf
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03047928
Lorentzen, C.L., Kjeldsen, J.W., Ehrnrooth, E., Andersen, M.H., Svane, I.M. Long-term follow-up and subgroup analyses of metastatic melanoma patients treated with IDO/PD-L1 targeting peptide vaccine and nivolumab.
