KEY TAKEAWAYS
- The SURPASS-3 phase II trial aimed to evaluate the efficacy and safety of ADP-A2M4CD8 TCR T-cell therapy in HLA-A*02-positive solid tumor patients, including platinum-resistant OC.
- The primary endpoint is OR. The SURPASS-3 trial is expected to begin in the second quarter of 2023.
ADP-A2M4CD8 is an immunotherapy that targets MAGE-A4, a protein expressed in about 25% of ovarian cancers(OC). This is effective in patients with the HLA-A*02 allele, found in about 45% of US and European people.
Researchers aimed to evaluate the efficacy and safety of ADP-A2M4CD8 TCR T-cell therapy in HLA-A*02-positive solid tumor patients, including platinum-resistant OC.
About 66 patients, aged 18–75, will be randomly assigned in a 1:1 ratio to either ADP-A2M4CD8 or ADP-A2M4CD8/nivolumab. To be eligible, patients must have histologically confirmed high-grade serous or endometrioid recurrent/progressive ovarian carcinoma.
Patients must have undergone ≥3 cycles of prior platinum-/taxane-based chemotherapy, exhibit measurable disease per RECIST v1.1, express MAGE-A4, possess HLA-A02:01P, 02:02P, 02:03P, or 02:06P alleles (excluding HLA-A02:05P), and have an ECOG performance status of 0 or 1.
Autologous T-cells will be collected via leukapheresis, transduced with a lentiviral vector, and infused after lymphodepletion chemotherapy (fludarabine 30 mg/m2/day for 4 days and cyclophosphamide 600 mg/m2/day for 3 days). Participants in the combination arm will receive nivolumab 480 mg every 4 weeks from week 4 post-infusion.
Imaging will occur at baseline, Weeks 8, 16, 24, and every 2 months ± 28 days after that until disease progression. The primary endpoint is objective response(OR) per RECIST v1.1 by an independent review.
Adverse events(AEs) will be monitored, and participants will be followed for 15 years from T-cell infusion. The SURPASS-3 trial is expected to begin in the second quarter of 2023.
Source: https://www.emma.events/site/programme/?sessiondetail=4534591&trackid=0&a=esgo2023#!
Clinical Trials: https://www.clinicaltrials.gov/study/NCT05601752?term=%20NCT05601752&rank=1
https://www.clinicaltrials.gov/study/NCT04044859?term=NCT04044859%20&rank=1
Kathleen Moore, Ana Oaknin, Isabelle Ray-Coquard, Robert L. Coleman, Thomas J. Herzog, David O’Malley, Stephanie Lheureux, Peter G. Rose, Robert Morris, David Starks, Grainger S. Lanneau, Fernanda Musa, Amy Sauer, Darren Jolliffe, Marisa Rosenberg, Dennis Williams, Elliot Norry, Bradley J. Monk. A Phase 2 Study (GOG-3084) Of ADP-A2M4CD8 TCR T-Cell Therapy, Alone Or In Combination With Nivolumab, In Patients With Recurrent Ovarian Cancers.
