ISA101 and nivolumab for HPV-16

BACKGROUND

The combination of ISA101, a human papilloma virus (HPV) 16 peptide vaccine, and nivolumab showed a promising response rate of 33% in patients with incurable HPV-16

METHODS

Patients with advanced HPV-16

RESULTS

Twenty-four patients were followed for a median of 46.5 months (95% CI, 46.0 months to not reached (NR)). The median duration of response was 11.2 months (95% CI, 8.51 months to NR); three out of eight (38%) patients with objective response were without progression at 3 years. The median and 3-year overall survival were 15.3 months (95% CI, 10.6 months to 27.2 months) and 12.5% (95% CI, 4.3% to 36%), respectively. The scores for activated T cells ((CD3

CONCLUSIONS

Efficacy of ISA101 and nivolumab remains promising in long-term follow-up. Increased infiltration by PD-1

TRIAL REGISTRATION NUMBER

NCT02426892.

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: RF: reports personal fees from Regeneron-Sanofi, Ayala Pharmaceuticals, Klus Pharma, Bicara Therapeutics, Medscape, Carevive systems, G1 Therapeutics, Prelude Therapeutics, Merck, and Intellisphere in the past 36 months outside of the submitted work; and institutional fees from AstraZeneca, Merck, Genentech, Pfizer, Rakuten, Nanobiotix, and EMD Serono in the past 36 months. WW has received honoraria/speaker’s fees and/or participated in advisory boards from Roche/Genentech, Bristol Myers Squibb, Eli Lilly, Merck, AstraZeneca, Pfizer, Takeda, Janssen, Boehringer Ingelheim, Novartis, Sanofi Aventis. CJMM is Chief Scientific Officer of ISA Pharmaceuticals, a biotech company aiming at registration of a long peptide vaccine very similar to the one studied in this manuscript. MAC reports grants and personal fees from ImmunoGenesis, Inc. and ImmunoMet, Inc., personal fees from Alligator Bioscience, Inc., ImmunOS, Inc., Oncoresponse, Inc., Pieris, Inc., Nurix, Inc., Aptevo, Inc., Servier, Inc., Kineta, Inc., Salarius, Inc., Xencor, Inc., Agenus, Inc., Mereo, Inc., Astrazeneca, Inc., Amunix, Inc., Adagene, Inc., outside the submitted work; In addition, Dr. Curran has a patent Methods and Composition for Localized Secretion of Anti-CTLA-4 Antibodies with royalties paid by multiple licensees, a patent Dual specificity antibodies which bind both PD-L1 and PD-L2 and prevent their binding to PD-1 with royalties paid by ImmunoGenesis, Inc. IIW reports consults fees from ROCHE, Bayer, BMS, Astra Zeneca, Pfizer, HTG molecular, Merck, ClaxoSmithKline, Guardant Health, Novartis, Flame, Sanofi, Janssen, Daiichi Sankyo, Oncocyte, Amgen, MSD, Medcape; honoraria from Medscape, Roche, Pfizer, AstraZeneca, Platform Health, Merck; and Grants from Genetech, HTG Molecular, Merck, BMS, Medimmune, Adaptive, Adaptimmune, EMD Serono, Pfizer, Takeda, Amgen, Karus, Johnson & Johnson, Bayer, Iovance, 4D, Novartis, Akova. JJL reports he received grant from Cancer Center Support Grant (CCSG) P30 CA016672 from National Cancer Institute. BG reports consult fees from Regeneron and grants from Pfizer Inc, ISA Pharmaceuticals, and Medimmune.