Reference Detail

Ref Type

abstract

PMID

Authors

C. Toullec S. Seo A.G. Robinson H-H. Chou P. Salman F. Ghiringhelli O. Ozyilkan C.I. Rojas M.A.N. Sendur C. Le Tourneau C.J. Yen S. Aksoy S. Ochsenreither E.P. Yanez Ruiz S.Y. Rha R. Shapira-Frommer Q. Liu M. Du Plessis T. Keenan C-H. Hsu

Title

855P Safety and efficacy of vibostolimab (anti-TIGIT) coformulated with pembrolizumab (vibo/pembro) in previously untreated advanced head and neck squamous cell carcinoma (HNSCC): Results from the phase II KEYVIBE-005 study

Journal	Vol	Issue	Date	Pages	Journal Short Title
Annals of Oncology	35	Supplement 2	2024

URL

https://www.annalsofoncology.org/article/S0923-7534(24)02436-0/fulltext

Abstract Text

Background In KEYNOTE-048, patients (pts) with recurrent or metastatic HNSCC and known PD-L1 status had a statistically significant improvement in OS with pembro monotherapy vs cetuximab + chemotherapy (known as the EXTREME regimen) in the PD-L1 combined positive score (CPS) ≥1 population (median, 12.3 vs 10.4 months; HR, 0.74; 95% CI, 0.61-0.89; P = 0.00080); a favorable safety profile was observed with pembro monotherapy. TIGIT is highly coexpressed with PD-L1 in HNSCC, thus dual blockade of TIGIT and PD-1 may improve upon the efficacy observed with pembro monotherapy. Here, we present data from cohort C of the open-label phase II KEYVIBE-005 study (NCT05007106), which evaluated coformulated vibo/pembro in pts with advanced HNSCC with PD-L1 CPS ≥1. Methods Eligible pts had locally recurrent unresectable or metastatic HNSCC with PD-L1 CPS ≥1, an ECOG PS of 0 or 1, and no prior systemic therapy. Pts received vibo 200 mg/pembro 200 mg IV every 3 weeks for ≤35 cycles. The primary end point was ORR per RECIST v1.1 by investigator review. Secondary end points were DOR, PFS, OS, and safety. Results A total of 42 pts were enrolled. Median age was 62.0 years, and most pts were male (86%), had an ECOG PS of 1 (83%), and had metastatic disease (69%); 40% had tumors with PD-L1 CPS ≥20. At the data cutoff (Oct 24, 2023), median follow-up duration was 18.4 months (range, 7.9-22.3). Efficacy is presented in the Table. Treatment-related adverse events (TRAEs) occurred in 35 pts (83%); the most common (≥15%) were pruritus (31%), hypothyroidism (19%), and asthenia (17%). Grade 3 TRAEs occurred in 6 pts (14%); no grade 4 or 5 events occurred. Immune-mediated AEs and infusion reactions occurred in 13 pts (31%); 1 (2.4%) was grade 3 and none were grade 4 or 5. Conclusions Antitumor activity was observed with vibo/pembro in pts with HNSCC with PD-L1 CPS ≥1; no new safety signals were observed. Clinical trial identification NCT05007106 (2021-09-16).

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 positive	head and neck squamous cell carcinoma	predicted - sensitive	MK-7684A	Phase II	Actionable	In a Phase II trial (KEYVIBE-005), MK-7684A treatment resulted in an objective response rate (ORR) of 29% (12/42), a median duration of response of 12.7 months, a median progression survival of 4.1 months, and a median overall survival of 15.5 months in patients with CD274 (PD-L1)-positive (CPS>/=1) head and neck squamous cell carcinoma, with an ORR of 21% (5/24) in patients with CPS=1-19 and an ORR of 41% with CPS>/=20 (Ann Oncol (2024) 35 (Suppl_2): S617-S618; NCT05007106).	detail...