21O - Coformulated vibostolimab/pembrolizumab in advanced cervical cancer: KEYVIBE-005

Background

Vibostolimab (vibo) (anti-TIGIT) + pembrolizumab (pembro) has shown promising efficacy in cervical cancer. KEYVIBE-005 (NCT05007106) evaluated coformulated vibo/pembro in previously treated cervical cancer (cohort A).

Methods

This open-label phase 2 trial enrolled patients (pts) aged ≥ 18 years with previously treated, anti- PD-[L]1 naïve, unresectable or metastatic cervical cancer, by PD-L1 status to cohort A1 (CPS ≥1) or A2 (CPS<1). Cohort A1 was randomized 1:1 to coformulated vibo 200 mg/pembro 200mg or pembro 200 mg Q3W. Cohort A2 received coformulated vibo 200 mg/pembro 200mg Q3W. Primary endpoints were PFS and ORR per RECIST 1.1 by BICR (cohort A1), and ORR per RECIST 1.1 by INV (cohort A2). Secondary endpoints were DOR (RECIST 1.1, BICR), OS and safety (cohort A1), and PFS and DOR (RECIST 1.1, INV), OS and safety (cohort A2). Data cut-off was October 24, 2023.

Results

At data cut-off, 169 pts were enrolled in cohort A1 (85 vibo/pembro, 84 pembro) and 31 in cohort A2. Median follow-up was 18.2 months (mo) for cohort A1 and 15.7 mo for cohort A2. The ORR was 20% for vibo/pembro vs 15.5% for pembro (p=0.2215). The ORR was 16.1% for cohort A2. Median PFS was 2.2 mo with vibo/pembro vs 2.1 mo with pembro (HR=0.99, p=0.4787). Median PFS was 2.2 mo for cohort A2 (Table). Drug-related adverse events (AEs) occurred in 64 pts (75%) with vibo/pembro, 48 (58%) with pembro (cohort A1), and 24 (77%) in cohort A2. Grade ≥3 drug-related AEs occurred in 15 (18%) pts with vibo/pembro, 10 (12%) with pembro (cohort A1), and 9 (29%) in cohort A2. One pt died due to a drug-related AE (septic shock) with vibo/pembro (cohort A1). Immune-mediated AEs occurred in 30 pts (35%) with vibo/pembro, 26 (31%) with pembro (cohort A1), and in 12 pts (39%) in cohort A2.Table: 21O

CPS= combine positive score, CR= complete response, mo= months NR= not reached, PR= partial response. *Per RECIST 1.1 by INV.

Conclusions

Efficacy outcomes with coformulated vibo/pembro were not superior to pembro in pts with previously treated PD-L1+ cervical cancer, consistent with that observed in other anti-TIGIT trials. No new safety signals were identified.

Clinical trial identification

MK-7684A-005; NCT05007106; first posted August 16, 2021.

Editorial acknowledgment

Editorial assistance was provided by Jose Casasnovas Nieves at Merck & Co., Inc., Rahway, NJ, USA.

Legal entity responsible for the study

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Funding

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Disclosure

A. 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