640 The combination of COM701 + nivolumab demonstrates preliminary antitumor activity in patients with metastatic breast cancer

BackgroundCOM701, a novel, first in-class immune checkpoint inhibitor, anti-PVRIG, that leads to activation of T-cells. PVRL2, the ligand of PVRIG, is highly expressed in breast cancer. We have reported preliminary antitumor activity with objective responses [partial responses and a complete respons...

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Published in:Journal for immunotherapy of cancer 2023-11, Vol.11 (Suppl 1), p.A732-A732
Main Authors: Dumbrava, Ecaterina, Chmielowski, Bartosz, Shepard, Dale, Vaena, Daniel, Rasco, Drew, Sharma, Manish, Hamilton, Erika, Papadopoulos, Kyriakos P, Wang, Judy S, Ophir, Eran, Ferre, Pierre, Barbiro, Inbal, Cojocaru, Gady, Adewoye, Adeboye H, Patel, Manish
Format: Article
Language:English
Subjects:
Breast cancer
Cancer therapies
Clinical trials
Immunotherapy
Metastasis
Monoclonal antibodies
Patients
Regular and Young Investigator Award Abstracts
Targeted cancer therapy
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Summary:BackgroundCOM701, a novel, first in-class immune checkpoint inhibitor, anti-PVRIG, that leads to activation of T-cells. PVRL2, the ligand of PVRIG, is highly expressed in breast cancer. We have reported preliminary antitumor activity with objective responses [partial responses and a complete response] in patients with solid tumors (MSS-CRC, platinum resistant OVCA, anal squamous CA, MSS-endometrial cancer] who received COM701 +/- nivolumab + BMS-986207 (anti-TIGIT antibody).1 2 We present results from the dose expansion cohort with COM701 + nivolumab in patients with metastatic breast cancer (MBC) (NCT03667716).MethodsWe enrolled 17 patients with MBC, all received COM701 20 mg/kg + nivolumab 480 mg, both IV Q4 weeks. Primary objectives were to determine safety and tolerability and secondary objective was to evaluate preliminary antitumor activity. Key inclusion criteria: Age ≥ 18 years, histologically confirmed locally advanced or MBC (regardless of ER/PR and HER2 status) with measurable disease, who exhausted all available standard treatments. Prior treatment with anti-PD-(L)-1, anti-CTLA-4 ICI was permissible. Key exclusion criteria: history of immune-related events that to immunotherapy treatment discontinuation, history of pneumonitis. Safety was evaluated per CTCAE v4.03 and investigator responses per RECIST v1.1.ResultsTreatment related adverse events reported in 12/17 (71%) patients, the majority [11/12 pts] were ≤G2, the most frequent was diarrhoea in 3 pts (all G1). One patient with G3 TRAE of pneumonitis (recovered), no ≥G4 TRAEs. Tumor assessments (by site): PD-L1 negative 9/17 (53%), positive/present 2/17 (12%), missing/not assessed 6/17 (35%); TMB low (
ISSN:2051-1426
DOI:10.1136/jitc-2023-SITC2023.0640