Abstract 159P
Background
There is a high unmet medical need for the treatment of patients [pts] with platinum-resistant epithelial ovarian cancer [PROC]. Immune checkpoint inhibitors (ICI) have limited activity in this pt population. COM701 is a novel, 1st-in-class ICI that binds to PVRIG, a DNAM-1 axis member, leading to activation of T-and NK-cells. We hypothesized that in pts with PROC, dual blockade of PVRIG and PD1 would demonstrate antitumor activity with a favorable safety and tolerability profile. We present encouraging preliminary results.
Methods
We enrolled 20 patients [pts] with PROC. All pts received COM701 20 mg/kg + nivolumab 480 mg both IV Q4W. Primary objectives were safety/tolerability, with secondary objective of preliminary antitumor activity. Key inclusion criteria: Age ≥ 18 yrs, histologically confirmed locally advanced or metastatic solid malignancy and has exhausted all available standard therapy. Key exclusion criteria: prior receipt of anti-PVRIG, anti-TIGIT, no limitation on the number of prior lines of therapy or prior PD-1/PD-L1 inhibitor. Investigator assessed responses were per RECIST v1.1, safety per CTCAE v4.03.
Results
Median age 61.5yrs, median of 6 prior lines of therapy [Min, Max: 2,9]. Objective response rate (ORR) of 2/20 [10%] pts: 1 pt with fallopian tube CA, 6 prior lines of therapy, clear cell histology; 1 pt with OVCA, serous adenoCA, 7 prior lines of therapy [including prior nivolumab with best response of progressive disease]; both subjects with PR have an ongoing response to therapy, no complete responses (CR); 5 pts with stable disease (SD). Disease control rate [CR + PR + SD] 7/20 [35%]. Most frequent AEs were G1/2 nausea 11 pts, fatigue 11 pts [all G1/2]. Increase of serum IFNg was observed, confirming the expected immune activation induced by COM701 given in combination with nivolumab.
Conclusions
COM701 + nivolumab demonstrates encouraging preliminary signal of antitumor activity and immune activation in pts with heavily pre-treated PROC with a favorable safety/tolerability profile. Additional data analyses and pt followup are ongoing and will be presented at the conference. Data extract 09/18/2022.
Clinical trial identification
NCT03667716.
Legal entity responsible for the study
Compugen Ltd.
Funding
Compugen Ltd in collaboration with Bristol Myers Squibb.
Disclosure
M. Patel: Financial Interests, Institutional, Funding, paid to institution: See https://coi.asco.org/share/BLY-NDGV/Manish%20Patel. G. Fleming: Financial Interests, Personal, Advisory Board: tersera; Financial Interests, Institutional, Invited Speaker, salary support: compugen, celldex, corcept, plexxicon, AstraZeneca, Molecular Templates, Molecular Templates, CytomX, Astellas, K Group beta, iovance; Non-Financial Interests, Personal, Other, co-coordinating PI for clinical trial, uncompensated: AbbVie; Non-Financial Interests, Institutional, Other, supply of product for mouse testing by a collaborator: corcept; Non-Financial Interests, Personal, Member: ASCO; Other, Personal, Other, support for CME activity: DSI, Merck, Caris, Eisai, AstraZeneca. E. Hamilton: Financial Interests, Institutional, Other, Consulting/Advisory Role: Genentech/Roche, Boehringer Ingelheim, Novartis, Dantari, Lilly, Merck, Puma Biotechnology, Silverback Therapeutics, CytomX, Pfizer, Mersana, Black Diamond, H3 Biomedicine, Daiichi Sankyo, AstraZeneca, Arvinas, Deciphera Pharmaceuticals, Eisai, Seagen, Arcus, iTeos, Janssen, Loxo, Relay Therapeutics; Financial Interests, Institutional, Research Grant: Oncomed, Genentech/Roche, Zymeworks, Rgenix, Arqule, Clovis, Silverback Therapeutics, Millenium, Acerta Pharma, Sermonix Pharmaceuticals, Black Diamond, Karyopharm, Curis, Syndax, Novartis, Boehringer Ingelheim, Immunomedics, FujiFilm, Taiho, Deciphera, Fochon, Molecular Templates, Onconova Therapeutics, Dana Farber Cancer Hospital, Hutchinson MediPharma, MedImmune, SeaGen, Compugen, TapImmune, Lilly, Pfizer, H3 Biomedicine, Merus, Regeneron, Arvinas, StemCentRx, Verastem, eFFECTOR Therapeutics, CytomX, InventisBio, Lycera, Mersana, Radius Health, AbbVie, Nucana, Leap Therapeutics, Zenith Epigenetics, Harpoon, Orinove, AstraZeneca, Tesaro, Macrogenics, EMD Serono, Daiichi Sankyo, Syros, Sutro, G1 Therapeutics, Merck, PharmaMar, Olema, Immunogen, Plexxicon, Amgen, Akesobio Australia, Shattuck Labs, ADC Therapeutics, Aravive, Atlas MedX, Ellipses, Incyte, Jacobio, Mabspace Biosciences, Myraid Genetic Labs, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pionyr Immunotherapeutics, Repertoire Immune Medicine, Treadwell Therapeutics, Vincerx Pharma. R.J. Sullivan: Financial Interests, Personal, Advisory Board: Merck, Novartis, Bristol Myers Squibb, Eisai, Iovance, Oncosec, Pfizer, Replimmune; Financial Interests, Personal, Royalties: Up-to-date; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Invited Speaker: GlaxoSmithKline, Pfizer, Sanofi, Moderna, Roche-Genentech, BiomedValley DIscoveries, Astex, Compugen, Beigene, Novartis, Rubius, Alkermes, Simcha Therapeutics, OnKure. B. Izar: Other, Personal, Other, Consulting: Janssen, Volastra Therapeutics; Other, Personal, Other, Paid speaking engagement: AstraZeneca. G. Cojocaru, E. Ophir, P.J. Ferre: Financial Interests, Personal, Full or part-time Employment: Compugen Ltd. All other authors have declared no conflicts of interest.