Abstract 158P
Background
Treatment [tx] options for platinum-resistant ovarian cancer [PROC] are limited [ltd]. Immune checkpoint inhibitors (ICI) have ltd activity in PROC. Clinical studies evaluating novel therapies are urgently needed. COM701, a novel, 1st in-class ICI binds to PVRIG, leading to activation of T-cells. BMS-986207 is an ICI blocker of TIGIT. We reported a partial response [PR] with COM701 monotherapy in a pt with primary peritoneal CA1. We hypothesized that in pts with PROC, blocking the DNAM axis with the triplet: COM701 + BMS-986207 + nivolumab, would demonstrate antitumor activity with a favorable safety and tolerability profile. We present preliminary results.
Methods
All 20 pts enrolled received COM701 20 mg/kg + BMS-986207 480 mg + nivolumab 480 mg IV Q4W. Primary objectives [obj] were safety/tolerability; secondary obj of antitumor activity. Key inclusion criteria: Age ≥ 18 yrs, histologically confirmed advanced malignancies and exhausted all available standard tx. Key exclusion criteria: prior receipt of any inhibitor of PVRIG, TIGIT, or PD-1/PD-L1. Investigator assessed responses per RECIST v1.1, safety per CTCAE v5.0.
Results
Median [med] age 61yr, med follow-up 51 days [range 1-202], med number of prior lines of therapy - 4 [range 1-10]. Objective response rate 4/20 [20%] pts [all ongoing study tx, 3 confirmed PR], 3 PRs - serous adenoCA, 1 PR - clear cell histology. No complete responses (CR); 4pts with stable disease (SD), disease control rate [CR+PR+SD] 8/20 [40%]. Most frequent [freq] histology - serous adenoCA 10/20 [50%], clear cell 3/20 [15%]. Most freq AE G1/2 fatigue in 11 pts. A sustained immune activation induced by the tx, with a maximum 7.6-fold average increase of peripheral IFNɣ in 16pts evaluated [p<0.005].
Conclusions
The combination of COM701 + BMS-986207 + nivolumab has encouraging signal of antitumor activity with immune activation in pts with heavily pre-treated PROC and is well tolerated. Additional data will be presented at the conference. Data extract 08/29/2022. 1. Vaena D et al, COM701±nivolumab: Results of an ongoing P1 study of safety, tolerability & preliminary antitumor activity in pts with advanced solid malig. J Clin Onco 39, 2021 (suppl 15; abst 2504).
Clinical trial identification
NCT04570839.
Legal entity responsible for the study
Compugen Ltd.
Funding
Compugen Ltd in collaboration with Bristol Myers Squibb.
Disclosure
J. Moroney: Financial Interests, Institutional, Principal Investigator: Compugen Ltd. O. Yeku: Financial Interests, Institutional, Principal Investigator: Compugen Ltd. 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. L.A. Emens: Financial Interests, Personal, Other, member of Steering Committee for IMpassion130, KATE3, incompensatedtransfers of value for writing support for conference abstracts, slide presentations, and publications: Genentech; Financial Interests, Personal, Other, member of Steering Committee for IMpassion130, KATE3, uncompensated transfers of value for writing support for conference abstracts, slide presentations, and publications: F Hoffman La Roche; Financial Interests, Personal, Other, Steering Committee Member for clinical trial CTMX-2009-002, uncompensated: CytomX; Financial Interests, Personal, Advisory Board, Advisory Board, compensated: Gilead, Immune Onc, Shionogi, AstraZeneca; Financial Interests, Personal, Advisory Board, Standing Advisor, compensated: Mersana; Financial Interests, Personal, Other, Consultant, compensated: GPCR; Financial Interests, Personal, Other, Advisor, uncompensated: Immutep; Financial Interests, Personal, Advisory Board, Advisory Meeting, compensated: Chugai; Financial Interests, Personal, Full or part-time Employment, Faculty Member: University of Pittsburgh; Financial Interests, Personal, Full or part-time Employment, Physician: University of Pittsburgh Medical Center Physicians Group; Financial Interests, Personal, Stocks/Shares, potential for future stock options: Molecuvax; Financial Interests, Institutional, Invited Speaker, clinical trial: AbbVie, Bolt Therapeutics, Bristol Myers Squibb, Compugen, CytomX, EMD Serono, Genentech/F Hoffman La Roche, Genentech/F Hoffman La Roche, Immune Onc, Merck, Next Cure, Silverback, Takeda, Tempest; Financial Interests, Institutional, Other, Investigator-Initiated trial at Johns Hopkins transferred to another PI: AstraZeneca; Non-Financial Interests, Personal, Leadership Role, Vice President: Society for Immunotherapy of Cancer. D. Vaena, E.E. Dumbrava, D. Rasco, M.R. Sharma: Financial Interests, Institutional, Principal Investigator: Compugen Ltd. A. Patnaik: Financial Interests, Institutional, Other, Institutional research funding: Compugen. 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. H.H. Adewoye, E. Ophir, G. Cojocaru, P.J. Ferre: Financial Interests, Personal, Full or part-time Employment: Compugen Ltd. B. Izar: Other, Personal, Other, Consulting: Janssen, Volastra Therapeutics; Other, Personal, Other, Paid speaking engagement: AstraZeneca. S. Gaillard: Financial Interests, Personal, Invited Speaker: Curio Science, NCCN, GOG Partners; Financial Interests, Personal, Advisory Board: Arcus, Elevar Therapeutics, GSK Diagnostics, Immunogen, Lumanity, Novartis; Financial Interests, Institutional, Invited Speaker: Sermonix Pharmaceuticals, AstraZeneca, Compugen, GOG Partners, Genentech, Iovance, NRG Oncology, Tempest; Financial Interests, Personal, Royalties: UpToDate. All other authors have declared no conflicts of interest.