Abstract 130P
Background
Novel agents are urgently needed for the treatment [tx] of patients [pts] with metastatic NSCLC including post immune checkpoint inhibitors (ICI). COM701 [anti-PVRIG] is a novel 1st in class ICI. We hypothesized that COM701 ± nivolumab will demonstrate antitumor activity with a favorable safety and tolerability profile in pts with heavily pretreated NSCLC. Here, we present preliminary results on antitumor activity.
Methods
We enrolled 7 pts with NSCLC: 5 COM701 monotherapy [mtx] [4 - COM701 20 mg/kg IV Q4W mtx expansion, 1 pt COM701 0.01 mg/kg IV Q3W], 2 pts COM701 + nivolumab [COM701/nivolumab 3mg/kg/360 mg both IV Q3W, COM701/nivolumab 10 mg/kg/480 mg both IV Q4W]. Key study objectives were safety/tolerability and preliminary antitumor activity; OS was an exploratory endpoint. Key inclusion criteria: Age ≥ 18 yrs, histologically confirmed metastatic solid malignancy and has exhausted all standard tx. Key exclusion criteria: history of immune toxicities on prior ICI tx leading to discontinuation. Safety per CTCAE v4.03, investigator-assessed response per RECIST v1.1.
Results
Age >65 4/7 [57%], female 6/7 [86%], prior lines median [Min, Max] 4 [3, 6], all pts received prior ICI, 4/7 [57%] received ≥2 prior lines with ICI. Disease control rate [CR+PR+SD) 5/7 [71%], no CR or PR. Median [m] PFS [all pts] 84 days 95% CI [22, 231], mOS in all pts 9.5 months [mos] [95% CI, 2.7-11.6] – [COM701 mtx 9.5 mos [2.7, NE]; combination 10.1 mos [95% CI, 8.6, NE]. The most frequent AE was G1 nausea in 2 pts. Post ICI NSCLC data - 1 prior line of ICI in metastatic setting, mOS 14.5 mos for ramucirumab + pembrolizumab1.
Conclusions
COM701 ± nivolumab has preliminary encouraging signal of antitumor activity in a heavily pretreated popn of pts with NSCLC with prior ICI txp comparable to historical data. A P1 study in post IO NSCLC evaluating COM902+COM701+PD-1 inhibitor, COM902+COM701+chemotherapy is planned. Datacut 07/17/2022. 1. Reckamp KL, et al Phase 2 Randomized Study of Ramucirumab and Pembrolizumab vs SOC in Advanced NSCLC Previously Treated With Immunotherapy-Lung-MAP S1800A. J Clin Oncol. 2022 Jul 20;40(21):2295-2306.
Clinical trial identification
NCT03667716.
Legal entity responsible for the study
Compugen Ltd.
Funding
Compugen Ltd in collaboration with Bristol Myers Squibb.
Disclosure
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, Orinove, Leap Therapeutics, Zenith Epigenetics, Harpoon, 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. B. Izar: Other, Personal, Other, Consulting: Janssen, Volastra Therapeutics; Other, Personal, Other, Paid speaking engagement: AstraZeneca. J. Gainor: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Merck, Genentech/Roche, Takeda, Lilly, Moderna, AstraZeneca, Pfizer, Novartis, iTeos, Karyopharm, Silverback Therapeutics, GlydeBio, BeiGene; Financial Interests, Personal, Stocks/Shares, Immediate family member is an employee. Note: Ironwood Pharmaceuticals is not involved in any oncology drug development. It is focused on gastroenterology; Financial Interests, Personal and Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Genentech, Bristol Myers Squibb, Merck, AstraZeneca, Moderna, Jounce, Alexo. H.H. Adewoye: Financial Interests, Personal, Full or part-time Employment: Compugen Ltd. P.J. Ferre: Financial Interests, Personal, Full or part-time Employment: Compugen Ltd. E. Ophir: Financial Interests, Personal, Full or part-time Employment: Compugen Ltd. M. Patel: Financial Interests, Institutional, Funding, paid to institution: See https://coi.asco.org/share/BLY-NDGV/Manish%20Patel. A. Patnaik: Financial Interests, Institutional, Other, Institutional research funding: Compugen. All other authors have declared no conflicts of interest.