On December 6, 2022 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported publication of ePosters by ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2022 (ESMO-IO), showing that Compugen’s COM701 (anti-PVRIG) in dual and triple combination with nivolumab ± BMS-986207 (anti-TIGIT) demonstrated preliminary durable anti-tumor activity and immune activation in patients with platinum resistant ovarian cancer with a favorable safety and toxicity profile (Press release, Compugen, DEC 6, 2022, View Source [SID1234624833]).
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The Company plans to host an investor conference call and webcast tomorrow, Wednesday, December 7, 2022, at 8:30 AM ET to review this data and data from a small cohort of metastatic NSCLC patients treated with COM701 ± nivolumab planned to be presented at ESMO (Free ESMO Whitepaper)-IO, December 8, 2022, Geneva, Switzerland. ePosters are available today on the ESMO (Free ESMO Whitepaper)-IO virtual platform, in the e-Poster section and the publication section of Compugen’s website.
"There are few effective and tolerable treatment options for patients with platinum resistant ovarian cancer," said John W. Moroney, M.D., Associate Professor of Gynecologic Oncology in the Dept. of Obstetrics and Gynecology at the University of Chicago. "It is both exciting and a privilege to see heavily pre-treated, chemotherapy refractory patients experience durable responses with this novel PVRIG/TIGIT/PD-1 immune checkpoint targeting combination. We observed deep and durable responses with minimal toxicity. For example, several of our responders continue to maintain full-time employment of more than 6 months into their enrollment. I’m interested in participating in further clinical development of this targeted combination."
Oladapo Yeku, M.D., Ph.D., FACP, Assistant Professor of Medicine, Harvard Medical School, and Director of Translational Research, Gynecologic Oncology Program, Massachusetts General Hospital, Boston, MA, added, "It is encouraging to see anti-tumor activity in these heavily pretreated heterogeneous platinum resistant ovarian cancer patients, with a disease control rate of 45% following both dual and triple combination treatment. The combination of drugs was well tolerated with a favorable safety profile consistent with what has previously been reported for COM701 with nivolumab ± BMS-986207. Because of the anti-tumor activity and tolerability of the combination, our patients on the study reported an improvement in quality of life. I look forward to seeing the further development of COM701 combinations in patients with platinum resistant ovarian cancer."
Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen, continued, "I am delighted to see that patients with hard-to-treat tumor types, who typically do not respond to or show low response rates to immunotherapy, gain benefit from COM701 as part of a dual and triple combination regimen. In November this year at the SITC (Free SITC Whitepaper) conference, we presented anti-tumor activity with responses in MSS-CRC patients with liver metastases, with a clear support of a COM701 mediated effect. Today we published compelling responses from preliminary data in platinum resistant ovarian cancer patients, including a patient who had 7 prior lines of treatment and progressed on nivolumab, and on this study experienced a confirmed partial response after treatment with the dual combination of COM701 and nivolumab. In addition, 3 patients responded to triple combination therapy who are ongoing on study treatment for at least 9 months, including a patient with more than 90% reduction in tumor target lesions."
Dr. Cohen-Dayag, added, "The data suggest a COM701 mediated mechanism of action, which could lead to the responses demonstrated by COM701 combinations. We have demonstrated that PVRIG blockade is associated with driving T cells into the tumor microenvironment, potentially sensitizing the tumors to PD-1 and/or TIGIT blockade and inducing a potent immune activation generally less typical with checkpoint inhibitors in such tumor types. While it is challenging to compare efficacy of the triple and dual combination arms given the small number of patients, the increase in response rate combined with the duration of response does suggest greater benefit with triple treatment, in line with our pre-clinical and translational clinical data. While the studies, including the biomarker and translational work, are still ongoing, the totality of the data, consisting of the disease control rates, the durability of responses, the supportive translational data, and the favorable safety profile, are encouraging considering these hard-to-treat cancers in which the patients have been extensively pretreated. We are looking forward to discussing the data being presented at ESMO (Free ESMO Whitepaper)-IO, during our investor call tomorrow, December 7, 2022."
Next Steps
Based on the data reported in the different studies, Compugen is planning to pursue two studies, with the purpose to strengthen the data it has already published and to build a path to future registration studies:
The first, in up to 20 patients with metastatic MSS-CRC, immune checkpoint inhibitor naïve patients with ≤ 2L of prior therapy, treated with a triple combination of Compugen’s anti-PVRIG, COM701, and its own anti-TIGIT, COM902, and pembrolizumab. Enrolment is expected to be completed in 2023.
The second is a follow up study currently under design in platinum resistant ovarian cancer immune checkpoint inhibitor naïve patients.
Compugen expects to share initial findings by the end of 2023.
The ePosters are published today on the ESMO (Free ESMO Whitepaper)-IO virtual platform in the e-Poster section, and the publication section of Compugen’s website.
To access the Wednesday, December 7, 2022, 8:30 am ET live investor conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, a replay will be available on the Company’s website.
Background
Key findings from poster: "Triple blockade of the DNAM-axis with COM701 + BMS-986207 + nivolumab demonstrates preliminary antitumor activity in patients with platinum resistant OVCA." (NCT04570839), with a cut-off date of November 23, 2022, include:
In 20 patients who had exhausted all standard therapies, with a median number of 4 prior therapies, the triple combination demonstrated:
Encouraging overall response rate of 20%, with 4 confirmed partial responses, out of which 3 are responding for at least 9 months. All 4 responders are still on study treatment at the data cut-off date, therefore median duration of response has not been reached
Disease control rate of 45% (4 confirmed partial responses, 5 stable disease)
Low pre-treatment PD-L1 expression in 2 of the responders (CPS <1 and 3), analysis of the other responders is still ongoing
Translational assessment of peripheral blood, including profiling of cytokines and circulating immune cells, showed a pharmacodynamic activation of the immune system
Most frequent treatment related adverse events grade 1/2, no grade 4/5 treatment related adverse events
55% of the patients had high-grade serous adenocarcinoma, including three of the responders
Key findings from poster: "COM701 in combination with nivolumab demonstrates preliminary antitumor activity in patients with platinum resistant epithelial ovarian cancer" (NCT03667716) with a cut-off date of November 23, 2022, include:
In 20 patients who had exhausted all standard therapies, with a median number of 6 prior therapies, the dual combination demonstrated:
Encouraging overall response rate of 10%, with 2 partial responses and 1 ongoing at the data cut-off date
Disease control rate of 45% (2 confirmed partial responses, 7 stable disease)
Translational assessment of peripheral blood, showed a pharmacodynamic activation of the immune system
One patient with a partial response supported by increased infiltration of CD8 cells into the tumor microenvironment, had high grade serous adenocarcinoma, 7 prior lines of treatment including best response of progressive disease on the combination of nivolumab and lucitanib (an investigational agent)
Most frequent treatment related adverse events grade 1/2, no grade 4/5 adverse events
65% of the patients had high-grade serous adenocarcinoma, including the two responders