Updated Data Announced for Both COM701 Monotherapy and in Combination with Nivolumab

Updated data were announced regarding COM701 in a phase 1 dose-escalation and -expansion study as monotherapy and in combination with nivolumab (Opdivo), according to a press release from Compugen, who is responsible for developing the therapy.

The first-in-class investigational therapeutic antibody is being examined to treat patients by targeting the novel immune checkpoint, PVRIG, via monotherapy or in combination with PD-1 inhibition.

“The data generated to date across our COM701 clinical program suggest that PVRIG may be an important immune checkpoint in patients who are unresponsive or refractory to currently available immunotherapies,” Anat Cohen-Dayag, PhD, President and CEO of Compugen, said in a press release. “We are highly encouraged by our updated results from the COM701 plus [nivolumab] combination dose escalation, which now include a confirmed complete response in a patient with prior progression on [nivolumab] and a previously reported patient with a durable confirmed partial response for almost a year.”

Focusing on the combination dose-escalation data, treatment was well tolerated among 15 patients who received a median of 5 prior anticancer therapies. More, the data found a disease control rate of 66.7%, including 1 complete response (6.7%) and 1 partial response (6.7%), and a stable disease rate of 53.3%.

Specifically, 1 patient with anal squamous cell carcinoma with stable disease now remains on treatment at 79 weeks with a complete response. Another patient with microsatellite stable (MSS) colorectal cancer and a durable confirmed partial response remains on treatment for 44 weeks.

“Combined with a disease control rate of 66.7% and ongoing durable signals of activity beyond or approaching 1 year in multiple patients and across indications, these results leave us increasingly confident that dual blockade of PVRIG and PD-1 may be key to driving anti-tumor immune responses in certain patient populations,” Cohen-Dayag continued.

Cohen-Dayag explained that further evaluation of this combination treatment for patients with ovarian, breast, endometrial, and MSS colorectal cancers in a cohort expansion study will be a priority for the second quarter.

When examining the monotherapy expansion data, a total of 20 patients were enrolled in biomarker- and data-informed indications. Specifically, 4 patients each had endometrial, non–small cell lung, ovarian, breast, and colorectal cancer.

Six patients had a best response of stable disease, with 2 remaining on treatment at the study’s cutoff date. Overall, there were no new safety findings observed in this cohort of patients.

“Our monotherapy cohort expansion study was an important milestone in our COM701 monotherapy evaluation,” explained Cohen-Dayag. “These data, together with data from our previously reported dose-escalation study, which includes a confirmed partial response with treatment ongoing for over 1 year as of our new data cutoff date, demonstrate durable signals of antitumor activity in tumor types typically unresponsive to immune checkpoint inhibitors, including patients with prior progression on these treatments.”

Cohen-Dayag concluded by explaining that Compugen will leverage these data to inform the next steps. Specifically, the clinical approach moving forward will include dual and triple blockade regimens of COM701 with TIGIT and PD-1.

Reference:

Compugen Announces Data Update from COM701 Phase 1 Clinical Trial. News release. Compugen. Published February 25, 2021. Accessed March 10, 2021. https://ir.cgen.com/news-and-events/news/news-details/2021/Compugen-Announces-Data-Update-from-COM701-Phase-1-Clinical-Trial/default.aspx