CG Oncology spotlights oncolytic virus combo data ahead of full readout due next year
CG Oncology has been quietly chugging along — only giving updates at sequential cancer conferences ahead of a full readout on its oncolytic virus cancer therapy next year.
In its latest at SITC, the Irvine, CA-based biotech showed up with longer-term data on its therapy, CG0070, in combination with Merck’s Keytruda. While the data are still early, they suggest more durability where the biotech had initially turned heads on efficacy.
The biotech is testing its therapy in patients with non-muscle invasive bladder cancer who did not respond to standard BCG therapy. Of 32 patients, 28 had no signs of cancer at the 3-month follow-up. Going out to 6 months, that number changes to 25 of 29. And at one year, the primary endpoint of the study, 11 of 15 patients had a complete response to treatment — good for a 73% response rate.
That adds two non-responders to the combo therapy since CG’s last update at ASCO in June, but of the patients who had a complete response at three months, while some have had disease recurrence, none have seen their disease progress, lead investigator Roger Li told Endpoints News. He also noted that of the two patients with two years’ follow-up at his site, Moffitt Cancer Center, both still have complete responses.
CG Oncology CEO Arthur Kuan noted that while the data are still early, they seem promising thus far, and the biotech is planning additional trials for the oncolytic virus treatment. The current trial is fully enrolled, and Kuan said that the biotech plans to read out the full data on the combo therapy at a major cancer conference sometime next year. The biotech is also testing the treatment as a monotherapy in a Phase III trial, but results are still a bit away, as the study won’t have topline data until 2024, according to clinicaltrials.gov.
Li said that one of the non-responders had a case of undiagnosed lymphoma at the time of enrollment, of which they don’t know the impact on the patient’s response to treatment.
In terms of safety, the most common adverse reactions were bladder-related, such as frequent urination, Li said. There was one case of grade three immune-mediated hepatitis and three cases of hyperthyroidism, which Li noted are in line with the side effects of Keytruda. “We don’t think that adding on CG0070 really adds too much to the systemic toxicity profile,” he said of the safety of the treatment overall.