dm+d

Unassigned

New Medicines

Non-muscle invasive bladder cancer, unresponsive to BCG

Information

New molecular entity
CG Oncology
CG Oncology

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

An armed oncolytic virus therapy containing an adenovirus vector that replicates in cancer cells until they rupture, which then leads to viral spread to neighbouring cancer cells and a continuing cycle of viral replication and tumour cell destruction.
Bladder cancer is the 7th most common cancer in the UK. However, because it is more common in men than in women it is the 4th most common cancer in men and the 11th in women [1].
Non-muscle invasive bladder cancer, unresponsive to BCG
Intravesical

Trial or other data

Nov 21PIII BOND-003 trial is recruiting, including in Australia, Japan, Republic of Korea and Taiwan. Timelines are unchanged [6].
Oct 20PIII BOND-003 trial to evaluate the activity of intravesical (IVE) administration of CG 0070 in patients with non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease starts (CG3002S; NCT04452591). 110 adults will be recruited in the US. Primary outcome is complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease) at 24 months; collection of these data is due to complete Dec 22 [5].
Aug 18Interim results of BOND2 study (NCT02365818) reported in May 2017. 45 of 67 enrolled patients had evaluable 6-month data; 24 patients had CIS only (Carcinoma In Situ), 12 CIS with Ta or T1 (CIS with papillary tumors), and 9, Ta or T1 (papillary only). The overall complete response rate was 46.7%. The estimated study primary completion date is Dec 18 [3,4].
Aug 18The NCT01438112 PII/PIII study was terminated in 2016 because of change in study design [3].
Mar 15The PII BOND2 trial is designed to assess the safety and efficacy of CG 0070 in high grade non-muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy (BOND 2 version 3.3; NCT02365818). The proportion of patients who experience a durable complete response lasting 12 months or longer from the initial confirmed complete response date and at least 18 months from the date of the first intravesical intervention is the primary endpoint of the trial. The open-label trial is expected to enrol approximately 122 patients in the US [2].
Jan 14Cold Genesys initiates a PII/III trial (BOND) of CG 0070 as an intravesical treatment for non-muscle invasive bladder cancer (NCT01438112). Cold Genesys and the US FDA had agreed on a Special Protocol Assessment (SPA) of the trial in Sep 012. This trial will enrol approximately 222 patients with non-muscle invasive bladder cancer with carcinoma in situ who have previously failed BCG treatment and declined cystectomy in the US. The SPA agreement with the US FDA provides assurance that the study design and statistical analysis address objectives necessary for regulatory submission, providing that conditions such as chemistry, manufacturing and controls of CG 0700 are tested in the PIII portion. Cold Genesys is seeking clinical and manufacturing partners to assist with the PIII portion [2].